{ "summary": { "scope": "non-CRF files, excluding (b)(6) personal-privacy markers, kept FOIA-redaction-classified hits only", "files_in_scope": 928, "files_with_kept_hits": 861, "files_missing_pdf": [], "files_errored": [], "total_kept": 64374, "total_dropped": 15462, "kept_likely_in_table": 40165, "by_substance_category": { "Other / uncategorized": 37433, "Manufacturing / CMC": 13143, "Pharmacology / toxicology": 3490, "Trade-secret claim": 3420, "Inspection / enforcement": 2778, "Trial design / efficacy": 2586, "Clinical safety / adverse events": 1473, "Internal FDA deliberation": 51 }, "by_marker": { "(b)(4)": 63981, "(b)(7)(C)": 302, "(b)(5)": 51, "(b)(7)(E)": 38, "(b)(8)": 1, "(b)(7)(A)": 1 }, "by_module": { "M5": 33476, "M4": 8972, "Memo/Other": 8892, "M1": 7184, "M3": 4589, "M2": 1261 }, "by_company": { "Pfizer": 39871, "Moderna": 24503 } }, "files": [ { "filename": "019736_S157_M5_vr-mvp-10074.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 49, "table_count": 21, "by_category": { "Trial design / efficacy": 15, "Manufacturing / CMC": 14, "Other / uncategorized": 12, "Trade-secret claim": 5, "Inspection / enforcement": 3 }, "by_marker": { "(b)(4)": 49 }, "top_examples": [ { "page": 9, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072984", "context_preview": "assay runs during validation. A low and a medium titered QCS will be run on alternating assay plates, @QCS per plate, on each plate of a given run. The QCS were generated from (b) (4) (b) (4) . and lower and upper specification limits will be established and documented prior to the start of validati", "likely_table": true }, { "page": 9, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072984", "context_preview": "tes, @QCS per plate, on each plate of a given run. The QCS were generated from (b) (4) (b) (4) . and lower and upper specification limits will be established and documented prior to the start of validation. 5.4. Negative Serum Diluent (b) (4) will be used as a negative serum diluent for dilutional l", "likely_table": true }, { "page": 9, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072984", "context_preview": "S per plate, on each plate of a given run. The QCS were generated from (b) (4) (b) (4) . and lower and upper specification limits will be established and documented prior to the start of validation. 5.4. Negative Serum Diluent (b) (4) will be used as a negative serum diluent for dilutional linearity", "likely_table": true } ] }, { "filename": "019736_S31_M1_response-ir-06jul2020-c4591001.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 5, "table_count": 0, "by_category": { "Other / uncategorized": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072448", "context_preview": "the BSL-3 laboratory at UTMB and the draft qualification report (VR-MQR-10214) and the test method (VR-MQR-10214-ATT01 - SHI-SOP-10011) is provided along with this submission. The main assay parameters that were assessed during qualification and other studies were precision (on a comprehensive panel", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072448", "context_preview": "3 laboratory at UTMB and the draft qualification report (VR-MQR-10214) and the test method (VR-MQR-10214-ATT01 - SHI-SOP-10011) is provided along with this submission. The main assay parameters that were assessed during qualification and other studies were precision (on a comprehensive panel of sera", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072449", "context_preview": "post PCR diagnosis. Testing of serum samples will be performed using Roche Cobas System at Pfizer\u2019s laboratories in Pearl River, NY. Roche\u2019s EUA information and results from assay performance assessments at Pfizer-Pearl River will be provided to CBER prior to the use of this assay in phase 2b/3. 2. ", "likely_table": false } ] }, { "filename": "019736_S31_M5_vr-mqr-10211.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 53, "table_count": 6, "by_category": { "Trade-secret claim": 31, "Other / uncategorized": 14, "Manufacturing / CMC": 8 }, "by_marker": { "(b)(4)": 53 }, "top_examples": [ { "page": 10, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072555", "context_preview": "090177e19452ddce\\Approved\\Approved On: 09-Jul-2020 18:31 (GMT) PF-07302048: Qualification Report for a Single-plex Direct Luminex Assay (dLIA) for Quantitation of IgG Antibodies to SARS-CoV-2 $1 Protein in Human Sera \u2014 Draft Report VR-MQR-10211, Ver. 1.0 Table 3. List of Critical Reagents (b) (4) S1", "likely_table": true }, { "page": 10, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072555", "context_preview": "090177e19452ddce\\Approved\\Approved On: 09-Jul-2020 18:31 (GMT) PF-07302048: Qualification Report for a Single-plex Direct Luminex Assay (dLIA) for Quantitation of IgG Antibodies to SARS-CoV-2 $1 Protein in Human Sera \u2014 Draft Report VR-MQR-10211, Ver. 1.0 Table 3. List of Critical Reagents (b) (4) S1", "likely_table": true }, { "page": 10, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072555", "context_preview": "090177e19452ddce\\Approved\\Approved On: 09-Jul-2020 18:31 (GMT) PF-07302048: Qualification Report for a Single-plex Direct Luminex Assay (dLIA) for Quantitation of IgG Antibodies to SARS-CoV-2 $1 Protein in Human Sera \u2014 Draft Report VR-MQR-10211, Ver. 1.0 Table 3. List of Critical Reagents (b) (4) S1", "likely_table": true } ] }, { "filename": "019736_S31_M5_vr-mqr-10212.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 54, "table_count": 0, "by_category": { "Trade-secret claim": 26, "Other / uncategorized": 21, "Manufacturing / CMC": 7 }, "by_marker": { "(b)(4)": 54 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072576", "context_preview": "sease coronavirus 2 (SARS-CoV-2). The performance parameters examined in the assay qualification were (Db) (4) linearity, precision and standard curve bias. From these data, the assay range, lower limit of quantitation, and descriptive statistics of assay parameters were determined. Key qualificatio", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072576", "context_preview": "mined in the assay qualification were (Db) (4) linearity, precision and standard curve bias. From these data, the assay range, lower limit of quantitation, and descriptive statistics of assay parameters were determined. Key qualification outcomes are highlighted in the table below. Key Qualification", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072576", "context_preview": ", precision and standard curve bias. From these data, the assay range, lower limit of quantitation, and descriptive statistics of assay parameters were determined. Key qualification outcomes are highlighted in the table below. Key Qualification Outcomes Assay Range Lower | Assay Range Upper} LLOQ? S", "likely_table": false } ] }, { "filename": "019736_S31_M5_vr-mqr-10214.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 27, "table_count": 0, "by_category": { "Manufacturing / CMC": 17, "Trade-secret claim": 6, "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 27 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "TABLE OF CONTENTS", "bates": "FDA-CBER-2021-5683-1072605", "context_preview": ":cccccceceeseeeeeeeeeeeees 9 4.3. Statistical Methods .00........eceeececcecescescescesceseeseeeceecceseeeceaceseeaecaeesecseceeseesesseeseaeeeeetees 9 4.3.1. PECISION 22.2.2... .eeececceecceecceseeeeesecesecseeesecsseeseesecsaeeseseseeaeceeceaeeeseeeeeaeeeseeseeees 10 4.3.2. Intermediate Precision ", "likely_table": false }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072608", "context_preview": "viral green particle counts that is used to report sample titers. Titers may be reported at 50% or 90% TDV. African green monkey kidney epithelial cell line Quality Control Sample 4. MATERIALS AND METHODS 4.1. Materials Reagents, supplies and equipment used in the precision assessment are listed in ", "likely_table": false }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072608", "context_preview": "reen particle counts that is used to report sample titers. Titers may be reported at 50% or 90% TDV. African green monkey kidney epithelial cell line Quality Control Sample 4. MATERIALS AND METHODS 4.1. Materials Reagents, supplies and equipment used in the precision assessment are listed in the tes", "likely_table": false } ] }, { "filename": "019736_S31_M5_vr-tm-10293.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 60, "table_count": 19, "by_category": { "Other / uncategorized": 26, "Trade-secret claim": 26, "Manufacturing / CMC": 8 }, "by_marker": { "(b)(4)": 60 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072642", "context_preview": "tic pipettes, various sizes \uf0b7 Disposable polypropylene tubes or containers, various sizes \uf0b7 Disposable light protective amber polypropylene centrifuge tubes or containers, various sizes \uf0b7 Aluminum sealing tape for 96 well plates \uf0b7 Reagent Reservoirs, various sizes \uf0b7 Polypropylene micro snap cap tube", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072642", "context_preview": "ttes, various sizes \uf0b7 Disposable polypropylene tubes or containers, various sizes \uf0b7 Disposable light protective amber polypropylene centrifuge tubes or containers, various sizes \uf0b7 Aluminum sealing tape for 96 well plates \uf0b7 Reagent Reservoirs, various sizes \uf0b7 Polypropylene micro snap cap tubes \uf0b7 Tube", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072642", "context_preview": "rious sizes \uf0b7 Disposable polypropylene tubes or containers, various sizes \uf0b7 Disposable light protective amber polypropylene centrifuge tubes or containers, various sizes \uf0b7 Aluminum sealing tape for 96 well plates \uf0b7 Reagent Reservoirs, various sizes \uf0b7 Polypropylene micro snap cap tubes \uf0b7 Tube racks \uf0b7", "likely_table": true } ] }, { "filename": "019736_S31_M5_vr-tm-10294.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 59, "table_count": 13, "by_category": { "Other / uncategorized": 27, "Trade-secret claim": 21, "Manufacturing / CMC": 11 }, "by_marker": { "(b)(4)": 59 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072661", "context_preview": "tic pipettes, various sizes \uf0b7 Disposable polypropylene tubes or containers, various sizes \uf0b7 Disposable light protective amber polypropylene centrifuge tubes or containers, various sizes \uf0b7 Aluminum sealing tape for 96 well plates \uf0b7 Reagent Reservoirs, various sizes \uf0b7 Polypropylene micro snap cap tube", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072661", "context_preview": "ttes, various sizes \uf0b7 Disposable polypropylene tubes or containers, various sizes \uf0b7 Disposable light protective amber polypropylene centrifuge tubes or containers, various sizes \uf0b7 Aluminum sealing tape for 96 well plates \uf0b7 Reagent Reservoirs, various sizes \uf0b7 Polypropylene micro snap cap tubes \uf0b7 Tube", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072661", "context_preview": "rious sizes \uf0b7 Disposable polypropylene tubes or containers, various sizes \uf0b7 Disposable light protective amber polypropylene centrifuge tubes or containers, various sizes \uf0b7 Aluminum sealing tape for 96 well plates \uf0b7 Reagent Reservoirs, various sizes \uf0b7 Polypropylene micro snap cap tubes \uf0b7 Tube racks \uf0b7", "likely_table": true } ] }, { "filename": "019736_S325_M5_c4591020-sap-track.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 61, "table_count": 0, "by_category": { "Other / uncategorized": 28, "Trial design / efficacy": 22, "Manufacturing / CMC": 8, "Clinical safety / adverse events": 2, "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 61 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "AGAINST COVID-19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE", "bates": "FDA-CBER-2021-5683-1073704", "context_preview": "Protocol C4591020 (PF-07302048) Statistical Analysis Plan PFIZER CONFIDENTIAL Page 1 Protocol C4591020 A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A LYOPHILIZED MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEA", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "AGAINST COVID-19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE", "bates": "FDA-CBER-2021-5683-1073704", "context_preview": "Protocol C4591020 (PF-07302048) Statistical Analysis Plan PFIZER CONFIDENTIAL Page 1 Protocol C4591020 A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A LYOPHILIZED MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEA", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "TABLE OF CONTENTS", "bates": "FDA-CBER-2021-5683-1073705", "context_preview": "enicity Hypotheses ......................................................................18 5.1.2. Multiplicity Considerations ........................................................................19 5.2. General Methods .............................................................................", "likely_table": false } ] }, { "filename": "019736_S325_M5_c4591020-sap.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 59, "table_count": 0, "by_category": { "Other / uncategorized": 30, "Trial design / efficacy": 14, "Clinical safety / adverse events": 8, "Manufacturing / CMC": 7 }, "by_marker": { "(b)(4)": 59 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "COVID-19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE", "bates": "FDA-CBER-2021-5683-1073674", "context_preview": "Protocol C4591020 (PF-07302048) Statistical Analysis Plan PFIZER CONFIDENTIAL Page 1 Protocol C4591020 A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY ADULTS 18", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "COVID-19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE", "bates": "FDA-CBER-2021-5683-1073674", "context_preview": "Protocol C4591020 (PF-07302048) Statistical Analysis Plan PFIZER CONFIDENTIAL Page 1 Protocol C4591020 A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY ADULTS 18", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "TABLE OF CONTENTS", "bates": "FDA-CBER-2021-5683-1073675", "context_preview": "nicity Hypotheses ......................................................................17 5.1.2. Multiplicity Considerations ........................................................................18 5.2. General Methods ..............................................................................", "likely_table": false } ] }, { "filename": "019736_S596_M5_5354_c4591014-wi255886-wi235284-sap.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2022-5812-0236162", "context_preview": "es of 2 doses of BNT162b2 received with \u22657 days between receipt of the 2nd dose and the index date (e.g., admission); partially vaccinated, defined as 1 dose (only) of BNT162b2 received with \u226514 days between the receipt of the 1st dose and the event date; ever vaccinated, defined as \u22651 dose of BNT16", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2022-5812-0236162", "context_preview": "doses of BNT162b2 received with \u22657 days between receipt of the 2nd dose and the index date (e.g., admission); partially vaccinated, defined as 1 dose (only) of BNT162b2 received with \u226514 days between the receipt of the 1st dose and the event date; ever vaccinated, defined as \u22651 dose of BNT162b2 rece", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2022-5812-0236162", "context_preview": "BNT162b2 received with \u22657 days between receipt of the 2nd dose and the index date (e.g., admission); partially vaccinated, defined as 1 dose (only) of BNT162b2 received with \u226514 days between the receipt of the 1st dose and the event date; ever vaccinated, defined as \u22651 dose of BNT162b2 received with", "likely_table": false } ] }, { "filename": "019736_S70_M1_response-ir-29jul2020-clin-assay-qual.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 61, "table_count": 7, "by_category": { "Other / uncategorized": 21, "Trade-secret claim": 20, "Manufacturing / CMC": 12, "Trial design / efficacy": 8 }, "by_marker": { "(b)(4)": 61 }, "top_examples": [ { "page": 18, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072472", "context_preview": "ck Meridian Health (where the assay will be validated) is important and submit the requested data and the validation protocol for CBER\u2019s review and comment. 2.20. CBER Request 20 We recommend that you submit the validation protocol for the SARS-CoV-2 MN assay for our review before starting the valid", "likely_table": true }, { "page": 18, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072472", "context_preview": "ian Health (where the assay will be validated) is important and submit the requested data and the validation protocol for CBER\u2019s review and comment. 2.20. CBER Request 20 We recommend that you submit the validation protocol for the SARS-CoV-2 MN assay for our review before starting the validation st", "likely_table": true }, { "page": 18, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072472", "context_preview": "th (where the assay will be validated) is important and submit the requested data and the validation protocol for CBER\u2019s review and comment. 2.20. CBER Request 20 We recommend that you submit the validation protocol for the SARS-CoV-2 MN assay for our review before starting the validation studies. 2", "likely_table": true } ] }, { "filename": "019736_S70_M5_vr-mqr-10211-10212-dlq.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 97, "table_count": 0, "by_category": { "Trade-secret claim": 97 }, "by_marker": { "(b)(4)": 97 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072704", "context_preview": "SARS-CoV-2 dLIA Linearity Qualification Data re VR-MQR-10211 and VR-MQR-10212 Experimental Data Listing - Linearity PFIZER CONFIDENTIAL Page 1 090177e194aedf59\\Approved\\Approved On: 18-Aug-2020 21:20 (GMT) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1072704", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072704", "context_preview": "SARS-CoV-2 dLIA Linearity Qualification Data re VR-MQR-10211 and VR-MQR-10212 Experimental Data Listing - Linearity PFIZER CONFIDENTIAL Page 1 090177e194aedf59\\Approved\\Approved On: 18-Aug-2020 21:20 (GMT) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1072704", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072704", "context_preview": "SARS-CoV-2 dLIA Linearity Qualification Data re VR-MQR-10211 and VR-MQR-10212 Experimental Data Listing - Linearity PFIZER CONFIDENTIAL Page 1 090177e194aedf59\\Approved\\Approved On: 18-Aug-2020 21:20 (GMT) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1072704", "likely_table": false } ] }, { "filename": "019736_S70_M5_vr-mqr-10211-10212-pq.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 26, "table_count": 0, "by_category": { "Trade-secret claim": 20, "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 26 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072737", "context_preview": "SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212 Page 2 090177e194aed916\\Approved\\Approved On: 18-Aug-2020 20:59 (GMT) (b) (4) FDA-CBER-2021-5683-1072737", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072738", "context_preview": "SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212 Page 3 090177e194aed916\\Approved\\Approved On: 18-Aug-2020 20:59 (GMT) (b) (4) FDA-CBER-2021-5683-1072738", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072739", "context_preview": "SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212 PFIZER CONFIDENTIAL Page 4 090177e194aed916\\Approved\\Approved On: 18-Aug-2020 20:59 (GMT) (b) (4) FDA-CBER-2021-5683-1072739", "likely_table": false } ] }, { "filename": "019736_S70_M5_vr-mqr-10211-att01.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 68, "table_count": 0, "by_category": { "Trade-secret claim": 63, "Manufacturing / CMC": 3, "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 68 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "LIST OF TABLES", "bates": "FDA-CBER-2021-5683-1072764", "context_preview": "...................3 LIST OF TABLES Table 1. Abbreviations..............................................................................................3 Table 2. Experimental Data Listing - Additional (Non-Clinical) Runs....................5 Table 3. Experimental Data Listing - Precision...........", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "LIST OF TABLES", "bates": "FDA-CBER-2021-5683-1072764", "context_preview": "...........3 LIST OF TABLES Table 1. Abbreviations..............................................................................................3 Table 2. Experimental Data Listing - Additional (Non-Clinical) Runs....................5 Table 3. Experimental Data Listing - Precision...................", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EVALUATIONS", "bates": "FDA-CBER-2021-5683-1072765", "context_preview": "090177e19498b0af\\Approved\\Approved On: 07-Aug-2020 22:25 (GMT) PF-07302048: Supportive Data for VR-MQR-10211 VR-MQR-10211-ATTO1, Ver. 2.0 1. DATA LISTING OF SAMPLE PRECISION AND (6) (4) ~\u2014s LINEARITY EVALUATIONS The data listing tables provide listing of precision and (Db) (4) linearity runs in addi", "likely_table": false } ] }, { "filename": "019736_S70_M5_vr-mqr-10211.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 101, "table_count": 20, "by_category": { "Other / uncategorized": 48, "Trade-secret claim": 39, "Manufacturing / CMC": 12, "Inspection / enforcement": 2 }, "by_marker": { "(b)(4)": 101 }, "top_examples": [ { "page": 20, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072694", "context_preview": "adjusted sample concentration. As described in Section 5.2.6.1, LLOQ is defined as the dilution-adjusted lower limit of the assay range. Table 9 lists the LLOQ value for the SARS CoV-2 S1 IgG dLIA. Table 9. Lower Limit of Quantitation (LLOQ) Antigen LLOQ (Units/mL) COVS1a 1.2665 a. Subunit 1 of the ", "likely_table": true }, { "page": 20, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072694", "context_preview": "sample concentration. As described in Section 5.2.6.1, LLOQ is defined as the dilution-adjusted lower limit of the assay range. Table 9 lists the LLOQ value for the SARS CoV-2 S1 IgG dLIA. Table 9. Lower Limit of Quantitation (LLOQ) Antigen LLOQ (Units/mL) COVS1a 1.2665 a. Subunit 1 of the Spike pro", "likely_table": true }, { "page": 20, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072694", "context_preview": "concentration. As described in Section 5.2.6.1, LLOQ is defined as the dilution-adjusted lower limit of the assay range. Table 9 lists the LLOQ value for the SARS CoV-2 S1 IgG dLIA. Table 9. Lower Limit of Quantitation (LLOQ) Antigen LLOQ (Units/mL) COVS1a 1.2665 a. Subunit 1 of the Spike protein of", "likely_table": true } ] }, { "filename": "019736_S70_M5_vr-mqr-10212-att01.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 69, "table_count": 8, "by_category": { "Trade-secret claim": 59, "Manufacturing / CMC": 8, "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 69 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EVALUATIONS", "bates": "FDA-CBER-2021-5683-1072839", "context_preview": "2.0 PFIZER CONFIDENTIAL Page 3 1. DATA LISTING OF SAMPLE PRECISION AND LINEARITY EVALUATIONS The data listing tables provide listing of precision and linearity runs in addition to non-clinical runs that were performed using same reagents and processes. The tables provide the batch name, date, sample", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EVALUATIONS", "bates": "FDA-CBER-2021-5683-1072839", "context_preview": "ZER CONFIDENTIAL Page 3 1. DATA LISTING OF SAMPLE PRECISION AND LINEARITY EVALUATIONS The data listing tables provide listing of precision and linearity runs in addition to non-clinical runs that were performed using same reagents and processes. The tables provide the batch name, date, sample barcod", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EVALUATIONS", "bates": "FDA-CBER-2021-5683-1072839", "context_preview": "IDENTIAL Page 3 1. DATA LISTING OF SAMPLE PRECISION AND LINEARITY EVALUATIONS The data listing tables provide listing of precision and linearity runs in addition to non-clinical runs that were performed using same reagents and processes. The tables provide the batch name, date, sample barcode, bead ", "likely_table": true } ] }, { "filename": "019736_S70_M5_vr-mqr-10212.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 153, "table_count": 110, "by_category": { "Other / uncategorized": 103, "Trade-secret claim": 41, "Manufacturing / CMC": 6, "Inspection / enforcement": 3 }, "by_marker": { "(b)(4)": 153 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "LIST OF TABLES", "bates": "FDA-CBER-2021-5683-1072812", "context_preview": ".............19 Table 7. Final IgG Assay Range \u2013 Well Concentration (Units/mL) ......................19 Table 8. ................................19 Table 9. Lower Limit of Quantitation (LLOQ) ......................................................20 Table 10. .........................................", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "LIST OF TABLES", "bates": "FDA-CBER-2021-5683-1072812", "context_preview": ".....19 Table 7. Final IgG Assay Range \u2013 Well Concentration (Units/mL) ......................19 Table 8. ................................19 Table 9. Lower Limit of Quantitation (LLOQ) ......................................................20 Table 10. .................................................", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "LIST OF TABLES", "bates": "FDA-CBER-2021-5683-1072812", "context_preview": "Table 7. Final IgG Assay Range \u2013 Well Concentration (Units/mL) ......................19 Table 8. ................................19 Table 9. Lower Limit of Quantitation (LLOQ) ......................................................20 Table 10. .........................................................", "likely_table": true } ] }, { "filename": "019736_S70_M5_vr-mqr-10214-att01.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 7, "table_count": 0, "by_category": { "Trade-secret claim": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072903", "context_preview": "PF-07302048: Precision Experiment Data Listing VR-MQR-10214-ATT01, Ver. 1.0 PFIZER CONFIDENTIAL Page 3 Table 1. Precision Experiment Data Listing 090177e194744534\\Approved\\Approved On: 28-Jul-2020 13:56 (GMT) (b) (4) FDA-CBER-2021-5683-1072903", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072904", "context_preview": "PF-07302048: Precision Experiment Data Listing VR-MQR-10214-ATT01, Ver. 1.0 PFIZER CONFIDENTIAL Page 4 Table 1. Precision Experiment Data Listing 090177e194744534\\Approved\\Approved On: 28-Jul-2020 13:56 (GMT) (b) (4) FDA-CBER-2021-5683-1072904", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072905", "context_preview": "PF-07302048: Precision Experiment Data Listing VR-MQR-10214-ATT01, Ver. 1.0 PFIZER CONFIDENTIAL Page 5 Table 1. Precision Experiment Data Listing 090177e194744534\\Approved\\Approved On: 28-Jul-2020 13:56 (GMT) (b) (4) FDA-CBER-2021-5683-1072905", "likely_table": false } ] }, { "filename": "019736_S70_M5_vr-mqr-10214-att02.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Trade-secret claim": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072928", "context_preview": "PF-07302048: QCS Data Listing VR-MQR-10214-ATT02, Ver. 1.0 PFIZER CONFIDENTIAL Page 3 Table 1. QCS Data Listing Quality Control Sample Date Titer 090177e194744851\\Approved\\Approved On: 28-Jul-2020 13:57 (GMT) (b) (4) FDA-CBER-2021-5683-1072928", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072929", "context_preview": "PF-07302048: QCS Data Listing VR-MQR-10214-ATT02, Ver. 1.0 PFIZER CONFIDENTIAL Page 4 Table 1. QCS Data Listing Quality Control Sample Date Titer 090177e194744851\\Approved\\Approved On: 28-Jul-2020 13:57 (GMT) (b) (4) FDA-CBER-2021-5683-1072929", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072930", "context_preview": "PF-07302048: QCS Data Listing VR-MQR-10214-ATT02, Ver. 1.0 PFIZER CONFIDENTIAL Page 5 Table 1. QCS Data Listing Quality Control Sample Date Titer 090177e194744851\\Approved\\Approved On: 28-Jul-2020 13:57 (GMT) (b) (4) FDA-CBER-2021-5683-1072930", "likely_table": false } ] }, { "filename": "019736_S70_M5_vr-mqr-10214-att03.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Trade-secret claim": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072934", "context_preview": "PF-07302048: QCS Infection Ratio Data Listing VR-MQR-10214-ATT03, Ver. 1.0 PFIZER CONFIDENTIAL Page 3 Table 1. QCS Infection Ratio Data Listing Date QCS/Plate Infection Ratio 090177e19474664e\\Approved\\Approved On: 28-Jul-2020 14:01 (GMT) (b) (4) FDA-CBER-2021-5683-1072934", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072935", "context_preview": "PF-07302048: QCS Infection Ratio Data Listing VR-MQR-10214-ATT03, Ver. 1.0 PFIZER CONFIDENTIAL Page 4 Table 1. QCS Infection Ratio Data Listing Date QCS/Plate Infection Ratio 090177e19474664e\\Approved\\Approved On: 28-Jul-2020 14:01 (GMT) (b) (4) FDA-CBER-2021-5683-1072935", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072936", "context_preview": "PF-07302048: QCS Infection Ratio Data Listing VR-MQR-10214-ATT03, Ver. 1.0 PFIZER CONFIDENTIAL Page 5 Table 1. QCS Infection Ratio Data Listing Date QCS/Plate Infection Ratio 090177e19474664e\\Approved\\Approved On: 28-Jul-2020 14:01 (GMT) (b) (4) FDA-CBER-2021-5683-1072936", "likely_table": false } ] }, { "filename": "019736_S70_M5_vr-mqr-10214.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 81, "table_count": 57, "by_category": { "Other / uncategorized": 48, "Manufacturing / CMC": 21, "Trade-secret claim": 7, "Inspection / enforcement": 5 }, "by_marker": { "(b)(4)": 81 }, "top_examples": [ { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072887", "context_preview": "oV-2 donors were obtained from . In addition, in-house antibody-depleted serum samples (prepared from pre-SARS-CoV-2 outbreak sera) and presumed negative serum samples (pre-SARS-CoV-2 outbreak) were also included. nested replicates were also included in the study (Table 3). All precision samples wer", "likely_table": true }, { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072887", "context_preview": "onors were obtained from . In addition, in-house antibody-depleted serum samples (prepared from pre-SARS-CoV-2 outbreak sera) and presumed negative serum samples (pre-SARS-CoV-2 outbreak) were also included. nested replicates were also included in the study (Table 3). All precision samples were heat", "likely_table": true }, { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072887", "context_preview": "re obtained from . In addition, in-house antibody-depleted serum samples (prepared from pre-SARS-CoV-2 outbreak sera) and presumed negative serum samples (pre-SARS-CoV-2 outbreak) were also included. nested replicates were also included in the study (Table 3). All precision samples were heat-inactiv", "likely_table": true } ] }, { "filename": "019736_S70_M5_vr-sop-lc-11120.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 27, "table_count": 7, "by_category": { "Manufacturing / CMC": 13, "Trade-secret claim": 9, "Other / uncategorized": 3, "Inspection / enforcement": 2 }, "by_marker": { "(b)(4)": 27 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1147638", "context_preview": "The data reviewer verifies that the results are correctly entered and authorizes the results in LabWare v6 LIMS. \uf0b7 In the event that LabWare v6 LIMS is unavailable, sample preparation and assay completion worksheets should be filled out to capture the required metadata. These worksheets must be scan", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1147638", "context_preview": "reviewer verifies that the results are correctly entered and authorizes the results in LabWare v6 LIMS. \uf0b7 In the event that LabWare v6 LIMS is unavailable, sample preparation and assay completion worksheets should be filled out to capture the required metadata. These worksheets must be scanned into ", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1147638", "context_preview": "r verifies that the results are correctly entered and authorizes the results in LabWare v6 LIMS. \uf0b7 In the event that LabWare v6 LIMS is unavailable, sample preparation and assay completion worksheets should be filled out to capture the required metadata. These worksheets must be scanned into LabWare", "likely_table": true } ] }, { "filename": "019736_S70_M5_vr-tm-10293.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 64, "table_count": 13, "by_category": { "Other / uncategorized": 29, "Trade-secret claim": 23, "Manufacturing / CMC": 12 }, "by_marker": { "(b)(4)": 64 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072943", "context_preview": "plastic pipettes, various sizes \uf0b7 Disposable polypropylene tubes or containers, various sizes \uf0b7 Disposable light protective amber polypropylene centrifuge tubes or containers, various sizes \uf0b7 Aluminum sealing tape for 96 well plates \uf0b7 Reagent Reservoirs, various sizes \uf0b7 Polypropylene micro snap cap ", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072943", "context_preview": "pipettes, various sizes \uf0b7 Disposable polypropylene tubes or containers, various sizes \uf0b7 Disposable light protective amber polypropylene centrifuge tubes or containers, various sizes \uf0b7 Aluminum sealing tape for 96 well plates \uf0b7 Reagent Reservoirs, various sizes \uf0b7 Polypropylene micro snap cap tubes \uf0b7 ", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072943", "context_preview": ", various sizes \uf0b7 Disposable polypropylene tubes or containers, various sizes \uf0b7 Disposable light protective amber polypropylene centrifuge tubes or containers, various sizes \uf0b7 Aluminum sealing tape for 96 well plates \uf0b7 Reagent Reservoirs, various sizes \uf0b7 Polypropylene micro snap cap tubes \uf0b7 Tube rac", "likely_table": true } ] }, { "filename": "019736_S70_M5_vr-tm-10294.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 60, "table_count": 13, "by_category": { "Other / uncategorized": 28, "Trade-secret claim": 24, "Manufacturing / CMC": 8 }, "by_marker": { "(b)(4)": 60 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072962", "context_preview": "plastic pipettes, various sizes \uf0b7 Disposable polypropylene tubes or containers, various sizes \uf0b7 Disposable light protective amber polypropylene centrifuge tubes or containers, various sizes \uf0b7 Aluminum sealing tape for 96 well plates \uf0b7 Reagent Reservoirs, various sizes \uf0b7 Polypropylene micro snap cap ", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072962", "context_preview": "pipettes, various sizes \uf0b7 Disposable polypropylene tubes or containers, various sizes \uf0b7 Disposable light protective amber polypropylene centrifuge tubes or containers, various sizes \uf0b7 Aluminum sealing tape for 96 well plates \uf0b7 Reagent Reservoirs, various sizes \uf0b7 Polypropylene micro snap cap tubes \uf0b7 ", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072962", "context_preview": ", various sizes \uf0b7 Disposable polypropylene tubes or containers, various sizes \uf0b7 Disposable light protective amber polypropylene centrifuge tubes or containers, various sizes \uf0b7 Aluminum sealing tape for 96 well plates \uf0b7 Reagent Reservoirs, various sizes \uf0b7 Polypropylene micro snap cap tubes \uf0b7 Tube rac", "likely_table": true } ] }, { "filename": "032-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-31-Reply.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 17, "table_count": 0, "by_category": { "Manufacturing / CMC": 9, "Internal FDA deliberation": 8 }, "by_marker": { "(b)(4)": 9, "(b)(5)": 8 }, "top_examples": [ { "page": 130, "marker": "(b)(5)", "category": "Internal FDA deliberation", "section_heading": null, "bates": null, "context_preview": "Fact and Conclusions of Law 6. 28 Id. 29 Id. at 9. See also Memorandum from Nathalie R. Asher, Acting Executive Associate Director, U.S. Immigration and Customs Enforcement, to Field Office Directors, Enforcement and Removal Operations, \"Migrant Protection Protocols Guidance\" (Feb. 12, 2019). Depart", "likely_table": false }, { "page": 130, "marker": "(b)(5)", "category": "Internal FDA deliberation", "section_heading": null, "bates": null, "context_preview": "utive Associate Director, U.S. Immigration and Customs Enforcement, to Field Office Directors, Enforcement and Removal Operations, \"Migrant Protection Protocols Guidance\" (Feb. 12, 2019). Department of Homeland Security Office of Privacy.30 ICE provided only a letter to accompany the produced docume", "likely_table": false }, { "page": 130, "marker": "(b)(5)", "category": "Internal FDA deliberation", "section_heading": null, "bates": null, "context_preview": "Enforcement and Removal Operations, \"Migrant Protection Protocols Guidance\" (Feb. 12, 2019). Department of Homeland Security Office of Privacy.30 ICE provided only a letter to accompany the produced documents.31 Two paragraphs in the letter address the redactions made pursuant to exemption (b)(5).32", "likely_table": false } ] }, { "filename": "100A_BLA-125742-0_08-20-2021_Memo_Other.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 12, "table_count": 7, "by_category": { "Manufacturing / CMC": 7, "Internal FDA deliberation": 3, "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 6, "(b)(5)": 3, "(b)(7)(E)": 3 }, "top_examples": [ { "page": 3, "marker": "(b)(5)", "category": "Internal FDA deliberation", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150326", "context_preview": "duct shortage, sudden increase in demand), Operational Considerations (e.g. temporary unavailability of resources), Lot-specific Compliance Considerations (e.g. questions raised during lot release protocol review). \u2022 Public Health Considerations (e.g., temporary product shortage, sudden increase in ", "likely_table": true }, { "page": 3, "marker": "(b)(7)(E)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150326", "context_preview": "tage, sudden increase in demand), Operational Considerations (e.g. temporary unavailability of resources), Lot-specific Compliance Considerations (e.g. questions raised during lot release protocol review). \u2022 Public Health Considerations (e.g., temporary product shortage, sudden increase in demand) \u2022", "likely_table": true }, { "page": 3, "marker": "(b)(5)", "category": "Internal FDA deliberation", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150326", "context_preview": "n increase in demand), Operational Considerations (e.g. temporary unavailability of resources), Lot-specific Compliance Considerations (e.g. questions raised during lot release protocol review). \u2022 Public Health Considerations (e.g., temporary product shortage, sudden increase in demand) \u2022 Operationa", "likely_table": true } ] }, { "filename": "100_BLA-125742-0_08-20-2021_Memo_Other.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 12, "table_count": 7, "by_category": { "Manufacturing / CMC": 7, "Internal FDA deliberation": 3, "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 6, "(b)(5)": 3, "(b)(7)(E)": 3 }, "top_examples": [ { "page": 3, "marker": "(b)(5)", "category": "Internal FDA deliberation", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150321", "context_preview": "duct shortage, sudden increase in demand), Operational Considerations (e.g. temporary unavailability of resources), Lot-specific Compliance Considerations (e.g. questions raised during lot release protocol review). \u2022 Public Health Considerations (e.g., temporary product shortage, sudden increase in ", "likely_table": true }, { "page": 3, "marker": "(b)(7)(E)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150321", "context_preview": "tage, sudden increase in demand), Operational Considerations (e.g. temporary unavailability of resources), Lot-specific Compliance Considerations (e.g. questions raised during lot release protocol review). \u2022 Public Health Considerations (e.g., temporary product shortage, sudden increase in demand) \u2022", "likely_table": true }, { "page": 3, "marker": "(b)(5)", "category": "Internal FDA deliberation", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150321", "context_preview": "se in demand), Operational Considerations (e.g. temporary unavailability of resources), Lot-specific Compliance Considerations (e.g. questions raised during lot release protocol review). \u2022 Public Health Considerations (e.g., temporary product shortage, sudden increase in demand) \u2022 Operational Consid", "likely_table": true } ] }, { "filename": "102D_BLA-125752-0_01-28-2022_Memo_Compliance-Check-Acce.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 9, "table_count": 9, "by_category": { "Manufacturing / CMC": 9 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EIR COVERSHEET", "bates": "FDA-CBER-2022-1614-3818243", "context_preview": "bservations were issued at the conclusion of the inspection; however, the following discussion items were reviewed with management during the closeout meeting: Gowning Procedures and Background Environments for Execution of Certain Upstream Activities Quality Management System (QMS) Enhancements Con", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EIR COVERSHEET", "bates": "FDA-CBER-2022-1614-3818243", "context_preview": "ons were issued at the conclusion of the inspection; however, the following discussion items were reviewed with management during the closeout meeting: Gowning Procedures and Background Environments for Execution of Certain Upstream Activities Quality Management System (QMS) Enhancements Controlled ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EIR COVERSHEET", "bates": "FDA-CBER-2022-1614-3818243", "context_preview": "issued at the conclusion of the inspection; however, the following discussion items were reviewed with management during the closeout meeting: Gowning Procedures and Background Environments for Execution of Certain Upstream Activities Quality Management System (QMS) Enhancements Controlled Issuance ", "likely_table": true } ] }, { "filename": "102_1_BLA-125742-0_08-20-2021_Memo_Test-Results.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 20, "table_count": 20, "by_category": { "Manufacturing / CMC": 20 }, "by_marker": { "(b)(4)": 20 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MEMORANDUM FOR RECORD", "bates": "FDA-CBER-2021-5683-1150329", "context_preview": "Inc. (Pfizer). The sterility and bacterial endotoxin results obtained by CBER along with those of Pfizer are listed below: Sterility and BET Results Lot Number CBER & Pfizer Sterility Test Results*1 BET Test Dilution CBER % Spike Recovery CBER Results*2 (EU/mL) Pfizer\u2019s Results (EU/mL) Proposed Spec", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MEMORANDUM FOR RECORD", "bates": "FDA-CBER-2021-5683-1150329", "context_preview": "izer). The sterility and bacterial endotoxin results obtained by CBER along with those of Pfizer are listed below: Sterility and BET Results Lot Number CBER & Pfizer Sterility Test Results*1 BET Test Dilution CBER % Spike Recovery CBER Results*2 (EU/mL) Pfizer\u2019s Results (EU/mL) Proposed Specificatio", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MEMORANDUM FOR RECORD", "bates": "FDA-CBER-2021-5683-1150329", "context_preview": "The sterility and bacterial endotoxin results obtained by CBER along with those of Pfizer are listed below: Sterility and BET Results Lot Number CBER & Pfizer Sterility Test Results*1 BET Test Dilution CBER % Spike Recovery CBER Results*2 (EU/mL) Pfizer\u2019s Results (EU/mL) Proposed Specification (EU/m", "likely_table": true } ] }, { "filename": "103D_BLA-125752-0_01-28-2022_Memo_Request-For-Complianc.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 9, "table_count": 9, "by_category": { "Manufacturing / CMC": 9 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EIR COVERSHEET", "bates": "FDA-CBER-2022-1614-3818252", "context_preview": "bservations were issued at the conclusion of the inspection; however, the following discussion items were reviewed with management during the closeout meeting: Gowning Procedures and Background Environments for Execution of Certain Upstream Activities Quality Management System (QMS) Enhancements Con", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EIR COVERSHEET", "bates": "FDA-CBER-2022-1614-3818252", "context_preview": "ons were issued at the conclusion of the inspection; however, the following discussion items were reviewed with management during the closeout meeting: Gowning Procedures and Background Environments for Execution of Certain Upstream Activities Quality Management System (QMS) Enhancements Controlled ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EIR COVERSHEET", "bates": "FDA-CBER-2022-1614-3818252", "context_preview": "issued at the conclusion of the inspection; however, the following discussion items were reviewed with management during the closeout meeting: Gowning Procedures and Background Environments for Execution of Certain Upstream Activities Quality Management System (QMS) Enhancements Controlled Issuance ", "likely_table": true } ] }, { "filename": "103_2_BLA-125742-0_08-20-2021_Memo_Test-Results.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 15, "table_count": 10, "by_category": { "Manufacturing / CMC": 15 }, "by_marker": { "(b)(4)": 15 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "STN 125742/0", "bates": "FDA-CBER-2021-5683-1150332", "context_preview": "CBER RSD Firm size (nm) Control FC3181 FC3184 FD0809 Determination of PDI Lot CBER PDI Firm PDI Control FC3181 FC3184 FD0809 The average size of the standard measured by DBSQC was with RSD of , meeting the acceptance criteria of respectively. The RSDs for the control and samples both met the same ac", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "STN 125742/0", "bates": "FDA-CBER-2021-5683-1150332", "context_preview": "Firm size (nm) Control FC3181 FC3184 FD0809 Determination of PDI Lot CBER PDI Firm PDI Control FC3181 FC3184 FD0809 The average size of the standard measured by DBSQC was with RSD of , meeting the acceptance criteria of respectively. The RSDs for the control and samples both met the same acceptance ", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "STN 125742/0", "bates": "FDA-CBER-2021-5683-1150332", "context_preview": "ize (nm) Control FC3181 FC3184 FD0809 Determination of PDI Lot CBER PDI Firm PDI Control FC3181 FC3184 FD0809 The average size of the standard measured by DBSQC was with RSD of , meeting the acceptance criteria of respectively. The RSDs for the control and samples both met the same acceptance criter", "likely_table": true } ] }, { "filename": "105_BLA-125742-0_08-20-2021_Telecon_Advice_Information.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 2, "table_count": 0, "by_category": { "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE", "bates": "FDA-CBER-2021-5683-1150334", "context_preview": "n doses at this point. We will also have comments on the Dear HCP. Thanks again Mary From: Boyce, Donna Sent: Thursday, August 19, 2021 5:33 PM To: Naik, Ramachandra Cc: Malarkey, Mary ; Harkins Tull, Elisa Sent: Thursday, August 19, 2021 5:33 PM To: Naik, Ramachandra Cc: Malarkey, Mary ; Harkins Tull, Elisa ) LNP Size Dynamic Light Scattering (DLS) LNP Polydispersity Dynamic Light Scattering (DLS) RNA Encapsulation Fluorescence assay RNA content Fluorescence assay ALC-0315 content HPLC-CAD ALC-0159 content HPLC-CAD DSPC content HPLC-CAD Cholesterol content HPLC-CAD Vial conten", "likely_table": true }, { "page": 10, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "COMIRNATY", "bates": "FDA-CBER-2021-5683-1150359", "context_preview": "smometry (USP <785>) LNP Size Dynamic Light Scattering (DLS) LNP Polydispersity Dynamic Light Scattering (DLS) RNA Encapsulation Fluorescence assay RNA content Fluorescence assay ALC-0315 content HPLC-CAD ALC-0159 content HPLC-CAD DSPC content HPLC-CAD Cholesterol content HPLC-CAD Vial content (volu", "likely_table": true }, { "page": 10, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "COMIRNATY", "bates": "FDA-CBER-2021-5683-1150359", "context_preview": "(USP <785>) LNP Size Dynamic Light Scattering (DLS) LNP Polydispersity Dynamic Light Scattering (DLS) RNA Encapsulation Fluorescence assay RNA content Fluorescence assay ALC-0315 content HPLC-CAD ALC-0159 content HPLC-CAD DSPC content HPLC-CAD Cholesterol content HPLC-CAD Vial content (volume) Conta", "likely_table": true } ] }, { "filename": "125742-0_20219001.PC1_.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 64, "table_count": 49, "by_category": { "Manufacturing / CMC": 47, "Other / uncategorized": 17 }, "by_marker": { "(b)(4)": 64 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "COMPONENTS", "bates": "FDA-CBER-2021-5683-1149958", "context_preview": "nufacture: 23-Jun-2021 Date of Expiry: 30-Nov-2021 Date of Fill: 24-Jun-2021 Product Information: COMPONENTS Component Description Batch Number Date of Manuf. Manufacture Site Quantity Target Concentration BNT162b2 Drug Substance Pfizer BNT162b2 Drug Substance Pfizer LNP Fabrication Pharmacia & Upjo", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "COMPONENTS", "bates": "FDA-CBER-2021-5683-1149958", "context_preview": "e: 23-Jun-2021 Date of Expiry: 30-Nov-2021 Date of Fill: 24-Jun-2021 Product Information: COMPONENTS Component Description Batch Number Date of Manuf. Manufacture Site Quantity Target Concentration BNT162b2 Drug Substance Pfizer BNT162b2 Drug Substance Pfizer LNP Fabrication Pharmacia & Upjohn Compa", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "COMPONENTS", "bates": "FDA-CBER-2021-5683-1149958", "context_preview": "un-2021 Date of Expiry: 30-Nov-2021 Date of Fill: 24-Jun-2021 Product Information: COMPONENTS Component Description Batch Number Date of Manuf. Manufacture Site Quantity Target Concentration BNT162b2 Drug Substance Pfizer BNT162b2 Drug Substance Pfizer LNP Fabrication Pharmacia & Upjohn Company LLC ", "likely_table": true } ] }, { "filename": "125742-0_20219002.PC1_.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 79, "table_count": 55, "by_category": { "Manufacturing / CMC": 54, "Other / uncategorized": 25 }, "by_marker": { "(b)(4)": 79 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "COMPONENTS", "bates": "FDA-CBER-2021-5683-1149994", "context_preview": "Date of Manufacture: 30-Jun-2021 Date of Expiry: 30-Nov-2021 Date of Fill: 30-Jun-2021 Product Information: COMPONENTS Component Description Batch Number Date of Manuf. Manufacture Site Quantity Target Concentration BNT162b2 Drug Substance Pfizer BNT162b2 Drug Substance Pfizer LNP Fabrication Pharma", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "COMPONENTS", "bates": "FDA-CBER-2021-5683-1149994", "context_preview": "of Manufacture: 30-Jun-2021 Date of Expiry: 30-Nov-2021 Date of Fill: 30-Jun-2021 Product Information: COMPONENTS Component Description Batch Number Date of Manuf. Manufacture Site Quantity Target Concentration BNT162b2 Drug Substance Pfizer BNT162b2 Drug Substance Pfizer LNP Fabrication Pharmacia &", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "COMPONENTS", "bates": "FDA-CBER-2021-5683-1149994", "context_preview": "acture: 30-Jun-2021 Date of Expiry: 30-Nov-2021 Date of Fill: 30-Jun-2021 Product Information: COMPONENTS Component Description Batch Number Date of Manuf. Manufacture Site Quantity Target Concentration BNT162b2 Drug Substance Pfizer BNT162b2 Drug Substance Pfizer LNP Fabrication Pharmacia & Upjohn ", "likely_table": true } ] }, { "filename": "125742-0_20219003.PC1_.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 70, "table_count": 41, "by_category": { "Manufacturing / CMC": 52, "Other / uncategorized": 18 }, "by_marker": { "(b)(4)": 70 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MEETS TEST", "bates": "FDA-CBER-2021-5683-1150030", "context_preview": "sity Dynamic Light Scattering (DLS) RNA Encapsulation Fluorescence assay % RNA content Fluorescence assay mg/mL ALC-0315 content HPLC-CAD mg/mL ALC-0159 content HPLC-CAD mg/mL DSPC content HPLC-CAD mg/mL Cholesterol content HPLC-CAD mg/mL Vial content Container Content Not less than mL Lipid identit", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MEETS TEST", "bates": "FDA-CBER-2021-5683-1150030", "context_preview": "namic Light Scattering (DLS) RNA Encapsulation Fluorescence assay % RNA content Fluorescence assay mg/mL ALC-0315 content HPLC-CAD mg/mL ALC-0159 content HPLC-CAD mg/mL DSPC content HPLC-CAD mg/mL Cholesterol content HPLC-CAD mg/mL Vial content Container Content Not less than mL Lipid identities HPL", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MEETS TEST", "bates": "FDA-CBER-2021-5683-1150030", "context_preview": "ght Scattering (DLS) RNA Encapsulation Fluorescence assay % RNA content Fluorescence assay mg/mL ALC-0315 content HPLC-CAD mg/mL ALC-0159 content HPLC-CAD mg/mL DSPC content HPLC-CAD mg/mL Cholesterol content HPLC-CAD mg/mL Vial content Container Content Not less than mL Lipid identities HPLC-CAD Re", "likely_table": true } ] }, { "filename": "125742-0_20219006.PC1_.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 77, "table_count": 49, "by_category": { "Manufacturing / CMC": 51, "Other / uncategorized": 26 }, "by_marker": { "(b)(4)": 77 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MEETS TEST", "bates": "FDA-CBER-2021-5683-1150100", "context_preview": "sity Dynamic Light Scattering (DLS) RNA Encapsulation Fluorescence assay % RNA content Fluorescence assay mg/mL ALC-0315 content HPLC-CAD mg/mL ALC-0159 content HPLC-CAD mg/mL DSPC content HPLC-CAD mg/mL Cholesterol content HPLC-CAD mg/mL Vial content Container Content Not less than mL Lipid identit", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MEETS TEST", "bates": "FDA-CBER-2021-5683-1150100", "context_preview": "namic Light Scattering (DLS) RNA Encapsulation Fluorescence assay % RNA content Fluorescence assay mg/mL ALC-0315 content HPLC-CAD mg/mL ALC-0159 content HPLC-CAD mg/mL DSPC content HPLC-CAD mg/mL Cholesterol content HPLC-CAD mg/mL Vial content Container Content Not less than mL Lipid identities HPL", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MEETS TEST", "bates": "FDA-CBER-2021-5683-1150100", "context_preview": "ght Scattering (DLS) RNA Encapsulation Fluorescence assay % RNA content Fluorescence assay mg/mL ALC-0315 content HPLC-CAD mg/mL ALC-0159 content HPLC-CAD mg/mL DSPC content HPLC-CAD mg/mL Cholesterol content HPLC-CAD mg/mL Vial content Container Content Not less than mL Lipid identities HPLC-CAD Re", "likely_table": true } ] }, { "filename": "125742-45_01-25-2022_Telecon_Information-Reque.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0500313", "context_preview": ".D. Captain, USPHS Senior Regulatory Review Officer Food and Drug Administration Center for Biologics Evaluation & Research Office of Vaccines Research & Review Division of Vaccines and Related Products Applications Tel: 301-796-2640 michael.smith2 fda.hhs.gov g Michael J. Smith -S4 Digitally signed", "likely_table": false } ] }, { "filename": "125742-45_04-08-2022_Telecon_Information-Reque.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 3, "table_count": 0, "by_category": { "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE", "bates": "FDA-CBER-2022-5812-0500364", "context_preview": "FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received th", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE", "bates": "FDA-CBER-2022-5812-0500364", "context_preview": "SCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this docu", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE", "bates": "FDA-CBER-2022-5812-0500364", "context_preview": "UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in e", "likely_table": false } ] }, { "filename": "125742-45_05-02-2022_Memo_Committee-Memo_CMC.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 3, "table_count": 0, "by_category": { "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0500407", "context_preview": "(i.e. lower bound of the 2-sided 95% CI for GMR > 0.67). Of note, the lower bound of the 2-sided 95% CI for the GMR is > 1 which indicates a statistically greater response in the adolescents than that of young adults. Seroresponse Among participants without evidence of SARS-CoV-2 infection up to 1 m", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0500407", "context_preview": "ower bound of the 2-sided 95% CI for GMR > 0.67). Of note, the lower bound of the 2-sided 95% CI for the GMR is > 1 which indicates a statistically greater response in the adolescents than that of young adults. Seroresponse Among participants without evidence of SARS-CoV-2 infection up to 1 month af", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0500407", "context_preview": "nd of the 2-sided 95% CI for GMR > 0.67). Of note, the lower bound of the 2-sided 95% CI for the GMR is > 1 which indicates a statistically greater response in the adolescents than that of young adults. Seroresponse Among participants without evidence of SARS-CoV-2 infection up to 1 month after Dose", "likely_table": false } ] }, { "filename": "125742-45_05-06-2022_Meeting-Summary_Committee.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 2, "table_count": 0, "by_category": { "Internal FDA deliberation": 2 }, "by_marker": { "(b)(5)": 2 }, "top_examples": [ { "page": 4, "marker": "(b)(5)", "category": "Internal FDA deliberation", "section_heading": "STN 125742/45", "bates": "FDA-CBER-2022-5812-0500414", "context_preview": "Previously provided targeted review completion date: 30 days after receipt of the completed Establishment Inspection Report (EIR) package. o All three clinical investigations for the supplement are completed and no 483s were issued. BIMO will complete their review and memo by end of May 2022. x CMC ", "likely_table": false }, { "page": 4, "marker": "(b)(5)", "category": "Internal FDA deliberation", "section_heading": "STN 125742/45", "bates": "FDA-CBER-2022-5812-0500414", "context_preview": "ly provided targeted review completion date: 30 days after receipt of the completed Establishment Inspection Report (EIR) package. o All three clinical investigations for the supplement are completed and no 483s were issued. BIMO will complete their review and memo by end of May 2022. x CMC (Xiao Wa", "likely_table": false } ] }, { "filename": "125742-45_S211_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0163467", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0163467", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0163467", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1005-10051449.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 392, "table_count": 206, "by_category": { "Other / uncategorized": 256, "Trial design / efficacy": 38, "Clinical safety / adverse events": 34, "Inspection / enforcement": 29, "Trade-secret claim": 17, "Manufacturing / CMC": 11, "Pharmacology / toxicology": 7 }, "by_marker": { "(b)(4)": 392 }, "top_examples": [ { "page": 90, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "A) OR OF SPANISH ORI", "bates": "FDA-CBER-2022-5812-0492875", "context_preview": "rn Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2006 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-12-2021 06:50:59 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-12-20", "likely_table": true }, { "page": 90, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "A) OR OF SPANISH ORI", "bates": "FDA-CBER-2022-5812-0492875", "context_preview": "(US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2006 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-12-2021 06:50:59 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-12-2021 06:50", "likely_table": true }, { "page": 90, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "A) OR OF SPANISH ORI", "bates": "FDA-CBER-2022-5812-0492875", "context_preview": "PF EINFP60 00 auto calc (autocalc) Data Entry: /2006 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-12-2021 06:50:59 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-12-2021 06:50:59 (UTC-05:00) Ea", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1007-10071499.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 441, "table_count": 104, "by_category": { "Other / uncategorized": 312, "Trial design / efficacy": 45, "Clinical safety / adverse events": 28, "Inspection / enforcement": 23, "Trade-secret claim": 19, "Manufacturing / CMC": 12, "Pharmacology / toxicology": 2 }, "by_marker": { "(b)(4)": 441 }, "top_examples": [ { "page": 106, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "UNK/UNK/1999", "bates": "FDA-CBER-2022-5812-0493068", "context_preview": "nada) ACV0PF EINFP60 00 Query 1: Opened DM: Medical History Start Date is before the date of birth 2006). Please review and correct as appropriate. Dec-03-2020 16:39:24 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Laura Pace Data Entry: UNK/UNK/1999 Initial Entry 1.a Ongoing: Date Locati", "likely_table": true }, { "page": 106, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "UNK/UNK/1999", "bates": "FDA-CBER-2022-5812-0493068", "context_preview": "P60 00 Query 1: Opened DM: Medical History Start Date is before the date of birth 2006). Please review and correct as appropriate. Dec-03-2020 16:39:24 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Laura Pace Data Entry: UNK/UNK/1999 Initial Entry 1.a Ongoing: Date Location User Value Rea", "likely_table": true }, { "page": 106, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "UNK/UNK/1999", "bates": "FDA-CBER-2022-5812-0493068", "context_preview": "Query 1: Opened DM: Medical History Start Date is before the date of birth 2006). Please review and correct as appropriate. Dec-03-2020 16:39:24 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Laura Pace Data Entry: UNK/UNK/1999 Initial Entry 1.a Ongoing: Date Location User Value Reason Dec", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1007-10071581.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 561, "table_count": 115, "by_category": { "Other / uncategorized": 339, "Clinical safety / adverse events": 108, "Trial design / efficacy": 45, "Inspection / enforcement": 32, "Manufacturing / CMC": 18, "Trade-secret claim": 14, "Pharmacology / toxicology": 5 }, "by_marker": { "(b)(4)": 561 }, "top_examples": [ { "page": 132, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "F (34.4 C).", "bates": "FDA-CBER-2022-5812-0493297", "context_preview": "UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Query 1: Opened eDiary: Per eDiary records, e-Diary Temperature value(s) recorded is < 94 F (34.4 C). Please confirm if the thermometer recording from subject or the entry is appropriate. Thanks. Dec-17-2020 16:41:40 (UTC-05:00) Eastern Time (U", "likely_table": true }, { "page": 132, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "F (34.4 C).", "bates": "FDA-CBER-2022-5812-0493297", "context_preview": "Time (US & Canada) ACV0PF EINFP60 00 Query 1: Opened eDiary: Per eDiary records, e-Diary Temperature value(s) recorded is < 94 F (34.4 C). Please confirm if the thermometer recording from subject or the entry is appropriate. Thanks. Dec-17-2020 16:41:40 (UTC-05:00) Eastern Time (US & Canada) ACV0PF ", "likely_table": true }, { "page": 132, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "F (34.4 C).", "bates": "FDA-CBER-2022-5812-0493297", "context_preview": "S & Canada) ACV0PF EINFP60 00 Query 1: Opened eDiary: Per eDiary records, e-Diary Temperature value(s) recorded is < 94 F (34.4 C). Please confirm if the thermometer recording from subject or the entry is appropriate. Thanks. Dec-17-2020 16:41:40 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1009-10091221.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 549, "table_count": 241, "by_category": { "Other / uncategorized": 429, "Trial design / efficacy": 40, "Inspection / enforcement": 37, "Clinical safety / adverse events": 22, "Trade-secret claim": 10, "Manufacturing / CMC": 9, "Pharmacology / toxicology": 2 }, "by_marker": { "(b)(4)": 549 }, "top_examples": [ { "page": 120, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "UNK/UNK/2018", "bates": "FDA-CBER-2022-5812-0493537", "context_preview": "9-2020 15:56:14 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 Data Entry: BILATERAL KNEE PAIN Initial Entry 1.a Start Date: Date Location User Value Reason Oct-19-2020 15:56:14 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 Data Entry: UNK/UNK/2018 Initial Entry 1.a Ongoing: D", "likely_table": true }, { "page": 120, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "UNK/UNK/2018", "bates": "FDA-CBER-2022-5812-0493537", "context_preview": "5:56:14 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 Data Entry: BILATERAL KNEE PAIN Initial Entry 1.a Start Date: Date Location User Value Reason Oct-19-2020 15:56:14 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 Data Entry: UNK/UNK/2018 Initial Entry 1.a Ongoing: Date Loca", "likely_table": true }, { "page": 120, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "UNK/UNK/2018", "bates": "FDA-CBER-2022-5812-0493537", "context_preview": ") Mountain Time (US & Canada) ACV0PF EINFP60 00 Data Entry: BILATERAL KNEE PAIN Initial Entry 1.a Start Date: Date Location User Value Reason Oct-19-2020 15:56:14 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 Data Entry: UNK/UNK/2018 Initial Entry 1.a Ongoing: Date Location User Value Re", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1009-10091294.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 974, "table_count": 460, "by_category": { "Other / uncategorized": 770, "Trial design / efficacy": 49, "Inspection / enforcement": 45, "Clinical safety / adverse events": 43, "Trade-secret claim": 25, "Pharmacology / toxicology": 24, "Manufacturing / CMC": 18 }, "by_marker": { "(b)(4)": 974 }, "top_examples": [ { "page": 227, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "UNK/UNK/2018", "bates": "FDA-CBER-2022-5812-0493895", "context_preview": "Data Entry: UNK/UNK/2018 Initial Entry 1.a Ongoing: Date Location User Value Reason Dec-07-2020 12:35:52 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 Data Entry: YES Initial Entry 1.b Date Location User Value Reason Dec-07-2020 12:36:36 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EIN", "likely_table": true }, { "page": 227, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "UNK/UNK/2018", "bates": "FDA-CBER-2022-5812-0493895", "context_preview": "try: UNK/UNK/2018 Initial Entry 1.a Ongoing: Date Location User Value Reason Dec-07-2020 12:35:52 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 Data Entry: YES Initial Entry 1.b Date Location User Value Reason Dec-07-2020 12:36:36 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00", "likely_table": true }, { "page": 227, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "UNK/UNK/2018", "bates": "FDA-CBER-2022-5812-0493895", "context_preview": "Initial Entry 1.a Ongoing: Date Location User Value Reason Dec-07-2020 12:35:52 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 Data Entry: YES Initial Entry 1.b Date Location User Value Reason Dec-07-2020 12:36:36 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 Data Entry: Line/", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1009-10091382.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1064, "table_count": 532, "by_category": { "Other / uncategorized": 755, "Clinical safety / adverse events": 127, "Trial design / efficacy": 61, "Inspection / enforcement": 50, "Pharmacology / toxicology": 30, "Trade-secret claim": 22, "Manufacturing / CMC": 19 }, "by_marker": { "(b)(4)": 1064 }, "top_examples": [ { "page": 203, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "STAGE 3 COHORTS", "bates": "FDA-CBER-2022-5812-0494315", "context_preview": "ous form 2. Birth Date: Date Location User Value Reason Jan-04-2021 16:48:15 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2006 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-04-2021 16:49:04 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EI", "likely_table": true }, { "page": 203, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "STAGE 3 COHORTS", "bates": "FDA-CBER-2022-5812-0494315", "context_preview": "2. Birth Date: Date Location User Value Reason Jan-04-2021 16:48:15 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2006 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-04-2021 16:49:04 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 ", "likely_table": true }, { "page": 203, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "STAGE 3 COHORTS", "bates": "FDA-CBER-2022-5812-0494315", "context_preview": "te Location User Value Reason Jan-04-2021 16:48:15 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2006 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-04-2021 16:49:04 (UTC-07:00) Mountain Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMAL", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1016-10161327.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 900, "table_count": 518, "by_category": { "Other / uncategorized": 583, "Clinical safety / adverse events": 107, "Inspection / enforcement": 87, "Trial design / efficacy": 63, "Trade-secret claim": 25, "Manufacturing / CMC": 21, "Pharmacology / toxicology": 14 }, "by_marker": { "(b)(4)": 900 }, "top_examples": [ { "page": 174, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "O(A) OR OF SPANISH ORI", "bates": "FDA-CBER-2022-5812-0494742", "context_preview": "& Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2008 Enrollment Entry 3. Sex: Date Location User Value Reason Oct-20-2020 11:54:37 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Oct-20-2020 11:54:37 ", "likely_table": true }, { "page": 174, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "O(A) OR OF SPANISH ORI", "bates": "FDA-CBER-2022-5812-0494742", "context_preview": "NFP60 00 auto calc (autocalc) Data Entry: /2008 Enrollment Entry 3. Sex: Date Location User Value Reason Oct-20-2020 11:54:37 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Oct-20-2020 11:54:37 (UTC-05:00) Eastern", "likely_table": true }, { "page": 174, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "O(A) OR OF SPANISH ORI", "bates": "FDA-CBER-2022-5812-0494742", "context_preview": "(autocalc) Data Entry: /2008 Enrollment Entry 3. Sex: Date Location User Value Reason Oct-20-2020 11:54:37 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Oct-20-2020 11:54:37 (UTC-05:00) Eastern Time (US & Canada)", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1039-10391285.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 737, "table_count": 386, "by_category": { "Other / uncategorized": 486, "Clinical safety / adverse events": 124, "Trial design / efficacy": 47, "Inspection / enforcement": 40, "Manufacturing / CMC": 19, "Trade-secret claim": 13, "Pharmacology / toxicology": 8 }, "by_marker": { "(b)(4)": 737 }, "top_examples": [ { "page": 140, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NOT HISPANIC OR LATIN", "bates": "FDA-CBER-2022-5812-0495088", "context_preview": "ocation User Value Reason Dec-18-2020 13:31:50 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2007 Enrollment Entry 3. Sex: Date Location User Value Reason Dec-18-2020 13:34:08 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMALE Ini", "likely_table": true }, { "page": 140, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NOT HISPANIC OR LATIN", "bates": "FDA-CBER-2022-5812-0495088", "context_preview": "ue Reason Dec-18-2020 13:31:50 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2007 Enrollment Entry 3. Sex: Date Location User Value Reason Dec-18-2020 13:34:08 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMALE Initial Entry 4. Et", "likely_table": true }, { "page": 140, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NOT HISPANIC OR LATIN", "bates": "FDA-CBER-2022-5812-0495088", "context_preview": "020 13:31:50 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2007 Enrollment Entry 3. Sex: Date Location User Value Reason Dec-18-2020 13:34:08 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMALE Initial Entry 4. Ethnicity: Date Loca", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1091-10911447.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 579, "table_count": 312, "by_category": { "Other / uncategorized": 383, "Clinical safety / adverse events": 76, "Trial design / efficacy": 43, "Inspection / enforcement": 33, "Trade-secret claim": 23, "Manufacturing / CMC": 12, "Pharmacology / toxicology": 9 }, "by_marker": { "(b)(4)": 579 }, "top_examples": [ { "page": 123, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NO(A) OR OF SPANISH O", "bates": "FDA-CBER-2022-5812-0495387", "context_preview": "C-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2005 Enrollment Entry 3. Sex: Date Location User Value Reason Dec-22-2020 12:13:26 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Rea", "likely_table": true }, { "page": 123, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NO(A) OR OF SPANISH O", "bates": "FDA-CBER-2022-5812-0495387", "context_preview": "Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2005 Enrollment Entry 3. Sex: Date Location User Value Reason Dec-22-2020 12:13:26 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Dec-22-2020 1", "likely_table": true }, { "page": 123, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NO(A) OR OF SPANISH O", "bates": "FDA-CBER-2022-5812-0495387", "context_preview": ") ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2005 Enrollment Entry 3. Sex: Date Location User Value Reason Dec-22-2020 12:13:26 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Dec-22-2020 12:13:26 (UTC-05:0", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1131-11311301.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 659, "table_count": 355, "by_category": { "Other / uncategorized": 449, "Clinical safety / adverse events": 73, "Trial design / efficacy": 54, "Inspection / enforcement": 50, "Trade-secret claim": 17, "Manufacturing / CMC": 11, "Pharmacology / toxicology": 5 }, "by_marker": { "(b)(4)": 659 }, "top_examples": [ { "page": 121, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "STAGE 3 COHORTS", "bates": "FDA-CBER-2022-5812-0495635", "context_preview": "ada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2007 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-15-2021 01:49:39 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Query 1: Closed Response satisfies query Jan-14-2021 15:58:32 (UTC-05:00) Eastern Time (US & Canada) AC", "likely_table": true }, { "page": 121, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "STAGE 3 COHORTS", "bates": "FDA-CBER-2022-5812-0495635", "context_preview": "P60 00 auto calc (autocalc) Data Entry: /2007 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-15-2021 01:49:39 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Query 1: Closed Response satisfies query Jan-14-2021 15:58:32 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 ", "likely_table": true }, { "page": 121, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "STAGE 3 COHORTS", "bates": "FDA-CBER-2022-5812-0495635", "context_preview": "(autocalc) Data Entry: /2007 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-15-2021 01:49:39 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Query 1: Closed Response satisfies query Jan-14-2021 15:58:32 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Query 1: Answered", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1139-11391246.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 592, "table_count": 249, "by_category": { "Other / uncategorized": 434, "Trial design / efficacy": 54, "Inspection / enforcement": 36, "Clinical safety / adverse events": 26, "Manufacturing / CMC": 18, "Trade-secret claim": 17, "Pharmacology / toxicology": 7 }, "by_marker": { "(b)(4)": 592 }, "top_examples": [ { "page": 120, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "O(A) OR OF SPANISH ORI", "bates": "FDA-CBER-2022-5812-0495912", "context_preview": "& Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2005 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-19-2021 13:55:34 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-19-2021 13:55:34 ", "likely_table": true }, { "page": 120, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "O(A) OR OF SPANISH ORI", "bates": "FDA-CBER-2022-5812-0495912", "context_preview": ") ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2005 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-19-2021 13:55:34 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-19-2021 13:55:34 (UTC-05:", "likely_table": true }, { "page": 120, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "O(A) OR OF SPANISH ORI", "bates": "FDA-CBER-2022-5812-0495912", "context_preview": "0 auto calc (autocalc) Data Entry: /2005 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-19-2021 13:55:34 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-19-2021 13:55:34 (UTC-05:00) Eastern Time (", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1147-11471281.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 485, "table_count": 198, "by_category": { "Other / uncategorized": 299, "Clinical safety / adverse events": 62, "Trial design / efficacy": 47, "Inspection / enforcement": 34, "Manufacturing / CMC": 19, "Trade-secret claim": 18, "Pharmacology / toxicology": 6 }, "by_marker": { "(b)(4)": 485 }, "top_examples": [ { "page": 95, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NOT HISPANIC OR LATI", "bates": "FDA-CBER-2022-5812-0496156", "context_preview": "e Location User Value Reason Dec-13-2020 14:05:55 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2007 Enrollment Entry 3. Sex: Date Location User Value Reason Dec-13-2020 14:17:07 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE In", "likely_table": true }, { "page": 95, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NOT HISPANIC OR LATI", "bates": "FDA-CBER-2022-5812-0496156", "context_preview": "on User Value Reason Dec-13-2020 14:05:55 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2007 Enrollment Entry 3. Sex: Date Location User Value Reason Dec-13-2020 14:17:07 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial En", "likely_table": true }, { "page": 95, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NOT HISPANIC OR LATI", "bates": "FDA-CBER-2022-5812-0496156", "context_preview": "son Dec-13-2020 14:05:55 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2007 Enrollment Entry 3. Sex: Date Location User Value Reason Dec-13-2020 14:17:07 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity:", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1147-11471327.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 513, "table_count": 208, "by_category": { "Other / uncategorized": 373, "Trial design / efficacy": 40, "Inspection / enforcement": 36, "Trade-secret claim": 29, "Clinical safety / adverse events": 22, "Manufacturing / CMC": 11, "Pharmacology / toxicology": 2 }, "by_marker": { "(b)(4)": 513 }, "top_examples": [ { "page": 116, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NO(A) OR OF SPANISH", "bates": "FDA-CBER-2022-5812-0496393", "context_preview": "Central Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2006 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-06-2021 16:40:38 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-0", "likely_table": true }, { "page": 116, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NO(A) OR OF SPANISH", "bates": "FDA-CBER-2022-5812-0496393", "context_preview": "Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2006 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-06-2021 16:40:38 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-07-2021 0", "likely_table": true }, { "page": 116, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NO(A) OR OF SPANISH", "bates": "FDA-CBER-2022-5812-0496393", "context_preview": ") ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2006 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-06-2021 16:40:38 (UTC-06:00) Central Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-07-2021 08:21:02 (UTC-06:0", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1150-11501210.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 743, "table_count": 365, "by_category": { "Other / uncategorized": 465, "Clinical safety / adverse events": 102, "Inspection / enforcement": 65, "Trial design / efficacy": 56, "Trade-secret claim": 23, "Manufacturing / CMC": 20, "Pharmacology / toxicology": 12 }, "by_marker": { "(b)(4)": 743 }, "top_examples": [ { "page": 159, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "O(A) OR OF SPANISH ORI", "bates": "FDA-CBER-2022-5812-0496659", "context_preview": "(UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2008 Enrollment Entry 3. Sex: Date Location User Value Reason Dec-15-2020 16:01:06 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMALE Initial Entry 4. Ethnicity: Date Location User Val", "likely_table": true }, { "page": 159, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "O(A) OR OF SPANISH ORI", "bates": "FDA-CBER-2022-5812-0496659", "context_preview": "ern Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2008 Enrollment Entry 3. Sex: Date Location User Value Reason Dec-15-2020 16:01:06 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMALE Initial Entry 4. Ethnicity: Date Location User Value Reason Dec-15", "likely_table": true }, { "page": 159, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "O(A) OR OF SPANISH ORI", "bates": "FDA-CBER-2022-5812-0496659", "context_preview": "ada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: /2008 Enrollment Entry 3. Sex: Date Location User Value Reason Dec-15-2020 16:01:06 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMALE Initial Entry 4. Ethnicity: Date Location User Value Reason Dec-15-2020 16:01:06 (UT", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1150-11501294.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 742, "table_count": 388, "by_category": { "Other / uncategorized": 504, "Clinical safety / adverse events": 69, "Inspection / enforcement": 62, "Trial design / efficacy": 54, "Trade-secret claim": 23, "Manufacturing / CMC": 20, "Pharmacology / toxicology": 10 }, "by_marker": { "(b)(4)": 742 }, "top_examples": [ { "page": 141, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "OR OF SPANISH ORIGIN", "bates": "FDA-CBER-2022-5812-0496978", "context_preview": "ern Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2008 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-11-2021 14:39:26 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-11-", "likely_table": true }, { "page": 141, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "OR OF SPANISH ORIGIN", "bates": "FDA-CBER-2022-5812-0496978", "context_preview": "(US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2008 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-11-2021 14:39:26 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-11-2021 14:3", "likely_table": true }, { "page": 141, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "OR OF SPANISH ORIGIN", "bates": "FDA-CBER-2022-5812-0496978", "context_preview": "0PF EINFP60 00 auto calc (autocalc) Data Entry: 2008 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-11-2021 14:39:26 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-11-2021 14:39:26 (UTC-05:00) ", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1156-11561357.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 645, "table_count": 33, "by_category": { "Other / uncategorized": 490, "Trial design / efficacy": 49, "Clinical safety / adverse events": 34, "Inspection / enforcement": 30, "Manufacturing / CMC": 19, "Trade-secret claim": 15, "Pharmacology / toxicology": 8 }, "by_marker": { "(b)(4)": 645 }, "top_examples": [ { "page": 235, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PD HAS BEEN", "bates": "FDA-CBER-2022-5812-0497398", "context_preview": "021 02:22:12 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Query 1: Closed Per site confirmation May-20-2021 13:54:24 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Hector Aguilar Query 1: Answered PD HAS BEEN COMPLETED. May-19-2021 06:23:06 (UTC-05:00) Eastern Time (US & Canada", "likely_table": true }, { "page": 235, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PD HAS BEEN", "bates": "FDA-CBER-2022-5812-0497398", "context_preview": "2:12 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Query 1: Closed Per site confirmation May-20-2021 13:54:24 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Hector Aguilar Query 1: Answered PD HAS BEEN COMPLETED. May-19-2021 06:23:06 (UTC-05:00) Eastern Time (US & Canada) ACV0PF", "likely_table": true }, { "page": 235, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PD HAS BEEN", "bates": "FDA-CBER-2022-5812-0497398", "context_preview": "C-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Query 1: Closed Per site confirmation May-20-2021 13:54:24 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Hector Aguilar Query 1: Answered PD HAS BEEN COMPLETED. May-19-2021 06:23:06 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1223-12231273.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1316, "table_count": 521, "by_category": { "Other / uncategorized": 965, "Clinical safety / adverse events": 104, "Inspection / enforcement": 86, "Manufacturing / CMC": 65, "Trial design / efficacy": 62, "Trade-secret claim": 22, "Pharmacology / toxicology": 12 }, "by_marker": { "(b)(4)": 1316 }, "top_examples": [ { "page": 249, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NO(A) OR OF SPANISH", "bates": "FDA-CBER-2022-5812-0497707", "context_preview": "Eastern Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2005 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-09-2021 11:51:56 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-0", "likely_table": true }, { "page": 249, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NO(A) OR OF SPANISH", "bates": "FDA-CBER-2022-5812-0497707", "context_preview": "S & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2005 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-09-2021 11:51:56 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-09-2021 11:51:56", "likely_table": true }, { "page": 249, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NO(A) OR OF SPANISH", "bates": "FDA-CBER-2022-5812-0497707", "context_preview": "EINFP60 00 auto calc (autocalc) Data Entry: 2005 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-09-2021 11:51:56 (UTC-05:00) Eastern Time (US & Canada) ACV0PF EINFP60 00 Data Entry: MALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-09-2021 11:51:56 (UTC-05:00) Easter", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-1270-12701237.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 2856, "table_count": 855, "by_category": { "Other / uncategorized": 2254, "Clinical safety / adverse events": 216, "Trial design / efficacy": 126, "Inspection / enforcement": 124, "Trade-secret claim": 59, "Pharmacology / toxicology": 46, "Manufacturing / CMC": 31 }, "by_marker": { "(b)(4)": 2856 }, "top_examples": [ { "page": 686, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "OR OF SPANISH ORIGIN", "bates": "FDA-CBER-2022-5812-0498664", "context_preview": "fic Time (US & Canada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2007 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-12-2021 12:19:54 (UTC-08:00) Pacific Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-12-", "likely_table": true }, { "page": 686, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "OR OF SPANISH ORIGIN", "bates": "FDA-CBER-2022-5812-0498664", "context_preview": "anada) ACV0PF EINFP60 00 auto calc (autocalc) Data Entry: 2007 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-12-2021 12:19:54 (UTC-08:00) Pacific Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-12-2021 12:19:54 (U", "likely_table": true }, { "page": 686, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "OR OF SPANISH ORIGIN", "bates": "FDA-CBER-2022-5812-0498664", "context_preview": "P60 00 auto calc (autocalc) Data Entry: 2007 Enrollment Entry 3. Sex: Date Location User Value Reason Jan-12-2021 12:19:54 (UTC-08:00) Pacific Time (US & Canada) ACV0PF EINFP60 00 Data Entry: FEMALE Initial Entry 4. Ethnicity: Date Location User Value Reason Jan-12-2021 12:19:54 (UTC-08:00) Pacific ", "likely_table": true } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adae-s091-d1-cut-ped-saf-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071569", "context_preview": "and HIVFL ne 'Y' and MULENRFL ne \"Y\"; run; data g_a_dsin; set datvprot.adae; if trt01an=8 and agegr4n=1 then trtarn=1; else if trt01an=8 and agegr4n=2 then trtarn=2; else if trt01an=9 and agegr4n=1 then trtarn=3; else if trt01an=9 and agegr4n=2 then trtarn=4; trtar=trt01a; analysis_subset='Y'; where", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adae-s091-pd2-ped-saf-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071582", "context_preview": "PEDREAFL='Y' and MULENRFL ne \"Y\"; run; data g_a_dsin; set datvprot.adae; if trt01an=8 and agegr4n=1 then trtarn=1; else if trt01an=8 and agegr4n=2 then trtarn=2; else if trt01an=9 and agegr4n=1 then trtarn=3; else if trt01an=9 and agegr4n=2 then trtarn=4; trtar=trt01a; analysis_subset='Y'; where AEC", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adae-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071648", "context_preview": "t ; by studyid usubjid idvar idvarval; run; proc transpose data= _spmdel_supp_dsin_subset_idvar1 out=_spmdel_supp_dsin_idvar1_h; by studyid usubjid idvar idvarval; id qnam; idlabel qlabel; var qval; quit; data _ds2 (drop=idvar idvarval _NAME_ _LABEL_); set _spmdel_supp_dsin_idvar1_h; if idvar=\"AESEQ", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adc19ef-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071733", "context_preview": "*****************************************************************************************; * Format *; ******************************************************************************************; proc format; value $stat 'UNK' = '1' 'UNKNOWN' = '1' 'N' = '2' 'NEG' = '2' 'IND' = '3' 'Y' = '4' 'POS' = ", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adc19ef-ve-cov-7pd2-peds-eval-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071784", "context_preview": "<= agetr01 <= 15 order by usubjid; quit; proc sql; create table adc19ef as select * from datvprot.adc19ef order by usubjid; quit; data tpop; merge adc19ef (in = a) popf (in = b); by usubjid; if a*b; run; /***** Total Population ****/ proc sql; create table dsin as select distinct subjid, trt01pn, tr", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adc19ef-ve-cov-7pd2-peds-wo-eval-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071800", "context_preview": "<= agetr01 <= 15 order by usubjid; quit; proc sql; create table adc19ef as select * from datvprot.adc19ef order by usubjid; quit; data tpop; merge adc19ef (in = a) popf (in = b); by usubjid; if a*b; run; /***** Total Population ****/ proc sql; create table dsin as select distinct subjid, trt01pn, tr", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adce-s010-lr-sev-ped-saf-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071830", "context_preview": "****************************************************************************; * Specification 2 *; * Input source data adfacevd and adsl *; ******************************************************************************************; data g_adsl_dsin; set DATVPROT.ADSL; where SAFFL eq 'Y' and PEDREAFL", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adce-s020-se-sev-ped-saf-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071897", "context_preview": "*************************************************************************; * Specification 2 *; * Input source data adfacevd and adsl *; ******************************************************************************************; data g_adsl_dsin; set DATVPROT.ADSL; where SAFFL eq 'Y' and PEDREAFL=\"Y", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adcevd-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072062", "context_preview": "select distinct min(FASEQ) as _minseq, max(FASEQ) as _maxseq from facevd; quit; data suppfacevd; set dataprot.suppface; do i=1 to n; set domseq point=i nobs=n; output; end; run; data suppfacevd(drop=_minseq _maxseq); set suppfacevd; where (strip(upcase(idvar))=\"FASEQ\" and _minseq<=input(idvarval,? b", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adcm-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072100", "context_preview": "********************************************************************************; **hup02 modified to fix mapping issue; data cm; length CMSTDTC $20; set dataprot.cm; if CMTRT='' and CMSTDTC='' then delete; if length(CMSTDTC)=10 then CMSTDTC=strip(CMSTDTC)||\"T23:59:59\"; **to fix period issue when su", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adds-s002-ped-rand-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072293", "context_preview": "18=\"No longer meets eligibility criteria\" 25=\"Refused further study procedures\" 26=\"Withdrawal by parent/guardian\"; run; /* Readin ADSL */ data ds; set datvprot.adds; run; data compltdt; set datvprot.adds; if dsdecodn=2 and dsphase='VACCINATION' and astdt ne .; keep usubjid astdt; run; proc sql undo", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adds-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072380", "context_preview": "ERROR WITHOUT ASSOCIATED ADVERSE EVENT\"=17 \"NO LONGER MEETS ELIGIBILITY CRITERIA\"=18 \"REFUSED FURTHER STUDY PROCEDURES\"=25 \"WITHDRAWAL BY PARENT/GUARDIAN\"=26; run; ******************************************************************************************; * Process *; *******************************", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-addv-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072390", "context_preview": "=\"&prot./analysis/esub/logs/addv.log\" new; run; proc sort data=dataprot.suppdv out=suppdv; by usubjid idvarval qnam; run; proc transpose data=suppdv out=suppdv1(drop=_NAME_ _LABEL_); by usubjid idvarval; var qval; id qnam; idlabel qlabel; run; data suppdv1; set suppdv1; dvseq=input(idvarval, best.);", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-admh-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072422", "context_preview": "*; *Subsetting Supplemental Dataset based on _supp_subset parameter*; *****************************************************************; data _spmdel_supp_dsin_subset; set dataprot.suppmh; run; data _spmdel_sdtm_ds; set dataprot.mh; run; **************************************************************", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adsl-fu-d2-ped-saf-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072601", "context_preview": "=min(FUP2CA1N, FUP2CA2N); if FUP2CATN=FUP2CA1N then FUP2CAT=FUP2CAT1; if FUP2CATN=FUP2CA2N then FUP2CAT=FUP2CAT2; FUP2CAT1_=FUP2CAT; if FUP2CATN=1 then do; FUP2CAT1_=\"(*ESC*){unicode 003c}1 Month\"; FUP2CA1N_=1; end; else if 3 >=FUP2CATN>1 then do; FUP2CAT1_=\"(*ESC*){unicode 2265}\"||tranwrd(FUP2CAT1_", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adsl-s005-demo-ped-saf-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072699", "context_preview": "Years' 2='16-55 Years' 3='18-55 Years' 4='65-85 Years' 5='>55 Years'; value Raciald 1=\"Indian Subcontinent Asian\" 10=\"African Caribbean\" 11=\"Saudi Arabian\" 12=\"Malay\" 13=\"Filipino\" 14=\"Vietnamese\" 15=\"Australian Aboriginal\" 16=\"Torres Strait Islander\" 17=\"Han Chinese\" 18=\"Non-Han Chinese\" 19=\"Ashken", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adsympt-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RENAL DYSFUNCTION', 'SIGNIFICANT ACUTE HEPATIC DYSFUNCTION', 'SIGNIFICANT ACUTE", "bates": "FDA-CBER-2022-5812-0073050", "context_preview": "(strip(cecat)); parcat2 = ''; if upcase(strip(cescat)) = 'SIGNIFICANT ACUTE RENAL DYSFUNCTION' then do; paramn = 25; paramcd = 'SARDFN'; param = upcase(strip(cescat)); end; else if upcase(strip(cescat)) = 'SIGNIFICANT ACUTE HEPATIC DYSFUNCTION' then do; paramn = 30; paramcd = 'SAHDFN'; param = upcas", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adva-s001-gmr-ped-ev-eval-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0073072", "context_preview": "ymbolgen; title; footnote; proc delete data=work._all_; run; proc printto log=\"&outlog\" new; run; proc format; value PARAMN 1=\"SARS-CoV-2 neutralization assay - NT50 (titer)\"; value visx 1=\"1/Prevax\" 6=\"2/1 Month\"; run; data adsl; set datvprot.adsl; if trt01pn=8 and agegr4n=1 then trtprn=1; else if ", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_1mth-P-adva-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0073098", "context_preview": "time to correct period */ data is; length isdtc $20; set dataprot.is; where not missing(istestcd); if (index(visit, \"COVID\") or visit in ('V101_VAX3' 'V201_SURVEIL_CONSENT')) then isdtc=strip(isdtc)||\"T23:59:59\"; else isdtc=strip(isdtc)||\"T00:00:00\"; run; /*Select retest result for Phase 1 subjects ", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adae-s091-6m1-ped6-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071521", "context_preview": "where saffl=\"Y\" and HIVFL ne \"Y\" and trt01an=8 and agegr4n in (1) and DS3KFL='Y'; run; data g_a_dsin; set datvprot.adae; if trt01an=8 and agegr4n=1 then trtarn=1; else if trt01an=8 and agegr4n=2 then trtarn=2; else if trt01an=9 and agegr4n=1 then trtarn=3; else if trt01an=9 and agegr4n=2 then trtarn", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adae-s091-6m2-ped6-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071537", "context_preview": "phasen ne 1 and HIVFL ne \"Y\" and trt01an = 8 and agegr4n=1 and DS3KFL='Y' ; run; data g_a_dsin; set datvprot.adae; if trt01an=8 and agegr4n=1 then trtarn=1; else if trt01an=8 and agegr4n=2 then trtarn=2; else if trt01an=9 and agegr4n=1 then trtarn=3; else if trt01an=9 and agegr4n=2 then trtarn=4; tr", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adae-s091-all-unb2-ped6-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071553", "context_preview": "\" and (VAX101DT ne . and BDCSRDT ne .) and (EOSDCDT gt input(\"13MAR2021\", date9.) or EOSDCDT eq .); run; data g_a_dsin; set datvprot.adae; if trt01an=8 and agegr4n=1 then trtarn=1; else if trt01an=8 and agegr4n=2 then trtarn=2; else if trt01an=9 and agegr4n=1 then trtarn=3; else if trt01an=9 and age", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adae-s092-all-unb1-ped6-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071596", "context_preview": "d HIVFL ne \"Y\" and (VAX101DT ne . and BDCSRDT ne .); run; data g_a_dsin; set datvprot.adae; if trt01an=8 and agegr4n=1 then trtarn=1; else if trt01an=8 and agegr4n=2 then trtarn=2; else if trt01an=9 and agegr4n=1 then trtarn=3; else if trt01an=9 and agegr4n=2 then trtarn=4; trtar=trt01a; analysis_su", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adae-s092-cut1-ped6-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071611", "context_preview": "else if trt01an=9 and agegr4n=2 then trtarn=4; trtar=trt01a; where saffl=\"Y\" and AGEGR4N=1 and HIVFL ne \"Y\" and trt02an=8 and trt01an=9 and VAX201DT>. and X1CSRDT>.; run; data g_a_dsin; set datvprot.adae; if trt01an=8 and agegr4n=1 then trtarn=1; else if trt01an=8 and agegr4n=2 then trtarn=2; else i", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adae-s130-sae-unb2-ped6-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071626", "context_preview": "1an=9 and agegr4n=2 then trtarn=4; trtar=trt01a; if trt01an eq 7 and agegr1n eq 3 then trtarn2=1; else if trt01an eq 9 and agegr1n eq 3 then trtarn2=2; else if trt01an eq 7 and agegr1n eq 4 then trtarn2=3; else if trt01an eq 9 and agegr1n eq 4 then trtarn2=4; where saffl=\"Y\" and agegr4n eq 1 and pha", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adae-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071665", "context_preview": "***********************************; *Specification 1: Merging SDTM and Supplemental Datasets *; *******************************************************************************; data _spmdel_supp_dsin_subset_idvar1; set dataprot.suppae; where idvar=\"AESEQ\"; proc sort; by studyid usubjid idvar idvarv", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adc19ef-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071690", "context_preview": "***************************************************************************************; proc delete data=work._all_; run; proc format; value $stat 'UNK'='1' 'UNKNOWN'='1' 'N'='2' 'NEG'='2' 'IND'='3' 'Y'='4' 'POS'='4'; value stat 0=' ' 1='UNK' 2='NEG' 3='IND' 4='POS'; run; ** Create status values re", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adc19ef-ve-cov-7pd2-p-sg-eval-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071806", "context_preview": "ted\" 22=\"(*ESC*){nbspace 10}\" 23=\"Country\" 24=\"(*ESC*){nbspace 4}USA\" 25=\"(*ESC*){nbspace 10}\" 26=\"Comorbidities(*ESC*){super f}\" 27=\"(*ESC*){nbspace 4}Yes\" 28=\"(*ESC*){nbspace 4}No\" 29=\"(*ESC*){nbspace 10}\" 30=\"Obese(*ESC*){super g}\" 31=\"(*ESC*){nbspace 4}Yes\" 32=\"(*ESC*){nbspace 4}No\" 33=\"(*ESC*){", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adc19ef-ve-cov-7pd2-p-wo-sg-eval-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071818", "context_preview": "ted\" 22=\"(*ESC*){nbspace 10}\" 23=\"Country\" 24=\"(*ESC*){nbspace 4}USA\" 25=\"(*ESC*){nbspace 10}\" 26=\"Comorbidities(*ESC*){super f}\" 27=\"(*ESC*){nbspace 4}Yes\" 28=\"(*ESC*){nbspace 4}No\" 29=\"(*ESC*){nbspace 10}\" 30=\"Obese(*ESC*){super g}\" 31=\"(*ESC*){nbspace 4}Yes\" 32=\"(*ESC*){nbspace 4}No\" 33=\"(*ESC*){", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adc19ef-ve-cov-7pd2-peds-eval-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071774", "context_preview": "03c}4 Months after Dose 2\" 11=\"(*ESC*){nbspace 3}(*ESC*){unicode 2265}4 Months after Dose 2\"; run; /*** Population Flag **/ proc sql; create table popf as select distinct usubjid, evaleffl, trt01pn, trt01p, aai2effl, dvstdt from datvprot.adsl where EVALEFFL='Y' and PHASEN ne 1 and HIVFL='N' and 12 <", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adc19ef-ve-cov-7pd2-peds-wo-eval-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0071789", "context_preview": "03c}4 Months after Dose 2\" 11=\"(*ESC*){nbspace 3}(*ESC*){unicode 2265}4 Months after Dose 2\"; run; /*** Population Flag **/ proc sql; create table popf as select distinct usubjid, evaleffl, trt01pn, trt01p, aai2effl, dvstdt from datvprot.adsl where EVALEFFL='Y' and PHASEN ne 1 and HIVFL='N' and 12 <", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adcm-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072080", "context_preview": "ewpx.whodrug; quit; ******************************************************************************************; * Specification 2 *; * Merge SDTM with Supplemental dataset if Supplemental CM Dataset Exists *; * Abort the program if SUPPCM.DICTVER does not match WHODRUG.VERSION or *; * if SUPPCM does", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072117", "context_preview": "terminated by sponsor\" 16=\"Withdrawal by subject\" 17=\"Medication error without associated adverse event\" 18=\"No longer meets eligibility criteria\" 25=\"Refused further study procedures\" 26=\"Withdrawal by parent/guardian\"; run; /* Readin ADSL */ data g_a_dsin; set datvprot.ADDS; analysis_subset='Y'; r", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adds-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072373", "context_preview": "NATED BY SPONSOR\"=14 \"WITHDRAWAL BY SUBJECT\"=16 \"MEDICATION ERROR WITHOUT ASSOCIATED ADVERSE EVENT\"=17 \"NO LONGER MEETS ELIGIBILITY CRITERIA\"=18 \"REFUSED FURTHER STUDY PROCEDURES\"=25 \"WITHDRAWAL BY PARENT/GUARDIAN\"=26; run; ****************************************************************************", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-addv-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072387", "context_preview": "only; proc printto print=\"&prot./output/addv.rpt\" log=\"&prot./logs/addv.log\" new; run; **** exit if not running a DP algorithm **************************************; proc sort data=dataprot.suppdv out=suppdv; by usubjid idvarval qnam; run; proc transpose data=suppdv out=suppdv1(drop=_NAME_ _LABEL_)", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-admh-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072437", "context_preview": "*******************************************************************************; proc sql noprint; select distinct QNAM into :_suppmh_keep_vars separated by \" \" from dataprot.suppmh; quit; *****************************************************************; *Specification 1: Reading INPUT SDTM and Sup", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-peds-eval-eff-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072457", "context_preview": "nbspace 5}American Indian or Alaska Native\" 4=\"(*ESC*){nbspace 5}Asian\" 5=\"(*ESC*){nbspace 5}Native Hawaiian or other Pacific Islander\" 6=\"(*ESC*){nbspace 5}Multiracial\" 7=\"(*ESC*){nbspace 5}Not reported\" 8=\"(*ESC*){nbspace 5}Unknown\"; run; proc sort data=datvprot.adsl out=adsl; by usubjid; run; pro", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072511", "context_preview": "nbspace 5}American Indian or Alaska Native\" 4=\"(*ESC*){nbspace 5}Asian\" 5=\"(*ESC*){nbspace 5}Native Hawaiian or other Pacific Islander\" 6=\"(*ESC*){nbspace 5}Multiracial\" 7=\"(*ESC*){nbspace 5}Not reported\" 8=\"(*ESC*){nbspace 5}Unknown\"; run; proc sort data=datvprot.adsl out=adsl; by usubjid; run; pro", "likely_table": false } ] }, { "filename": "125742-45_S211_M5_c4591001-A_6mth-P-adsl-fu-d21-ped6-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-5812-0072571", "context_preview": "UPCAT1$ 100 FUPCAT2$ 100; /* Total exposure from Dose 2 to cutoff date */ if ., Ph. Eur. 2.6.14 and JP 4.01. 090177e19700b009\\Approved\\", "likely_table": false } ] }, { "filename": "125742_S2_M3_32p52_analytical-procedure-overview.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Trade-secret claim": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "Section 3.2.R Standard Operating Procedures, Method Validation and Transfer Reports.", "bates": "FDA-CBER-2021-5683-1149276", "context_preview": "BNT162b2 3.2.P.5.2 Analytical Procedures Overview PFIZER CONFIDENTIAL Page 1 3.2.P.5.2. OVERVIEW Analytical procedures that are and are detailed in this section. As requested by FDA, the analytical standard operating procedures are presented in Section 3.2.R Standard Operating Procedures, Method Val", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "Section 3.2.R Standard Operating Procedures, Method Validation and Transfer Reports.", "bates": "FDA-CBER-2021-5683-1149276", "context_preview": "BNT162b2 3.2.P.5.2 Analytical Procedures Overview PFIZER CONFIDENTIAL Page 1 3.2.P.5.2. OVERVIEW Analytical procedures that are and are detailed in this section. As requested by FDA, the analytical standard operating procedures are presented in Section 3.2.R Standard Operating Procedures, Method Val", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "Section 3.2.R Standard Operating Procedures, Method Validation and Transfer Reports.", "bates": "FDA-CBER-2021-5683-1149276", "context_preview": "BNT162b2 3.2.P.5.2 Analytical Procedures Overview PFIZER CONFIDENTIAL Page 1 3.2.P.5.2. OVERVIEW Analytical procedures that are and are detailed in this section. As requested by FDA, the analytical standard operating procedures are presented in Section 3.2.R Standard Operating Procedures, Method Val", "likely_table": false } ] }, { "filename": "125742_S2_M3_32p52_analytical-procedure-rt-pcr.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "3.2.P.5.2", "bates": "FDA-CBER-2021-5683-1149277", "context_preview": "BNT162b2 3.2.P.5.2 Analytical Procedures Reverse Transcription-Polymerase Chain Reaction (RT-PCR) PFIZER CONFIDENTIAL Page 1 3.2.P.5.2. REVERSE TRANSCRIPTION-POLYMERASE CHAIN REACTION (RT-PCR) 090177e19700b028\\Approved\\Approved On: 12-May-2021 07:27 (GMT) (b) (4) FDA-CBER-2021-5683-1149277", "likely_table": false } ] }, { "filename": "125742_S2_M3_32p52_analytical-procedure-subvis-particulate-matter.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.2", "bates": "FDA-CBER-2021-5683-1149278", "context_preview": "BNT162b2 3.2.P.5.2 Analytical Procedures Subvisible Particulate Matter PFIZER CONFIDENTIAL Page 1 3.2.P.5.2. SUBVISIBLE PARTICULATE MATTER The analytical procedure for measuring subvisible particulate matter in BNT162b2 drug product is performed using the test in accordance with USP <787> and Ph. Eu", "likely_table": false } ] }, { "filename": "125742_S2_M3_32p53_validation-analytical-procedure-cap-gel-electro.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "3.2.P.5.3", "bates": "FDA-CBER-2021-5683-1149279", "context_preview": "BNT162b2 3.2.P.5.3 Validation of Analytical Procedures Capillary Gel Electrophoresis PFIZER CONFIDENTIAL Page 1 3.2.P.5.3. CAPILLARY GEL ELECTROPHORESIS 090177e195573d36\\Approved\\Approved On: 24-Oct-2020 06:09 (GMT) (b) (4) FDA-CBER-2021-5683-1149279", "likely_table": false } ] }, { "filename": "125742_S2_M3_32p53_validation-analytical-procedure-rt-pcr.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "3.2.P.5.3", "bates": "FDA-CBER-2021-5683-1149280", "context_preview": "BNT162b2 3.2.P.5.3 Validation of Analytical Procedures Reverse Transcription-Polymerase Chain Reaction (RT-PCR) PFIZER CONFIDENTIAL Page 1 3.2.P.5.3. REVERSE TRANSCRIPTION-POLYMERASE CHAIN REACTION (RT-PCR) 090177e195573d32\\Approved\\Approved On: 24-Oct-2020 06:09 (GMT) (b) (4) FDA-CBER-2021-5683-114", "likely_table": false } ] }, { "filename": "125742_S2_M3_32p53_validation-analytical-procedures-overview.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.3", "bates": "FDA-CBER-2021-5683-1149281", "context_preview": "ial and microbiological compendial validations/verifications performed for BNT162b2 drug product release and stability analytical procedures are provided in this section, except which are provided in Section 3.2.S.4.3 Validation of Analytical Procedures. As requested by FDA, the analytical method va", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.3", "bates": "FDA-CBER-2021-5683-1149281", "context_preview": "microbiological compendial validations/verifications performed for BNT162b2 drug product release and stability analytical procedures are provided in this section, except which are provided in Section 3.2.S.4.3 Validation of Analytical Procedures. As requested by FDA, the analytical method validation", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.3", "bates": "FDA-CBER-2021-5683-1149281", "context_preview": "logical compendial validations/verifications performed for BNT162b2 drug product release and stability analytical procedures are provided in this section, except which are provided in Section 3.2.S.4.3 Validation of Analytical Procedures. As requested by FDA, the analytical method validation and tra", "likely_table": false } ] }, { "filename": "125742_S2_M3_32p5_batch-analyses.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 221, "table_count": 113, "by_category": { "Manufacturing / CMC": 185, "Other / uncategorized": 36 }, "by_marker": { "(b)(4)": 221 }, "top_examples": [ { "page": 15, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149061", "context_preview": "RNA content Fluorescence assay ALC-0315 content HPLC-CAD Report result, mg/mL ALC-0159 content HPLC-CAD Report result, mg/mL DSPC content HPLC-CAD Report result, mg/mL Cholesterol content HPLC-CAD Report result, mg/mL Lipid identities HPLC-CAD Retention times consistent with references Conforms to r", "likely_table": true }, { "page": 15, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149061", "context_preview": "ntent Fluorescence assay ALC-0315 content HPLC-CAD Report result, mg/mL ALC-0159 content HPLC-CAD Report result, mg/mL DSPC content HPLC-CAD Report result, mg/mL Cholesterol content HPLC-CAD Report result, mg/mL Lipid identities HPLC-CAD Retention times consistent with references Conforms to referen", "likely_table": true }, { "page": 15, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149061", "context_preview": "uorescence assay ALC-0315 content HPLC-CAD Report result, mg/mL ALC-0159 content HPLC-CAD Report result, mg/mL DSPC content HPLC-CAD Report result, mg/mL Cholesterol content HPLC-CAD Report result, mg/mL Lipid identities HPLC-CAD Retention times consistent with references Conforms to reference Confo", "likely_table": true } ] }, { "filename": "125742_S2_M3_32p5_specifications.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 11, "table_count": 10, "by_category": { "Manufacturing / CMC": 11 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149103", "context_preview": "ty. d. Acceptance criteria values reflect viscosity correction. See Section 3.2 P.5.6.8 for detailed explanation. e. . Abbreviations: LNP = Lipid nanoparticles; CAD = charged aerosol detector; RT-PCR = reverse transcription polymerase chain reaction; FACS = fluorescence activated cell sorter; ddPCR ", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149103", "context_preview": "cceptance criteria values reflect viscosity correction. See Section 3.2 P.5.6.8 for detailed explanation. e. . Abbreviations: LNP = Lipid nanoparticles; CAD = charged aerosol detector; RT-PCR = reverse transcription polymerase chain reaction; FACS = fluorescence activated cell sorter; ddPCR = drople", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149103", "context_preview": "e criteria values reflect viscosity correction. See Section 3.2 P.5.6.8 for detailed explanation. e. . Abbreviations: LNP = Lipid nanoparticles; CAD = charged aerosol detector; RT-PCR = reverse transcription polymerase chain reaction; FACS = fluorescence activated cell sorter; ddPCR = droplet digita", "likely_table": true } ] }, { "filename": "125742_S2_M3_32p8_stability-data-accelerated.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 495, "table_count": 478, "by_category": { "Manufacturing / CMC": 495 }, "by_marker": { "(b)(4)": 495 }, "top_examples": [ { "page": 8, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149112", "context_preview": "tent ALC-0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity Timepoint/ Acceptance Criteriaa 0 6M S S S S S S 12M S S S S S S 18M S S S S S S 24M S S S S S S a. Acceptance criteria in place at time of testing. b. Subvisible particles are reported per container. W = Week, ", "likely_table": true }, { "page": 8, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149112", "context_preview": "-0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity Timepoint/ Acceptance Criteriaa 0 6M S S S S S S 12M S S S S S S 18M S S S S S S 24M S S S S S S a. Acceptance criteria in place at time of testing. b. Subvisible particles are reported per container. W = Week, M = Mont", "likely_table": true }, { "page": 8, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149112", "context_preview": "ntent DSPC Content Cholesterol Content In Vitro Expression RNA Integrity Timepoint/ Acceptance Criteriaa 0 6M S S S S S S 12M S S S S S S 18M S S S S S S 24M S S S S S S a. Acceptance criteria in place at time of testing. b. Subvisible particles are reported per container. W = Week, M = Month, S = T", "likely_table": true } ] }, { "filename": "125742_S2_M3_32p8_stability-data-long-term.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 266, "table_count": 250, "by_category": { "Manufacturing / CMC": 266 }, "by_marker": { "(b)(4)": 266 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149177", "context_preview": "S S S S S S NS NS NS 3M S S S S S S NS NS NS 6M S S S S S S NS NS NS 9M S S S S S S NS NS NS 12M S S S S S S S S S 18M S S S S S S NS NS NS 24M S S S S S S S S S a. Acceptance criteria in place at time of testing. b. Subvisible particles are reported per container. W = Week, M = Month, S = To be Sch", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149177", "context_preview": "S S NS NS NS 3M S S S S S S NS NS NS 6M S S S S S S NS NS NS 9M S S S S S S NS NS NS 12M S S S S S S S S S 18M S S S S S S NS NS NS 24M S S S S S S S S S a. Acceptance criteria in place at time of testing. b. Subvisible particles are reported per container. W = Week, M = Month, S = To be Scheduled, ", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149177", "context_preview": "NS NS 3M S S S S S S NS NS NS 6M S S S S S S NS NS NS 9M S S S S S S NS NS NS 12M S S S S S S S S S 18M S S S S S S NS NS NS 24M S S S S S S S S S a. Acceptance criteria in place at time of testing. b. Subvisible particles are reported per container. W = Week, M = Month, S = To be Scheduled, NS = No", "likely_table": true } ] }, { "filename": "125742_S2_M3_32p8_stability-data-photostability.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 8, "table_count": 8, "by_category": { "Manufacturing / CMC": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149215", "context_preview": "llary Gel Electrophoresis ALC-0315 Content ALC-0159 Content DSPC Content Cholesterol Content In vitro Expression RNA Integrity Acceptance Criteria ab With Light Protection Without Light Protection a. 1.2 million lux hours of light and 200 watt hours/m2 of near ultraviolet light at 5 \u00b1 3 \u00b0C. b. Accep", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149215", "context_preview": "l Electrophoresis ALC-0315 Content ALC-0159 Content DSPC Content Cholesterol Content In vitro Expression RNA Integrity Acceptance Criteria ab With Light Protection Without Light Protection a. 1.2 million lux hours of light and 200 watt hours/m2 of near ultraviolet light at 5 \u00b1 3 \u00b0C. b. Acceptance cr", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149215", "context_preview": "rophoresis ALC-0315 Content ALC-0159 Content DSPC Content Cholesterol Content In vitro Expression RNA Integrity Acceptance Criteria ab With Light Protection Without Light Protection a. 1.2 million lux hours of light and 200 watt hours/m2 of near ultraviolet light at 5 \u00b1 3 \u00b0C. b. Acceptance criteria ", "likely_table": true } ] }, { "filename": "125742_S2_M3_32p8_stability-data-thermal-stress-cycling.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 184, "table_count": 133, "by_category": { "Manufacturing / CMC": 159, "Pharmacology / toxicology": 16, "Other / uncategorized": 9 }, "by_marker": { "(b)(4)": 184 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149222", "context_preview": "159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity Timepoint / Acceptance Criteriaa 0 1W 2W 1M a. Acceptance criteria in b. T=0 testing performed for this lot (release values not utilized. W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP =", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149222", "context_preview": "t Cholesterol Content In Vitro Expression RNA Integrity Timepoint / Acceptance Criteriaa 0 1W 2W 1M a. Acceptance criteria in b. T=0 testing performed for this lot (release values not utilized. W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HP", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149222", "context_preview": "terol Content In Vitro Expression RNA Integrity Timepoint / Acceptance Criteriaa 0 1W 2W 1M a. Acceptance criteria in b. T=0 testing performed for this lot (release values not utilized. W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD =", "likely_table": true } ] }, { "filename": "125742_S2_M3_32p8_stability-summary.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 49, "table_count": 19, "by_category": { "Manufacturing / CMC": 47, "Trial design / efficacy": 1, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 49 }, "top_examples": [ { "page": 21, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.P.5.6 Justification of Specification(s) (modRNA). Both of these lots expire in", "bates": "FDA-CBER-2021-5683-1149268", "context_preview": "f Specification(s) (modRNA) presents the trend analysis data for drug product stability lots that both meet the tightened release acceptance criterion and are manufactured using either from an updated process or from . These data demonstrate that drug product stored at 5 \u00b1 3\u00b0C for 31 days meet the s", "likely_table": true }, { "page": 21, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.P.5.6 Justification of Specification(s) (modRNA). Both of these lots expire in", "bates": "FDA-CBER-2021-5683-1149268", "context_preview": "ication(s) (modRNA) presents the trend analysis data for drug product stability lots that both meet the tightened release acceptance criterion and are manufactured using either from an updated process or from . These data demonstrate that drug product stored at 5 \u00b1 3\u00b0C for 31 days meet the specifica", "likely_table": true }, { "page": 21, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.P.5.6 Justification of Specification(s) (modRNA). Both of these lots expire in", "bates": "FDA-CBER-2021-5683-1149268", "context_preview": "s) (modRNA) presents the trend analysis data for drug product stability lots that both meet the tightened release acceptance criterion and are manufactured using either from an updated process or from . These data demonstrate that drug product stored at 5 \u00b1 3\u00b0C for 31 days meet the specification of ", "likely_table": true } ] }, { "filename": "125742_S2_M3_32r_reg-info-lot-release-documentation-package.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 19, "table_count": 13, "by_category": { "Other / uncategorized": 14, "Trade-secret claim": 4, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 19 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "MIC 49001 USA", "bates": "FDA-CBER-2021-5683-1149285", "context_preview": "090177e196fd19b4\\Approved\\Approved On: 10-May-2021 08:42 (GMT) ( b (b ) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1149285", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "MIC 49001 USA", "bates": "FDA-CBER-2021-5683-1149285", "context_preview": "090177e196fd19b4\\Approved\\Approved On: 10-May-2021 08:42 (GMT) ( b (b ) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1149285", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "MIC 49001 USA", "bates": "FDA-CBER-2021-5683-1149285", "context_preview": "090177e196fd19b4\\Approved\\Approved On: 10-May-2021 08:42 (GMT) ( b (b ) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1149285", "likely_table": true } ] }, { "filename": "125742_S2_M3_32r_reg-info-manufacturing-schedules.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.R.2", "bates": "FDA-CBER-2021-5683-1149288", "context_preview": "BNT162b2 3.2.R Manufacturing Schedules PFIZER CONFIDENTIAL Page 1 3.2.R.2. MANUFACTURING SCHEDULES Due to the urgent need for pandemic supplies the , Kalamazoo and Puurs facilities expect to be in routine production weekly through October 2021 with the following exceptions for the facility: 090177e1", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.R.2", "bates": "FDA-CBER-2021-5683-1149288", "context_preview": "BNT162b2 3.2.R Manufacturing Schedules PFIZER CONFIDENTIAL Page 1 3.2.R.2. MANUFACTURING SCHEDULES Due to the urgent need for pandemic supplies the , Kalamazoo and Puurs facilities expect to be in routine production weekly through October 2021 with the following exceptions for the facility: 090177e1", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.R.2", "bates": "FDA-CBER-2021-5683-1149288", "context_preview": "BNT162b2 3.2.R Manufacturing Schedules PFIZER CONFIDENTIAL Page 1 3.2.R.2. MANUFACTURING SCHEDULES Due to the urgent need for pandemic supplies the , Kalamazoo and Puurs facilities expect to be in routine production weekly through October 2021 with the following exceptions for the facility: 090177e1", "likely_table": false } ] }, { "filename": "125742_S2_M3_32s2_control-critical-steps-manuf-process.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.4.2", "bates": "FDA-CBER-2021-5683-1149290", "context_preview": "ribed in Section 3.2.S.2.4 In-Process Test Methods [Andover]. 3.2.S.2.4.2. Manufacturing Process Controls As described above, Table 3.2.S.2.4-1 provides a list of in-process controls (critical process parameters and IPT-Cs) with their acceptable ranges/acceptance criteria for the drug substance manu", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.4.2", "bates": "FDA-CBER-2021-5683-1149290", "context_preview": "Section 3.2.S.2.4 In-Process Test Methods [Andover]. 3.2.S.2.4.2. Manufacturing Process Controls As described above, Table 3.2.S.2.4-1 provides a list of in-process controls (critical process parameters and IPT-Cs) with their acceptable ranges/acceptance criteria for the drug substance manufacturing", "likely_table": false } ] }, { "filename": "125742_S2_M3_32s2_manufacturer.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1", "bates": "FDA-CBER-2021-5683-1149291", "context_preview": "terfield, MO 63017 United States FEI: 1940118 DUNS: 004954111 Release and Stability Testing a. The legal entity name change from Wyeth BioPharma Division of Wyeth Pharmaceuticals was changed at the acquisition by Pfizer in 2009, since then the Wyeth Pharmaceuticals manufacturing site in Andover, Mas", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1", "bates": "FDA-CBER-2021-5683-1149291", "context_preview": ", MO 63017 United States FEI: 1940118 DUNS: 004954111 Release and Stability Testing a. The legal entity name change from Wyeth BioPharma Division of Wyeth Pharmaceuticals was changed at the acquisition by Pfizer in 2009, since then the Wyeth Pharmaceuticals manufacturing site in Andover, Massachuset", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1", "bates": "FDA-CBER-2021-5683-1149291", "context_preview": "s FEI: 1940118 DUNS: 004954111 Release and Stability Testing a. The legal entity name change from Wyeth BioPharma Division of Wyeth Pharmaceuticals was changed at the acquisition by Pfizer in 2009, since then the Wyeth Pharmaceuticals manufacturing site in Andover, Massachusetts belongs to Pfizer\u2019s ", "likely_table": false } ] }, { "filename": "125742_S2_M3_32s4_analytical-procedure-overview.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.4.2", "bates": "FDA-CBER-2021-5683-1149292", "context_preview": "BNT162b2 3.2.S.4.2 Analytical Procedures Overview PFIZER CONFIDENTIAL Page 1 3.2.S.4.2. OVERVIEW Analytical procedures for the control of BNT162b2 drug substance, are presented in this section, as listed in Table 3.2.S.4.2-1 and Table 3.2.S.4.2-2. As requested by FDA, the analytical standard operati", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.4.2", "bates": "FDA-CBER-2021-5683-1149292", "context_preview": "BNT162b2 3.2.S.4.2 Analytical Procedures Overview PFIZER CONFIDENTIAL Page 1 3.2.S.4.2. OVERVIEW Analytical procedures for the control of BNT162b2 drug substance, are presented in this section, as listed in Table 3.2.S.4.2-1 and Table 3.2.S.4.2-2. As requested by FDA, the analytical standard operati", "likely_table": false } ] }, { "filename": "125742_S2_M3_32s4_specification.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.4.1", "bates": "FDA-CBER-2021-5683-1149293", "context_preview": "oxin Endotoxin (LAL) (Ph. Eur 2.6.14, USP <85>, JP 4.01) Bioburden Bioburden (Ph. Eur. 2.6.12, USP <61>, JP 4.05) a. Assay not performed on stability. Abbreviations: NTU = Nephelometric Turbidity Units; B = brown; RT-PCR = reverse transcription polymerase chain reaction; ddPCR = droplet digital PCR;", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.4.1", "bates": "FDA-CBER-2021-5683-1149293", "context_preview": "otoxin (LAL) (Ph. Eur 2.6.14, USP <85>, JP 4.01) Bioburden Bioburden (Ph. Eur. 2.6.12, USP <61>, JP 4.05) a. Assay not performed on stability. Abbreviations: NTU = Nephelometric Turbidity Units; B = brown; RT-PCR = reverse transcription polymerase chain reaction; ddPCR = droplet digital PCR; qPCR = ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.4.1", "bates": "FDA-CBER-2021-5683-1149293", "context_preview": "LAL) (Ph. Eur 2.6.14, USP <85>, JP 4.01) Bioburden Bioburden (Ph. Eur. 2.6.12, USP <61>, JP 4.05) a. Assay not performed on stability. Abbreviations: NTU = Nephelometric Turbidity Units; B = brown; RT-PCR = reverse transcription polymerase chain reaction; ddPCR = droplet digital PCR; qPCR = quantita", "likely_table": false } ] }, { "filename": "125742_S2_M3_32s4_validation-analyt-procedure-overview.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.4.3", "bates": "FDA-CBER-2021-5683-1149294", "context_preview": "BNT162b2 3.2.S.4.3 Validation of Analytical Procedures Overview PFIZER CONFIDENTIAL Page 1 3.2.S.4.3. OVERVIEW Validation of analytical procedures was performed to ensure the composition, strength, identity, purity, and safety of BNT162b2 drug substance. All non-compendial and compendial analytical ", "likely_table": false } ] }, { "filename": "125742_S30_M1_response-26jul2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149482", "context_preview": "le parameters used during validation and in normal production operations, validation acceptance criteria, results and any deviations.\u201d On 30 July 2021 Pfizer provided a partial response to this query. Due to the file size of some of the attachments to Response #10, not all the supporting documents w", "likely_table": false } ] }, { "filename": "125742_S32_M1_cover.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "WRITTEN CONSENT OF PFIZER INC.", "bates": "FDA-CBER-2021-5683-0950865", "context_preview": "ics License Application (BLA) submitted 19 May 2021 for the COVID-19 mRNA Vaccine (BNT162/PF-07302048) developed by BioNTech and Pfizer under BB-IND 19736 for the prevention of COVID-19 caused by SARS-CoV-2 in individuals >16 years of age. The purpose of this submission is to respond to CBER\u2019s 02 Au", "likely_table": false } ] }, { "filename": "125742_S32_M1_response-02aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 57, "table_count": 48, "by_category": { "Other / uncategorized": 52, "Trade-secret claim": 5 }, "by_marker": { "(b)(4)": 57 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-0950870", "context_preview": "iscussed and agreed previously with CBER under BB-IND 19736. Final qualification reports were submitted to the IND as part of the Response to 29 July 2020 Information Request \u2013 Clinical Assay Qualification on 25 August 2020 (Serial Number 0068) and are also included in the BLA. The validated will be", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-0950870", "context_preview": "and agreed previously with CBER under BB-IND 19736. Final qualification reports were submitted to the IND as part of the Response to 29 July 2020 Information Request \u2013 Clinical Assay Qualification on 25 August 2020 (Serial Number 0068) and are also included in the BLA. The validated will be used for", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-0950870", "context_preview": "eed previously with CBER under BB-IND 19736. Final qualification reports were submitted to the IND as part of the Response to 29 July 2020 Information Request \u2013 Clinical Assay Qualification on 25 August 2020 (Serial Number 0068) and are also included in the BLA. The validated will be used for the st", "likely_table": true } ] }, { "filename": "125742_S33_M5_c4591001_adc19ef-ve-sev-7pd2-cdc-eval-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-0950197", "context_preview": "me..log; %let outtable=&prot./analysis/esub/output/&codename..html; proc printto log=\"&outlog.\" new; run; /*** Population Flag **/ proc sql; create table popf as select distinct usubjid, evaleffl, trt01pn, trt01p, aai2effl from datvprot.adsl where EVALEFFL='Y' and MULENRFL ne \"Y\" and PHASEN ne 1 and", "likely_table": false } ] }, { "filename": "125742_S33_M5_c4591001_adc19ef-ve-sev-7pd2-cdc-wo-eval-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-0950203", "context_preview": "me..log; %let outtable=&prot./analysis/esub/output/&codename..html; proc printto log=\"&outlog.\" new; run; /*** Population Flag **/ proc sql; create table popf as select distinct usubjid, evaleffl, trt01pn, trt01p, aai2effl from datvprot.adsl where EVALEFFL='Y' and MULENRFL ne \"Y\" and PHASEN ne 1 and", "likely_table": false } ] }, { "filename": "125742_S34_M1_response-03aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 43, "table_count": 24, "by_category": { "Manufacturing / CMC": 22, "Other / uncategorized": 15, "Trade-secret claim": 6 }, "by_marker": { "(b)(4)": 43 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149491", "context_preview": "0Y513C301 \u2013 20Y513C601, was set However, in Table 4-5 Results for Additional Process Inputs, rate for all the impacted batches was recorded as Please explain this discrepancy. RESPONSE 3 Literature References None SUPPORTING DOCUMENTATION New or Replaced Supporting Documentation INX100433827: COVID-", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149491", "context_preview": "1 \u2013 20Y513C601, was set However, in Table 4-5 Results for Additional Process Inputs, rate for all the impacted batches was recorded as Please explain this discrepancy. RESPONSE 3 Literature References None SUPPORTING DOCUMENTATION New or Replaced Supporting Documentation INX100433827: COVID-19 Vacci", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149491", "context_preview": "13C601, was set However, in Table 4-5 Results for Additional Process Inputs, rate for all the impacted batches was recorded as Please explain this discrepancy. RESPONSE 3 Literature References None SUPPORTING DOCUMENTATION New or Replaced Supporting Documentation INX100433827: COVID-19 Vaccine Drug ", "likely_table": true } ] }, { "filename": "125742_S34_M3_32a3_excipient-information-nomenclature-alc-0315.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.A.3.1.1", "bates": "FDA-CBER-2021-5683-1149499", "context_preview": "e) Chemical Abstract Service Chemical Name Decanoic acid, 2-hexyl-, 1,1\u2019-[[(4-hydroxybutyl)imino]di- 6,1-hexanediyl] ester Other Chemical Name (s) 6-[{6-[(2-Hexyldecanoyl)oxy]hexyl}(4- hydroxybutyl)amino]hexyl 2-hexyldecanoate ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2- hexyldecanoate) 6-[", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.A.3.1.1", "bates": "FDA-CBER-2021-5683-1149499", "context_preview": "cal Abstract Service Chemical Name Decanoic acid, 2-hexyl-, 1,1\u2019-[[(4-hydroxybutyl)imino]di- 6,1-hexanediyl] ester Other Chemical Name (s) 6-[{6-[(2-Hexyldecanoyl)oxy]hexyl}(4- hydroxybutyl)amino]hexyl 2-hexyldecanoate ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2- hexyldecanoate) 6-[N-6-(2-h", "likely_table": false } ] }, { "filename": "125742_S35_M1_response-04aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 13, "table_count": 7, "by_category": { "Other / uncategorized": 5, "Manufacturing / CMC": 4, "Inspection / enforcement": 4 }, "by_marker": { "(b)(4)": 13 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149503", "context_preview": "DA IR \u2013 Regarding potency assay for determination of IVE by flow cytometry PFIZER CONFIDENTIAL Page 2 QUERY 2 We note that, in Tables 14-1 and 14-2 on Page 21 of the report, the mean S1+ (%) results from compared to the results from . This trend becomes more , which may indicate some systematic diff", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149503", "context_preview": "Regarding potency assay for determination of IVE by flow cytometry PFIZER CONFIDENTIAL Page 2 QUERY 2 We note that, in Tables 14-1 and 14-2 on Page 21 of the report, the mean S1+ (%) results from compared to the results from . This trend becomes more , which may indicate some systematic difference b", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149503", "context_preview": "g potency assay for determination of IVE by flow cytometry PFIZER CONFIDENTIAL Page 2 QUERY 2 We note that, in Tables 14-1 and 14-2 on Page 21 of the report, the mean S1+ (%) results from compared to the results from . This trend becomes more , which may indicate some systematic difference between .", "likely_table": true } ] }, { "filename": "125742_S36_M1_response-02aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 38, "table_count": 37, "by_category": { "Other / uncategorized": 21, "Manufacturing / CMC": 17 }, "by_marker": { "(b)(4)": 38 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149508", "context_preview": "1 FDA IR \u2013 Assay Methods and Lot release PFIZER CONFIDENTIAL Page 2 QUERY 1 In your validation report for the 5\u2019-cap assay for drug substance (VAL100136648), the accuracy study report includes a calculation of Please explain how you obtained the values in attachment 8. RESPONSE 1 Literature Referenc", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149508", "context_preview": "\u2013 Assay Methods and Lot release PFIZER CONFIDENTIAL Page 2 QUERY 1 In your validation report for the 5\u2019-cap assay for drug substance (VAL100136648), the accuracy study report includes a calculation of Please explain how you obtained the values in attachment 8. RESPONSE 1 Literature References None S", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149508", "context_preview": "Methods and Lot release PFIZER CONFIDENTIAL Page 2 QUERY 1 In your validation report for the 5\u2019-cap assay for drug substance (VAL100136648), the accuracy study report includes a calculation of Please explain how you obtained the values in attachment 8. RESPONSE 1 Literature References None SUPPORTIN", "likely_table": true } ] }, { "filename": "125742_S37_M1_response-05aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 0, "by_category": { "Other / uncategorized": 4, "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149520", "context_preview": "s Container Yes Plastic Vial, 10 mL Closure Yes Stopper, 20 mm Gray Compound, Snap Plug Seala No Seal, 20 mm, Flip-Off, Green, Matte Top a. While integral to the drug product packaging, the aluminum seal is not considered a primary packaging component, as it does not have direct contact with the sol", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149520", "context_preview": "ner Yes Plastic Vial, 10 mL Closure Yes Stopper, 20 mm Gray Compound, Snap Plug Seala No Seal, 20 mm, Flip-Off, Green, Matte Top a. While integral to the drug product packaging, the aluminum seal is not considered a primary packaging component, as it does not have direct contact with the solution. T", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149521", "context_preview": "y Packaging Component Direct Solution Contact Yes/No Description Manufacturer Name and Address Container Yes Plastic Vial 3ml Closure Yes Stopper, 20 mm Gray , Stopper, 20 mm Stopper, 20 mm Gray, Seal No Seal, 13mm, Aluminum Crimp Flip Cap Seal Seal 13mm, Aluminum Flip-off Seal Literature References", "likely_table": false } ] }, { "filename": "125742_S40_M1_response-06aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 13, "table_count": 13, "by_category": { "Manufacturing / CMC": 13 }, "by_marker": { "(b)(4)": 13 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.3.3 Description of Manufacturing Process and Process Controls \u2013 LNP Production and", "bates": "FDA-CBER-2021-5683-1149525", "context_preview": "e. An updated 3.2.P.3.3 Description of Manufacturing Process and Process Controls \u2013 LNP Production and Bulk Drug Product Formulation [Puurs] is provided. Literature References None SUPPORTING DOCUMENTATION New or Replaced Supporting Documentation 3.2.P.3.3 Description of Manufacturing Process and Pr", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.3.3 Description of Manufacturing Process and Process Controls \u2013 LNP Production and", "bates": "FDA-CBER-2021-5683-1149525", "context_preview": "dated 3.2.P.3.3 Description of Manufacturing Process and Process Controls \u2013 LNP Production and Bulk Drug Product Formulation [Puurs] is provided. Literature References None SUPPORTING DOCUMENTATION New or Replaced Supporting Documentation 3.2.P.3.3 Description of Manufacturing Process and Process Co", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.3.3 Description of Manufacturing Process and Process Controls \u2013 LNP Production and", "bates": "FDA-CBER-2021-5683-1149525", "context_preview": "2.P.3.3 Description of Manufacturing Process and Process Controls \u2013 LNP Production and Bulk Drug Product Formulation [Puurs] is provided. Literature References None SUPPORTING DOCUMENTATION New or Replaced Supporting Documentation 3.2.P.3.3 Description of Manufacturing Process and Process Controls \u2013", "likely_table": true } ] }, { "filename": "125742_S42_M1_response-04aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 38, "table_count": 38, "by_category": { "Manufacturing / CMC": 19, "Other / uncategorized": 19 }, "by_marker": { "(b)(4)": 38 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149528", "context_preview": "mple, . Insert the for the reference standard above the sample lines and label all the . The page on which the are provided should include a table with test date, specifications and results for each lipid content and identity. Page 4 of 6 Table 1 (Continued) Filled Vaccine Quality Control Tests \uf0b7 Pl", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149528", "context_preview": "Insert the for the reference standard above the sample lines and label all the . The page on which the are provided should include a table with test date, specifications and results for each lipid content and identity. Page 4 of 6 Table 1 (Continued) Filled Vaccine Quality Control Tests \uf0b7 Please rem", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149528", "context_preview": "the for the reference standard above the sample lines and label all the . The page on which the are provided should include a table with test date, specifications and results for each lipid content and identity. Page 4 of 6 Table 1 (Continued) Filled Vaccine Quality Control Tests \uf0b7 Please remove the", "likely_table": true } ] }, { "filename": "125742_S42_M3_32r_comirnaty-lot-release-template.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 21, "table_count": 0, "by_category": { "Manufacturing / CMC": 16, "Other / uncategorized": 5 }, "by_marker": { "(b)(4)": 21 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "FILL INFORMATION", "bates": "FDA-CBER-2021-5683-1149534", "context_preview": "N Container Type: Volume per container: Approved Storage Period: Storage Temperature: Number of containers manufactured: Number of Doses per container: Number of containers for release: Volume of single human dose: Start Date of period of Validity: All lot release tests conducted on this lot, as per", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "FILL INFORMATION", "bates": "FDA-CBER-2021-5683-1149535", "context_preview": "9 - 7.9 Osmolality Osmometry LNP Size Dynamic Light Scattering (DLS) LNP Polydispersity Dynamic Light Scattering (DLS) RNA Encapsulation Fluorescence assay RNA content Fluorescence assay ALC-0315 content HPLC-CAD ALC-0159 content HPLC-CAD DSPC content HPLC-CAD Cholesterol content HPLC-CAD Vial conte", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "FILL INFORMATION", "bates": "FDA-CBER-2021-5683-1149535", "context_preview": "Osmolality Osmometry LNP Size Dynamic Light Scattering (DLS) LNP Polydispersity Dynamic Light Scattering (DLS) RNA Encapsulation Fluorescence assay RNA content Fluorescence assay ALC-0315 content HPLC-CAD ALC-0159 content HPLC-CAD DSPC content HPLC-CAD Cholesterol content HPLC-CAD Vial content Conta", "likely_table": false } ] }, { "filename": "125742_S43_M1_cover.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "WRITTEN CONSENT OF PFIZER INC.", "bates": "FDA-CBER-2021-5683-1149544", "context_preview": "ly 2021 in response to CBER\u2019s 26 July 2021 Information Request regarding manufacturing and equipment to Pfizer, received via email from Laura Gottschalk, PhD (CBER/OVRR). Specifically, this response also includes a follow-up to response 16e on information for portable tank . Should you have any ques", "likely_table": false } ] }, { "filename": "125742_S43_M1_response-05aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 103, "table_count": 75, "by_category": { "Other / uncategorized": 71, "Manufacturing / CMC": 13, "Trade-secret claim": 9, "Inspection / enforcement": 5, "Trial design / efficacy": 5 }, "by_marker": { "(b)(4)": 103 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "LIST OF TABLES", "bates": "FDA-CBER-2021-5683-1149546", "context_preview": "..........21 LIST OF TABLES Table 1. List of Critical Equipment/Materials Used in Manufacturing of the ...................................................................................................................4 Table 2. Cleaning Validation Results Portable Tank ............................6", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "LIST OF TABLES", "bates": "FDA-CBER-2021-5683-1149546", "context_preview": "..21 LIST OF TABLES Table 1. List of Critical Equipment/Materials Used in Manufacturing of the ...................................................................................................................4 Table 2. Cleaning Validation Results Portable Tank ............................6 Table 3", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "LIST OF TABLES", "bates": "FDA-CBER-2021-5683-1149546", "context_preview": "T OF TABLES Table 1. List of Critical Equipment/Materials Used in Manufacturing of the ...................................................................................................................4 Table 2. Cleaning Validation Results Portable Tank ............................6 Table 3. Deviat", "likely_table": true } ] }, { "filename": "125742_S43_M3_32p3_manufacturers.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.3.1", "bates": "FDA-CBER-2021-5683-1149570", "context_preview": "ring Belgium NV Rijksweg 12 Puurs, 2870 Belgium FEI: 1000654629 DUNS: 370156507 LNP production and bulk drug product formulation Fill and finish Primary packaging Secondary packaging Release and stability testing: (Pfier Global Supply) Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC a 1 Burtt ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.3.1", "bates": "FDA-CBER-2021-5683-1149570", "context_preview": "gium NV Rijksweg 12 Puurs, 2870 Belgium FEI: 1000654629 DUNS: 370156507 LNP production and bulk drug product formulation Fill and finish Primary packaging Secondary packaging Release and stability testing: (Pfier Global Supply) Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC a 1 Burtt Road And", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.3.1", "bates": "FDA-CBER-2021-5683-1149570", "context_preview": "Rijksweg 12 Puurs, 2870 Belgium FEI: 1000654629 DUNS: 370156507 LNP production and bulk drug product formulation Fill and finish Primary packaging Secondary packaging Release and stability testing: (Pfier Global Supply) Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC a 1 Burtt Road Andover, MA", "likely_table": false } ] }, { "filename": "125742_S44_M1_response-10aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149574", "context_preview": "c Light Scattering\u201d for drug product. RESPONSE 1 Table 1 provides the established and maximum polydispersity index (PDI) for control lot PF-07302048-DP-RM. Table 1. Established Acceptable and PDI Ranges for PF-07302048-DP-RM (Lot # EE8493) Control Criterion Upper Limit Lower Limit Literature Referen", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149574", "context_preview": "Scattering\u201d for drug product. RESPONSE 1 Table 1 provides the established and maximum polydispersity index (PDI) for control lot PF-07302048-DP-RM. Table 1. Established Acceptable and PDI Ranges for PF-07302048-DP-RM (Lot # EE8493) Control Criterion Upper Limit Lower Limit Literature References None", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149574", "context_preview": "ng\u201d for drug product. RESPONSE 1 Table 1 provides the established and maximum polydispersity index (PDI) for control lot PF-07302048-DP-RM. Table 1. Established Acceptable and PDI Ranges for PF-07302048-DP-RM (Lot # EE8493) Control Criterion Upper Limit Lower Limit Literature References None SUPPORT", "likely_table": false } ] }, { "filename": "125742_S47_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 9, "table_count": 9, "by_category": { "Other / uncategorized": 9 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078591", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (6) (b) (4), (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078591", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (6) (b) (4), (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078591", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (6) (b) (4), (b) (", "likely_table": true } ] }, { "filename": "125742_S47_M1_response-11aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 2, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149581", "context_preview": "ckage: 25 Vials/ Pack single wall corrugate Vials packaged in kits with other ancillary supplies (masks, syringes, gloves, etc.) Three 25-count or Eight 25-count packs per shipper Live 24/7 monitoring of shipment 10 mL Hospira: Package; 25 vials/pack single wall corrugate Vials packaged in kits with", "likely_table": false }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "FOLLOW-UP TO 05 AUGUST 2021 IR- DILUENTS-QUERY 3)", "bates": "FDA-CBER-2021-5683-1149583", "context_preview": "l, 10 mL Closure Yes Stopper, 20 mm Gray Compound, Snap Plug Seala No Seal, 20 mm, Flip-Off, Green, Matte Top a. While integral to the drug product packaging, the aluminum seal is not considered a primary packaging component, as it does not have direct contact with the solution. The seal keeps the e", "likely_table": false }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "FOLLOW-UP TO 05 AUGUST 2021 IR- DILUENTS-QUERY 3)", "bates": "FDA-CBER-2021-5683-1149583", "context_preview": "Closure Yes Stopper, 20 mm Gray Compound, Snap Plug Seala No Seal, 20 mm, Flip-Off, Green, Matte Top a. While integral to the drug product packaging, the aluminum seal is not considered a primary packaging component, as it does not have direct contact with the solution. The seal keeps the elastomeri", "likely_table": false } ] }, { "filename": "125742_S47_M3_32p3_manufacturer-diluent.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.3.1", "bates": "FDA-CBER-2021-5683-1149585", "context_preview": "of 2 mL size diluent vials) Hospira, Inc Manufacture, testing and release (of 10 mL size diluent vials) Pfizer Healthcare India Pvt. Ltd. Plot No. 116, 117, 118, 119, 111 (Part) and 123 (Part)Jawaharlal Nehru Pharma City (SEZ) Parawada MandalVisakhapatnamAndhra Pradesh 531019 India FEI# 3008316085 D", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.3.1", "bates": "FDA-CBER-2021-5683-1149585", "context_preview": "size diluent vials) Hospira, Inc Manufacture, testing and release (of 10 mL size diluent vials) Pfizer Healthcare India Pvt. Ltd. Plot No. 116, 117, 118, 119, 111 (Part) and 123 (Part)Jawaharlal Nehru Pharma City (SEZ) Parawada MandalVisakhapatnamAndhra Pradesh 531019 India FEI# 3008316085 DUNS# 860", "likely_table": false } ] }, { "filename": "125742_S48_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 9, "table_count": 9, "by_category": { "Other / uncategorized": 9 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078599", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078599", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078599", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true } ] }, { "filename": "125742_S48_M1_cover.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "OF PFIZER INC.", "bates": "FDA-CBER-2021-5683-1149586", "context_preview": "viduals \u226516 years of age. On 06 August 2021, the Agency sent an Information Request regarding the measurement of endotoxins using the LAL procedures. The requested information is provided in Response to 06 August 2021 FDA Query on the Measurement of Endotoxins in Module 1.11.1. Should you have any q", "likely_table": false } ] }, { "filename": "125742_S48_M1_response-06aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 22, "table_count": 22, "by_category": { "Manufacturing / CMC": 15, "Pharmacology / toxicology": 7 }, "by_marker": { "(b)(4)": 22 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149589", "context_preview": "ested a response as soon as possible and no later than Friday, August 13, 2021. QUERY 1 Your procedure for measuring endotoxin in Drug Product (DP) includes a step. While you provide data demonstrating the does not impact the activity of endotoxin that is you have not provided data to evaluate the p", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149589", "context_preview": "response as soon as possible and no later than Friday, August 13, 2021. QUERY 1 Your procedure for measuring endotoxin in Drug Product (DP) includes a step. While you provide data demonstrating the does not impact the activity of endotoxin that is you have not provided data to evaluate the potential", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149589", "context_preview": "as soon as possible and no later than Friday, August 13, 2021. QUERY 1 Your procedure for measuring endotoxin in Drug Product (DP) includes a step. While you provide data demonstrating the does not impact the activity of endotoxin that is you have not provided data to evaluate the potential endotoxi", "likely_table": true } ] }, { "filename": "125742_S49_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 10, "table_count": 10, "by_category": { "Other / uncategorized": 10 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078607", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078607", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078607", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S50_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 9, "table_count": 9, "by_category": { "Other / uncategorized": 9 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078615", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078615", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078615", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true } ] }, { "filename": "125742_S50_M1_response-13aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 29, "table_count": 21, "by_category": { "Manufacturing / CMC": 19, "Other / uncategorized": 10 }, "by_marker": { "(b)(4)": 29 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149597", "context_preview": "e If available, provide the work instructions for CGE or commit to generating these instructions. RESPONSE 1 Pfizer Kalamazoo uses As Pfizer Kalamazoo does not have work instructions for , we commit to formalizing these instructions by 30 September 2021. Literature References None SUPPORTING DOCUMEN", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149597", "context_preview": "f available, provide the work instructions for CGE or commit to generating these instructions. RESPONSE 1 Pfizer Kalamazoo uses As Pfizer Kalamazoo does not have work instructions for , we commit to formalizing these instructions by 30 September 2021. Literature References None SUPPORTING DOCUMENTAT", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149597", "context_preview": "ble, provide the work instructions for CGE or commit to generating these instructions. RESPONSE 1 Pfizer Kalamazoo uses As Pfizer Kalamazoo does not have work instructions for , we commit to formalizing these instructions by 30 September 2021. Literature References None SUPPORTING DOCUMENTATION New ", "likely_table": true } ] }, { "filename": "125742_S50_M3_32r_comirnaty-lot-release-template.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 17, "table_count": 0, "by_category": { "Manufacturing / CMC": 14, "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 17 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "FDA-CBER-2021-3082614 48662", "bates": "FDA-CBER-2021-5683-1149605", "context_preview": "ber: License Name of Product: [COVID-19 mRNA Vaccine (nucleoside modified)] Manufacturing Site: Pharmacia & Upjohn Company LLC, 7000 Portage Rd., Kalamazoo, MIC 49001 USA Date of Manufacture: Date of Expiry: Date of Fill: Product Information: COMPONENTS Component Description Batch Number Date of Man", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "FDA-CBER-2021-3082614 48662", "bates": "FDA-CBER-2021-5683-1149606", "context_preview": "090177e197d20d57\\Approved\\Approved On: 16-Aug-2021 18:08 (GMT) ec: STN 125742-0/2229/FC Lot Number: License Name of Product: [COVID-19 mRNA Vaccine (nucleoside modified) ] Table 1. Filled Vaccine Quality Control Tests A (Visibl May contain white to off- ie - ti ) mre la ppearance (Particles)white op", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "FDA-CBER-2021-3082614 48662", "bates": "FDA-CBER-2021-5683-1149606", "context_preview": "090177e197d20d57\\Approved\\Approved On: 16-Aug-2021 18:08 (GMT) ec: STN 125742-0/2229/FC Lot Number: License Name of Product: [COVID-19 mRNA Vaccine (nucleoside modified) ] Table 1. Filled Vaccine Quality Control Tests A (Visibl May contain white to off- ie - ti ) mre la ppearance (Particles)white op", "likely_table": false } ] }, { "filename": "125742_S51_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 10, "table_count": 10, "by_category": { "Other / uncategorized": 10 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078623", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078623", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078623", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S52_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 10, "table_count": 10, "by_category": { "Other / uncategorized": 10 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078631", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078631", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078631", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 8 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S53_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078639", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078639", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078639", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true } ] }, { "filename": "125742_S53_M1_response-13aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 59, "table_count": 21, "by_category": { "Manufacturing / CMC": 48, "Inspection / enforcement": 7, "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 59 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149624", "context_preview": "ease identify the equipment with its unique identifier and provide a concise description of the qualification (e.g., IQ, OQ, performance qualification (PQ)). RESPONSE 2 Table 2 below lists the cold rooms, freezers, refrigerators, and the freeze/thaw systems associated with the manufacture of the BNT", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149624", "context_preview": "ntify the equipment with its unique identifier and provide a concise description of the qualification (e.g., IQ, OQ, performance qualification (PQ)). RESPONSE 2 Table 2 below lists the cold rooms, freezers, refrigerators, and the freeze/thaw systems associated with the manufacture of the BNT162b2 dr", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149624", "context_preview": "equipment with its unique identifier and provide a concise description of the qualification (e.g., IQ, OQ, performance qualification (PQ)). RESPONSE 2 Table 2 below lists the cold rooms, freezers, refrigerators, and the freeze/thaw systems associated with the manufacture of the BNT162b2 drug substan", "likely_table": true } ] }, { "filename": "125742_S54_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078646", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078646", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078646", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S55_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078653", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078653", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078653", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true } ] }, { "filename": "125742_S55_M2_32p8_stability-data-accelerated.pdf", "module": "M2", "company": "Pfizer", "license": "BLA", "total_kept": 656, "table_count": 621, "by_category": { "Manufacturing / CMC": 656 }, "by_marker": { "(b)(4)": 656 }, "top_examples": [ { "page": 11, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149650", "context_preview": "ontent ALC-0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity Timepoint/ Acceptance Criteriaa 0 6M S S S S S S 12M S S S S S S 18M S S S S S S 24M S S S S S S a. Acceptance criteria in place at time of testing. b. Subvisible particles are reported per container. W = Week", "likely_table": true }, { "page": 11, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149650", "context_preview": "LC-0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity Timepoint/ Acceptance Criteriaa 0 6M S S S S S S 12M S S S S S S 18M S S S S S S 24M S S S S S S a. Acceptance criteria in place at time of testing. b. Subvisible particles are reported per container. W = Week, M = Mo", "likely_table": true }, { "page": 11, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149650", "context_preview": "Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity Timepoint/ Acceptance Criteriaa 0 6M S S S S S S 12M S S S S S S 18M S S S S S S 24M S S S S S S a. Acceptance criteria in place at time of testing. b. Subvisible particles are reported per container. W = Week, M = Month, S =", "likely_table": true } ] }, { "filename": "125742_S55_M2_drug-product-stability.pdf", "module": "M2", "company": "Pfizer", "license": "BLA", "total_kept": 47, "table_count": 21, "by_category": { "Manufacturing / CMC": 43, "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 47 }, "top_examples": [ { "page": 23, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149770", "context_preview": "20 \u00b1 5 \uf0b0C accelerated condition provides additional supportive data for the long- term storage under recommended condition, supports temporary temperature excursions from the recommended storage condition, and supports storage of the drug product for up to 2 weeks at -20 \u00b1 5 \uf0b0C. Additionally, figure", "likely_table": true }, { "page": 23, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149770", "context_preview": "C accelerated condition provides additional supportive data for the long- term storage under recommended condition, supports temporary temperature excursions from the recommended storage condition, and supports storage of the drug product for up to 2 weeks at -20 \u00b1 5 \uf0b0C. Additionally, figures showin", "likely_table": true }, { "page": 23, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149770", "context_preview": "rated condition provides additional supportive data for the long- term storage under recommended condition, supports temporary temperature excursions from the recommended storage condition, and supports storage of the drug product for up to 2 weeks at -20 \u00b1 5 \uf0b0C. Additionally, figures showing data g", "likely_table": true } ] }, { "filename": "125742_S55_M2_introduction.pdf", "module": "M2", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Module 3", "bates": "FDA-CBER-2021-5683-1149777", "context_preview": "data from additional lots and additional time points. Added figures illustrating stability data for LNP polydispersity, LNP size, RNA content, RNA encapsulation, lipid content, RNA integrity, and in vitro expression. Both upright and inverted vial orientation results now included for lots EK4242, EL", "likely_table": false } ] }, { "filename": "125742_S55_M3_32p8_stability-data-long-term.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 317, "table_count": 315, "by_category": { "Manufacturing / CMC": 317 }, "by_marker": { "(b)(4)": 317 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149785", "context_preview": "nalytical Procedure/Quality Attribute HPLC-CAD Cell-based Flow Cytometry Capillary Gel Electrophoresis Endotoxin (LAL) Sterility Dye Incursion ALC-0315 Content ALC-0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity Container Closure Integrity Timepoint/ Acceptance Criter", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149785", "context_preview": "l Procedure/Quality Attribute HPLC-CAD Cell-based Flow Cytometry Capillary Gel Electrophoresis Endotoxin (LAL) Sterility Dye Incursion ALC-0315 Content ALC-0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity Container Closure Integrity Timepoint/ Acceptance Criteriaa 0 Pa", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149785", "context_preview": "dure/Quality Attribute HPLC-CAD Cell-based Flow Cytometry Capillary Gel Electrophoresis Endotoxin (LAL) Sterility Dye Incursion ALC-0315 Content ALC-0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity Container Closure Integrity Timepoint/ Acceptance Criteriaa 0 Pass 2W N", "likely_table": true } ] }, { "filename": "125742_S55_M3_32p8_stability-summary.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 57, "table_count": 33, "by_category": { "Manufacturing / CMC": 54, "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 57 }, "top_examples": [ { "page": 24, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149862", "context_preview": "proposed commercial specifications through at least the 1 month time point and the -20 \u00b1 5 \uf0b0C accelerated condition provides additional supportive data for the long- term storage under recommended condition, supports temporary temperature excursions from the recommended storage condition, and suppor", "likely_table": true }, { "page": 24, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149862", "context_preview": "d commercial specifications through at least the 1 month time point and the -20 \u00b1 5 \uf0b0C accelerated condition provides additional supportive data for the long- term storage under recommended condition, supports temporary temperature excursions from the recommended storage condition, and supports stor", "likely_table": true }, { "page": 24, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149862", "context_preview": "cial specifications through at least the 1 month time point and the -20 \u00b1 5 \uf0b0C accelerated condition provides additional supportive data for the long- term storage under recommended condition, supports temporary temperature excursions from the recommended storage condition, and supports storage of t", "likely_table": true } ] }, { "filename": "125742_S56_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078660", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078660", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078660", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true } ] }, { "filename": "125742_S56_M1_cover.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BLA 125742.0", "bates": "FDA-CBER-2021-5683-1149869", "context_preview": "d for testing samples. In addition, on 16 August 2021, the Agency and Pfizer met via teleconference to obtain clarity on the given request. The requested information and commitment are provided in Commitment to Implement an Additional Endotoxin Method on DP in Module 1.11.1. Should you have any ques", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BLA 125742.0", "bates": "FDA-CBER-2021-5683-1149869", "context_preview": "sting samples. In addition, on 16 August 2021, the Agency and Pfizer met via teleconference to obtain clarity on the given request. The requested information and commitment are provided in Commitment to Implement an Additional Endotoxin Method on DP in Module 1.11.1. Should you have any questions re", "likely_table": false } ] }, { "filename": "125742_S56_M1_response-13aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 12, "table_count": 12, "by_category": { "Manufacturing / CMC": 12 }, "by_marker": { "(b)(4)": 12 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149871", "context_preview": "ed of DP lot release. Commitment to Implement Endotoxin Test Method Pfizer commits to implementing a new method that includes testing the sample for routine lot release testing of Drug Product by 06 December 2021. Implementation of the method would occur following method transfer and verification st", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149871", "context_preview": "P lot release. Commitment to Implement Endotoxin Test Method Pfizer commits to implementing a new method that includes testing the sample for routine lot release testing of Drug Product by 06 December 2021. Implementation of the method would occur following method transfer and verification steps. A ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1149871", "context_preview": "lease. Commitment to Implement Endotoxin Test Method Pfizer commits to implementing a new method that includes testing the sample for routine lot release testing of Drug Product by 06 December 2021. Implementation of the method would occur following method transfer and verification steps. A new rout", "likely_table": true } ] }, { "filename": "125742_S57_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078667", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078667", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078667", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true } ] }, { "filename": "125742_S57_M1_response-16aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section 3.2.P.3.1 Manufacturer(s) (DILUENT), has been updated.", "bates": "FDA-CBER-2021-5683-1149874", "context_preview": "mL Vial supplier to Pfizer Healthcare India Pvt. Ltd. Table 1 as amended with the updated container closure supplier information is shown below for reference. Table 1. 0.9% Sodium Chloride Injection Container/Closure Information 10 mL vial Primary Packaging Component Direct Solution Contact (Yes/No)", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section 3.2.P.3.1 Manufacturer(s) (DILUENT), has been updated.", "bates": "FDA-CBER-2021-5683-1149874", "context_preview": "supplier to Pfizer Healthcare India Pvt. Ltd. Table 1 as amended with the updated container closure supplier information is shown below for reference. Table 1. 0.9% Sodium Chloride Injection Container/Closure Information 10 mL vial Primary Packaging Component Direct Solution Contact (Yes/No) Descrip", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section 3.2.P.3.1 Manufacturer(s) (DILUENT), replaced", "bates": "FDA-CBER-2021-5683-1149875", "context_preview": "inum seal is not considered a primary packaging component, as it does not have direct contact with the solution. The seal keeps the elastomeric closure in its proper position in the neck of the vial. It does not have solution contact. Literature References None SUPPORTING DOCUMENTATION New or Replac", "likely_table": false } ] }, { "filename": "125742_S57_M3_32p3_manufacturer-diluent.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.3.1", "bates": "FDA-CBER-2021-5683-1149876", "context_preview": "e production of 0.9% sodium chloride, USP diluent and their specified functions. Table 3.2.P.3.1-1. Sites and Responsibilities for Diluent (0.9% Sodium Chloride, USP) Manufacture Site FEI / DUNS Numbers Responsibility Fresenius-Kabi USA, LLC Manufacture, testing and release (of 2 mL size diluent via", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.3.1", "bates": "FDA-CBER-2021-5683-1149876", "context_preview": "tion of 0.9% sodium chloride, USP diluent and their specified functions. Table 3.2.P.3.1-1. Sites and Responsibilities for Diluent (0.9% Sodium Chloride, USP) Manufacture Site FEI / DUNS Numbers Responsibility Fresenius-Kabi USA, LLC Manufacture, testing and release (of 2 mL size diluent vials) Hosp", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.3.1", "bates": "FDA-CBER-2021-5683-1149876", "context_preview": "0.9% sodium chloride, USP diluent and their specified functions. Table 3.2.P.3.1-1. Sites and Responsibilities for Diluent (0.9% Sodium Chloride, USP) Manufacture Site FEI / DUNS Numbers Responsibility Fresenius-Kabi USA, LLC Manufacture, testing and release (of 2 mL size diluent vials) Hospira, Inc", "likely_table": false } ] }, { "filename": "125742_S58_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 7, "table_count": 7, "by_category": { "Other / uncategorized": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078674", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4) (b) (4", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078674", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4) (b) (4", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078674", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4) (b) (4", "likely_table": true } ] }, { "filename": "125742_S59_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078681", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078681", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078681", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) (b) (6) (b) (6", "likely_table": true } ] }, { "filename": "125742_S59_M1_response-17aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 1069, "table_count": 1068, "by_category": { "Other / uncategorized": 413, "Manufacturing / CMC": 374, "Trial design / efficacy": 144, "Inspection / enforcement": 138 }, "by_marker": { "(b)(4)": 1069 }, "top_examples": [ { "page": 16, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "Section 5.1, the sample site selection followed a", "bates": "FDA-CBER-2021-5683-1149894", "context_preview": "esentative sample locations. Procedure , describes the routine monitoring program for the compressed air system. As part of the routine monitoring program, are representative sample locations of the compressed air system with a sampling frequency of which is based on Validation Protocol . Per Valida", "likely_table": true }, { "page": 16, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "Section 5.1, the sample site selection followed a", "bates": "FDA-CBER-2021-5683-1149894", "context_preview": "ve sample locations. Procedure , describes the routine monitoring program for the compressed air system. As part of the routine monitoring program, are representative sample locations of the compressed air system with a sampling frequency of which is based on Validation Protocol . Per Validation Pro", "likely_table": true }, { "page": 16, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "Section 5.1, the sample site selection followed a", "bates": "FDA-CBER-2021-5683-1149894", "context_preview": "e locations. Procedure , describes the routine monitoring program for the compressed air system. As part of the routine monitoring program, are representative sample locations of the compressed air system with a sampling frequency of which is based on Validation Protocol . Per Validation Protocol Se", "likely_table": true } ] }, { "filename": "125742_S5_M1_cover.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "WRITTEN CONSENT OF PFIZER INC.", "bates": "FDA-CBER-2021-5683-1149296", "context_preview": "elgium site. A teleconference has been scheduled and confirmed for Tuesday, 25 May 2021 starting at 10:00 AM ET. Should you have any questions regarding this submission, or require additional information, please contact me via phone at 215-280-5503; via facsimile at 845-474-3500; or via e-mail at el", "likely_table": false } ] }, { "filename": "125742_S5_M1_response-20-may-2021-facilities.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 15, "table_count": 6, "by_category": { "Manufacturing / CMC": 15 }, "by_marker": { "(b)(4)": 15 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149297", "context_preview": "iday for the associated personnel. to support future BNT162b2 drug substance production demands, in are currently anticipated to occur between 01 June 2021 and 04 June 2021 and then from 19 July 2021 through 07 August 2021. The production schedule is dynamic and subject to change. Literature Referen", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149297", "context_preview": "the associated personnel. to support future BNT162b2 drug substance production demands, in are currently anticipated to occur between 01 June 2021 and 04 June 2021 and then from 19 July 2021 through 07 August 2021. The production schedule is dynamic and subject to change. Literature References None ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149297", "context_preview": "el. to support future BNT162b2 drug substance production demands, in are currently anticipated to occur between 01 June 2021 and 04 June 2021 and then from 19 July 2021 through 07 August 2021. The production schedule is dynamic and subject to change. Literature References None SUPPORTING DOCUMENTATI", "likely_table": true } ] }, { "filename": "125742_S60_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 10, "table_count": 9, "by_category": { "Other / uncategorized": 7, "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 19736, DMF 012683, DMF 9543, DMF 15209, DMF 011793, DMF 011820, DMF 011321, DMF 10953,", "bates": "FDA-CBER-2021-5683-1078683", "context_preview": "Response to FDA 17 August 2021 Information Request Regarding Drug Substance for and Drug Product at Kalamazoo and Puurs Pharmacia and Upjohn Company LLC (Pfizer) 7000 Portage Road Kalamazoo MI USA 49001 1810189 618054084 LNP production and bulk drug product formulation, Fill and finish, Primary pack", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 19736, DMF 012683, DMF 9543, DMF 15209, DMF 011793, DMF 011820, DMF 011321, DMF 10953,", "bates": "FDA-CBER-2021-5683-1078683", "context_preview": "Response to FDA 17 August 2021 Information Request Regarding Drug Substance for and Drug Product at Kalamazoo and Puurs Pharmacia and Upjohn Company LLC (Pfizer) 7000 Portage Road Kalamazoo MI USA 49001 1810189 618054084 LNP production and bulk drug product formulation, Fill and finish, Primary pack", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 19736, DMF 012683, DMF 9543, DMF 15209, DMF 011793, DMF 011820, DMF 011321, DMF 10953,", "bates": "FDA-CBER-2021-5683-1078683", "context_preview": "Response to FDA 17 August 2021 Information Request Regarding Drug Substance for and Drug Product at Kalamazoo and Puurs Pharmacia and Upjohn Company LLC (Pfizer) 7000 Portage Road Kalamazoo MI USA 49001 1810189 618054084 LNP production and bulk drug product formulation, Fill and finish, Primary pack", "likely_table": true } ] }, { "filename": "125742_S60_M1_cover.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 9, "table_count": 9, "by_category": { "Manufacturing / CMC": 9 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Module 1.11.1.", "bates": "FDA-CBER-2021-5683-1149915", "context_preview": "-CoV-2 in individuals \u226516 years of age. The purpose of this submission is to respond to CBER\u2019s 17 August 2021 Information Request, received via email regarding drug substance and drug product The Response to FDA 17 August 2021 Information Request is provided in Module 1.11.1. Should you have any que", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Module 1.11.1.", "bates": "FDA-CBER-2021-5683-1149915", "context_preview": "n individuals \u226516 years of age. The purpose of this submission is to respond to CBER\u2019s 17 August 2021 Information Request, received via email regarding drug substance and drug product The Response to FDA 17 August 2021 Information Request is provided in Module 1.11.1. Should you have any questions r", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Module 1.11.1.", "bates": "FDA-CBER-2021-5683-1149915", "context_preview": "iduals \u226516 years of age. The purpose of this submission is to respond to CBER\u2019s 17 August 2021 Information Request, received via email regarding drug substance and drug product The Response to FDA 17 August 2021 Information Request is provided in Module 1.11.1. Should you have any questions regardin", "likely_table": true } ] }, { "filename": "125742_S60_M1_response-17aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 37, "table_count": 37, "by_category": { "Manufacturing / CMC": 26, "Other / uncategorized": 11 }, "by_marker": { "(b)(4)": 37 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.2 Manufacturing Process Andover and Section 3.2.S.2.4 Controls of Critical Steps", "bates": "FDA-CBER-2021-5683-1149917", "context_preview": "ing Process Development-Process Development and Characterization and Table 3.2.S.2.6-11 has been copied below. The full range of the study gave acceptable results, with no trends noted. Table 3.2.S.2.6-11. Study Results Data in the study was compared with original specifications. The commercial acce", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.2 Manufacturing Process Andover and Section 3.2.S.2.4 Controls of Critical Steps", "bates": "FDA-CBER-2021-5683-1149917", "context_preview": "cess Development-Process Development and Characterization and Table 3.2.S.2.6-11 has been copied below. The full range of the study gave acceptable results, with no trends noted. Table 3.2.S.2.6-11. Study Results Data in the study was compared with original specifications. The commercial acceptance ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.2 Manufacturing Process Andover and Section 3.2.S.2.4 Controls of Critical Steps", "bates": "FDA-CBER-2021-5683-1149917", "context_preview": "elopment-Process Development and Characterization and Table 3.2.S.2.6-11 has been copied below. The full range of the study gave acceptable results, with no trends noted. Table 3.2.S.2.6-11. Study Results Data in the study was compared with original specifications. The commercial acceptance criteria", "likely_table": true } ] }, { "filename": "125742_S60_M3_32s2_control-critical-steps-manuf-process.pdf", "module": "M3", "company": "Pfizer", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.4.2", "bates": "FDA-CBER-2021-5683-1149921", "context_preview": "ibed in Section 3.2.S.2.4 In-Process Test Methods [Andover]. 3.2.S.2.4.2. Manufacturing Process Controls As described above, Table 3.2.S.2.4-1 provides a list of in-process controls (critical process parameters and IPT-Cs) with their acceptable ranges/acceptance criteria for the drug substance manuf", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.4.2", "bates": "FDA-CBER-2021-5683-1149921", "context_preview": "Section 3.2.S.2.4 In-Process Test Methods [Andover]. 3.2.S.2.4.2. Manufacturing Process Controls As described above, Table 3.2.S.2.4-1 provides a list of in-process controls (critical process parameters and IPT-Cs) with their acceptable ranges/acceptance criteria for the drug substance manufacturing", "likely_table": false } ] }, { "filename": "125742_S61_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078695", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (6) (b) (4), (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078695", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (6) (b) (4), (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078695", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (6) (b) (4), (b) (", "likely_table": true } ] }, { "filename": "125742_S61_M1_response-17aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149925", "context_preview": "nufacture as defined by the Pfizer Kalamazoo manufacturing site is the date of The date of manufacture as defined by the Pfizer Puurs manufacturing site is the date of the Across both the Pfizer Kalamazoo and Pfizer Puurs sites, the date of manufacture is no later than the date of Literature Referen", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149925", "context_preview": "e as defined by the Pfizer Kalamazoo manufacturing site is the date of The date of manufacture as defined by the Pfizer Puurs manufacturing site is the date of the Across both the Pfizer Kalamazoo and Pfizer Puurs sites, the date of manufacture is no later than the date of Literature References None", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149925", "context_preview": "ined by the Pfizer Kalamazoo manufacturing site is the date of The date of manufacture as defined by the Pfizer Puurs manufacturing site is the date of the Across both the Pfizer Kalamazoo and Pfizer Puurs sites, the date of manufacture is no later than the date of Literature References None SUPPORT", "likely_table": false } ] }, { "filename": "125742_S62_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078702", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078702", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078702", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S63_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078709", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078709", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078709", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S63_M1_response-18aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 16, "table_count": 15, "by_category": { "Other / uncategorized": 16 }, "by_marker": { "(b)(4)": 16 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149929", "context_preview": "d Pfizer scientists are essential to define the scope of the changes being requested. We propose to have these discussions by 24 Sept 2021, based on availability of CBER personnel, and to submit the additional instructions on an agreed upon timeline, but not later than June 2022. Literature Referenc", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149929", "context_preview": "scientists are essential to define the scope of the changes being requested. We propose to have these discussions by 24 Sept 2021, based on availability of CBER personnel, and to submit the additional instructions on an agreed upon timeline, but not later than June 2022. Literature References None S", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "SUPPORTING DOCUMENTATION", "bates": "FDA-CBER-2021-5683-1149929", "context_preview": "sts are essential to define the scope of the changes being requested. We propose to have these discussions by 24 Sept 2021, based on availability of CBER personnel, and to submit the additional instructions on an agreed upon timeline, but not later than June 2022. Literature References None SUPPORTI", "likely_table": true } ] }, { "filename": "125742_S64_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078716", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078716", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078716", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S67_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078723", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078723", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078723", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S68_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078730", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078730", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078730", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S69_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078737", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078737", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078737", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S6_M5_5314_vr-vtn-10436.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 21, "table_count": 0, "by_category": { "Other / uncategorized": 13, "Trade-secret claim": 8 }, "by_marker": { "(b)(4)": 21 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072369", "context_preview": "he alternative sequence, 2) the codon of the reference and the alternative codon if the nucleotide variant results in a nonsynonymous substitution, and 3) the nucleotide translation and information about the mutation (synonymous, missense plus deletions). For each sample, a whole-genome sequence is ", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072369", "context_preview": "native sequence, 2) the codon of the reference and the alternative codon if the nucleotide variant results in a nonsynonymous substitution, and 3) the nucleotide translation and information about the mutation (synonymous, missense plus deletions). For each sample, a whole-genome sequence is generate", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072369", "context_preview": "equence, 2) the codon of the reference and the alternative codon if the nucleotide variant results in a nonsynonymous substitution, and 3) the nucleotide translation and information about the mutation (synonymous, missense plus deletions). For each sample, a whole-genome sequence is generated in a F", "likely_table": false } ] }, { "filename": "125742_S6_M5_5351_c4591001-sequencing-report.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 9, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072385", "context_preview": "al RNA content (ie, Ct values for both the N and E gene targets >34) were designated \u2018quantity not sufficient\u2019 (QNS). SARS-CoV-2 lineage assignment was based on Pangolin software, which runs a multinomial logistic regression model trained against lineage assignments based on isolate data from GISAID", "likely_table": false }, { "page": 9, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072385", "context_preview": "ontent (ie, Ct values for both the N and E gene targets >34) were designated \u2018quantity not sufficient\u2019 (QNS). SARS-CoV-2 lineage assignment was based on Pangolin software, which runs a multinomial logistic regression model trained against lineage assignments based on isolate data from GISAID, a glob", "likely_table": false }, { "page": 9, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1072385", "context_preview": "ie, Ct values for both the N and E gene targets >34) were designated \u2018quantity not sufficient\u2019 (QNS). SARS-CoV-2 lineage assignment was based on Pangolin software, which runs a multinomial logistic regression model trained against lineage assignments based on isolate data from GISAID, a global scien", "likely_table": false } ] }, { "filename": "125742_S6_M5_c4591001_adxb-sas.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-0950041", "context_preview": "ew; run; *********************************************************************************** *******; * Clean *; *********************************************************************************** *******; proc delete data=work._all_; run; /******Bring in SDTM XB dataset****/ proc sort data= datapro", "likely_table": false } ] }, { "filename": "125742_S70_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078744", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078744", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078744", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S71_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078751", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078751", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078751", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S72_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078758", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078758", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078758", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S73_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078765", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078765", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078765", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S74_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078772", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078772", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078772", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S75_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 7, "table_count": 7, "by_category": { "Other / uncategorized": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078779", "context_preview": "(b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) FDA-CBER-2021-5683-1078779", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078779", "context_preview": "(b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) FDA-CBER-2021-5683-1078779", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078779", "context_preview": "(b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (4) (b) (4) FDA-CBER-2021-5683-1078779", "likely_table": true } ] }, { "filename": "125742_S76_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078786", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078786", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078786", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S77_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078793", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078793", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078793", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S78_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078800", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078800", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078800", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S79_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078807", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078807", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078807", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S7_M5_5351_bnt162-01-interim3-reports.pdf", "module": "M5", "company": "Pfizer", "license": "BLA", "total_kept": 16, "table_count": 15, "by_category": { "Other / uncategorized": 15, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 16 }, "top_examples": [ { "page": 33, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "4.6 \nSARS-CoV-2 S1 and RBD IgG", "bates": "FDA-CBER-2021-5683-0784221", "context_preview": "say buffer manually or by a qualified liquid- handling workstation, and each diluted sample was transferred from the dilution plate to a 96-well assay plate. Sample preparations on the robot consisted of dilutions of each sample ). Three dilutions were used to increase the likelihood that at least o", "likely_table": true }, { "page": 33, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "4.6 \nSARS-CoV-2 S1 and RBD IgG", "bates": "FDA-CBER-2021-5683-0784221", "context_preview": "er manually or by a qualified liquid- handling workstation, and each diluted sample was transferred from the dilution plate to a 96-well assay plate. Sample preparations on the robot consisted of dilutions of each sample ). Three dilutions were used to increase the likelihood that at least one resul", "likely_table": true }, { "page": 33, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "4.6 \nSARS-CoV-2 S1 and RBD IgG", "bates": "FDA-CBER-2021-5683-0784221", "context_preview": "lly or by a qualified liquid- handling workstation, and each diluted sample was transferred from the dilution plate to a 96-well assay plate. Sample preparations on the robot consisted of dilutions of each sample ). Three dilutions were used to increase the likelihood that at least one result for an", "likely_table": true } ] }, { "filename": "125742_S80_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078814", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078814", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078814", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S82_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078821", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078821", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078821", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125742_S85_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 7, "table_count": 7, "by_category": { "Other / uncategorized": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078828", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4), (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078828", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4), (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078828", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (6) (b) (4), (b) (", "likely_table": true } ] }, { "filename": "125742_S89_M1_356h.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 6, "table_count": 6, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078835", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078835", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1078835", "context_preview": "Fresenius Kabi USA LLC Anthony Giessert N/A manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) Hospira Inc. Paul Lucas manufacture, testing and release of diluent (0.9% Sodium chloride Injection, USP) 7 7 (b) (4), (b) (6) (b) (6) (b) (4), (b) (6) (b) (4), (b) (6) (b) (", "likely_table": true } ] }, { "filename": "125752_S10_M1_form-356h-0010.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815447", "context_preview": "A 02026 116912313 Emma Harrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 00", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815448", "context_preview": "000 USA 03801 093149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard ", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815448", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S11_M1_form-356h-0011.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S11_M1_rsp-fda-cmts-ir3-cmc-23sept2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 8, "table_count": 6, "by_category": { "Manufacturing / CMC": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.4.5 Justification of Specification {CX-024414}, 3.2.S.4.5 Justification of Specification", "bates": null, "context_preview": "o continue testing the purity of the mRNA-1273 Drug Product, CX-024414 mRNA and mRNA-1273 LNP in accordance with SOP-0996 until the BLA is approved. Once the BLA is approved, the transition of the purity testing of the mRNA-1273 Drug Product, CX-024414 mRNA and mRNA-1273 LNP from SOP-0996 to SOP-114", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.4.5 Justification of Specification {CX-024414}, 3.2.S.4.5 Justification of Specification", "bates": null, "context_preview": "ue testing the purity of the mRNA-1273 Drug Product, CX-024414 mRNA and mRNA-1273 LNP in accordance with SOP-0996 until the BLA is approved. Once the BLA is approved, the transition of the purity testing of the mRNA-1273 Drug Product, CX-024414 mRNA and mRNA-1273 LNP from SOP-0996 to SOP-1142 will i", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.4.5 Justification of Specification {CX-024414}, 3.2.S.4.5 Justification of Specification", "bates": null, "context_preview": "ng the purity of the mRNA-1273 Drug Product, CX-024414 mRNA and mRNA-1273 LNP in accordance with SOP-0996 until the BLA is approved. Once the BLA is approved, the transition of the purity testing of the mRNA-1273 Drug Product, CX-024414 mRNA and mRNA-1273 LNP from SOP-0996 to SOP-1142 will independe", "likely_table": true } ] }, { "filename": "125752_S11_M1_rsp-fda-cmts-ir6-cmc-28sept2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 19, "table_count": 6, "by_category": { "Manufacturing / CMC": 15, "Trade-secret claim": 4 }, "by_marker": { "(b)(4)": 19 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "section 3.2.S.4.5 Justification of specification). Please provide a justification for this change", "bates": null, "context_preview": "mRNA-1273 Response to Comments on CMC Dated 28 September 2021 Confidential Page 3 Sponsor Response results are available for lots of CX-024414 mRNA following SOP-0491. The is shown in Figure 1. All results are far below the specification limit of (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-C", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "section 3.2.S.4.5 Justification of specification). Please provide a justification for this change", "bates": null, "context_preview": "mRNA-1273 Response to Comments on CMC Dated 28 September 2021 Confidential Page 3 Sponsor Response results are available for lots of CX-024414 mRNA following SOP-0491. The is shown in Figure 1. All results are far below the specification limit of (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-C", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "section 3.2.S.4.5 Justification of specification). Please provide a justification for this change", "bates": null, "context_preview": "mRNA-1273 Response to Comments on CMC Dated 28 September 2021 Confidential Page 3 Sponsor Response results are available for lots of CX-024414 mRNA following SOP-0491. The is shown in Figure 1. All results are far below the specification limit of (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-C", "likely_table": true } ] }, { "filename": "125752_S12_M1_form-356h-0012.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S12_M1_rsp-fda-cmts-ir7-cmc-05oct2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 26, "table_count": 18, "by_category": { "Other / uncategorized": 18, "Trade-secret claim": 5, "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 26 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 05 OCTOBER 2021", "bates": null, "context_preview": "en tests performed both at Moderna TX and Lonza Portsmouth facilities to include the test sample volume, , product lot numbers tested, as well as Sponsor Response The complete verification reports for CX-024414 Bioburden tests performed at ModernaTX, Inc and at Lonza Portsmouth are provided as attac", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 05 OCTOBER 2021", "bates": null, "context_preview": "performed both at Moderna TX and Lonza Portsmouth facilities to include the test sample volume, , product lot numbers tested, as well as Sponsor Response The complete verification reports for CX-024414 Bioburden tests performed at ModernaTX, Inc and at Lonza Portsmouth are provided as attachments as", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 05 OCTOBER 2021", "bates": null, "context_preview": "ed both at Moderna TX and Lonza Portsmouth facilities to include the test sample volume, , product lot numbers tested, as well as Sponsor Response The complete verification reports for CX-024414 Bioburden tests performed at ModernaTX, Inc and at Lonza Portsmouth are provided as attachments as indica", "likely_table": true } ] }, { "filename": "125752_S13_M1_form-356h-0013.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815453", "context_preview": "A 02026 116912313 Emma Harrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 00", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815454", "context_preview": "000 USA 03801 093149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard ", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815454", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S14_M1_cover-0014.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 5, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.7.1", "bates": "FDA-CBER-2022-1614-3815456", "context_preview": "n 3.2.S.7.1 {mRNA-1273 LNP} in BLA 125752 SN002 and executed stability data to be provided on October 15, 2021) x Catalent Vial Line PPQ for 6.3 mL Fill (VPPQ-256-100-00010-P-ADD01 protocol submitted in BLA 125752 SN002, executed PPQ data to be provided on October 15, 2021) As clarified in the Respo", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.7.1", "bates": "FDA-CBER-2022-1614-3815456", "context_preview": ".7.1 {mRNA-1273 LNP} in BLA 125752 SN002 and executed stability data to be provided on October 15, 2021) x Catalent Vial Line PPQ for 6.3 mL Fill (VPPQ-256-100-00010-P-ADD01 protocol submitted in BLA 125752 SN002, executed PPQ data to be provided on October 15, 2021) As clarified in the Response to ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.7.1", "bates": "FDA-CBER-2022-1614-3815456", "context_preview": "NA-1273 LNP} in BLA 125752 SN002 and executed stability data to be provided on October 15, 2021) x Catalent Vial Line PPQ for 6.3 mL Fill (VPPQ-256-100-00010-P-ADD01 protocol submitted in BLA 125752 SN002, executed PPQ data to be provided on October 15, 2021) As clarified in the Response to Informat", "likely_table": true } ] }, { "filename": "125752_S14_M1_form-356h-0014.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815461", "context_preview": "A 02026 116912313 Emma Harrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 00", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815462", "context_preview": "000 USA 03801 093149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard ", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815462", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S14_M1_quality-info-amendment.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 73, "table_count": 69, "by_category": { "Manufacturing / CMC": 64, "Inspection / enforcement": 9 }, "by_marker": { "(b)(4)": 73 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.S.7.2", "bates": "FDA-CBER-2022-1614-3815464", "context_preview": "iation list for Table 4 \u2022 Added Process PPQ lots manufacturing information (Table 18, Table 20, Table 24) \u2022 Updated batch release tables for Process PPQ lots (Table 25 \u2013 Table 28) \u2022 Added Lot 5007421578 stability protocol and reference for -60\u00b0C to -90\u00b0C and 5\u00b0C \u00b1 3\u00b0C storage conditions. (Section 2.", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.S.7.2", "bates": "FDA-CBER-2022-1614-3815464", "context_preview": "ist for Table 4 \u2022 Added Process PPQ lots manufacturing information (Table 18, Table 20, Table 24) \u2022 Updated batch release tables for Process PPQ lots (Table 25 \u2013 Table 28) \u2022 Added Lot 5007421578 stability protocol and reference for -60\u00b0C to -90\u00b0C and 5\u00b0C \u00b1 3\u00b0C storage conditions. (Section 2.3.S.7.1 ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.S.7.2", "bates": "FDA-CBER-2022-1614-3815464", "context_preview": "Table 4 \u2022 Added Process PPQ lots manufacturing information (Table 18, Table 20, Table 24) \u2022 Updated batch release tables for Process PPQ lots (Table 25 \u2013 Table 28) \u2022 Added Lot 5007421578 stability protocol and reference for -60\u00b0C to -90\u00b0C and 5\u00b0C \u00b1 3\u00b0C storage conditions. (Section 2.3.S.7.1 and Sect", "likely_table": true } ] }, { "filename": "125752_S14_M2_23_qos-drug-product.pdf", "module": "M2", "company": "Moderna", "license": "BLA", "total_kept": 113, "table_count": 32, "by_category": { "Manufacturing / CMC": 74, "Other / uncategorized": 22, "Trade-secret claim": 15, "Inspection / enforcement": 2 }, "by_marker": { "(b)(4)": 113 }, "top_examples": [ { "page": 10, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "BLA 125752", "bates": "FDA-CBER-2022-1614-4146568", "context_preview": "ed. Table 4: Properties of mRNA-1273 LNP and DP Solutions Property Nominal 20\uf0b0C Nominal 5\uf0b0C Density (g/mL) Viscosity (cP) Surface tension (mN/m) Osmolality (mOsm/kg) (a) Glass transition temperature (Tg\u2032) (\uf0b0C) Abbreviations: DP = drug product; LNP = lipid nanoparticle; N/A = not applicable a Osmolal", "likely_table": true }, { "page": 10, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "BLA 125752", "bates": "FDA-CBER-2022-1614-4146568", "context_preview": "le 4: Properties of mRNA-1273 LNP and DP Solutions Property Nominal 20\uf0b0C Nominal 5\uf0b0C Density (g/mL) Viscosity (cP) Surface tension (mN/m) Osmolality (mOsm/kg) (a) Glass transition temperature (Tg\u2032) (\uf0b0C) Abbreviations: DP = drug product; LNP = lipid nanoparticle; N/A = not applicable a Osmolality for", "likely_table": true }, { "page": 10, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "BLA 125752", "bates": "FDA-CBER-2022-1614-4146568", "context_preview": "roperties of mRNA-1273 LNP and DP Solutions Property Nominal 20\uf0b0C Nominal 5\uf0b0C Density (g/mL) Viscosity (cP) Surface tension (mN/m) Osmolality (mOsm/kg) (a) Glass transition temperature (Tg\u2032) (\uf0b0C) Abbreviations: DP = drug product; LNP = lipid nanoparticle; N/A = not applicable a Osmolality for releas", "likely_table": true } ] }, { "filename": "125752_S14_M3_32p51_specifications.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 10, "table_count": 10, "by_category": { "Other / uncategorized": 10 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815471", "context_preview": "anion exchange high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; DLS = dynamic light scattering; DSPC = 1,2-distearoyl-sn-glycero-3-phosphocholine; EU = endotoxin unit(s); RP-HPLC = reverse-phase high-performance liquid chromatography", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815471", "context_preview": "xchange high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; DLS = dynamic light scattering; DSPC = 1,2-distearoyl-sn-glycero-3-phosphocholine; EU = endotoxin unit(s); RP-HPLC = reverse-phase high-performance liquid chromatography; RTSS ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815471", "context_preview": "high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; DLS = dynamic light scattering; DSPC = 1,2-distearoyl-sn-glycero-3-phosphocholine; EU = endotoxin unit(s); RP-HPLC = reverse-phase high-performance liquid chromatography; RTSS = revers", "likely_table": true } ] }, { "filename": "125752_S14_M3_32p52_analytical-procedures.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section 3.2.P.5.2 {Container Closure", "bates": "FDA-CBER-2022-1614-3815472", "context_preview": "P.5.2 {Bacterial Endotoxins} Sterility USP <71>, Ph Eur. 2.6.1 Section 3.2.P.5.2{Sterility} Container Closure Integrity Section 3.2.P.5.2 {Container Closure Integrity} Abbreviations: AEX-HPLC = anion exchange high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performanc", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section 3.2.P.5.2 {Container Closure", "bates": "FDA-CBER-2022-1614-3815472", "context_preview": "acterial Endotoxins} Sterility USP <71>, Ph Eur. 2.6.1 Section 3.2.P.5.2{Sterility} Container Closure Integrity Section 3.2.P.5.2 {Container Closure Integrity} Abbreviations: AEX-HPLC = anion exchange high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section 3.2.P.5.2 {Container Closure", "bates": "FDA-CBER-2022-1614-3815472", "context_preview": "Endotoxins} Sterility USP <71>, Ph Eur. 2.6.1 Section 3.2.P.5.2{Sterility} Container Closure Integrity Section 3.2.P.5.2 {Container Closure Integrity} Abbreviations: AEX-HPLC = anion exchange high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromato", "likely_table": false } ] }, { "filename": "125752_S14_M3_32p54_batch-analyses.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 59, "table_count": 26, "by_category": { "Manufacturing / CMC": 49, "Other / uncategorized": 10 }, "by_marker": { "(b)(4)": 59 }, "top_examples": [ { "page": 31, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.4 Batch Analyses", "bates": "FDA-CBER-2022-1614-4146655", "context_preview": "LDP: 7006320006 Abbreviations: AEX = anion exchange chromatography; HPLC = high-performance liquid chromatography; LDP = labeled drug product; RP = reverse phase; UDP =unlabeled drug product a Pivotal Phase 3 clinical study lots. b Test not present on specification for this lot. c RNA Content specif", "likely_table": true }, { "page": 31, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.4 Batch Analyses", "bates": "FDA-CBER-2022-1614-4146655", "context_preview": "6320006 Abbreviations: AEX = anion exchange chromatography; HPLC = high-performance liquid chromatography; LDP = labeled drug product; RP = reverse phase; UDP =unlabeled drug product a Pivotal Phase 3 clinical study lots. b Test not present on specification for this lot. c RNA Content specification ", "likely_table": true }, { "page": 31, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.4 Batch Analyses", "bates": "FDA-CBER-2022-1614-4146655", "context_preview": "Abbreviations: AEX = anion exchange chromatography; HPLC = high-performance liquid chromatography; LDP = labeled drug product; RP = reverse phase; UDP =unlabeled drug product a Pivotal Phase 3 clinical study lots. b Test not present on specification for this lot. c RNA Content specification was for ", "likely_table": true } ] }, { "filename": "125752_S14_M3_32p54_coa-2267-dp-lot-6010721002-023f21a.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 5, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815473", "context_preview": "ty Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 28-Jul-2021 Generated Date: Number: COA-2267 Version: 1.0 Effective Date: 29 Jul 2021", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815473", "context_preview": "ic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 28-Jul-2021 Generated Date: Number: COA-2267 Version: 1.0 Effective Date: 29 Jul 2021 mRNA-12", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815474", "context_preview": "ties % Area 1 % Area 2 % Area 3 % Area 4 % Area 5 % Area 6 % Area 7 % Area 8 % Area 9 % Area 10 RRT 1 Page 2 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 28-Jul-2021 Generated Date: Number: COA-2267 Version: 1.0 Effective Date: 29 Jul 2021", "likely_table": false } ] }, { "filename": "125752_S14_M3_32s41_specification_mrna-1273.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "GROUP-109208", "bates": "FDA-CBER-2022-1614-3815479", "context_preview": "= charged aerosol detection; CFU = colony-forming unit(s); DP = drug product; EU = endotoxin unit(s); HPLC-CAD = high-performance liquid chromatography; IG = impurity group; RP = reverse phase; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; RT = reverse transcription; RT", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "GROUP-109208", "bates": "FDA-CBER-2022-1614-3815479", "context_preview": "d aerosol detection; CFU = colony-forming unit(s); DP = drug product; EU = endotoxin unit(s); HPLC-CAD = high-performance liquid chromatography; IG = impurity group; RP = reverse phase; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; RT = reverse transcription; RTSS = rev", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "GROUP-109208", "bates": "FDA-CBER-2022-1614-3815479", "context_preview": "l detection; CFU = colony-forming unit(s); DP = drug product; EU = endotoxin unit(s); HPLC-CAD = high-performance liquid chromatography; IG = impurity group; RP = reverse phase; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; RT = reverse transcription; RTSS = reverse tra", "likely_table": false } ] }, { "filename": "125752_S14_M3_32s42_analytical-procedures-mrna-1273-lnp.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section 3.2.S.4.2 {mRNA-1273 LNP - Bioburden}", "bates": "FDA-CBER-2022-1614-3815481", "context_preview": "Eur. 2.6.14 Section 3.2.S.4.2 {mRNA-1273 LNP \u2013 Bacterial Endotoxin} Section 3.2.P.5.2 {Bacterial Endotoxin} Bioburden USP <61>, Ph. Eur. 2.6.12 Section 3.2.S.4.2 {mRNA-1273 LNP - Bioburden} Abbreviations: AEX-HPLC = anion exchange high-performance liquid chromatography; DLS = dynamic light scatterin", "likely_table": false } ] }, { "filename": "125752_S14_M3_32s43_val-of-analyt-proc-mrna-1273-lnp.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Section 3.2.S.4.3 {mRNA-1273 LNP - Bioburden}", "bates": "FDA-CBER-2022-1614-3815483", "context_preview": "3.2.P.5.3 {Bacterial Endotoxin} Bioburden USP <61>, Ph. Eur. 2.6.12 Section 3.2.S.4.3 {mRNA-1273 LNP - Bioburden} Abbreviations: AEX-HPLC = anion exchange high-performance liquid chromatography; DLS = dynamic light scattering; RP-IP-HPLC = reverse-phase ion-pair high-performance liquid chromatograph", "likely_table": false } ] }, { "filename": "125752_S14_M3_32s44_coa-01689-cx-024414-mrna-lot-4007921027.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 6, "table_count": 0, "by_category": { "Trade-secret claim": 4, "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 5, "(b)(8)": 1 }, "top_examples": [ { "page": 3, "marker": "(b)(8)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": null, "context_preview": "Number: COA-1689 Version: 1.0 Effective Date: 17 Sep 2021 CX-024414 mRNA Certificate of Analysis Lot 4007921027 (Lonza Lot 996648) Document Approvals Approved Date: 17 Sep 2021 (b) (6) (b) (8)@ modernatx.com) Quality Control Approval 17-Sep-2021 05:54:13 GMT+0000 provall (6) \u00a9) Verdict: Approved (b)", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CERTIFICATE OF ANALYSIS", "bates": null, "context_preview": "Number: COA-1689 Version: 1.0 Effective Date: 17 Sep 2021 CX-024414 mRNA Certificate of Analysis Lot 4007921027 (Lonza Lot 996648) mM O qd a l N Q One Moderna Way + Norwood, MA 02062 aaa a aE eh a Phone 617.714.6500 * Fax 617.583.1998 CERTIFICATE OF ANALYSIS Product Description: CX-024414 Moderna Pa", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": null, "context_preview": "tity Total RNA Content SOP-0995 Total RNA Content Purity SOP-0996 Purity % |G1 % |IG2 % 5' Capped SOP-0997 Cap1 % Poly A Tailed and . Tailless mRNA SOP-0994 % Main Peak Area % Pre-Main Peak Residual DNA template \u00a9 SOP-1020 _ Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacteria", "likely_table": false } ] }, { "filename": "125752_S14_M3_32s44_coa-2921-cx-024414-mrna-lot-4007921028.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 6, "table_count": 0, "by_category": { "Trade-secret claim": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815487", "context_preview": "SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 13-Sep-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-2921 Version: 1.0 Effective Date: 15 Sep 2021 CX-0244", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815487", "context_preview": "pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 13-Sep-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-2921 Version: 1.0 Effective Date: 15 Sep 2021 CX-024414 Certif", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815487", "context_preview": "erial Endotoxins USP <85> Bacterial Endotoxins Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 13-Sep-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-2921 Version: 1.0 Effective Date: 15 Sep 2021 CX-024414 Certificate o", "likely_table": false } ] }, { "filename": "125752_S14_M3_32s44_coa-2980-lot-5008921001.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 9, "table_count": 0, "by_category": { "Manufacturing / CMC": 5, "Trade-secret claim": 4 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815490", "context_preview": "e Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-2980 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815490", "context_preview": "spersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-2980 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lip", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815490", "context_preview": "Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-2980 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lipid Nanopa", "likely_table": false } ] }, { "filename": "125752_S14_M3_32s44_coa-3087-lot-5008921569.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 11, "table_count": 0, "by_category": { "Trade-secret claim": 6, "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815494", "context_preview": "Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3087 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-12", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815494", "context_preview": "persity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3087 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lipi", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815494", "context_preview": "Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3087 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lipid Nanopa", "likely_table": false } ] }, { "filename": "125752_S14_M3_32s44_coa-3131-cx-024414-mrna-lot-4007921029.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 6, "table_count": 0, "by_category": { "Trade-secret claim": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815499", "context_preview": "SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 30-Sep-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3131 Version: 1.0 Effective Date: 01 Oct 2021 CX-0244", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815499", "context_preview": "pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 30-Sep-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3131 Version: 1.0 Effective Date: 01 Oct 2021 CX-024414 Certif", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815499", "context_preview": "erial Endotoxins USP <85> Bacterial Endotoxins Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 30-Sep-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3131 Version: 1.0 Effective Date: 01 Oct 2021 CX-024414 Certificate o", "likely_table": false } ] }, { "filename": "125752_S14_M3_32s44_coa-3134-lot-5008921002.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 11, "table_count": 0, "by_category": { "Trade-secret claim": 9, "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815502", "context_preview": "age 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3143 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lipid Nanoparticle Certificate of Analysis Lot 5008921002 his", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815502", "context_preview": "4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3143 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lipid Nanoparticle Certificate of Analysis Lot 5008921002 his document", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815502", "context_preview": "DENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3143 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lipid Nanoparticle Certificate of Analysis Lot 5008921002 his document copy w", "likely_table": false } ] }, { "filename": "125752_S14_M3_32s44_coa-3136-lot-5008921576.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 12, "table_count": 0, "by_category": { "Trade-secret claim": 7, "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 12 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815507", "context_preview": "Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 30-Sep-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3136 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-12", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815507", "context_preview": "persity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 30-Sep-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3136 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lipi", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815507", "context_preview": "Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 30-Sep-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3136 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lipid Nanopa", "likely_table": false } ] }, { "filename": "125752_S14_M3_32s44_coa-3137-lot-5008921557.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 11, "table_count": 0, "by_category": { "Trade-secret claim": 6, "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815512", "context_preview": "Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3137 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-12", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815512", "context_preview": "persity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3137 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lipi", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815512", "context_preview": "Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3137 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lipid Nanopa", "likely_table": false } ] }, { "filename": "125752_S14_M3_32s44_coa-3150-lot-5008921005.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 11, "table_count": 0, "by_category": { "Trade-secret claim": 8, "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815517", "context_preview": "Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3150 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-12", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815517", "context_preview": "persity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3150 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lipi", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815517", "context_preview": "Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3150 Version: 1.0 Effective Date: 01 Oct 2021 mRNA-1273 Lipid Nanopa", "likely_table": false } ] }, { "filename": "125752_S15_M1_form-356h-0015.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S16_M1_form-356h-0016.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S17_M1_coa-0483-lot-dh-03180-1.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Trade-secret claim": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL-DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815522", "context_preview": ".0 \u2013 Original 2.0 \u2013 Updated retest date to 1 year from DOM 3.0 \u2013 Updated description, part #, and container to align with specification. Added storage condition. 4.0 \u2013 Updated retest date per requalification report MQR-0306 v1.0 Document Number: COA-0483 Version: 4.0 Final Date: Summary of Testing f", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL-DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815522", "context_preview": "ginal 2.0 \u2013 Updated retest date to 1 year from DOM 3.0 \u2013 Updated description, part #, and container to align with specification. Added storage condition. 4.0 \u2013 Updated retest date per requalification report MQR-0306 v1.0 Document Number: COA-0483 Version: 4.0 Final Date: Summary of Testing for CX-02", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL-DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815522", "context_preview": ".0 \u2013 Updated retest date to 1 year from DOM 3.0 \u2013 Updated description, part #, and container to align with specification. Added storage condition. 4.0 \u2013 Updated retest date per requalification report MQR-0306 v1.0 Document Number: COA-0483 Version: 4.0 Final Date: Summary of Testing for CX-024414 Re", "likely_table": false } ] }, { "filename": "125752_S17_M1_coa-2908-ds-lot-4007921039.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CERTIFICATE OF ANALYSIS", "bates": null, "context_preview": "Number: COA-2908 Version: 1.0 Effective Date: 15 Sep 2021 CX-024414 Drug Substance Certificate of Analysis Lot 4007921039 mM O qd \u00a9 l N Q One Moderna Way + Norwood, MA 02062 eee \u2014\u2014 Phone 617.714.6500 * Fax 617.583.1998 CERTIFICATE OF ANALYSIS Product Description: CX-024414 Moderna Part #: 40079 Manu", "likely_table": false } ] }, { "filename": "125752_S17_M1_coa-3019-ds-lot-4007921050.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 6, "table_count": 0, "by_category": { "Trade-secret claim": 3, "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815526", "context_preview": "Residual DNA template SOP-1020 Residual DNA Templat pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 21-Sep-2021 Generated Date: Database: Report: CommonCoA v1 Number: CO", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815526", "context_preview": "DNA template SOP-1020 Residual DNA Templat pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 21-Sep-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3019 Ve", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815526", "context_preview": "plate SOP-1020 Residual DNA Templat pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 21-Sep-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3019 Version: ", "likely_table": false } ] }, { "filename": "125752_S17_M1_coa-3214-dp-lot-7006521151.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 7, "table_count": 0, "by_category": { "Manufacturing / CMC": 5, "Trade-secret claim": 2 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815529", "context_preview": "G3 In vitro Translation SOP-0937 Result White to off-white dispersion. May contain visible, white or translucent product- related particles (Target: 0.20 mg/mL) % Encapsulation 7006521151 031H21A 24Aug2021 70065 10R Velocity Glass Vial, 20 mm Stopper, 20 mm Cap SPC-1128 24Mar2022 Number: COA-3214 Ve", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815529", "context_preview": "tro Translation SOP-0937 Result White to off-white dispersion. May contain visible, white or translucent product- related particles (Target: 0.20 mg/mL) % Encapsulation 7006521151 031H21A 24Aug2021 70065 10R Velocity Glass Vial, 20 mm Stopper, 20 mm Cap SPC-1128 24Mar2022 Number: COA-3214 Version: 1", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815530", "context_preview": "SOP-0288 pH Osmolality SOP-0279 Osmolality Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol DSPC PEG-DMG SM102 Cholesterol DSPC PEG-DMG Lipid Content 7006521151 031H21A 24Aug2021 70065 10R Velocity Glass Vial, 20 mm Stopper, 20 mm Cap SPC-1128 24Mar2022 Number: COA-3214 V", "likely_table": false } ] }, { "filename": "125752_S17_M1_coa-3224-dp-lot-7006521143.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 8, "table_count": 0, "by_category": { "Trade-secret claim": 4, "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815534", "context_preview": "ite to off-white dispersion Essentially Free of Particulates CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Page 1 of 4 Generated Date: 08-Oct-2021 70065 10R Velocity Glass Vial, 20 mm Stopper, 20 mm Cap SPC-1128 01Apr2022 Number: COA-3224 Versio", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815534", "context_preview": "ff-white dispersion Essentially Free of Particulates CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Page 1 of 4 Generated Date: 08-Oct-2021 70065 10R Velocity Glass Vial, 20 mm Stopper, 20 mm Cap SPC-1128 01Apr2022 Number: COA-3224 Version: 1.0 E", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815534", "context_preview": "dispersion Essentially Free of Particulates CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Page 1 of 4 Generated Date: 08-Oct-2021 70065 10R Velocity Glass Vial, 20 mm Stopper, 20 mm Cap SPC-1128 01Apr2022 Number: COA-3224 Version: 1.0 Effective ", "likely_table": false } ] }, { "filename": "125752_S17_M1_coa-3321-ds-lot-4007921054.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 6, "table_count": 0, "by_category": { "Trade-secret claim": 3, "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815539", "context_preview": "esidual DNA template SOP-1020 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 14-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: CO", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815539", "context_preview": "DNA template SOP-1020 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 14-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3321 V", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815539", "context_preview": "late SOP-1020 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 14-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3321 Version: ", "likely_table": false } ] }, { "filename": "125752_S17_M1_coa-3345-dp-lot-7007621154.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 11, "table_count": 0, "by_category": { "Manufacturing / CMC": 7, "Trade-secret claim": 4 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815542", "context_preview": "lt pH SOP-0288 pH Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3345", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815542", "context_preview": "P-0288 pH Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3345 Version", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815542", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Page 1 of 4 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Oct-2021 Generated Date: Database: Report: CommonCoA v1 Number: COA-3345 Version: 1.0 Ef", "likely_table": false } ] }, { "filename": "125752_S17_M1_form-356h-0017.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815550", "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815551", "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815551", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S17_M1_rsp-fda-cmts-cmc-06oct2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 31, "table_count": 28, "by_category": { "Inspection / enforcement": 13, "Other / uncategorized": 9, "Manufacturing / CMC": 9 }, "by_marker": { "(b)(4)": 31 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 06 OCTOBER 2021", "bates": "FDA-CBER-2022-1614-3815553", "context_preview": "s of will be provided. Refer to Summary of Analysis document DSAD-SOA-0285. b. 40 x 300\u00b5L vials of CX-024414 mRNA Reference Material lot DH-03180.1 will be provided (40 vials total for all requests). Refer to certificate of analysis document COA-0483. c. 10 x 100\u00b5L vials of will be provided. d. Uppe", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 06 OCTOBER 2021", "bates": "FDA-CBER-2022-1614-3815553", "context_preview": "ill be provided. Refer to Summary of Analysis document DSAD-SOA-0285. b. 40 x 300\u00b5L vials of CX-024414 mRNA Reference Material lot DH-03180.1 will be provided (40 vials total for all requests). Refer to certificate of analysis document COA-0483. c. 10 x 100\u00b5L vials of will be provided. d. Upper Limi", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 06 OCTOBER 2021", "bates": "FDA-CBER-2022-1614-3815553", "context_preview": "rovided. Refer to Summary of Analysis document DSAD-SOA-0285. b. 40 x 300\u00b5L vials of CX-024414 mRNA Reference Material lot DH-03180.1 will be provided (40 vials total for all requests). Refer to certificate of analysis document COA-0483. c. 10 x 100\u00b5L vials of will be provided. d. Upper Limit backpr", "likely_table": true } ] }, { "filename": "125752_S17_M1_sm-102-coa-cpc-ihrs-0089-batch-al-067-12.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 2, "by_category": { "Other / uncategorized": 2, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "SPECIFICATION LIMIT", "bates": "FDA-CBER-2022-1614-3815562", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) FDA-CBER-2022-1614-3815562", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "SPECIFICATION LIMIT", "bates": "FDA-CBER-2022-1614-3815562", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) FDA-CBER-2022-1614-3815562", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SPECIFICATION LIMIT", "bates": "FDA-CBER-2022-1614-3815561", "context_preview": "Use Instructions: As-is Report ID: 20-2530 TEST METHOD SPECIFICATION LIMIT RESULTS Appearance A/VI Visual ID by 1H-NMR USP <761> EP 2.2.33 JP <2.21> ID by 13C-NMR ID by UPLC-MS R-QCM-2017 ID by IR-Spectrum (ATR) AGM104=05 USP <197-A> Solubility (1% in Ethanol) Visual Purity by UPLC-CAD R-QCM-2007 ID", "likely_table": false } ] }, { "filename": "125752_S18_M1_form-356h-0018.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S19_M1_form-356h-0019.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815567", "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815568", "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815568", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S19_M1_rsp-fda-cmts-ir10-cmc-20oct2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 20, "table_count": 20, "by_category": { "Manufacturing / CMC": 20 }, "by_marker": { "(b)(4)": 20 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 20 OCTOBER 2021", "bates": "FDA-CBER-2022-1614-3815570", "context_preview": "Class VI, non-cytotoxic, USP <661>, non-pyrogenic, and FDA 21CFR 177.1315, and are suitable for use in storage conditions of -100\u00b0 to +100\u00b0C. ITEM 3: Please provide the maximum hold time for each manufacturing step of the linear DNA template and provide the at scale Sponsor Response Linear DNA templ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 20 OCTOBER 2021", "bates": "FDA-CBER-2022-1614-3815570", "context_preview": "I, non-cytotoxic, USP <661>, non-pyrogenic, and FDA 21CFR 177.1315, and are suitable for use in storage conditions of -100\u00b0 to +100\u00b0C. ITEM 3: Please provide the maximum hold time for each manufacturing step of the linear DNA template and provide the at scale Sponsor Response Linear DNA template is ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 20 OCTOBER 2021", "bates": "FDA-CBER-2022-1614-3815570", "context_preview": "-cytotoxic, USP <661>, non-pyrogenic, and FDA 21CFR 177.1315, and are suitable for use in storage conditions of -100\u00b0 to +100\u00b0C. ITEM 3: Please provide the maximum hold time for each manufacturing step of the linear DNA template and provide the at scale Sponsor Response Linear DNA template is a crit", "likely_table": true } ] }, { "filename": "125752_S1_M1_form-356h-0001.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard E Saint Jean Drive 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "tional Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard E Saint Jean Drive 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jea", "likely_table": true } ] }, { "filename": "125752_S1_M4.2.3.2 report-body-5002033.pdf", "module": "M4", "company": "Moderna", "license": "BLA", "total_kept": 172, "table_count": 63, "by_category": { "Other / uncategorized": 161, "Manufacturing / CMC": 4, "Clinical safety / adverse events": 3, "Pharmacology / toxicology": 2, "Inspection / enforcement": 2 }, "by_marker": { "(b)(4)": 172 }, "top_examples": [ { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RESPONSIBLE PERSONNEL", "bates": null, "context_preview": ".2. Individual Scientists (IS) at Test Facility Analytical Chemistry (Concentration and Particle size Analysis) CR MTL, Senneville, QC Ophthalmology CR MTL, Senneville, QC Biomarkers (IL-1\u00df, IL-6, TNF-\u03b1, IP-10, MIP-1-\u03b1, MCP-1) CR MTL, Senneville, QC Immunology (Purity Analysis) CR MTL, Senneville, Q", "likely_table": true }, { "page": 125, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "heir assigned phase of the study, which will be included as an appendix to the Final Report. The phase report will include the following: \uf0b7 The archive site for all records, samples, specimens and reports generated from the phase or segment (alternatively, details regarding the retention of the mate", "likely_table": true }, { "page": 157, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "ase report will include the following: \uf0b7 The archive site for all records, samples, specimens and reports generated from the phase or segment (alternatively, details regarding the retention of the materials may be provided to the Study Director for inclusion in the Final Report) \uf0b7 A listing of criti", "likely_table": true } ] }, { "filename": "125752_S1_M4.2.3.2 report-body-5002034.pdf", "module": "M4", "company": "Moderna", "license": "BLA", "total_kept": 143, "table_count": 73, "by_category": { "Other / uncategorized": 122, "Inspection / enforcement": 21 }, "by_marker": { "(b)(4)": 143 }, "top_examples": [ { "page": 131, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Appendix 1", "bates": null, "context_preview": "r a minimum of 6 months following issuance of the Audited Draft Report after which samples will be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earl", "likely_table": true }, { "page": 131, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Appendix 1", "bates": null, "context_preview": "mum of 6 months following issuance of the Audited Draft Report after which samples will be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier disc", "likely_table": true }, { "page": 131, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Appendix 1", "bates": null, "context_preview": "months following issuance of the Audited Draft Report after which samples will be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of th", "likely_table": true } ] }, { "filename": "125752_S1_M4.2.3.2 report-body-5002045.pdf", "module": "M4", "company": "Moderna", "license": "BLA", "total_kept": 164, "table_count": 77, "by_category": { "Other / uncategorized": 163, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 164 }, "top_examples": [ { "page": 100, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "mples will be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of these residual/retained samples may also be requested and authorized b", "likely_table": true }, { "page": 100, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "ll be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of these residual/retained samples may also be requested and authorized by the St", "likely_table": true }, { "page": 100, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "carded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of these residual/retained samples may also be requested and authorized by the Study Direc", "likely_table": true } ] }, { "filename": "125752_S1_M4.2.3.2 report-body-5002158.pdf", "module": "M4", "company": "Moderna", "license": "BLA", "total_kept": 248, "table_count": 142, "by_category": { "Other / uncategorized": 222, "Inspection / enforcement": 12, "Manufacturing / CMC": 12, "Clinical safety / adverse events": 2 }, "by_marker": { "(b)(4)": 248 }, "top_examples": [ { "page": 128, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Appendix 1", "bates": null, "context_preview": "boratory, the samples will be stored at -80\u00b0C. The samples will be analyzed for rat anti-CMV antibodies using a qualified ELISA method. Any residual/retained samples will be maintained for a minimum of 6 months following issuance of the Audited Draft Report after which samples will be discarded. Alt", "likely_table": true }, { "page": 128, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Appendix 1", "bates": null, "context_preview": ", the samples will be stored at -80\u00b0C. The samples will be analyzed for rat anti-CMV antibodies using a qualified ELISA method. Any residual/retained samples will be maintained for a minimum of 6 months following issuance of the Audited Draft Report after which samples will be discarded. Alternative", "likely_table": true }, { "page": 128, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Appendix 1", "bates": null, "context_preview": "ples will be stored at -80\u00b0C. The samples will be analyzed for rat anti-CMV antibodies using a qualified ELISA method. Any residual/retained samples will be maintained for a minimum of 6 months following issuance of the Audited Draft Report after which samples will be discarded. Alternatively, resid", "likely_table": true } ] }, { "filename": "125752_S1_M4.2.3.2 report-body-5002231.pdf", "module": "M4", "company": "Moderna", "license": "BLA", "total_kept": 154, "table_count": 57, "by_category": { "Other / uncategorized": 148, "Manufacturing / CMC": 4, "Clinical safety / adverse events": 2 }, "by_marker": { "(b)(4)": 154 }, "top_examples": [ { "page": 109, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "mples will be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of these residual/retained samples may also be requested and authorized b", "likely_table": true }, { "page": 109, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "ll be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of these residual/retained samples may also be requested and authorized by the St", "likely_table": true }, { "page": 109, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "carded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of these residual/retained samples may also be requested and authorized by the Study Direc", "likely_table": true } ] }, { "filename": "125752_S1_M4.2.3.2 report-body-5002400.pdf", "module": "M4", "company": "Moderna", "license": "BLA", "total_kept": 92, "table_count": 46, "by_category": { "Other / uncategorized": 67, "Trade-secret claim": 10, "Inspection / enforcement": 7, "Manufacturing / CMC": 5, "Pharmacology / toxicology": 3 }, "by_marker": { "(b)(4)": 92 }, "top_examples": [ { "page": 13, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "COMPLIANCE STATEMENT", "bates": null, "context_preview": "rs (Cytokines Analysis And interpretation) Charles River Laboratories Montreal ULC Sherbrooke Site (CR SHB), Canada Pathology Charles River Laboratories Montreal ULC, Senneville Site (CR MTL), Canada 1.3. PIs at Sponsor-designated Test Site Immunogenicity Battelle Biomedical Research Center (BBRC) C", "likely_table": true }, { "page": 27, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "4.10.2.1\nBlood (target volume of 0.5 mL collected in serum separator tube) was collected from animals", "bates": null, "context_preview": "opathology M F Necropsy Tissue Collection Organ Weights 1 10 10 30 X X X Full Tissuea Full Tissuea 2 10 10 Full Tissuea Gross Lesions Target Tissues 3 10 10 Full Tissuea Gross Lesions Target Tissues 4 10 10 Full Tissuea Full Tissuea 1 5 5 43 X X X Full Tissuea Full Tissuea 4 5 5 Full Tissuea Full Ti", "likely_table": true }, { "page": 27, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "4.10.2.1\nBlood (target volume of 0.5 mL collected in serum separator tube) was collected from animals", "bates": null, "context_preview": "gy M F Necropsy Tissue Collection Organ Weights 1 10 10 30 X X X Full Tissuea Full Tissuea 2 10 10 Full Tissuea Gross Lesions Target Tissues 3 10 10 Full Tissuea Gross Lesions Target Tissues 4 10 10 Full Tissuea Full Tissuea 1 5 5 43 X X X Full Tissuea Full Tissuea 4 5 5 Full Tissuea Full Tissuea X ", "likely_table": true } ] }, { "filename": "125752_S1_M4.2.3.2-report-body-5002033.pdf", "module": "M4", "company": "Moderna", "license": null, "total_kept": 172, "table_count": 63, "by_category": { "Other / uncategorized": 161, "Manufacturing / CMC": 4, "Clinical safety / adverse events": 3, "Pharmacology / toxicology": 2, "Inspection / enforcement": 2 }, "by_marker": { "(b)(4)": 172 }, "top_examples": [ { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RESPONSIBLE PERSONNEL", "bates": null, "context_preview": ".2. Individual Scientists (IS) at Test Facility Analytical Chemistry (Concentration and Particle size Analysis) CR MTL, Senneville, QC Ophthalmology CR MTL, Senneville, QC Biomarkers (IL-1\u00df, IL-6, TNF-\u03b1, IP-10, MIP-1-\u03b1, MCP-1) CR MTL, Senneville, QC Immunology (Purity Analysis) CR MTL, Senneville, Q", "likely_table": true }, { "page": 125, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "heir assigned phase of the study, which will be included as an appendix to the Final Report. The phase report will include the following: \uf0b7 The archive site for all records, samples, specimens and reports generated from the phase or segment (alternatively, details regarding the retention of the mate", "likely_table": true }, { "page": 157, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "ase report will include the following: \uf0b7 The archive site for all records, samples, specimens and reports generated from the phase or segment (alternatively, details regarding the retention of the materials may be provided to the Study Director for inclusion in the Final Report) \uf0b7 A listing of criti", "likely_table": true } ] }, { "filename": "125752_S1_M4.2.3.2-report-body-5002034.pdf", "module": "M4", "company": "Moderna", "license": null, "total_kept": 143, "table_count": 73, "by_category": { "Other / uncategorized": 122, "Inspection / enforcement": 21 }, "by_marker": { "(b)(4)": 143 }, "top_examples": [ { "page": 131, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Appendix 1", "bates": null, "context_preview": "r a minimum of 6 months following issuance of the Audited Draft Report after which samples will be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earl", "likely_table": true }, { "page": 131, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Appendix 1", "bates": null, "context_preview": "mum of 6 months following issuance of the Audited Draft Report after which samples will be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier disc", "likely_table": true }, { "page": 131, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Appendix 1", "bates": null, "context_preview": "months following issuance of the Audited Draft Report after which samples will be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of th", "likely_table": true } ] }, { "filename": "125752_S1_M4.2.3.2-report-body-5002045.pdf", "module": "M4", "company": "Moderna", "license": null, "total_kept": 164, "table_count": 77, "by_category": { "Other / uncategorized": 163, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 164 }, "top_examples": [ { "page": 100, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "mples will be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of these residual/retained samples may also be requested and authorized b", "likely_table": true }, { "page": 100, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "ll be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of these residual/retained samples may also be requested and authorized by the St", "likely_table": true }, { "page": 100, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "carded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of these residual/retained samples may also be requested and authorized by the Study Direc", "likely_table": true } ] }, { "filename": "125752_S1_M4.2.3.2-report-body-5002158.pdf", "module": "M4", "company": "Moderna", "license": null, "total_kept": 248, "table_count": 142, "by_category": { "Other / uncategorized": 222, "Inspection / enforcement": 12, "Manufacturing / CMC": 12, "Clinical safety / adverse events": 2 }, "by_marker": { "(b)(4)": 248 }, "top_examples": [ { "page": 128, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Appendix 1", "bates": null, "context_preview": "boratory, the samples will be stored at -80\u00b0C. The samples will be analyzed for rat anti-CMV antibodies using a qualified ELISA method. Any residual/retained samples will be maintained for a minimum of 6 months following issuance of the Audited Draft Report after which samples will be discarded. Alt", "likely_table": true }, { "page": 128, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Appendix 1", "bates": null, "context_preview": ", the samples will be stored at -80\u00b0C. The samples will be analyzed for rat anti-CMV antibodies using a qualified ELISA method. Any residual/retained samples will be maintained for a minimum of 6 months following issuance of the Audited Draft Report after which samples will be discarded. Alternative", "likely_table": true }, { "page": 128, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "Appendix 1", "bates": null, "context_preview": "ples will be stored at -80\u00b0C. The samples will be analyzed for rat anti-CMV antibodies using a qualified ELISA method. Any residual/retained samples will be maintained for a minimum of 6 months following issuance of the Audited Draft Report after which samples will be discarded. Alternatively, resid", "likely_table": true } ] }, { "filename": "125752_S1_M4.2.3.2-report-body-5002231.pdf", "module": "M4", "company": "Moderna", "license": null, "total_kept": 154, "table_count": 57, "by_category": { "Other / uncategorized": 148, "Manufacturing / CMC": 4, "Clinical safety / adverse events": 2 }, "by_marker": { "(b)(4)": 154 }, "top_examples": [ { "page": 109, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "mples will be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of these residual/retained samples may also be requested and authorized b", "likely_table": true }, { "page": 109, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "ll be discarded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of these residual/retained samples may also be requested and authorized by the St", "likely_table": true }, { "page": 109, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1", "bates": null, "context_preview": "carded. Alternatively, residual/retained samples will be discarded prior to the 6 month period should the issuance of the Final Report occur prior to the end of the 6 month retention period. An earlier discard of these residual/retained samples may also be requested and authorized by the Study Direc", "likely_table": true } ] }, { "filename": "125752_S1_M4.2.3.2-report-body-5002400.pdf", "module": "M4", "company": "Moderna", "license": null, "total_kept": 92, "table_count": 46, "by_category": { "Other / uncategorized": 67, "Trade-secret claim": 10, "Inspection / enforcement": 7, "Manufacturing / CMC": 5, "Pharmacology / toxicology": 3 }, "by_marker": { "(b)(4)": 92 }, "top_examples": [ { "page": 13, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "COMPLIANCE STATEMENT", "bates": null, "context_preview": "rs (Cytokines Analysis And interpretation) Charles River Laboratories Montreal ULC Sherbrooke Site (CR SHB), Canada Pathology Charles River Laboratories Montreal ULC, Senneville Site (CR MTL), Canada 1.3. PIs at Sponsor-designated Test Site Immunogenicity Battelle Biomedical Research Center (BBRC) C", "likely_table": true }, { "page": 27, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "4.10.2.1\nBlood (target volume of 0.5 mL collected in serum separator tube) was collected from animals", "bates": null, "context_preview": "opathology M F Necropsy Tissue Collection Organ Weights 1 10 10 30 X X X Full Tissuea Full Tissuea 2 10 10 Full Tissuea Gross Lesions Target Tissues 3 10 10 Full Tissuea Gross Lesions Target Tissues 4 10 10 Full Tissuea Full Tissuea 1 5 5 43 X X X Full Tissuea Full Tissuea 4 5 5 Full Tissuea Full Ti", "likely_table": true }, { "page": 27, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "4.10.2.1\nBlood (target volume of 0.5 mL collected in serum separator tube) was collected from animals", "bates": null, "context_preview": "gy M F Necropsy Tissue Collection Organ Weights 1 10 10 30 X X X Full Tissuea Full Tissuea 2 10 10 Full Tissuea Gross Lesions Target Tissues 3 10 10 Full Tissuea Gross Lesions Target Tissues 4 10 10 Full Tissuea Full Tissuea 1 5 5 43 X X X Full Tissuea Full Tissuea 4 5 5 Full Tissuea Full Tissuea X ", "likely_table": true } ] }, { "filename": "125752_S1_M4_report-body-20248897 .pdf", "module": "M4", "company": "Moderna", "license": "BLA", "total_kept": 10, "table_count": 0, "by_category": { "Trade-secret claim": 5, "Other / uncategorized": 3, "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 205, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "Appendix 2", "bates": null, "context_preview": "200 Tech Square \u2022 Cambridge MA 02139 phone 617-714-6500 \u2022 fax 617-583-1998 Page 1 of 3 SUMMARY OF ANALYSIS Number: DPAD-00735 Version: 1.0 Approved Date: 05 Jun 2020 Summary of Analysis: Lot DH-03026 Release This copy of the document was retrieved from the system by on 05 Jun 2020 Page 1 of 4 Confid", "likely_table": false }, { "page": 206, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "Appendix 2", "bates": null, "context_preview": "200 Tech Square \u2022 Cambridge MA 02139 phone 617-714-6500 \u2022 fax 617-583-1998 Page 2 of 3 Number: DPAD-00735 Version: 1.0 Approved Date: 05 Jun 2020 Summary of Analysis: Lot DH-03026 Release This copy of the document was retrieved from the system by on 05 Jun 2020 Page 2 of 4 Confidential and Proprie T", "likely_table": false }, { "page": 209, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Appendix 2", "bates": null, "context_preview": "fax 617-583-1998 Page 1 of 1 SUMMARY OF ANALYSIS REVISION HISTORY Revision # Change Details Author Effective Date 1.0 Introduction of a New Document Date of Approval Number: DPAD-00745 Version: 1.0 Approved Date: 08 Jun 2020 Summary of Analysis: Lot DH-03026.2 Formulation Buffer This copy of the doc", "likely_table": false } ] }, { "filename": "125752_S1_M4_report-body-20248897-.pdf", "module": "M4", "company": "Moderna", "license": null, "total_kept": 10, "table_count": 0, "by_category": { "Trade-secret claim": 5, "Other / uncategorized": 3, "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 205, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "Appendix 2", "bates": null, "context_preview": "200 Tech Square \u2022 Cambridge MA 02139 phone 617-714-6500 \u2022 fax 617-583-1998 Page 1 of 3 SUMMARY OF ANALYSIS Number: DPAD-00735 Version: 1.0 Approved Date: 05 Jun 2020 Summary of Analysis: Lot DH-03026 Release This copy of the document was retrieved from the system by on 05 Jun 2020 Page 1 of 4 Confid", "likely_table": false }, { "page": 206, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "Appendix 2", "bates": null, "context_preview": "200 Tech Square \u2022 Cambridge MA 02139 phone 617-714-6500 \u2022 fax 617-583-1998 Page 2 of 3 Number: DPAD-00735 Version: 1.0 Approved Date: 05 Jun 2020 Summary of Analysis: Lot DH-03026 Release This copy of the document was retrieved from the system by on 05 Jun 2020 Page 2 of 4 Confidential and Proprie T", "likely_table": false }, { "page": 209, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Appendix 2", "bates": null, "context_preview": "fax 617-583-1998 Page 1 of 1 SUMMARY OF ANALYSIS REVISION HISTORY Revision # Change Details Author Effective Date 1.0 Introduction of a New Document Date of Approval Number: DPAD-00745 Version: 1.0 Approved Date: 08 Jun 2020 Summary of Analysis: Lot DH-03026.2 Formulation Buffer This copy of the doc", "likely_table": false } ] }, { "filename": "125752_S20_M1_form-356h-0020.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S20_M1_rsp-fda-cmts-ir11-cmc-22oct2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 105, "table_count": 83, "by_category": { "Other / uncategorized": 59, "Trade-secret claim": 39, "Manufacturing / CMC": 5, "Trial design / efficacy": 2 }, "by_marker": { "(b)(4)": 105 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 22 OCTOBER 2021", "bates": null, "context_preview": "Response Factor (RF) of is used for determination of free mRNA. Please provide in detail how the RF was determined. Sponsor Response: The Sponsor performed method development studies to demonstrate that a response factor (RF) was applicable to this assay as shown here in Figure 1. Method development", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 22 OCTOBER 2021", "bates": null, "context_preview": "e Factor (RF) of is used for determination of free mRNA. Please provide in detail how the RF was determined. Sponsor Response: The Sponsor performed method development studies to demonstrate that a response factor (RF) was applicable to this assay as shown here in Figure 1. Method development studie", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 22 OCTOBER 2021", "bates": null, "context_preview": "(RF) of is used for determination of free mRNA. Please provide in detail how the RF was determined. Sponsor Response: The Sponsor performed method development studies to demonstrate that a response factor (RF) was applicable to this assay as shown here in Figure 1. Method development studies perform", "likely_table": true } ] }, { "filename": "125752_S21_M1_form-356h-0021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S22_M1_form-356h-0022.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 4, "table_count": 3, "by_category": { "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815575", "context_preview": "A 02026 116912313 Emma Harrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 00", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815576", "context_preview": "000 USA 03801 093149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard ", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815576", "context_preview": "03801 093149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 0", "likely_table": true } ] }, { "filename": "125752_S23_M1_form-356h-0023.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S24_M1_form-356h-0024.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815582", "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815583", "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815583", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S24_M1_rsp-fda-cmts-ir13-cmc-01nov2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 46, "table_count": 30, "by_category": { "Other / uncategorized": 40, "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 46 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "part of this submission), a review of", "bates": "FDA-CBER-2022-1614-3815595", "context_preview": "ing them aside for Hold Duration Study. The subsequent duration of exposure for Hold study vials was based upon the process duration (Elapsed process time at CRT and 2-8\u00b0C) that they had already experienced by the fill/stopper/cap step. of the vials were held at CRT for an additional period of time,", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "part of this submission), a review of", "bates": "FDA-CBER-2022-1614-3815595", "context_preview": "aside for Hold Duration Study. The subsequent duration of exposure for Hold study vials was based upon the process duration (Elapsed process time at CRT and 2-8\u00b0C) that they had already experienced by the fill/stopper/cap step. of the vials were held at CRT for an additional period of time, until th", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "part of this submission), a review of", "bates": "FDA-CBER-2022-1614-3815595", "context_preview": "or Hold Duration Study. The subsequent duration of exposure for Hold study vials was based upon the process duration (Elapsed process time at CRT and 2-8\u00b0C) that they had already experienced by the fill/stopper/cap step. of the vials were held at CRT for an additional period of time, until their tot", "likely_table": true } ] }, { "filename": "125752_S24_M1_rsp-fda-cmts-ir9-cmc-14oct2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 26, "table_count": 17, "by_category": { "Manufacturing / CMC": 21, "Other / uncategorized": 5 }, "by_marker": { "(b)(4)": 26 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 14 OCTOBER 2021", "bates": "FDA-CBER-2022-1614-3815585", "context_preview": "ill remain above the shelf life purity limit through the end of shelf life. Thus, the extended PARs for CPD and TOR prior to release testing do not increase the risk of DP lots failing during shelf life. As discussed in Section 3.2.P.5.6.2.4, the projected purity ranged from at the point of administ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 14 OCTOBER 2021", "bates": "FDA-CBER-2022-1614-3815585", "context_preview": "ain above the shelf life purity limit through the end of shelf life. Thus, the extended PARs for CPD and TOR prior to release testing do not increase the risk of DP lots failing during shelf life. As discussed in Section 3.2.P.5.6.2.4, the projected purity ranged from at the point of administration ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "RESPONSE TO FDA COMMENTS ON CMC RECEIVED ON 14 OCTOBER 2021", "bates": "FDA-CBER-2022-1614-3815585", "context_preview": "e the shelf life purity limit through the end of shelf life. Thus, the extended PARs for CPD and TOR prior to release testing do not increase the risk of DP lots failing during shelf life. As discussed in Section 3.2.P.5.6.2.4, the projected purity ranged from at the point of administration in the P", "likely_table": true } ] }, { "filename": "125752_S24_M3_32p51_specifications.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 8, "table_count": 8, "by_category": { "Other / uncategorized": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815632", "context_preview": "anion exchange high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; DLS = dynamic light scattering; DSPC = 1,2-distearoyl-sn-glycero-3-phosphocholine; EU = endotoxin unit(s); RP-HPLC = reverse-phase high-performance liquid chromatography", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815632", "context_preview": "xchange high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; DLS = dynamic light scattering; DSPC = 1,2-distearoyl-sn-glycero-3-phosphocholine; EU = endotoxin unit(s); RP-HPLC = reverse-phase high-performance liquid chromatography; RTSS ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815632", "context_preview": "high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; DLS = dynamic light scattering; DSPC = 1,2-distearoyl-sn-glycero-3-phosphocholine; EU = endotoxin unit(s); RP-HPLC = reverse-phase high-performance liquid chromatography; RTSS = revers", "likely_table": true } ] }, { "filename": "125752_S24_M3_32p8_stability-summary.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 26, "table_count": 6, "by_category": { "Other / uncategorized": 20, "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 26 }, "top_examples": [ { "page": 14, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.1.2", "bates": "FDA-CBER-2022-1614-3815614", "context_preview": "frozen state to storage at 5\u00b0C. DP lots that were conditioned at -70\u00b0C or at -20\u00b0C for up to 2 months and then moved to storage at 5\u00b0C remained in specification for at least 3 months at 5\u00b0C. Supporting stability data also demonstrate that storage of the vials at 25\u00b0C following the end-to- end studie", "likely_table": true }, { "page": 14, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.1.2", "bates": "FDA-CBER-2022-1614-3815614", "context_preview": "state to storage at 5\u00b0C. DP lots that were conditioned at -70\u00b0C or at -20\u00b0C for up to 2 months and then moved to storage at 5\u00b0C remained in specification for at least 3 months at 5\u00b0C. Supporting stability data also demonstrate that storage of the vials at 25\u00b0C following the end-to- end studies for u", "likely_table": true }, { "page": 14, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.1.2", "bates": "FDA-CBER-2022-1614-3815614", "context_preview": "storage at 5\u00b0C. DP lots that were conditioned at -70\u00b0C or at -20\u00b0C for up to 2 months and then moved to storage at 5\u00b0C remained in specification for at least 3 months at 5\u00b0C. Supporting stability data also demonstrate that storage of the vials at 25\u00b0C following the end-to- end studies for up to 72 h", "likely_table": true } ] }, { "filename": "125752_S25_M1_form-356h-0025.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815639", "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815640", "context_preview": "93149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815640", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S25_M1_rsp-to-discu-pnts-moderna-fda-inspectn-25-29oct2021-norwood.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 111, "table_count": 66, "by_category": { "Other / uncategorized": 111 }, "by_marker": { "(b)(4)": 111 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-4146667", "context_preview": "3 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-4146667", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-4146667", "context_preview": "3 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-4146667", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-4146667", "context_preview": "3 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-4146667", "likely_table": true } ] }, { "filename": "125752_S26_M1_form-356h-0026.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815646", "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815647", "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815647", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S26_M1_rsp-fda-cmts-ir18-cmc-10nov2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 38, "table_count": 6, "by_category": { "Trade-secret claim": 27, "Manufacturing / CMC": 11 }, "by_marker": { "(b)(4)": 38 }, "top_examples": [ { "page": 16, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815664", "context_preview": "fidential Page 16 ITEM 12: Bridge Study Report QC-OTH-0801: SOP-0996 and SOP-1142: Regarding the comparability or results from SOP 0996 and SOP 1142, although the calculations for RNA purity (main peak) and for provide results for SOP 1142 than for SOP 0996, the release and stability acceptance crit", "likely_table": true }, { "page": 16, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815664", "context_preview": "l Page 16 ITEM 12: Bridge Study Report QC-OTH-0801: SOP-0996 and SOP-1142: Regarding the comparability or results from SOP 0996 and SOP 1142, although the calculations for RNA purity (main peak) and for provide results for SOP 1142 than for SOP 0996, the release and stability acceptance criteria for", "likely_table": true }, { "page": 16, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815664", "context_preview": "16 ITEM 12: Bridge Study Report QC-OTH-0801: SOP-0996 and SOP-1142: Regarding the comparability or results from SOP 0996 and SOP 1142, although the calculations for RNA purity (main peak) and for provide results for SOP 1142 than for SOP 0996, the release and stability acceptance criteria for RNA pu", "likely_table": true } ] }, { "filename": "125752_S27_M1_form-356h-0027.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S28_M1_form-356h-0028.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "93149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S29_M1_form-356h-0029.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815674", "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815675", "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815675", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S29_M1_rsp-fda-cmts-ir25-cmc-29nov2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 31, "table_count": 28, "by_category": { "Manufacturing / CMC": 16, "Other / uncategorized": 15 }, "by_marker": { "(b)(4)": 31 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.S.2.5", "bates": "FDA-CBER-2022-1614-3815677", "context_preview": "have the following questions: The following comments pertain to the : ITEM 1: Sponsor Response: Section 3.2.S.4.4 has been updated with the requested information. ITEM 2: a. b. c. Sponsor Response: Moderna will update the appropriate documents, Section 3.2.S.2.2 and Section 3.2.S.2.5 with a maximum ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.S.2.5", "bates": "FDA-CBER-2022-1614-3815677", "context_preview": "following questions: The following comments pertain to the : ITEM 1: Sponsor Response: Section 3.2.S.4.4 has been updated with the requested information. ITEM 2: a. b. c. Sponsor Response: Moderna will update the appropriate documents, Section 3.2.S.2.2 and Section 3.2.S.2.5 with a maximum hold time", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.S.2.5", "bates": "FDA-CBER-2022-1614-3815677", "context_preview": "ng questions: The following comments pertain to the : ITEM 1: Sponsor Response: Section 3.2.S.4.4 has been updated with the requested information. ITEM 2: a. b. c. Sponsor Response: Moderna will update the appropriate documents, Section 3.2.S.2.2 and Section 3.2.S.2.5 with a maximum hold time of whi", "likely_table": true } ] }, { "filename": "125752_S29_M3_32p31_manufacturers.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DUNS 116912313", "bates": "FDA-CBER-2022-1614-3815841", "context_preview": "X, Inc. One Moderna Way Norwood, MA 02062 FEI 3014937058 DUNS 116912313 Release and stability testing (excluding bacterial endotoxin and sterility testing) Lot Release ModernaTX, Inc. (Quality Control Laboratory Annex) 210 Rustcraft Road Dedham, MA 02062 FEI 3014937058 DUNS 116912313 Release and sta", "likely_table": false } ] }, { "filename": "125752_S29_M3_32p8_6007320005-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 13, "table_count": 0, "by_category": { "Manufacturing / CMC": 13 }, "by_marker": { "(b)(4)": 13 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815681", "context_preview": "NT* - - Cholesterol - NT* - - DSPC - NT* - - PEG2000-DMG - NT* - - SM-102 - NT* - - Cholesterol - NT* - - DSPC - NT* - - PEG2000-DMG - NT* - - - NT* - - - NT* - - Lipid Identification Lipid Content UPLC-CAD Lipid Impurities UPLC-CAD UPLC-CAD Dynamic light scattering Number: QCR-0185 Version: 1.0 App", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815681", "context_preview": "Cholesterol - NT* - - DSPC - NT* - - PEG2000-DMG - NT* - - SM-102 - NT* - - Cholesterol - NT* - - DSPC - NT* - - PEG2000-DMG - NT* - - - NT* - - - NT* - - Lipid Identification Lipid Content UPLC-CAD Lipid Impurities UPLC-CAD UPLC-CAD Dynamic light scattering Number: QCR-0185 Version: 1.0 Approved Da", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815682", "context_preview": "Not Tested, Refer to QE-005517 ; NT**: Not Tested, Refer to QE-008189; \"-\": Not applicable per the stability protocol Future Timepoint a % RNA Encapsulation method changed from ) during the study. Methods are equivalent. Particulate Matter USP <788> Method 2 Number: QCR-0185 Version: 1.0 Approved Da", "likely_table": false } ] }, { "filename": "125752_S29_M3_32p8_6007320010-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815692", "context_preview": "P <791> - - Particle Size NT** Polydispersity NT** SM-102 - - Cholesterol - - DSPC - - PEG2000-DMG - - SM-102 - - Cholesterol - - DSPC - - PEG2000-DMG - - - - - - Dynamic light scattering Lipid Identification UPLC-CAD UPLC-CAD Lipid Impurities UPLC-CAD Lipid Content Number: QCR-0204 Version: 1.0 App", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815691", "context_preview": "t-related particulates Essentially free of particulates - - RNA Content AEX-HPLC - - Purity RP-HPLC NT** NT** NT** NT** % RNA Encapsulation - - In vitro Translation In vitro translation / methionine labelling - - Appearance Visual Product-related Impurities RP-HPLC Number: QCR-0204 Version: 1.0 Appr", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815691", "context_preview": "d particulates Essentially free of particulates - - RNA Content AEX-HPLC - - Purity RP-HPLC NT** NT** NT** NT** % RNA Encapsulation - - In vitro Translation In vitro translation / methionine labelling - - Appearance Visual Product-related Impurities RP-HPLC Number: QCR-0204 Version: 1.0 Approved Dat", "likely_table": false } ] }, { "filename": "125752_S29_M3_32p8_6007520002-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 58, "table_count": 27, "by_category": { "Manufacturing / CMC": 58 }, "by_marker": { "(b)(4)": 58 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815697", "context_preview": "es - UPLC-CAD NT* NT* - - - NT* NT* NT* NT* - 2 Months 3 Months 6 Months 9 Months 12 Months Table 1: Stability Data for Product 60075, Lot 6007520002 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Release 1 Month USP <791> - Lipid Content Lipid Identification Number: QCR-0167 Version: 2.0 Approved ", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815697", "context_preview": "C-CAD NT* NT* - - - NT* NT* NT* NT* - 2 Months 3 Months 6 Months 9 Months 12 Months Table 1: Stability Data for Product 60075, Lot 6007520002 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Release 1 Month USP <791> - Lipid Content Lipid Identification Number: QCR-0167 Version: 2.0 Approved Date: 13", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815697", "context_preview": "* NT* - - - NT* NT* NT* NT* - 2 Months 3 Months 6 Months 9 Months 12 Months Table 1: Stability Data for Product 60075, Lot 6007520002 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Release 1 Month USP <791> - Lipid Content Lipid Identification Number: QCR-0167 Version: 2.0 Approved Date: 13 Oct 202", "likely_table": true } ] }, { "filename": "125752_S29_M3_32p8_6007520003-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 72, "table_count": 48, "by_category": { "Manufacturing / CMC": 72 }, "by_marker": { "(b)(4)": 72 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815720", "context_preview": "NT* - - NT* - - NT* - NT* NT* - - - NT* NT* - USP <791> NT* NT* Table 1: Stability Data for Product 60075, Lot 6007520003 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Acceptance Criteria Release 1 Month 2 Months 3 Months Lipid Content Lipid Identification Number: QCR-0168 Version: 2.0 Approved Da", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815720", "context_preview": "NT* - - NT* - NT* NT* - - - NT* NT* - USP <791> NT* NT* Table 1: Stability Data for Product 60075, Lot 6007520003 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Acceptance Criteria Release 1 Month 2 Months 3 Months Lipid Content Lipid Identification Number: QCR-0168 Version: 2.0 Approved Date: 13 O", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815720", "context_preview": "NT* - NT* NT* - - - NT* NT* - USP <791> NT* NT* Table 1: Stability Data for Product 60075, Lot 6007520003 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Acceptance Criteria Release 1 Month 2 Months 3 Months Lipid Content Lipid Identification Number: QCR-0168 Version: 2.0 Approved Date: 13 Oct 2021 ", "likely_table": true } ] }, { "filename": "125752_S29_M3_32p8_6007920003-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 9, "table_count": 0, "by_category": { "Manufacturing / CMC": 9 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815746", "context_preview": "esterol - - DSPC - - PEG2000-DMG - - - - - - NT*: Not Tested, Refer to QE-005517 \"-\": Not applicable per the stability protocol NT**: Not Tested, Refer to QE-008189 Lipid Identification UPLC-CAD Lipid Content UPLC-CAD Lipid Impurities UPLC-CAD Dynamic light scattering Number: QCR-0207 Version: 1.0 A", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815746", "context_preview": "- - DSPC - - PEG2000-DMG - - - - - - NT*: Not Tested, Refer to QE-005517 \"-\": Not applicable per the stability protocol NT**: Not Tested, Refer to QE-008189 Lipid Identification UPLC-CAD Lipid Content UPLC-CAD Lipid Impurities UPLC-CAD Dynamic light scattering Number: QCR-0207 Version: 1.0 Approved ", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815746", "context_preview": "- - PEG2000-DMG - - - - - - NT*: Not Tested, Refer to QE-005517 \"-\": Not applicable per the stability protocol NT**: Not Tested, Refer to QE-008189 Lipid Identification UPLC-CAD Lipid Content UPLC-CAD Lipid Impurities UPLC-CAD Dynamic light scattering Number: QCR-0207 Version: 1.0 Approved Date: 18 ", "likely_table": false } ] }, { "filename": "125752_S29_M3_32p8_6008221002-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 7, "table_count": 0, "by_category": { "Manufacturing / CMC": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815751", "context_preview": "esterol DSPC PEG2000-DMG - Lipid Content Lipid Impurities UPLC-CAD - UPLC-CAD - - - - USP <791> - Dynamic light scattering Table 1: Stability Data for Product 60082, Lot 6008221002 at -20\u00b0C \u00b1 5\u00b0C (continued) 3 Months Method Release 6 Months 12 Months Number: QCR-0202 Version: 1.0 Approved Date: 13 O", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815755", "context_preview": "able 3: Stability Data for Product 60082, Lot 6008221002 at 5\u00b0C \u00b1 3\u00b0C (continued) Lipid Content \" - \": Not applicable per the stability protocol NR: No result reported. See next timepoint to bracket result. UPLC-CAD Method Release 1 Month 3 Months Number: QCR-0202 Version: 1.0 Approved Date: 13 Oct ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815750", "context_preview": "White to off-white dispersion - Table 1: Stability Data for Product 60082, Lot 6008221002 at -20\u00b0C \u00b1 5\u00b0C Method Release 3 Months 6 Months 12 Months Essentially free of particulates - Manufacturing Date: Construct/mRNA Code: Manufacturing Site: Number: QCR-0202 Version: 1.0 Approved Date: 13 Oct 2021", "likely_table": false } ] }, { "filename": "125752_S29_M3_32p8_6008221003-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 7, "table_count": 0, "by_category": { "Manufacturing / CMC": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815759", "context_preview": "esterol DSPC PEG2000-DMG Table 1: Stability Data for Product 60082, Lot 6008221003 at -20\u00b0C \u00b1 5\u00b0C (continued) Lipid Content - - - - Dynamic light scattering USP <791> - Method Release 3 Months 6 Months 12 Months Lipid Impurities UPLC-CAD - UPLC-CAD - Number: QCR-0203 Version: 1.0 Approved Date: 14 O", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815763", "context_preview": "xt timepoint to bracket result. UPLC-CAD - - - - - USP <791> - Method Release 1 Month 3 Months Table 3: Stability Data for Product 60082, Lot 6008221003 at 5\u00b0C \u00b1 3\u00b0C (continued) Dynamic light scattering NR NR - Lipid Content UPLC-CAD Lipid Impurities Number: QCR-0203 Version: 1.0 Approved Date: 14 O", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815758", "context_preview": "Stopper, 20 mm Cap Essentially free of particulates - 12 Months 3 Months 6 Months 2-Apr-21 mRNA-1273 Stability Study Lot Number: Product: Bloomington, IN Appearance Visual White to off-white dispersion - AEX-HPLC - RP-HPLC Product-related Impurities Number: QCR-0203 Version: 1.0 Approved Date: 14 Oc", "likely_table": false } ] }, { "filename": "125752_S29_M3_32p8_6008520001-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 10, "table_count": 0, "by_category": { "Manufacturing / CMC": 10 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815767", "context_preview": "lesterol - DSPC - PEG2000-DMG - SM-102 - Cholesterol - DSPC - PEG2000-DMG - - - Table 1: Stability Data for Product 60085, Lot 6008520001 at -20\u00b0C \u00b1 5\u00b0C (continued) Lipid Identification Lipid Content Dynamic light scattering UPLC-CAD UPLC-CAD Lipid Impurities UPLC-CAD Number: QCR-0195 Version: 1.0 A", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815767", "context_preview": "- DSPC - PEG2000-DMG - SM-102 - Cholesterol - DSPC - PEG2000-DMG - - - Table 1: Stability Data for Product 60085, Lot 6008520001 at -20\u00b0C \u00b1 5\u00b0C (continued) Lipid Identification Lipid Content Dynamic light scattering UPLC-CAD UPLC-CAD Lipid Impurities UPLC-CAD Number: QCR-0195 Version: 1.0 Approved D", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815771", "context_preview": "le per the stability protocol a Assays were initiated outside of the 14-day test window (QE-008191) Table 3: Stability Data for Product 60085, Lot 6008520001 at 5\u00b0C \u00b1 3\u00b0C (continued) Dynamic light scattering Lipid Identification UPLC-CAD UPLC-CAD Lipid Content UPLC-CAD Number: QCR-0195 Version: 1.0 ", "likely_table": false } ] }, { "filename": "125752_S29_M3_32p8_6008921001-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 8, "table_count": 0, "by_category": { "Manufacturing / CMC": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815775", "context_preview": "sterol DSPC PEG2000-DMG Lipid Content - - Method Release 3 Months 6 Months 12 Months - Lipid Impurities UPLC-CAD - - UPLC-CAD Table 1: Stability Data for Product 60089, Lot 6008921001 at -20\u00b0C \u00b1 5\u00b0C (Continued) Dynamic light scattering USP <791> - - Number: QCR-0187 Version: 1.0 Approved Date: 13 Oc", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815779", "context_preview": "purities UPLC-CAD - - UPLC-CAD - Dynamic light scattering Table 3: Stability Data for Product 60089, Lot 6008921001 at 5\u00b0C \u00b1 3\u00b0C (Continued) Method Release 1 Month 3 Month USP <791> - USP <1207> - - - USP <71>, Ph. Eur. 2.6.1 - - Lipid Content - - Number: QCR-0187 Version: 1.0 Approved Date: 13 Oct ", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815779", "context_preview": "UPLC-CAD - - UPLC-CAD - Dynamic light scattering Table 3: Stability Data for Product 60089, Lot 6008921001 at 5\u00b0C \u00b1 3\u00b0C (Continued) Method Release 1 Month 3 Month USP <791> - USP <1207> - - - USP <71>, Ph. Eur. 2.6.1 - - Lipid Content - - Number: QCR-0187 Version: 1.0 Approved Date: 13 Oct 2021 Stab", "likely_table": false } ] }, { "filename": "125752_S29_M3_32p8_6009821002-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815783", "context_preview": "ersity Lipid Content SM-102 Cholesterol DSPC PEG2000-DMG Table 1: Stability Data for Product 60098, Lot 6009821002 at -20\u00b0C \u00b1 5\u00b0C (Continued) Dynamic light scattering USP <791> - - Lipid Impurities Method Release 3 Months 6 Months 12 Months UPLC-CAD - - - UPLC-CAD - - Number: QCR-0196 Version: 1.0 A", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815787", "context_preview": "1>, Ph. Eur. 2.6.1 - - Lipid Content - NT* - Lipid Impurities UPLC-CAD - NT* - NT* UPLC-CAD NT* 1 Month 3 Months USP <791> - - NT* - NT* Dynamic light scattering NT* NT* Table 3: Stability Data for Product 60098, Lot 6009821002 at 5\u00b0C \u00b1 3\u00b0C (Continued) Method Release Number: QCR-0196 Version: 1.0 Ap", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815782", "context_preview": "ble 1: Stability Data for Product 60098, Lot 6009821002 at -20\u00b0C \u00b1 5\u00b0C Method Release 3 Months 6 Months 12 Months Appearance RP-HPLC Essentially free of particulates - In vitro translation / methionine labelling - Visual White to off-white dispersion - AEX-HPLC - - Number: QCR-0196 Version: 1.0 Appr", "likely_table": false } ] }, { "filename": "125752_S29_M3_32p8_6009921006-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815791", "context_preview": "lesterol DSPC PEG2000-DMG USP <791> - Table 1: Stability Data for Product 60099, Lot 6009921006 at -20\u00b0C \u00b1 5\u00b0C (Continued) - Method Release 3 Months 6 Months 12 Months Dynamic light scattering UPLC-CAD - - - - Lipid Impurities - UPLC-CAD Lipid Content Number: QCR-0188 Version: 1.0 Approved Date: 13 ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815790", "context_preview": "itro translation / methionine labelling - Appearance - - STY_01066 6009921006 (7007621030) 60099 10R Ompi Glass Vial, 20 mm Stopper, 20 mm Cap Manufacturing Date: Manufacturing Site: 27-Apr-21 mRNA-1273 Catalent, Bloomington, IN Construct/mRNA Code: Number: QCR-0188 Version: 1.0 Approved Date: 13 Oc", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815790", "context_preview": "anslation / methionine labelling - Appearance - - STY_01066 6009921006 (7007621030) 60099 10R Ompi Glass Vial, 20 mm Stopper, 20 mm Cap Manufacturing Date: Manufacturing Site: 27-Apr-21 mRNA-1273 Catalent, Bloomington, IN Construct/mRNA Code: Number: QCR-0188 Version: 1.0 Approved Date: 13 Oct 2021 ", "likely_table": false } ] }, { "filename": "125752_S29_M3_32p8_6010121002-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 7, "table_count": 0, "by_category": { "Manufacturing / CMC": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815796", "context_preview": "C PEG2000-DMG SM-102 - - Dynamic light scattering UPLC-CAD - - - Release 3 Months 6 Months 12 Months Table 1: Stability Data for Product 60101, Lot 6010121002 at -20\u00b0C \u00b1 5\u00b0C (continued) Method USP <791> - Lipid Content Lipid Impurities UPLC-CAD - Number: QCR-0205 Version: 1.0 Approved Date: 15 Oct 2", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815797", "context_preview": "the stability protocol Future Timepoint USP <71>, Ph. Eur. 2.6.1 - - USP <788> Method 2 - - - - Particulate Matter Table 1: Stability Data for Product 60101, Lot 6010121002 at -20\u00b0C \u00b1 5\u00b0C (continued) Method Release 3 Months 6 Months 12 Months Number: QCR-0205 Version: 1.0 Approved Date: 15 Oct 2021 ", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815800", "context_preview": "SP <791> - Lipid Impurities UPLC-CAD - - Dynamic light scattering - - - NT*: Not Tested. Refer to QE-008189. \" - \": Not applicable per the stability protocol a Purity result fell outside of the reference acceptance criteria Lipid Content UPLC-CAD - Number: QCR-0205 Version: 1.0 Approved Date: 15 Oct", "likely_table": false } ] }, { "filename": "125752_S29_M3_32p8_stability-data.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 8, "table_count": 6, "by_category": { "Other / uncategorized": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "8.0 \nCorning Valor 10R", "bates": "FDA-CBER-2022-1614-3815807", "context_preview": "licate glass vials -20 \u00b1 5\u00b0C 12 months 3 months 6010121002 5 \u00b1 3\u00b0C 3 months 3 months 6008221002 Scale B Baxter (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 3 months 6008221002 5 \u00b1 3\u00b0C 3 months 3 months 6008221003 Scale B Baxter (Vial Line 8.0 Corning Valor 1", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "8.0 \nCorning Valor 10R", "bates": "FDA-CBER-2022-1614-3815807", "context_preview": "lass vials -20 \u00b1 5\u00b0C 12 months 3 months 6010121002 5 \u00b1 3\u00b0C 3 months 3 months 6008221002 Scale B Baxter (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 3 months 6008221002 5 \u00b1 3\u00b0C 3 months 3 months 6008221003 Scale B Baxter (Vial Line 8.0 Corning Valor 10R clear", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "8.0 \nCorning Valor 10R", "bates": "FDA-CBER-2022-1614-3815807", "context_preview": "ls -20 \u00b1 5\u00b0C 12 months 3 months 6010121002 5 \u00b1 3\u00b0C 3 months 3 months 6008221002 Scale B Baxter (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 3 months 6008221002 5 \u00b1 3\u00b0C 3 months 3 months 6008221003 Scale B Baxter (Vial Line 8.0 Corning Valor 10R clear alumino", "likely_table": true } ] }, { "filename": "125752_S29_M3_32p8_stability-summary.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 29, "table_count": 12, "by_category": { "Other / uncategorized": 18, "Manufacturing / CMC": 11 }, "by_marker": { "(b)(4)": 29 }, "top_examples": [ { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "8.0 \nCorning Valor 10R", "bates": "FDA-CBER-2022-1614-3815820", "context_preview": "010121002 Scale B Catalent Biologics, LLC (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 5 \u00b1 3\u00b0C 3 months 6008221002 Scale B Baxter (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 5 \u00b1 3\u00b0C 3 months 6008221003 Scale B Baxte", "likely_table": true }, { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "8.0 \nCorning Valor 10R", "bates": "FDA-CBER-2022-1614-3815820", "context_preview": "2 Scale B Catalent Biologics, LLC (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 5 \u00b1 3\u00b0C 3 months 6008221002 Scale B Baxter (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 5 \u00b1 3\u00b0C 3 months 6008221003 Scale B Baxter (Vial ", "likely_table": true }, { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "8.0 \nCorning Valor 10R", "bates": "FDA-CBER-2022-1614-3815820", "context_preview": "B Catalent Biologics, LLC (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 5 \u00b1 3\u00b0C 3 months 6008221002 Scale B Baxter (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 5 \u00b1 3\u00b0C 3 months 6008221003 Scale B Baxter (Vial Line 8.0", "likely_table": true } ] }, { "filename": "125752_S2_M1_form-356h-0002.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3814901", "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3814902", "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3814902", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S2_M3_32a2_adventitious-agents-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.A.2 \nAdventitious Agents Safety Evaluation", "bates": "FDA-CBER-2022-1614-3814904", "context_preview": "ModernaTX, Inc. mRNA-1273 3.2.A.2 Adventitious Agents Safety Evaluation BLA 125752 Confidential Page 1 3.2.A.2 Adventitious Agents Safety Evaluation There are no materials of animal or human origin used in the manufacture of the mRNA-1273 Drug Product (DP). Document Number: VV-QUAL-003715 eDMS Versi", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p1_description-and-composition.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 5, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT", "bates": "FDA-CBER-2022-1614-3814906", "context_preview": "24414 mRNA and mg of SM-102 LNP as a white to off-white dispersion in a preservative-free buffer containing 20 mM Tromethamine (Tris), acetate, 87 g/L sucrose at pH 7.5. The target fill volume is 8.0 mL, which allows removal of a maximum of 15 doses (0.5 mL per dose) per vial. The label fill volume ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT", "bates": "FDA-CBER-2022-1614-3814906", "context_preview": "NA and mg of SM-102 LNP as a white to off-white dispersion in a preservative-free buffer containing 20 mM Tromethamine (Tris), acetate, 87 g/L sucrose at pH 7.5. The target fill volume is 8.0 mL, which allows removal of a maximum of 15 doses (0.5 mL per dose) per vial. The label fill volume is 7.5 m", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT", "bates": "FDA-CBER-2022-1614-3814906", "context_preview": "mg of SM-102 LNP as a white to off-white dispersion in a preservative-free buffer containing 20 mM Tromethamine (Tris), acetate, 87 g/L sucrose at pH 7.5. The target fill volume is 8.0 mL, which allows removal of a maximum of 15 doses (0.5 mL per dose) per vial. The label fill volume is 7.5 mL. Deta", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p3_manufacturers.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DUNS 116912313", "bates": "FDA-CBER-2022-1614-3814909", "context_preview": "esting of drug product (bacterial endotoxin) ModernaTX, Inc. One Moderna Way Norwood, MA 02062 FEI 3014937058 DUNS 116912313 Release and stability testing (excluding bacterial endotoxin and sterility testing) Lot Release ModernaTX, Inc. (Quality Control Laboratory Annex) 210 Rustcraft Road Dedham, M", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p51_specifications.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 8, "table_count": 8, "by_category": { "Other / uncategorized": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815120", "context_preview": "anion exchange high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; DLS = dynamic light scattering; DSPC = 1,2-distearoyl-sn-glycero-3-phosphocholine; EU = endotoxin unit(s); RP-HPLC = reverse-phase high-performance liquid chromatography", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815120", "context_preview": "xchange high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; DLS = dynamic light scattering; DSPC = 1,2-distearoyl-sn-glycero-3-phosphocholine; EU = endotoxin unit(s); RP-HPLC = reverse-phase high-performance liquid chromatography; RTSS ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815120", "context_preview": "high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; DLS = dynamic light scattering; DSPC = 1,2-distearoyl-sn-glycero-3-phosphocholine; EU = endotoxin unit(s); RP-HPLC = reverse-phase high-performance liquid chromatography; RTSS = revers", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p52_analytical-procedures.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section 3.2.P.5.2.15 {Container", "bates": "FDA-CBER-2022-1614-3815121", "context_preview": "on 3.2.P.5.2.14 {Sterility} Container Closure Integrity Section 3.2.P.5.2.15 {Container Closure Integrity} Abbreviations: AEX-HPLC = anion exchange high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; DLS = dynamic light scattering; ; RT", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section 3.2.P.5.2.15 {Container", "bates": "FDA-CBER-2022-1614-3815121", "context_preview": ".5.2.14 {Sterility} Container Closure Integrity Section 3.2.P.5.2.15 {Container Closure Integrity} Abbreviations: AEX-HPLC = anion exchange high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; DLS = dynamic light scattering; ; RTSS = rev", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section 3.2.P.5.2.15 {Container", "bates": "FDA-CBER-2022-1614-3815121", "context_preview": "{Sterility} Container Closure Integrity Section 3.2.P.5.2.15 {Container Closure Integrity} Abbreviations: AEX-HPLC = anion exchange high-performance liquid chromatography; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; DLS = dynamic light scattering; ; RTSS = reverse tra", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_batch-analyses.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 58, "table_count": 25, "by_category": { "Manufacturing / CMC": 48, "Other / uncategorized": 10 }, "by_marker": { "(b)(4)": 58 }, "top_examples": [ { "page": 31, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.4 Batch Analyses", "bates": "FDA-CBER-2022-1614-3815157", "context_preview": "LDP: 7006320006 Abbreviations: AEX = anion exchange chromatography; HPLC = high-performance liquid chromatography; LDP = labeled drug product; RP = reverse phase; UDP =unlabeled drug product a Pivotal Phase 3 clinical study lots. b Test not present on specification for this lot. c RNA Content specif", "likely_table": true }, { "page": 31, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.4 Batch Analyses", "bates": "FDA-CBER-2022-1614-3815157", "context_preview": "6320006 Abbreviations: AEX = anion exchange chromatography; HPLC = high-performance liquid chromatography; LDP = labeled drug product; RP = reverse phase; UDP =unlabeled drug product a Pivotal Phase 3 clinical study lots. b Test not present on specification for this lot. c RNA Content specification ", "likely_table": true }, { "page": 31, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.4 Batch Analyses", "bates": "FDA-CBER-2022-1614-3815157", "context_preview": "Abbreviations: AEX = anion exchange chromatography; HPLC = high-performance liquid chromatography; LDP = labeled drug product; RP = reverse phase; UDP =unlabeled drug product a Pivotal Phase 3 clinical study lots. b Test not present on specification for this lot. c RNA Content specification was for ", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p54_coa-0437-dp-lot-6007520001.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815167", "context_preview": "ering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Mar-2021 Generated Date: Number: COA-0437 Version: 4.0 Effective Date: 17 Mar 2021 mRNA-1273", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815167", "context_preview": "article Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Mar-2021 Generated Date: Number: COA-0437 Version: 4.0 Effective Date: 17 Mar 2021 mRNA-1273 Drug Product Ce", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0438-dp-lot-6007520002.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 2, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815171", "context_preview": "ight Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Nov-2020 Generated Date: Number: COA-0438 Version: 3.0 Effective Date: 18 Nov 2020", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815172", "context_preview": "Impurities % Area 1 % Area 2 % Area 3 % Area 4 % Area 5 % Area 6 RRT 1 RRT 2 RRT 3 RRT 4 RRT 5 RRT 6 Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Nov-2020 Generated Date: Number: COA-0438 Version: 3.0 Effective Date: 18 Nov 2020 ", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815173", "context_preview": "Extend expiry from 02Dec2020 (6M) to 02Mar2021 (9M) from DOM. Reference DPAD-01025. Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Nov-2020 Generated Date: Number: COA-0438 Version: 3.0 Effective Date: 18 Nov 2020", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0439-dp-lot-6007520003.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Trade-secret claim": 2, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815175", "context_preview": "ht Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Nov-2020 Generated Date: Number: COA-0439 Version: 4.0 Effective Date: 18 Nov 2020 m", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815176", "context_preview": "mpurities % Area 1 % Area 2 % Area 3 % Area 4 % Area 5 % Area 6 RRT 1 RRT 2 RRT 3 RRT 4 RRT 5 RRT 6 Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Nov-2020 Generated Date: Number: COA-0439 Version: 4.0 Effective Date: 18 Nov 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815177", "context_preview": "xtend expiry from 04Dec2020 (6M) to 04Mar2021(9M) from DOM. Reference DPAD-01025. Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Nov-2020 Generated Date: Number: COA-0439 Version: 4.0 Effective Date: 18 Nov 2020 m", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0465-dp-lot-6007520005.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 0, "by_category": { "Other / uncategorized": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815183", "context_preview": "(b) (6) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815183", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815183", "context_preview": "(b) (6) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815183", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815183", "context_preview": "(b) (6) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815183", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0466-dp-lot-6007520006.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Trade-secret claim": 2, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815187", "context_preview": "ht Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 11-Nov-2020 Generated Date: Number: COA-0466 Version: 3.0 Effective Date: 12 Nov 2020 m", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815188", "context_preview": "mpurities Particulate Matter SOP-0509 10 \u00b5m particles per container 25 \u00b5m particles per container Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 11-Nov-2020 Generated Date: Number: COA-0466 Version: 3.0 Effective Date: 12 Nov 2020 mRN", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815189", "context_preview": "nded expiry from 08Jan2021 (6M) to 08Apr2021 (9M) from DOM. Reference DPAD-01025. Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 11-Nov-2020 Generated Date: Number: COA-0466 Version: 3.0 Effective Date: 12 Nov 2020 m", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0475-dp-lot-7006320007.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815191", "context_preview": "0288 pH Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 09-Mar-2021 Generated Date: Number: C", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815191", "context_preview": "Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 09-Mar-2021 Generated Date: Number: COA-0475 ", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815192", "context_preview": "Area 3 % Area 4 RRT 1 RRT 2 RRT 3 RRT 4 % Total Impurities Particulate Matter SOP-0509 10 \u00b5m particles per container 25 \u00b5m particles per container Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 09-Mar-2021 Generated Date: Number: COA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0548-dp-coa-lot-6007320005-011j20.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815195", "context_preview": "P-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number: COA-0548 Version: 3.0 Effective Date: 16 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815197", "context_preview": "version history Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number: COA-0548 Version: 3.0 Effective Date: 16 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815197", "context_preview": "history Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number: COA-0548 Version: 3.0 Effective Date: 16 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0571-dp-lot-7006520006-025j20a.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815199", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0571 Version: 2.0 Effective Date: 16 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815201", "context_preview": "A (from 025J20) Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0571 Version: 2.0 Effective Date: 16 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815201", "context_preview": "025J20) Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0571 Version: 2.0 Effective Date: 16 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0572-dp-lot-7006520007-025j20-2a.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815203", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0572 Version: 2.0 Effective Date: 16 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815205", "context_preview": "(from 025J20-2) Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0572 Version: 2.0 Effective Date: 16 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815205", "context_preview": "5J20-2) Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0572 Version: 2.0 Effective Date: 16 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0598-dp-coa-7006520008-029k20a.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815207", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number: COA-0598 Version: 1.0 Effective Date: 15 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815209", "context_preview": "Lot 6007320006 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number: COA-0598 Version: 1.0 Effective Date: 15 Dec 2020 mR", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815209", "context_preview": "7320006 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number: COA-0598 Version: 1.0 Effective Date: 15 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0599-dp-coa-lot-7006520009-029k20-2a.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815211", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number: COA-0599 Version: 1.0 Effective Date: 15 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815213", "context_preview": "Lot 6007320007 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number: COA-0599 Version: 1.0 Effective Date: 15 Dec 2020 mR", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815213", "context_preview": "7320007 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number: COA-0599 Version: 1.0 Effective Date: 15 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0601-dp-lot-7006520014-038k20a.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815215", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Dec-2020 Generated Date: Steven Anderson Number: COA-0601 Version: 2.0 Effective Date: 18 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815217", "context_preview": "Lot 6007320011 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Dec-2020 Generated Date: Steven Anderson Number: COA-0601 Version: 2.0 Effective Date: 18 Dec 2020 mR", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815217", "context_preview": "7320011 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Dec-2020 Generated Date: Steven Anderson Number: COA-0601 Version: 2.0 Effective Date: 18 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0605-dp-lot-7006520010-039k20a.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815219", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0605 Version: 1.0 Effective Date: 16 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815221", "context_preview": "Lot 6007320008 Drug Substance Manufacturer: Lonza, Portsmouth, NH Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0605 Version: 1.0 Effective Date: 16 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815221", "context_preview": "320008 Drug Substance Manufacturer: Lonza, Portsmouth, NH Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0605 Version: 1.0 Effective Date: 16 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0606-dp-lot-7006520013-025l20a.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815223", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0606 Version: 2.0 Effective Date: 16 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815225", "context_preview": "Lot 6008620001 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0606 Version: 2.0 Effective Date: 16 Dec 2020 mR", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815225", "context_preview": "8620001 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0606 Version: 2.0 Effective Date: 16 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0607-dp-lot-7006520015-026l20a.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815227", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0607 Version: 2.0 Effective Date: 16 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815229", "context_preview": "Lot 6008620002 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0607 Version: 2.0 Effective Date: 16 Dec 2020 mR", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815229", "context_preview": "8620002 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number: COA-0607 Version: 2.0 Effective Date: 16 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0613-dp-lot-6008620003-027l20.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815231", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 19-Dec-2020 Generated Date: Steven Anderson Number: COA-0613 Version: 2.0 Effective Date: 19 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815233", "context_preview": "ersion history. Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 19-Dec-2020 Generated Date: Steven Anderson Number: COA-0613 Version: 2.0 Effective Date: 19 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815233", "context_preview": "istory. Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 19-Dec-2020 Generated Date: Steven Anderson Number: COA-0613 Version: 2.0 Effective Date: 19 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0615-6007320012-011l20.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815235", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 20-Dec-2020 Generated Date: Steven Anderson Number: COA-0615 Version: 1.0 Effective Date: 20 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815237", "context_preview": "ber: 7006520017 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 20-Dec-2020 Generated Date: Steven Anderson Number: COA-0615 Version: 1.0 Effective Date: 20 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815237", "context_preview": "6520017 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 20-Dec-2020 Generated Date: Steven Anderson Number: COA-0615 Version: 1.0 Effective Date: 20 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0640-dp-lot-6008620007-028l20.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815239", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 26-Dec-2020 Generated Date: Steven Anderson Number: COA-0640 Version: 1.0 Effective Date: 26 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815241", "context_preview": "turer: Moderna, Norwood, MA Drug Substance Lot Number: 5007520009 Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 26-Dec-2020 Generated Date: Steven Anderson Number: COA-0640 Version: 1.0 Effective Date: 26 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815241", "context_preview": "oderna, Norwood, MA Drug Substance Lot Number: 5007520009 Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 26-Dec-2020 Generated Date: Steven Anderson Number: COA-0640 Version: 1.0 Effective Date: 26 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0643-dp-lot-7006520024-004m20a.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815243", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 29-Dec-2020 Generated Date: Steven Anderson Number: COA-0643 Version: 1.0 Effective Date: 30 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815245", "context_preview": "turer: Moderna, Norwood, MA Drug Substance Lot Number: 5007520016 Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 29-Dec-2020 Generated Date: Steven Anderson Number: COA-0643 Version: 1.0 Effective Date: 30 Dec 2020 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815245", "context_preview": "oderna, Norwood, MA Drug Substance Lot Number: 5007520016 Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 29-Dec-2020 Generated Date: Steven Anderson Number: COA-0643 Version: 1.0 Effective Date: 30 Dec 2020 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0714-dp-lot-6008520001-030m20.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815247", "context_preview": "P-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 20-Jan-2021 Generated Date: Steven Anderson Number: COA-0714 Version: 1.0 Effective Date: 20 Jan 2021 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815249", "context_preview": "turer: Moderna, Norwood, MA Drug Substance Lot Number: 5007520024 Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 20-Jan-2021 Generated Date: Steven Anderson Number: COA-0714 Version: 1.0 Effective Date: 20 Jan 2021 m", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815249", "context_preview": "oderna, Norwood, MA Drug Substance Lot Number: 5007520024 Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 20-Jan-2021 Generated Date: Steven Anderson Number: COA-0714 Version: 1.0 Effective Date: 20 Jan 2021 mRNA-1273", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0994-dp-lot-6010121002-033b21.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815251", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 1 of 2 Number: COA-0994 Version: 1.0 Effective Date: 20 Mar 2021 mRNA-1273 Drug Product Certificate of Analysis", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815252", "context_preview": "lent) Drug Substance Manufacturer: Moderna, Norwood, MA Drug Substance Lot Number: 5007521046 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 2 of 2 Number: COA-0994 Version: 1.0 Effective Date: 20 Mar 2021 mRNA-1273 Drug Prod", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815252", "context_preview": "rug Substance Manufacturer: Moderna, Norwood, MA Drug Substance Lot Number: 5007521046 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 2 of 2 Number: COA-0994 Version: 1.0 Effective Date: 20 Mar 2021 mRNA-1273 Drug Product Cer", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-0995-dp-lot-6009821002-022b21.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815254", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 1 of 2 Number: COA-0995 Version: 2.0 Effective Date: 05 Apr 2021 mRNA-1273 Drug Product Certificate of Analysis", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815255", "context_preview": "nt) Drug Substance Manufacturer: Moderna, Norwood, MA Drug Substance Lot Number: 5007521045 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 2 of 2 Number: COA-0995 Version: 2.0 Effective Date: 05 Apr 2021 mRNA-1273 Drug Produc", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815255", "context_preview": "g Substance Manufacturer: Moderna, Norwood, MA Drug Substance Lot Number: 5007521045 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 2 of 2 Number: COA-0995 Version: 2.0 Effective Date: 05 Apr 2021 mRNA-1273 Drug Product Certi", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-1277-dp-lot-7007621003-939599.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815257", "context_preview": "g SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 1 of 2 Number: COA-1277 Version: 1.0 Effective Date: 04 May 2021 mRNA-1273 Drug Product Ce", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815258", "context_preview": "xter) Drug Substance Manufacturer: Moderna, Norwood, MA Drug Substance Lot Number: 5007521132 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 2 of 2 Number: COA-1277 Version: 1.0 Effective Date: 04 May 2021 mRNA-1273 Drug Prod", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815258", "context_preview": "rug Substance Manufacturer: Moderna, Norwood, MA Drug Substance Lot Number: 5007521132 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 2 of 2 Number: COA-1277 Version: 1.0 Effective Date: 04 May 2021 mRNA-1273 Drug Product Cer", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-1278-dp-lot-7007621004-939600.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815260", "context_preview": "g SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 1 of 2 Number: COA-1278 Version: 1.0 Effective Date: 04 May 2021 mRNA-1273 Drug Product Ce", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815261", "context_preview": "ter) Drug Substance Manufacturer: Lonza, Portsmouth, NH Drug Substance Lot Number: 5007521075 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 2 of 2 Number: COA-1278 Version: 1.0 Effective Date: 04 May 2021 mRNA-1273 Drug Prod", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815261", "context_preview": "ug Substance Manufacturer: Lonza, Portsmouth, NH Drug Substance Lot Number: 5007521075 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 2 of 2 Number: COA-1278 Version: 1.0 Effective Date: 04 May 2021 mRNA-1273 Drug Product Cer", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-1279-dp-lot-7007621006-939676.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 2, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815263", "context_preview": "g SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 1 of 2 Number: COA-1279 Version: 1.0 Effective Date: 04 May 2021 mRNA-1273 Drug Product Ce", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815264", "context_preview": ", MA Drug Substance Lot Number: 5007521075 (Lonza), 5007521132 (Moderna) CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 2 of 2 Number: COA-1279 Version: 1.0 Effective Date: 04 May 2021 mRNA-1273 Drug Product Certificate of An", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815264", "context_preview": "ug Substance Lot Number: 5007521075 (Lonza), 5007521132 (Moderna) CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 2 of 2 Number: COA-1279 Version: 1.0 Effective Date: 04 May 2021 mRNA-1273 Drug Product Certificate of Analysis ", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-1461-dp-lot-6009921006-038d21.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815266", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 1 of 2 Number: COA-1461 Version: 1.0 Effective Date: 14 May 2021 mRNA-1273 Drug Product Certificate of Analysis", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815267", "context_preview": "(Catalent) Drug Substance Manufacturer: Moderna, Norwood, MA Drug Substance Lot Number: 5007521162 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Number: COA-1461 Version: 1.0 Effective Date: 14 May 2021 mRNA-1273 Drug Product Cer", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815267", "context_preview": "t) Drug Substance Manufacturer: Moderna, Norwood, MA Drug Substance Lot Number: 5007521162 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Number: COA-1461 Version: 1.0 Effective Date: 14 May 2021 mRNA-1273 Drug Product Certificate", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-1509-dp-lot-6003921002-047d21.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815269", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 1 of 2 Number: COA-1509 Version: 1.0 Effective Date: 24 May 2021 mRNA-1273 Drug Product Certificate of Analysis", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815270", "context_preview": "rug Substance Manufacturer: Moderna, Norwood, MA Drug Substance Lot Number: 5007521181 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 2 of 2 Number: COA-1509 Version: 1.0 Effective Date: 24 May 2021 mRNA-1273 Drug Product Cer", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815270", "context_preview": "tance Manufacturer: Moderna, Norwood, MA Drug Substance Lot Number: 5007521181 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Page 2 of 2 Number: COA-1509 Version: 1.0 Effective Date: 24 May 2021 mRNA-1273 Drug Product Certificate", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_coa-1510-dp-lot-6010121003-054d21.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION.", "bates": "FDA-CBER-2022-1614-3815272", "context_preview": "attering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION. Generated By: Steven Anderson Page 1 of 2 Number: COA-1510 Version: 1.0 Effective Date: 21 May 2021 mRNA-1273 Drug Pr", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION.", "bates": "FDA-CBER-2022-1614-3815273", "context_preview": "4D21A (Catalent) Drug Substance Manufacturer: Moderna, Norwood, MA Drug Substance Lot Number: 5007521184 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION. Generated By: Steven Anderson Page 2 of 2 Number: COA-1510 Version: 1.0 Effective Date: 21 May 2021 mRNA-12", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION.", "bates": "FDA-CBER-2022-1614-3815273", "context_preview": "atalent) Drug Substance Manufacturer: Moderna, Norwood, MA Drug Substance Lot Number: 5007521184 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION. Generated By: Steven Anderson Page 2 of 2 Number: COA-1510 Version: 1.0 Effective Date: 21 May 2021 mRNA-1273 Drug ", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_cofa-0363-dp-lot-8520100101.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Trade-secret claim": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815275", "context_preview": "icate of Analysis Lot 8520100101 Page 1 of 3 Confidential and Proprietary Document Number: VV-QUAL-002799 eDMS Version: 2.0 (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815275", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815275", "context_preview": "Analysis Lot 8520100101 Page 1 of 3 Confidential and Proprietary Document Number: VV-QUAL-002799 eDMS Version: 2.0 (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815275", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815275", "context_preview": "s Lot 8520100101 Page 1 of 3 Confidential and Proprietary Document Number: VV-QUAL-002799 eDMS Version: 2.0 (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815275", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_cofa-0386-dp-lot-8520100102.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNA INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815278", "context_preview": "Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0973 Result Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNA INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Apr-2020 Generated Date: Steven Anderson Number: COA-0386 Version: 2.0 Effective Date: 16 Apr 2020 mR", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_cofa-0387-dp-lot-8520100103.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Manufacturing / CMC": 3, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815282", "context_preview": "2 % IG3 % RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0973 Result Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Dec-2020 Generated Date: Number: COA-0387 Version: 3.0 Effective Date: 03 Dec 2020 m", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815282", "context_preview": "% RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0973 Result Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Dec-2020 Generated Date: Number: COA-0387 Version: 3.0 Effective Date: 03 Dec 2020 mRNA-1273", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815283", "context_preview": "d Content SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 RRT 1 Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Dec-2020 Generated Date: Number: COA-0387 Version: 3.0 Effective Date: 03 Dec 2020 m", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p54_cofa-0393-dp-lot-8520100104.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Manufacturing / CMC": 3, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815286", "context_preview": "IG2 % IG3 % RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0973 Result Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 11-Mar-2021 Generated Date: Number: COA-0393 Version: 4.0 Effective Date: 16 Mar 2021", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815286", "context_preview": "3 % RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0973 Result Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 11-Mar-2021 Generated Date: Number: COA-0393 Version: 4.0 Effective Date: 16 Mar 2021 mRNA-12", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815287", "context_preview": "Content SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 % Area 5 Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 11-Mar-2021 Generated Date: Number: COA-0393 Version: 4.0 Effective Date: 16 Mar 2021 ", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p8_6007320005-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 13, "table_count": 0, "by_category": { "Manufacturing / CMC": 13 }, "by_marker": { "(b)(4)": 13 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814914", "context_preview": "2 Months pH USP <791> - NT* - - Particle Size NT* NT* NT** Polydispersity NT* NT* NT** SM-102 - NT* - - Cholesterol - NT* - - DSPC - NT* - - PEG2000-DMG - NT* - - SM-102 - NT* - - Cholesterol - NT* - - DSPC - NT* - - PEG2000-DMG - NT* - - - NT* - - - NT* - - Dynamic light scattering UPLC-CAD Lipid I", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814914", "context_preview": "pH USP <791> - NT* - - Particle Size NT* NT* NT** Polydispersity NT* NT* NT** SM-102 - NT* - - Cholesterol - NT* - - DSPC - NT* - - PEG2000-DMG - NT* - - SM-102 - NT* - - Cholesterol - NT* - - DSPC - NT* - - PEG2000-DMG - NT* - - - NT* - - - NT* - - Dynamic light scattering UPLC-CAD Lipid Impurities", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814915", "context_preview": "2.6.14 - - - - - - Sterility USP <71>, Ph. Eur. 2.6.1 - - - - - - Container Closure Integrity USP <1207> Pass - - - - - - - NT*: Not Tested, Refer to QE-005517 ; NT**: Not Tested, Refer to QE-008189; \"-\": Not applicable per the stability protocol Future Timepoint USP <788> Method 2 a % RNA Encapsula", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p8_6007320008-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 20, "table_count": 12, "by_category": { "Manufacturing / CMC": 20 }, "by_marker": { "(b)(4)": 20 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "NFIDENTIA - DO NO D S RIB", "bates": "FDA-CBER-2022-1614-3814926", "context_preview": "ion - May contain visible, white or translucent product-related particulates Essentially Free of Particulates - Essentially Free of Particulates - RNA Content AEX-HPLC - - Purity RP-HPLC NT* NT* NT* NT* % RNA Encapsulation - - In vitro Translation In vitro translation / methionine labelling - - Appe", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "NFIDENTIA - DO NO D S RIB", "bates": "FDA-CBER-2022-1614-3814926", "context_preview": "ay contain visible, white or translucent product-related particulates Essentially Free of Particulates - Essentially Free of Particulates - RNA Content AEX-HPLC - - Purity RP-HPLC NT* NT* NT* NT* % RNA Encapsulation - - In vitro Translation In vitro translation / methionine labelling - - Appearance ", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "NFIDENTIA - DO NO D S RIB", "bates": "FDA-CBER-2022-1614-3814926", "context_preview": "in visible, white or translucent product-related particulates Essentially Free of Particulates - Essentially Free of Particulates - RNA Content AEX-HPLC - - Purity RP-HPLC NT* NT* NT* NT* % RNA Encapsulation - - In vitro Translation In vitro translation / methionine labelling - - Appearance Visual P", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p8_6007320009-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 11, "table_count": 0, "by_category": { "Manufacturing / CMC": 11 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "D RNA X NC W THOUT", "bates": "FDA-CBER-2022-1614-3814930", "context_preview": "te to off-white dispersion. White to off-white dispersion - May contain visible, white or translucent product-related particulates Essentially Free of Particulates - RNA Content AEX-HPLC - Purity RP-HPLC % RNA Encapsulation - In vitro Translation In vitro translation / methionine labelling - Appeara", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "D RNA X NC W THOUT", "bates": "FDA-CBER-2022-1614-3814930", "context_preview": "f-white dispersion. White to off-white dispersion - May contain visible, white or translucent product-related particulates Essentially Free of Particulates - RNA Content AEX-HPLC - Purity RP-HPLC % RNA Encapsulation - In vitro Translation In vitro translation / methionine labelling - Appearance Visu", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "D RNA X NC W THOUT", "bates": "FDA-CBER-2022-1614-3814931", "context_preview": "at -20\u00b0C \u00b1 5\u00b0C (continued) Test Method Shelf-Life Acceptance Criteria Release 3 Month 6 Months 9 Months 12 Months pH USP <791> - Particle Size Polydispersity SM-102 - Cholesterol - DSPC - PEG2000-DMG - SM-102 - Cholesterol - DSPC - PEG2000-DMG - - - Dynamic light scattering UPLC-CAD UPLC-CAD Lipid I", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p8_6007320010-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814939", "context_preview": "roduct 60073, Lot 6007320010 at -20\u00b0C \u00b1 5\u00b0C (continued) Test Method Shelf-Life Acceptance Criteria Release 1 Month 3 Months 6 Months 9 Months 12 Months pH USP <791> - - Particle Size Polydispersity SM-102 - - Cholesterol - - DSPC - - PEG2000-DMG - - SM-102 - - Cholesterol - - DSPC - - PEG2000-DMG - ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3814938", "context_preview": "ase 1 Month 3 Months 6 Months 9 Months 12 Months White to off-white dispersion White to off-white dispersion - - May contain visible, white or translucent product-related particulates Essentially free of particulates - - RNA Content AEX-HPLC - - Purity RP-HPLC % RNA Encapsulation - - In vitro Transl", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3814938", "context_preview": "nth 3 Months 6 Months 9 Months 12 Months White to off-white dispersion White to off-white dispersion - - May contain visible, white or translucent product-related particulates Essentially free of particulates - - RNA Content AEX-HPLC - - Purity RP-HPLC % RNA Encapsulation - - In vitro Translation In", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p8_6007320012-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 8, "table_count": 0, "by_category": { "Manufacturing / CMC": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "NFIDENTIA - DO NO D S RIB", "bates": "FDA-CBER-2022-1614-3814942", "context_preview": "White to off-white dispersion. White to off-white dispersion - May contain visible, white or translucent product-related particulates Essentially free of particulates - RNA Content AEX-HPLC - Purity RP-HPLC % RNA Encapsulation - In vitro Translation In vitro translation / methionine labelling - Appe", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "NFIDENTIA - DO NO D S RIB", "bates": "FDA-CBER-2022-1614-3814942", "context_preview": "off-white dispersion. White to off-white dispersion - May contain visible, white or translucent product-related particulates Essentially free of particulates - RNA Content AEX-HPLC - Purity RP-HPLC % RNA Encapsulation - In vitro Translation In vitro translation / methionine labelling - Appearance Vi", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "NFIDENTIA - DO NO D S RIB", "bates": "FDA-CBER-2022-1614-3814943", "context_preview": "12 at -20\u00b0C \u00b1 5\u00b0C (continued) Test Method Shelf-Life Acceptance Criteria Release 3 Month 6 Months 9 Months 12 Months pH USP <791> - Particle Size Polydispersity SM-102 - Cholesterol - DSPC - PEG2000-DMG - SM-102 - Cholesterol - DSPC - PEG2000-DMG - - - Lipid Content Dynamic light scattering UPLC-CAD", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p8_6007520001-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 76, "table_count": 48, "by_category": { "Manufacturing / CMC": 60, "Pharmacology / toxicology": 16 }, "by_marker": { "(b)(4)": 76 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814951", "context_preview": "ities UPLC-CAD NT* Dynamic light scattering USP <791> - NT* NT* Table 1: Stability Data for Product 60075, Lot 6007520001 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Acceptance Criteria Release 1 Month 2 Months 3 Months 6 Months 9 Months 12 Months - UPLC-CAD NT* - NT* - NT* - NT* - UPLC-CAD NT* ", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814951", "context_preview": "LC-CAD NT* Dynamic light scattering USP <791> - NT* NT* Table 1: Stability Data for Product 60075, Lot 6007520001 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Acceptance Criteria Release 1 Month 2 Months 3 Months 6 Months 9 Months 12 Months - UPLC-CAD NT* - NT* - NT* - NT* - UPLC-CAD NT* NT* NT* ", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814951", "context_preview": "T* Dynamic light scattering USP <791> - NT* NT* Table 1: Stability Data for Product 60075, Lot 6007520001 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Acceptance Criteria Release 1 Month 2 Months 3 Months 6 Months 9 Months 12 Months - UPLC-CAD NT* - NT* - NT* - NT* - UPLC-CAD NT* NT* NT* - - - - ", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p8_6007520002-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 67, "table_count": 46, "by_category": { "Manufacturing / CMC": 67 }, "by_marker": { "(b)(4)": 67 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814974", "context_preview": "12 Months USP <791> - NT* NT* - NT* - NT* - NT* NT* - - - NT* - UPLC-CAD NT* - NT* Lipid Identification Lipid Content Table 1: Stability Data for Product 60075, Lot 6007520002 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Acceptance Criteria Release 1 Month 2 Months 3 Months NT* Lipid Impurities D", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814974", "context_preview": "hs USP <791> - NT* NT* - NT* - NT* - NT* NT* - - - NT* - UPLC-CAD NT* - NT* Lipid Identification Lipid Content Table 1: Stability Data for Product 60075, Lot 6007520002 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Acceptance Criteria Release 1 Month 2 Months 3 Months NT* Lipid Impurities Dynamic ", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814974", "context_preview": "791> - NT* NT* - NT* - NT* - NT* NT* - - - NT* - UPLC-CAD NT* - NT* Lipid Identification Lipid Content Table 1: Stability Data for Product 60075, Lot 6007520002 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Acceptance Criteria Release 1 Month 2 Months 3 Months NT* Lipid Impurities Dynamic light sc", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p8_6007520003-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 69, "table_count": 45, "by_category": { "Manufacturing / CMC": 55, "Pharmacology / toxicology": 10, "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 69 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814996", "context_preview": "1> - NT* NT* - NT* - - NT* - - NT* - NT* NT* NT* - - NT* Lipid Impurities UPLC-CAD UPLC-CAD Dynamic light scattering - NT* UPLC-CAD Lipid Content Lipid Identification Table 1: Stability Data for Product 60075, Lot 6007520003 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Acceptance Criteria Release", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814996", "context_preview": "NT* - NT* - - NT* - - NT* - NT* NT* NT* - - NT* Lipid Impurities UPLC-CAD UPLC-CAD Dynamic light scattering - NT* UPLC-CAD Lipid Content Lipid Identification Table 1: Stability Data for Product 60075, Lot 6007520003 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Acceptance Criteria Release 1 Month ", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3814996", "context_preview": "T* - - NT* - - NT* - NT* NT* NT* - - NT* Lipid Impurities UPLC-CAD UPLC-CAD Dynamic light scattering - NT* UPLC-CAD Lipid Content Lipid Identification Table 1: Stability Data for Product 60075, Lot 6007520003 at -60\u00b0C to -90\u00b0C (continued) Method Shelf-life Acceptance Criteria Release 1 Month 2 Month", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p8_6007520004-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 64, "table_count": 40, "by_category": { "Manufacturing / CMC": 64 }, "by_marker": { "(b)(4)": 64 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815017", "context_preview": "eria Release 1 Month 2 Month 3 Months 6 Months 9 Months 12 Months pH USP <791> - NT* Particle Size NT* NT** Polydispersity NT* NT** SM-102 - NT* NT** Cholesterol - NT* NT** DSPC - NT* NT** PEG2000-DMG - NT* NT** SM102 - NT* NT** Cholesterol - NT* NT** DSPC - NT* NT** PEG2000-DMG - NT* NT** - NT* NT*", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815017", "context_preview": "ease 1 Month 2 Month 3 Months 6 Months 9 Months 12 Months pH USP <791> - NT* Particle Size NT* NT** Polydispersity NT* NT** SM-102 - NT* NT** Cholesterol - NT* NT** DSPC - NT* NT** PEG2000-DMG - NT* NT** SM102 - NT* NT** Cholesterol - NT* NT** DSPC - NT* NT** PEG2000-DMG - NT* NT** - NT* NT** - NT* ", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815017", "context_preview": "onth 2 Month 3 Months 6 Months 9 Months 12 Months pH USP <791> - NT* Particle Size NT* NT** Polydispersity NT* NT** SM-102 - NT* NT** Cholesterol - NT* NT** DSPC - NT* NT** PEG2000-DMG - NT* NT** SM102 - NT* NT** Cholesterol - NT* NT** DSPC - NT* NT** PEG2000-DMG - NT* NT** - NT* NT** - NT* NT** Dyn", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p8_6007920001-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 9, "table_count": 6, "by_category": { "Manufacturing / CMC": 9 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815034", "context_preview": "ed particulates Essentially free of particulates NT* NT* Essentially free of particulates RNA Content AEX-HPLC NT* Purity RP-HPLC NT* NT* NT* NT* % RNA Encapsulation In vitro Translation In vitro translation / methionine labelling Appearance Visual Product-related Impurities RP-HPLC Document Number:", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815034", "context_preview": "iculates Essentially free of particulates NT* NT* Essentially free of particulates RNA Content AEX-HPLC NT* Purity RP-HPLC NT* NT* NT* NT* % RNA Encapsulation In vitro Translation In vitro translation / methionine labelling Appearance Visual Product-related Impurities RP-HPLC Document Number: VV-QUA", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815034", "context_preview": "Essentially free of particulates NT* NT* Essentially free of particulates RNA Content AEX-HPLC NT* Purity RP-HPLC NT* NT* NT* NT* % RNA Encapsulation In vitro Translation In vitro translation / methionine labelling Appearance Visual Product-related Impurities RP-HPLC Document Number: VV-QUAL-006729 ", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p8_6007920002-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 7, "table_count": 5, "by_category": { "Manufacturing / CMC": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815040", "context_preview": "White to off-white dispersion NT* NT* White to off-white dispersion May contain visible, white or translucent product- related particulates Essentially free of particulates NT* NT* Essentially free of particulates RNA Content AEX-HPLC NT* Purity RP-HPLC NT* NT* NT* NT* % RNA Encapsulation In vitro T", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815040", "context_preview": "o off-white dispersion NT* NT* White to off-white dispersion May contain visible, white or translucent product- related particulates Essentially free of particulates NT* NT* Essentially free of particulates RNA Content AEX-HPLC NT* Purity RP-HPLC NT* NT* NT* NT* % RNA Encapsulation In vitro Translat", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815040", "context_preview": "ite dispersion NT* NT* White to off-white dispersion May contain visible, white or translucent product- related particulates Essentially free of particulates NT* NT* Essentially free of particulates RNA Content AEX-HPLC NT* Purity RP-HPLC NT* NT* NT* NT* % RNA Encapsulation In vitro Translation In v", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p8_6007920003-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 10, "table_count": 0, "by_category": { "Manufacturing / CMC": 10 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815048", "context_preview": "at -20\u00b0C \u00b1 5\u00b0C (continued) Test Method Shelf-Life Acceptance Criteria Release 3 Months 6 Months 9 Months 12 Months \u2265 10 \u00b5m - \u2265 25 \u00b5m - Bacterial Endotoxins USP <85>, Ph. Eur. 2.6.14 - Sterility USP <71>, Ph. Eur. 2.6.1 - Container Closure Integrity USP <1207> Pass - - NT*: Not Tested, Refer to QE-00", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815051", "context_preview": "nths 4 Months pH USP <791> - - Particle Size NT* NT** Polydispersity NT* NT** SM-102 - - Cholesterol - - DSPC - - PEG2000-DMG - - SM-102 - - Cholesterol - - DSPC - - PEG2000-DMG - - - - - - NT*: Not Tested, Refer to QE-005517 \"-\": Not applicable per the stability protocol NT**: Not Tested, Refer to ", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815051", "context_preview": "onths pH USP <791> - - Particle Size NT* NT** Polydispersity NT* NT** SM-102 - - Cholesterol - - DSPC - - PEG2000-DMG - - SM-102 - - Cholesterol - - DSPC - - PEG2000-DMG - - - - - - NT*: Not Tested, Refer to QE-005517 \"-\": Not applicable per the stability protocol NT**: Not Tested, Refer to QE-00818", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p8_6008520001-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 17, "table_count": 5, "by_category": { "Manufacturing / CMC": 17 }, "by_marker": { "(b)(4)": 17 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815058", "context_preview": "hite dispersion. White to off-white dispersion. - White to off-white dispersion. May contain visible, white or translucent product-related particulates Essentially Free of Particulates - Essentially Free of Particulates RNA Content AEX-HPLC - Purity RP-HPLC % RNA Encapsulation - In vitro Translation", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815058", "context_preview": "spersion. White to off-white dispersion. - White to off-white dispersion. May contain visible, white or translucent product-related particulates Essentially Free of Particulates - Essentially Free of Particulates RNA Content AEX-HPLC - Purity RP-HPLC % RNA Encapsulation - In vitro Translation In vit", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815058", "context_preview": ". White to off-white dispersion. - White to off-white dispersion. May contain visible, white or translucent product-related particulates Essentially Free of Particulates - Essentially Free of Particulates RNA Content AEX-HPLC - Purity RP-HPLC % RNA Encapsulation - In vitro Translation In vitro trans", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p8_6008620001-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 10, "table_count": 5, "by_category": { "Manufacturing / CMC": 10 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815062", "context_preview": "onths pH USP <791> NT* Particle Size NT* Polydispersity NT* SM-102 NT* NT** Cholesterol NT* NT** DSPC NT* NT** PEG2000-DMG NT* NT** SM-102 NT* NT** Cholesterol NT* NT** DSPC NT* NT** PEG2000-DMG NT* NT** NT* NT** NT* NT** UPLC-CAD UPLC-CAD UPLC-CAD Lipid Content Lipid Impurities Dynamic light scatte", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815062", "context_preview": "USP <791> NT* Particle Size NT* Polydispersity NT* SM-102 NT* NT** Cholesterol NT* NT** DSPC NT* NT** PEG2000-DMG NT* NT** SM-102 NT* NT** Cholesterol NT* NT** DSPC NT* NT** PEG2000-DMG NT* NT** NT* NT** NT* NT** UPLC-CAD UPLC-CAD UPLC-CAD Lipid Content Lipid Impurities Dynamic light scattering Lipi", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815062", "context_preview": "1> NT* Particle Size NT* Polydispersity NT* SM-102 NT* NT** Cholesterol NT* NT** DSPC NT* NT** PEG2000-DMG NT* NT** SM-102 NT* NT** Cholesterol NT* NT** DSPC NT* NT** PEG2000-DMG NT* NT** NT* NT** NT* NT** UPLC-CAD UPLC-CAD UPLC-CAD Lipid Content Lipid Impurities Dynamic light scattering Lipid Ident", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p8_6008620002-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 11, "table_count": 10, "by_category": { "Manufacturing / CMC": 11 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815066", "context_preview": "5\u00b0C (continued) Test Parameter Shelf-Life Acceptance Criteria Release 1 Month 3 Months 6 Months 9 Months 12 Months pH USP <791> NT* Particle Size NT* Polydispersity NT* SM-102 NT* NT** Cholesterol NT* NT** DSPC NT* NT** PEG2000-DMG NT* NT** SM-102 NT* NT** Cholesterol NT* NT** DSPC NT* NT** PEG2000-", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815066", "context_preview": "tinued) Test Parameter Shelf-Life Acceptance Criteria Release 1 Month 3 Months 6 Months 9 Months 12 Months pH USP <791> NT* Particle Size NT* Polydispersity NT* SM-102 NT* NT** Cholesterol NT* NT** DSPC NT* NT** PEG2000-DMG NT* NT** SM-102 NT* NT** Cholesterol NT* NT** DSPC NT* NT** PEG2000-DMG NT* ", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815066", "context_preview": "Test Parameter Shelf-Life Acceptance Criteria Release 1 Month 3 Months 6 Months 9 Months 12 Months pH USP <791> NT* Particle Size NT* Polydispersity NT* SM-102 NT* NT** Cholesterol NT* NT** DSPC NT* NT** PEG2000-DMG NT* NT** SM-102 NT* NT** Cholesterol NT* NT** DSPC NT* NT** PEG2000-DMG NT* NT** NT*", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p8_6008620007-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 9, "table_count": 5, "by_category": { "Manufacturing / CMC": 9 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815070", "context_preview": "ter Shelf-Life Acceptance Criteria Release 1 Month 3 Months 6 Months 9 Months 12 Months pH USP <791> NT* Particle Size NT* Polydispersity NT* SM-102 NT* Cholesterol NT* DSPC NT* PEG2000-DMG NT* SM-102 NT* Cholesterol NT* DSPC NT* PEG2000-DMG NT* NT* NT* Lipid Content UPLC-CAD Lipid Impurities UPLC-C", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815070", "context_preview": "f-Life Acceptance Criteria Release 1 Month 3 Months 6 Months 9 Months 12 Months pH USP <791> NT* Particle Size NT* Polydispersity NT* SM-102 NT* Cholesterol NT* DSPC NT* PEG2000-DMG NT* SM-102 NT* Cholesterol NT* DSPC NT* PEG2000-DMG NT* NT* NT* Lipid Content UPLC-CAD Lipid Impurities UPLC-CAD Lipid", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815070", "context_preview": "cceptance Criteria Release 1 Month 3 Months 6 Months 9 Months 12 Months pH USP <791> NT* Particle Size NT* Polydispersity NT* SM-102 NT* Cholesterol NT* DSPC NT* PEG2000-DMG NT* SM-102 NT* Cholesterol NT* DSPC NT* PEG2000-DMG NT* NT* NT* Lipid Content UPLC-CAD Lipid Impurities UPLC-CAD Lipid Identif", "likely_table": true } ] }, { "filename": "125752_S2_M3_32p8_freezethaw-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815074", "context_preview": "e dispersion, essentially free of particulates White to off-white dispersion, essentially free of particulates White to off-white dispersion, essentially free of particulates White to off-white dispersion, essentially free of particulates % RNA encapsulation Purity by RP-HPLC Product related impurit", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815074", "context_preview": "ersion, essentially free of particulates White to off-white dispersion, essentially free of particulates White to off-white dispersion, essentially free of particulates White to off-white dispersion, essentially free of particulates % RNA encapsulation Purity by RP-HPLC Product related impurities by", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815074", "context_preview": "essentially free of particulates White to off-white dispersion, essentially free of particulates White to off-white dispersion, essentially free of particulates White to off-white dispersion, essentially free of particulates % RNA encapsulation Purity by RP-HPLC Product related impurities by RP-HPLC", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p8_modeling-stability-report.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Other / uncategorized": 3, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "DH-03453.3", "bates": "FDA-CBER-2022-1614-3815076", "context_preview": ".3 Development DH-03453.3 Development DHM-47516 Development DHM-47516 Development DHM-47517 Development DHM-47517 Development DHM-47519 Development DHM-47519 Development DHM-47521 Development DHM-47521 Development DHM-49621 Development DHM-53331 Development DHM-53331 Development 6007520001 Clinical ", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DH-03453.2", "bates": "FDA-CBER-2022-1614-3815077", "context_preview": "IDENTIAL \u2013 DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION. Table 2: mRNA-1273 Drug Product Modeling Purity Stability Data, -40\u00b0C \u00b1 5\u00b0C Lot Purpose Purity Method Time Point (months) 0 1 2 3 6 9 12 DH-03453.1 Development DH-03453.1 Development DH-03453.2 Development DH-03453.2", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "DH-03453.2 (PC)", "bates": "FDA-CBER-2022-1614-3815078", "context_preview": "elopment DH-03453.2 Development DH-03453.2 (PC) Development DH-03453.2 (PC) Development DHM-47504 Development DHM-47504 Development DHM-47517 Development DHM-47517 Development DHM-47519 Development DHM-47519 Development DHM-47521 Development DHM-47521 Development 6007320001 Scale A 6007320002 Scale ", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p8_stability-data.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "8.0 \nCorning Valor 10R", "bates": "FDA-CBER-2022-1614-3815087", "context_preview": "Biologics, LLC (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months Pending N/A 6008221002 Scale B Baxter (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months Pending N/A 6008221003 Scale B Baxter (Vial Line 8.0 Corning Valor 10R cl", "likely_table": false } ] }, { "filename": "125752_S2_M3_32p8_stability-summary.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 34, "table_count": 21, "by_category": { "Other / uncategorized": 28, "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 34 }, "top_examples": [ { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "8.0 \nCorning Valor", "bates": "FDA-CBER-2022-1614-3815100", "context_preview": "clear aluminosilicate glass vial -20 \u00b1 5\u00b0C 12 months 6010121002 Scale B Catalent Biologics, LLC (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 6008221002 Scale B Baxter (Vial Line 8.0 Corning Valor clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 60082210", "likely_table": true }, { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "8.0 \nCorning Valor", "bates": "FDA-CBER-2022-1614-3815100", "context_preview": "minosilicate glass vial -20 \u00b1 5\u00b0C 12 months 6010121002 Scale B Catalent Biologics, LLC (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 6008221002 Scale B Baxter (Vial Line 8.0 Corning Valor clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 6008221003 Scale ", "likely_table": true }, { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "8.0 \nCorning Valor", "bates": "FDA-CBER-2022-1614-3815100", "context_preview": "ate glass vial -20 \u00b1 5\u00b0C 12 months 6010121002 Scale B Catalent Biologics, LLC (Vial Line 8.0 Corning Valor 10R clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 6008221002 Scale B Baxter (Vial Line 8.0 Corning Valor clear aluminosilicate glass vials -20 \u00b1 5\u00b0C 12 months 6008221003 Scale B Baxter ", "likely_table": true } ] }, { "filename": "125752_S2_M3_32s41_specification_mrna-1273-lnp-all.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "GROUP-109208", "bates": "FDA-CBER-2022-1614-3815296", "context_preview": "ed aerosol detection; CFU = colony- forming unit(s); DP = drug product; EU = endotoxin unit(s); HPLC-CAD = high-performance liquid chromatography; IG = impurity group; Shift; RP = reverse phase; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; RT = reverse transcription; R", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "GROUP-109208", "bates": "FDA-CBER-2022-1614-3815296", "context_preview": "ol detection; CFU = colony- forming unit(s); DP = drug product; EU = endotoxin unit(s); HPLC-CAD = high-performance liquid chromatography; IG = impurity group; Shift; RP = reverse phase; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; RT = reverse transcription; RTSS = re", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "GROUP-109208", "bates": "FDA-CBER-2022-1614-3815296", "context_preview": "tion; CFU = colony- forming unit(s); DP = drug product; EU = endotoxin unit(s); HPLC-CAD = high-performance liquid chromatography; IG = impurity group; Shift; RP = reverse phase; RP-IP-HPLC = reverse phase ion-pair high performance liquid chromatography; RT = reverse transcription; RTSS = reverse tr", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s42_analytical-procedures-mrna-1273-lnp.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section 3.2.S.4.2 {mRNA-1273 LNP - Bioburden}", "bates": "FDA-CBER-2022-1614-3815298", "context_preview": "r. 2.6.14 Section 3.2.S.4.2 {mRNA-1273 LNP \u2013 Bacterial Endotoxin} Section 3.2.P.5.2 {Bacterial Endotoxin} Bioburden USP <61>, Ph. Eur. 2.6.12 Section 3.2.S.4.2 {mRNA-1273 LNP - Bioburden} Abbreviations: AEX-HPLC = anion exchange high-performance liquid chromatography; DLS = dynamic light scattering;", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s43_val-of-analyt-proc-mrna-1273-lnp.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section 3.2.S.4.3 {mRNA-1273 LNP - Bioburden}", "bates": "FDA-CBER-2022-1614-3815300", "context_preview": ".14 Section 3.2.P.5.3 {Bacterial Endotoxin} Bioburden USP <61>, Ph. Eur. 2.6.12 Section 3.2.S.4.3 {mRNA-1273 LNP - Bioburden} Abbreviations: AEX-HPLC = anion exchange high-performance liquid chromatography; DLS = dynamic light scattering; RP-HPLC = reverse-phase high-performance liquid chromatograph", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0363-mrna-1273-dp-lot-8520100101.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815301", "context_preview": "Document Number: COA-0363 Version: 2.0 Final Date: mRNA-1273 Drug Product Certificate of Analysis Lot 8520100101 Document Number: VV-QUAL-006902 eDMS Version: 1.0 (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815301", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815301", "context_preview": "Document Number: COA-0363 Version: 2.0 Final Date: mRNA-1273 Drug Product Certificate of Analysis Lot 8520100101 Document Number: VV-QUAL-006902 eDMS Version: 1.0 (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815301", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0386-mrna-1273-dp-lot-8520100102.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNA INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815304", "context_preview": "ntity Purity SOP-0383 Purity % IG1 % IG2 % IG3 % RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0973 Result Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNA INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Apr-2020 Generated Date: Steven Anderson Number:", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0387-mrna-1273-dp-lot-8520100103.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815307", "context_preview": "SOP-0492 Identity Purity SOP-0383 Purity % IG1 % IG2 % IG3 % RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0973 Result Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Dec-2020 Generated Date: Number: ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815307", "context_preview": "2 Identity Purity SOP-0383 Purity % IG1 % IG2 % IG3 % RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0973 Result Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Dec-2020 Generated Date: Number: COA-038", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815308", "context_preview": "ication SOP-0502 SM102 Cholesterol DSPC PEG-DMG Lipid Content SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 RRT 1 Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Dec-2020 Generated Date: Number:", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0393-mrna-1273-dp-lot-8520100104.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815310", "context_preview": "SOP-0492 Identity Purity SOP-0383 Purity % IG1 % IG2 % IG3 % RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0973 Result Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 11-Mar-2021 Generated Date: Number: ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815310", "context_preview": "2 Identity Purity SOP-0383 Purity % IG1 % IG2 % IG3 % RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0973 Result Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 11-Mar-2021 Generated Date: Number: COA-039", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815311", "context_preview": "tion SOP-0502 SM102 Cholesterol DSPC PEG-DMG Lipid Content SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 % Area 5 Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 11-Mar-2021 Generated Date: Number:", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0430-cx-024414-ds-lot-4007220002.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815313", "context_preview": "sidual DNA template SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 08-Jun-2020 Generated Date: Steven Anders", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0434-lot-5006820002.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Trade-secret claim": 2, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815315", "context_preview": "ize Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol DSPC PEG-DMG Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 19-Jun-2020 Generated Date: Steven Anderson Number: COA-0434 Version: 1.0 Effective Date: 19 Jun 2020 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815316", "context_preview": "Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 19-Jun-2020 Generated Date: Steven Anderson Number: COA-0434 Version: 1.0 Effective Date: 19 Jun 2020 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815316", "context_preview": "l Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 19-Jun-2020 Generated Date: Steven Anderson Number: COA-0434 Version: 1.0 Effective Date: 19 Jun 2020 mRNA-1273 Lip", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0440-cx-024414-ds-lot-4007220003.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815319", "context_preview": "emplate SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 03-Aug-2020 Generated Date: Steven Anderson Number: C", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815320", "context_preview": "- Corrected SOP-0291 pre-main peak acceptance criteria from in alignment with the approved specification SPC-0995 Revision History: Page 2 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 03-Aug-2020 Generated Date: Steven Anderson Number: COA", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0453-cx-024414-ds-lot-4007220004.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815321", "context_preview": "emplate SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Jul-2020 Generated Date: Steven Anderson Number: C", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0456-lot-5006820003.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 1, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815323", "context_preview": "ize Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol DSPC PEG-DMG Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 20-Jul-2020 Generated Date: Steven Anderson Number: COA-0456 Version: 1.0 Effective Date: 20 Jul 2020 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815324", "context_preview": "Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 20-Jul-2020 Generated Date: Steven Anderson Number: COA-0456 Version: 1.0 Effective Date: 20 Jul 2020 mRNA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0459-lot-5006820004.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815327", "context_preview": "ize Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol DSPC PEG-DMG Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 24-Jul-2020 Generated Date: Steven Anderson Number: COA-0459 Version: 1.0 Effective Date: 24 Jul 2020 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815328", "context_preview": "MC TYMC This material meets specification: Yes 1.0 - Original Revision History: Page 2 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 24-Jul-2020 Generated Date: Steven Anderson Number: COA-0459 Version: 1.0 Effective Date: 24 Jul 2020 mRNA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0520-cx-024414-ds-lot-4007420001.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815330", "context_preview": "emplate SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 23-Oct-2020 Generated Date: Steven Anderson Number: C", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0523-cx-024414-ds-lot-4007420002.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815332", "context_preview": "emplate SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 21-Oct-2020 Generated Date: Steven Anderson Number: C", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0549-mrna-cx-024414-lot-4007420003.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CERTIFICATE OF ANALYSIS", "bates": null, "context_preview": "Number: COA-0549 Version: 1.0 Effective Date: 18 Nov 2020 mRNA CX-024414 Certificate of Analysis Lot 4007420003 One Moderna Way + Norwood, MA 02062 Phone 617.714.6500 * Fax 617.583.1998 CERTIFICATE OF ANALYSIS Product Description: CX-024414 Moderna Part #: 40074 Manufacturer Name: Moderna Container/", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CERTIFICATE OF ANALYSIS", "bates": null, "context_preview": "Number: COA-0549 Version: 1.0 Effective Date: 18 Nov 2020 mRNA CX-024414 Certificate of Analysis Lot 4007420003 rna Way \u00ab Norwood, MA 02062 moderna soe eee wa i ear Phone 617.714.6500 \u00ab Fax 617.583.1998 CERTIFICATE OF ANALYSIS Product Description: CX-024414 Moderna Part #: 40074 Manufacturer Name: M", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0556-lot-5007520001.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 1, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815336", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol DSPC PEG-DMG Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 23-Nov-2020 Generated Date: Steven Anderson Number: COA-0556 Version: 1.0 Effective Date: 24 Nov 2020 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815337", "context_preview": "Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 23-Nov-2020 Generated Date: Steven Anderson Number: COA-0556 Version: 1.0 Effective Date: 24 Nov 2020 mRNA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0558-lot-5007520002.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 1, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815340", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol DSPC PEG-DMG Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 05-Feb-2021 Generated Date: Steven Anderson Number: COA-0558 Version: 2.0 Effective Date: 05 Feb 2021 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815341", "context_preview": "s 1.0 - Original 2.0 - Corrected expiration date to 04Feb2021 Revision History: Page 2 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 05-Feb-2021 Generated Date: Steven Anderson Number: COA-0558 Version: 2.0 Effective Date: 05 Feb 2021 mRNA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0573-cx-024414-ds-lot-4007420004.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815343", "context_preview": "emplate SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 07-Dec-2020 Generated Date: Steven Anderson Number: C", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0576-lot-5007520501.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 1, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815345", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol DSPC PEG-DMG Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 10-Dec-2020 Generated Date: Steven Anderson Number: COA-0576 Version: 2.0 Effective Date: 10 Dec 2020 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815346", "context_preview": "2020 to 05Nov2020 and expiry date from 04Jul2021 to 03Jul2021 Revision History: Page 2 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 10-Dec-2020 Generated Date: Steven Anderson Number: COA-0576 Version: 2.0 Effective Date: 10 Dec 2020 mRNA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0584-lot-5007520003.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815348", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol DSPC PEG-DMG Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 13-Dec-2020 Generated Date: Steven Anderson Number: COA-0584 Version: 1.0 Effective Date: 14 Dec 2020 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815349", "context_preview": "MC TYMC This material meets specification: Yes 1.0 - Original Revision History: Page 2 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 13-Dec-2020 Generated Date: Steven Anderson Number: COA-0584 Version: 1.0 Effective Date: 14 Dec 2020 mRNA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0588-cx-024414-ds-lot-4007420007.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815351", "context_preview": "emplate SOP-1020 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number: C", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0589-lot-5007520013.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 1, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815353", "context_preview": "ol DSPC PEG-DMG Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 13-Dec-2020 Generated Date: Steven Anderson Number: COA-0589 Version: 1.0 Effective Date: 14 Dec 2020 mRNA-1273 Lipid Nanoparticle Certificate of Analysis Lot 5007520013 T", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815354", "context_preview": "-0480 TAMC TYMC Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 13-Dec-2020 Generated Date: Steven Anderson Number: COA-0589 Version: 1.0 Effective Date: 14 Dec 2020 mRNA-1273 Lipid Nanoparticle Certificate of Analysis Lot 5007520013 T", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0590-lot-5007520004.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 1, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815357", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol DSPC PEG-DMG Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 14-Dec-2020 Generated Date: Steven Anderson Number: COA-0590 Version: 1.0 Effective Date: 14 Dec 2020 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815358", "context_preview": "Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 14-Dec-2020 Generated Date: Steven Anderson Number: COA-0590 Version: 1.0 Effective Date: 14 Dec 2020 mRNA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0591-lot-5007520009.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 1, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815361", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol DSPC PEG-DMG Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 13-Dec-2020 Generated Date: Steven Anderson Number: COA-0591 Version: 1.0 Effective Date: 16 Dec 2020 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815362", "context_preview": "Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 13-Dec-2020 Generated Date: Steven Anderson Number: COA-0591 Version: 1.0 Effective Date: 16 Dec 2020 mRNA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0594-cx-024414-ds-lot-4007420006.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815365", "context_preview": "template SOP-0491 Residual DNA Templat pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number: C", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0604-lot-5007520502.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 1, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815367", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol DSPC PEG-DMG Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 22-Dec-2020 Generated Date: Steven Anderson Number: COA-0604 Version: 2.0 Effective Date: 22 Dec 2020 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815368", "context_preview": "Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden USP <61> TAMC TYMC Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 22-Dec-2020 Generated Date: Steven Anderson Number: COA-0604 Version: 2.0 Effective Date: 22 Dec 2020 mRNA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0627-cx-024414-mrna-lot-4007420010.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815371", "context_preview": "dual DNA template SOP-1020 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden USP <61> TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 23-Dec-2020 Generated Date: Steven Anderson", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0655-cx-024414-mrna-lot-4007420501.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815373", "context_preview": "DNA template SOP-1020 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden USP <61> TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 04-Jan-2021 Generated Date: Steven Anderson Numb", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0736-cx-024414-mrna-lot-4007420016.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815375", "context_preview": "dual DNA template SOP-1020 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 25-Jan-2021 Generated Date: Steven Anderson", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0808-lot-5007521502.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 2, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815377", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol DSPC PEG-DMG Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Feb-2021 Generated Date: Steven Anderson Number: COA-0808 Version: 1.0 Effective Date: 18 Feb 2021 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815378", "context_preview": "molality SOP-0279 Osmolality Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Feb-2021 Generated Date: Steven Anderson Number: COA-0808 Version: 1.0 Effective Date: 18 Feb 2021 mRNA-", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815379", "context_preview": "MC TYMC This material meets specification: Yes 1.0 - Original Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Feb-2021 Generated Date: Steven Anderson Number: COA-0808 Version: 1.0 Effective Date: 18 Feb 2021 mRNA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0834-lot-5007521028.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 2, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815381", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol DSPC PEG-DMG Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 22-Feb-2021 Generated Date: Steven Anderson Number: COA-0834 Version: 1.0 Effective Date: 22 Feb 2021 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815382", "context_preview": "molality SOP-0279 Osmolality Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 22-Feb-2021 Generated Date: Steven Anderson Number: COA-0834 Version: 1.0 Effective Date: 22 Feb 2021 mRNA-", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815383", "context_preview": "MC TYMC This material meets specification: Yes 1.0 - Original Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 22-Feb-2021 Generated Date: Steven Anderson Number: COA-0834 Version: 1.0 Effective Date: 22 Feb 2021 mRNA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0866-lot-5007521020.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 2, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815385", "context_preview": "ize Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol DSPC PEG-DMG Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Mar-2021 Generated Date: Steven Anderson Number: COA-0866 Version: 1.0 Effective Date: 02 Mar 2021 mRNA-", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815386", "context_preview": "molality SOP-0279 Osmolality Bacterial Endotoxins USP <85> Bacterial Endotoxins Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Mar-2021 Generated Date: Steven Anderson Number: COA-0866 Version: 1.0 Effective Date: 02 Mar 2021 mRNA-", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815387", "context_preview": "MC TYMC This material meets specification: Yes 1.0 - Original Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 01-Mar-2021 Generated Date: Steven Anderson Number: COA-0866 Version: 1.0 Effective Date: 02 Mar 2021 mRNA-", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0883-cx-024414-mrna-lot-4007420021.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815389", "context_preview": "dual DNA template SOP-1020 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 03-Mar-2021 Generated Date: Steven Anderson", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0916-cx-024414-mrna-lot-4007421013.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815391", "context_preview": "dual DNA template SOP-1020 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden USP <61> TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 08-Mar-2021 Generated Date: Steven Anderson", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0956-mrna-cx-024414-lot-4007421017.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815393", "context_preview": "dual DNA template SOP-1020 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden USP <61> TAMC TYMC Page 1 of 2 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Mar-2021 Generated Date: Steven Anderson", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0977-cx-024414-mrna-lot-4007421005.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 1, "by_category": { "Trade-secret claim": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815396", "context_preview": "Number: COA-0977 Version: 1.0 Effective Date: 18 Mar 2021 CX-024414 mRNA Certificate of Analysis Lot 4007421005 Confidential and Proprietary Document Number: VV-QUAL-006895 eDMS Version: 1.0 (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (4) FDA-CBER-2022-1614-3815396", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815395", "context_preview": "Number: COA-0977 Version: 1.0 Effective Date: 18 Mar 2021 CX-024414 mRNA Certificate of Analysis Lot 4007421005 Confidential and Proprietary Document Number: VV-QUAL-006895 eDMS Version: 1.0 (b) (6) (b) (4) FDA-CBER-2022-1614-3815395", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-0987-lot-5007521010.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 0, "by_category": { "Trade-secret claim": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815397", "context_preview": "Number: COA-0987 Version: 1.0 Effective Date: 19 Mar 2021 mRNA-1273 Lipid Nanoparticle Certificate of Analysis Lot 5007521010 (CMO Lot 43001) This document copy was retrieved by Heidi Guzalo on 28 Jul 2021. Page 1 of 4 Confidential and Proprietary Document Number: VV-QUAL-006637 eDMS Version: 1.0 (b", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815397", "context_preview": "Number: COA-0987 Version: 1.0 Effective Date: 19 Mar 2021 mRNA-1273 Lipid Nanoparticle Certificate of Analysis Lot 5007521010 (CMO Lot 43001) This document copy was retrieved by Heidi Guzalo on 28 Jul 2021. Page 1 of 4 Confidential and Proprietary Document Number: VV-QUAL-006637 eDMS Version: 1.0 (b", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815398", "context_preview": "Number: COA-0987 Version: 1.0 Effective Date: 19 Mar 2021 mRNA-1273 Lipid Nanoparticle Certificate of Analysis Lot 5007521010 (CMO Lot 43001) This document copy was retrieved by Heidi Guzalo on 28 Jul 2021. Page 2 of 4 Confidential and Proprietary Document Number: VV-QUAL-006637 eDMS Version: 1.0 (b", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-1002-cx-024414-mrna-lot-4007421006.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815401", "context_preview": "(b) (6) (b) (4) FDA-CBER-2022-1614-3815401", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-1004-lot-5007521011.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 6, "table_count": 4, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815404", "context_preview": "(b) (6) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815404", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815404", "context_preview": "(b) (6) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815404", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815404", "context_preview": "(b) (6) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815404", "likely_table": true } ] }, { "filename": "125752_S2_M3_32s44_coa-1051-cx-024414-mrna-lot-4007421008.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815406", "context_preview": "(b) (6) (b) (4) FDA-CBER-2022-1614-3815406", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-1054-mrna-cx-024414-lot-4007421022.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-3815408", "context_preview": "SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC This material meets specification: Yes Revision History: 1.0 - Original CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: Steven Anderson Number: COA-1054 Ve", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-1062-lot-5007521036.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 6, "table_count": 4, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815410", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815410", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815410", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815410", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815410", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815410", "likely_table": true } ] }, { "filename": "125752_S2_M3_32s44_coa-1087-lot-5007521012.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 8, "table_count": 2, "by_category": { "Other / uncategorized": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815413", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) FDA-CBER-2022-1614-3815413", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815413", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) FDA-CBER-2022-1614-3815413", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815411", "context_preview": "(b) (6) (b) (4) (b) (4) FDA-CBER-2022-1614-3815411", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-1091-lot-5007521100.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 8, "table_count": 6, "by_category": { "Other / uncategorized": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815415", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815415", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815415", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815415", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815415", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815415", "likely_table": true } ] }, { "filename": "125752_S2_M3_32s44_coa-1134-lot-5007521118.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 6, "table_count": 4, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815418", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815418", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815418", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815418", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815418", "context_preview": "(b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-3815418", "likely_table": true } ] }, { "filename": "125752_S2_M3_32s44_coa-1237-cx-024414-mrna-lot-4007421067.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815419", "context_preview": "(b) (6) (b) (4) FDA-CBER-2022-1614-3815419", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-1238-cx-024414-mrna-lot-4007421009.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815421", "context_preview": "(b) (6) (b) (4) FDA-CBER-2022-1614-3815421", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-1319-cx-024414-mrna-lot-4007921001.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION.", "bates": "FDA-CBER-2022-1614-3815423", "context_preview": "H Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC This material meets specification: Yes Revision History: 1.0 - Original CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION. Generated By: Steven Anderson Page 1 of 1 Number: COA-1319", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-1320-cx-024414-mrna-lot-4007921003.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION.", "bates": "FDA-CBER-2022-1614-3815424", "context_preview": "H Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC This material meets specification: Yes Revision History: 1.0 - Original CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION. Generated By: Steven Anderson Page 1 of 1 Number: COA-1320", "likely_table": false } ] }, { "filename": "125752_S2_M3_32s44_coa-1321-cx-024414-mrna-lot-4007921005.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION.", "bates": "FDA-CBER-2022-1614-3815425", "context_preview": "H Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC This material meets specification: Yes Revision History: 1.0 - Original CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION. Generated By: Steven Anderson Page 1 of 1 Number: COA-1321", "likely_table": false } ] }, { "filename": "125752_S30_M1_form-356h-0030.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815847", "context_preview": "3 Emma Harrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815848", "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815848", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S30_M1_rsp-fda-cmts-ir26-cmc-01dec2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 20, "table_count": 16, "by_category": { "Manufacturing / CMC": 14, "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 20 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DATED DECEMBER 01, 2021", "bates": "FDA-CBER-2022-1614-3815850", "context_preview": "n is more soluble in water than in nonpolar solvents. Lipid-based drug substances / products are known to present complications for bacterial endotoxin testing. Lipopolysaccharides are amphipathic in nature. During method development, the Sponsor worked with Associates of Cape Cod, Inc. (ACC) to The", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DATED DECEMBER 01, 2021", "bates": "FDA-CBER-2022-1614-3815850", "context_preview": "e soluble in water than in nonpolar solvents. Lipid-based drug substances / products are known to present complications for bacterial endotoxin testing. Lipopolysaccharides are amphipathic in nature. During method development, the Sponsor worked with Associates of Cape Cod, Inc. (ACC) to The Sponsor", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DATED DECEMBER 01, 2021", "bates": "FDA-CBER-2022-1614-3815850", "context_preview": "e in water than in nonpolar solvents. Lipid-based drug substances / products are known to present complications for bacterial endotoxin testing. Lipopolysaccharides are amphipathic in nature. During method development, the Sponsor worked with Associates of Cape Cod, Inc. (ACC) to The Sponsor underst", "likely_table": true } ] }, { "filename": "125752_S31_M1_form-356h-0031.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815856", "context_preview": "A 02026 116912313 Emma Harrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 00", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815857", "context_preview": "000 USA 03801 093149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard ", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815857", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S32_M1_form-356h-0032.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S33_M1_form-356h-0033.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S34_M1_form-356h-0034.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815862", "context_preview": "SA 02026 116912313 Emma Harrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815863", "context_preview": "93149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-00", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815863", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean D", "likely_table": true } ] }, { "filename": "125752_S35_M1_form-356h-0035.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815870", "context_preview": "A 02026 116912313 Emma Harrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 00", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815871", "context_preview": "000 USA 03801 093149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard ", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815871", "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true } ] }, { "filename": "125752_S36_M1_form-356h-0036.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815877", "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815878", "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815878", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S36_M1_rsp-fda-cmts-ir28-cmc-07dec2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 11, "table_count": 6, "by_category": { "Manufacturing / CMC": 10, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SOP-0996.", "bates": "FDA-CBER-2022-1614-3815882", "context_preview": "please include additional information as stated in the proposed template below: Sponsor Response: The additional information for the In vitro translation test has been added to the Spikevax Lot Release Protocol template. ITEM 8: Page 11 of 12: Sterility test \u2013 please include the test method and test", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SOP-0996.", "bates": "FDA-CBER-2022-1614-3815882", "context_preview": "nclude additional information as stated in the proposed template below: Sponsor Response: The additional information for the In vitro translation test has been added to the Spikevax Lot Release Protocol template. ITEM 8: Page 11 of 12: Sterility test \u2013 please include the test method and test result ", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SOP-0996.", "bates": "FDA-CBER-2022-1614-3815882", "context_preview": "dditional information as stated in the proposed template below: Sponsor Response: The additional information for the In vitro translation test has been added to the Spikevax Lot Release Protocol template. ITEM 8: Page 11 of 12: Sterility test \u2013 please include the test method and test result details.", "likely_table": true } ] }, { "filename": "125752_S36_M3_32r_qc-oth-0609-lot-release-protocol.pdf", "module": "M3", "company": "Moderna", "license": "BLA", "total_kept": 9, "table_count": 5, "by_category": { "Other / uncategorized": 7, "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815891", "context_preview": "aphy; RP-IP-HPLC = reverse phase ion- pair high performance liquid chromatography; DLS = dynamic light scattering; DSPC = 1,2-distearoyl-sn-glycero-3- phosphocholine; EU = endotoxin unit(s); ; RP-HPLC = reverse-phase high-performance liquid chromatography; RTSS = reverse transcription Sangar sequenc", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815891", "context_preview": "-IP-HPLC = reverse phase ion- pair high performance liquid chromatography; DLS = dynamic light scattering; DSPC = 1,2-distearoyl-sn-glycero-3- phosphocholine; EU = endotoxin unit(s); ; RP-HPLC = reverse-phase high-performance liquid chromatography; RTSS = reverse transcription Sangar sequencing; HPL", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3815891", "context_preview": "= reverse phase ion- pair high performance liquid chromatography; DLS = dynamic light scattering; DSPC = 1,2-distearoyl-sn-glycero-3- phosphocholine; EU = endotoxin unit(s); ; RP-HPLC = reverse-phase high-performance liquid chromatography; RTSS = reverse transcription Sangar sequencing; HPLC-CAD = h", "likely_table": true } ] }, { "filename": "125752_S37_M1_form-356h-0037.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815897", "context_preview": "A 02026 116912313 Emma Harrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 00", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815898", "context_preview": "h NH 000000 USA 03801 093149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 ", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815898", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S38_M1_form-356h-0038.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S38_M1_rsp-fda-cmts-ir32-cmc-10dec2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 27, "table_count": 7, "by_category": { "Manufacturing / CMC": 17, "Other / uncategorized": 10 }, "by_marker": { "(b)(4)": 27 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RECEIVED ON DECEMBER 10, 2021", "bates": null, "context_preview": "e to measure free endotoxin. The drug delivery system utilized by the Sponsor includes encapsulated mRNA. In order to ensure the assay is able to detect any endotoxin that may be present, including entrapped endotoxin, sample pretreatment steps were incorporated. a. b. Characterization studies to ev", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RECEIVED ON DECEMBER 10, 2021", "bates": null, "context_preview": "sure free endotoxin. The drug delivery system utilized by the Sponsor includes encapsulated mRNA. In order to ensure the assay is able to detect any endotoxin that may be present, including entrapped endotoxin, sample pretreatment steps were incorporated. a. b. Characterization studies to evaluate t", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RECEIVED ON DECEMBER 10, 2021", "bates": null, "context_preview": "e endotoxin. The drug delivery system utilized by the Sponsor includes encapsulated mRNA. In order to ensure the assay is able to detect any endotoxin that may be present, including entrapped endotoxin, sample pretreatment steps were incorporated. a. b. Characterization studies to evaluate the assay", "likely_table": true } ] }, { "filename": "125752_S39_M1_form-356h-0039.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 3, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": null, "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": null, "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S3_M1_agreed-ipsp.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 12, "table_count": 0, "by_category": { "Pharmacology / toxicology": 6, "Manufacturing / CMC": 3, "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 12 }, "top_examples": [ { "page": 13, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2022-1614-4064986", "context_preview": "embryonic kidney 293 cells transfected with mRNA expressing the SARS-CoV-2 S-2P protein successfully expressed the protein. Recent studies in mice demonstrate that mRNA-1273 induces both potent neutralizing antibody and CD8 T cell responses. In addition, mRNA-1273 protects mice against SARS-CoV-2 in", "likely_table": false }, { "page": 13, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2022-1614-4064986", "context_preview": "c kidney 293 cells transfected with mRNA expressing the SARS-CoV-2 S-2P protein successfully expressed the protein. Recent studies in mice demonstrate that mRNA-1273 induces both potent neutralizing antibody and CD8 T cell responses. In addition, mRNA-1273 protects mice against SARS-CoV-2 infection ", "likely_table": false }, { "page": 21, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "7.0 \n AGE-APPROPRIATE FORMULATION DEVELOPMENT", "bates": "FDA-CBER-2022-1614-4064994", "context_preview": "on Detailed instructions for dilution of the drug product with the diluent and administration in a short time window have been established and are summarised below. In the pediatric population from birth to <18 years, the applicant proposes to investigate the safety, reactogenicity and effectiveness", "likely_table": false } ] }, { "filename": "125752_S3_M1_form-356h-0003.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 4, "table_count": 3, "by_category": { "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 019745", "bates": "FDA-CBER-2022-1614-3815429", "context_preview": "arrington One Moderna Way 000-000-0000 Norwood MA USA 02062 @modernatx.com Release, stability, in-process testing of ModernaTX, Inc. Norwood,MA 02062 , mRNA-1273 LNP Stability and release testing of mRNA-1273 Drug Product Aldevron 4055 41st Avenue South 1111111111 Fargo ND 000000 USA 58104 048764943", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815430", "context_preview": "3149750 101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3815430", "context_preview": "101 International Drive 000-000-0000 Portsmouth NH USA 03801 Manufacture , Release testing, storage of , mRNA-1273 LNP, CX-24414 Stability Testing of CX-24414 Associates of Cape Cod 124 Bernard Street 1219145 Jean Drive East Falmouth MA 000000 USA 02536 076574078 124 Bernard Street 000-000-0000 Jean", "likely_table": true } ] }, { "filename": "125752_S3_M1_request-for-a-waiver-1.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 9, "table_count": 9, "by_category": { "Manufacturing / CMC": 9 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "1.12.5 Request for a Waiver", "bates": "FDA-CBER-2022-1614-3815432", "context_preview": "been demonstrated through evaluation of in-process controls and critical process parameters against expected ranges or proven acceptable ranges (PARs). The comparability acceptance criteria were the same as or tighter than the lot release specifications. The assessment covered all the constituent ma", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "1.12.5 Request for a Waiver", "bates": "FDA-CBER-2022-1614-3815432", "context_preview": "onstrated through evaluation of in-process controls and critical process parameters against expected ranges or proven acceptable ranges (PARs). The comparability acceptance criteria were the same as or tighter than the lot release specifications. The assessment covered all the constituent materials,", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "1.12.5 Request for a Waiver", "bates": "FDA-CBER-2022-1614-3815432", "context_preview": "d through evaluation of in-process controls and critical process parameters against expected ranges or proven acceptable ranges (PARs). The comparability acceptance criteria were the same as or tighter than the lot release specifications. The assessment covered all the constituent materials, Continu", "likely_table": true } ] }, { "filename": "125752_S3_M1_request-for-a-waiver.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 10, "table_count": 0, "by_category": { "Other / uncategorized": 6, "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "BLA 125752", "bates": "FDA-CBER-2022-1614-4065019", "context_preview": "s of the lipid nanoparticle (LNP)-based product, and (2) the efficiencies offered by the multiple-dose vial in utilizing fill/finish, container/closure as well as supply chain resources in a pandemic response situation. Data generated to date considering the impact of testing, support the preservati", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "BLA 125752", "bates": "FDA-CBER-2022-1614-4065019", "context_preview": "lipid nanoparticle (LNP)-based product, and (2) the efficiencies offered by the multiple-dose vial in utilizing fill/finish, container/closure as well as supply chain resources in a pandemic response situation. Data generated to date considering the impact of testing, support the preservative-free m", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "BLA 125752", "bates": "FDA-CBER-2022-1614-4065019", "context_preview": "anoparticle (LNP)-based product, and (2) the efficiencies offered by the multiple-dose vial in utilizing fill/finish, container/closure as well as supply chain resources in a pandemic response situation. Data generated to date considering the impact of testing, support the preservative-free multiple", "likely_table": false } ] }, { "filename": "125752_S3_M1_rmp-v2-2.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 4, "table_count": 0, "by_category": { "Other / uncategorized": 2, "Manufacturing / CMC": 1, "Pharmacology / toxicology": 1 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 9, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Module 1", "bates": "FDA-CBER-2022-1614-4065035", "context_preview": "e (S) protein of SARS-CoV-2. The other ingredients are Lipid SM-102 (heptadecan-9-yl 8- {(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino}octanoate), Cholesterol, 1,2- distearoyl-sn-glycero-3-phosphocholine (DSPC), 1,2-Dimyristoyl-rac-glycero-3- methoxypolyethylene glycol-2000 (PEG2000 DMG), Trometa", "likely_table": false }, { "page": 20, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "Part II: Module SII Nonclinical Part of the Safety Specification", "bates": "FDA-CBER-2022-1614-4065046", "context_preview": "safety concerns have been identified. Pharmacokinetics and Drug Metabolism Distribution Study A biodistribution study was performed with mRNA-1647, an mRNA-based vaccine against human cytomegalovirus also formulated in . As observed with other IM-delivered vaccines, the highest mRNA concentrations w", "likely_table": false }, { "page": 491, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Part VII: Annexes :", "bates": "FDA-CBER-2022-1614-4065517", "context_preview": "p Intermediary Delivery Events Status Timestamp Certified Delivery Events Status Timestamp Carbon Copy Events Status Timestamp Witness Events Signature Timestamp Notary Events Signature Timestamp Envelope Summary Events Status Timestamps Envelope Sent Hashed/Encrypted 18-Aug-2021 | 10:07 Certified D", "likely_table": false } ] }, { "filename": "125752_S3_M2_23_qos-appendices.pdf", "module": "M2", "company": "Moderna", "license": "BLA", "total_kept": 10, "table_count": 0, "by_category": { "Manufacturing / CMC": 6, "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "2.3.A.1.4 \nCorden Pharma Liestal", "bates": "FDA-CBER-2022-1614-3815435", "context_preview": "r The formulation and filling of the DP are performed at Baxter Pharmaceutical Solutions (also referred to as Baxter) facility located at 927 S. Curry Pike, Bloomington, Indiana, USA 47403. See 3.2.A.1 {Baxter} for additional detail. 2.3.A.1.3 Corden Pharma Colorado Corden Pharma Colorado (Boulder, ", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.3.A.1.4 \nCorden Pharma Liestal", "bates": "FDA-CBER-2022-1614-3815435", "context_preview": "ormulation and filling of the DP are performed at Baxter Pharmaceutical Solutions (also referred to as Baxter) facility located at 927 S. Curry Pike, Bloomington, Indiana, USA 47403. See 3.2.A.1 {Baxter} for additional detail. 2.3.A.1.3 Corden Pharma Colorado Corden Pharma Colorado (Boulder, CO, USA", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.3.A.1.4 \nCorden Pharma Liestal", "bates": "FDA-CBER-2022-1614-3815435", "context_preview": "on and filling of the DP are performed at Baxter Pharmaceutical Solutions (also referred to as Baxter) facility located at 927 S. Curry Pike, Bloomington, Indiana, USA 47403. See 3.2.A.1 {Baxter} for additional detail. 2.3.A.1.3 Corden Pharma Colorado Corden Pharma Colorado (Boulder, CO, USA) manufa", "likely_table": false } ] }, { "filename": "125752_S3_M2_23_qos-drug-product.pdf", "module": "M2", "company": "Moderna", "license": "BLA", "total_kept": 104, "table_count": 32, "by_category": { "Manufacturing / CMC": 74, "Other / uncategorized": 21, "Trade-secret claim": 5, "Inspection / enforcement": 4 }, "by_marker": { "(b)(4)": 104 }, "top_examples": [ { "page": 10, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "BLA 125752", "bates": "FDA-CBER-2022-1614-4065527", "context_preview": "d. Table 4: Properties of mRNA-1273 LNP and DP Solutions Property Nominal 20\uf0b0C Nominal 5\uf0b0C Density (g/mL) Viscosity (cP) Surface tension (mN/m) Osmolality (mOsm/kg) (a) Glass transition temperature (Tg\u2032) (\uf0b0C) Abbreviations: DP = drug product; LNP = lipid nanoparticle; N/A = not applicable a Osmolali", "likely_table": true }, { "page": 10, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "BLA 125752", "bates": "FDA-CBER-2022-1614-4065527", "context_preview": "e 4: Properties of mRNA-1273 LNP and DP Solutions Property Nominal 20\uf0b0C Nominal 5\uf0b0C Density (g/mL) Viscosity (cP) Surface tension (mN/m) Osmolality (mOsm/kg) (a) Glass transition temperature (Tg\u2032) (\uf0b0C) Abbreviations: DP = drug product; LNP = lipid nanoparticle; N/A = not applicable a Osmolality for ", "likely_table": true }, { "page": 10, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "BLA 125752", "bates": "FDA-CBER-2022-1614-4065527", "context_preview": "operties of mRNA-1273 LNP and DP Solutions Property Nominal 20\uf0b0C Nominal 5\uf0b0C Density (g/mL) Viscosity (cP) Surface tension (mN/m) Osmolality (mOsm/kg) (a) Glass transition temperature (Tg\u2032) (\uf0b0C) Abbreviations: DP = drug product; LNP = lipid nanoparticle; N/A = not applicable a Osmolality for release", "likely_table": true } ] }, { "filename": "125752_S3_M2_23_qos-introduction.pdf", "module": "M2", "company": "Moderna", "license": "BLA", "total_kept": 26, "table_count": 22, "by_category": { "Manufacturing / CMC": 14, "Other / uncategorized": 12 }, "by_marker": { "(b)(4)": 26 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "INTRODUCTION", "bates": "FDA-CBER-2022-1614-3815438", "context_preview": "per dose) per vial. Labeled Fill volume 7.5 mL (0.5 mL per dose) vial: Each vial contains mg of CX- 024414 mRNA and mg of SM-102 LNP as a white to off-white dispersion in a preservative-free buffer containing 20 mM Tromethamine (Tris), acetate, 87 g/L sucrose at pH 7.5. The target fill volume is 8.0", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "INTRODUCTION", "bates": "FDA-CBER-2022-1614-3815438", "context_preview": ") per vial. Labeled Fill volume 7.5 mL (0.5 mL per dose) vial: Each vial contains mg of CX- 024414 mRNA and mg of SM-102 LNP as a white to off-white dispersion in a preservative-free buffer containing 20 mM Tromethamine (Tris), acetate, 87 g/L sucrose at pH 7.5. The target fill volume is 8.0 mL, whi", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "INTRODUCTION", "bates": "FDA-CBER-2022-1614-3815438", "context_preview": "al. Labeled Fill volume 7.5 mL (0.5 mL per dose) vial: Each vial contains mg of CX- 024414 mRNA and mg of SM-102 LNP as a white to off-white dispersion in a preservative-free buffer containing 20 mM Tromethamine (Tris), acetate, 87 g/L sucrose at pH 7.5. The target fill volume is 8.0 mL, which allow", "likely_table": true } ] }, { "filename": "125752_S3_M2_24_nonclinical-overview.pdf", "module": "M2", "company": "Moderna", "license": "BLA", "total_kept": 11, "table_count": 0, "by_category": { "Pharmacology / toxicology": 6, "Other / uncategorized": 3, "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.4.1.2 \nTest Material", "bates": "FDA-CBER-2022-1614-3018157", "context_preview": "he novel lipid used in mRNA-1273, and the commercially available PEG2000-DMG were evaluated as individual agents in GLP-compliant in vitro genotoxicity studies. The potential effects of mRNA-1273 on fertility and pre- and postnatal development in pregnant and lactating female Sprague Dawley rats was", "likely_table": false }, { "page": 9, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.4 Nonclinical Overview", "bates": "FDA-CBER-2022-1614-3018160", "context_preview": "us test using an mRNA-based vaccine formulated in SM-102 LNPs (mRNA-1706) and a non-GLP-compliant in vivo rat micronucleus test using a reporter mRNA (nascent peptide imaging [NPI] luciferase mRNA) formulated in SM-102 LNPs. Additionally, a GLP-compliant combined developmental and perinatal/postnata", "likely_table": false }, { "page": 11, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.4.2.1 \nPrimary Pharmacology", "bates": "FDA-CBER-2022-1614-3018162", "context_preview": "gen was confirmed in vitro and in vivo. Sustained levels of antigen expression were observed over 24, 48, and 72 hours in HEK293T cells transiently transfected with a dose range (0.003125 through 0.2 \u03bcg) of an mRNA construct that encodes the SARS-CoV-2 S-2P antigen, as demonstrated by an overall inc", "likely_table": false } ] }, { "filename": "125752_S3_M2_26_introduction.pdf", "module": "M2", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Trial design / efficacy": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "REFERENCES", "bates": "FDA-CBER-2022-1614-3018188", "context_preview": "d well tolerated, is immunogenic, fully protects animals from viral challenge, and does not promote ERD at either optimal or suboptimal dose levels. These data support the clinical evaluation of the efficacy and safety of 100 \u00b5g of mRNA-1273 administered as 2 IM injections 28 days apart. 2.6.2 REFER", "likely_table": false } ] }, { "filename": "125752_S3_M2_26_pharmacol-tabulated-summary.pdf", "module": "M2", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Pharmacology / toxicology": 1, "Trial design / efficacy": 1 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "4.2.3.7.7 \nProtection from WT", "bates": "FDA-CBER-2022-1614-3018265", "context_preview": "er, National Institutes of Health Building 40, Room 2608 VRC02 4.2.1.1 Five-week (2 doses: prime/boost) repeat dose immunogenicity with safety endpoints Rat, Sprague Dawley IM Charles River Laboratories, Inc. 54943 North Main Street Mattawan, MI 49071 2308-123 4.2.3.7.7 Protection from WT SARS-CoV-2", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "4.2.1.1 \nEvaluation of", "bates": "FDA-CBER-2022-1614-3018266", "context_preview": "ian-origin) IM Viral Pathogenesis Laboratory, Vaccine Research Center, National Institutes of Health Building 40 Room 2608 VRC04 4.2.1.1 Evaluation of immunogenicity and efficacy from expanded dose range in NHPs NHP, rhesus macaque (Indian-origin) IM Viral Pathogenesis Laboratory, Vaccine Research C", "likely_table": false } ] }, { "filename": "125752_S3_M2_26_pharmacol-written-summary.pdf", "module": "M2", "company": "Moderna", "license": "BLA", "total_kept": 20, "table_count": 0, "by_category": { "Pharmacology / toxicology": 8, "Other / uncategorized": 8, "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 20 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-3018196", "context_preview": "e heptad repeat 1 domain SARS severe acute respiratory syndrome SARS-CoV severe acute respiratory syndrome coronavirus SARS-CoV-1 severe acute respiratory syndrome coronavirus-1 SARS-CoV-1 DIV double-inactivated severe acute respiratory syndrome coronavirus-1 SARS-CoV-2 2019 novel coronavirus SD sta", "likely_table": false }, { "page": 13, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.6.2.2.1 \nExpression of SARS-CoV-2 S-2P Encoded by mRNA (In Vitro) or", "bates": "FDA-CBER-2022-1614-3018202", "context_preview": "ltiplying the frequency of positive cells by the mean fluorescence intensity (MFI [ (MFI \u00d7 frequency]), which indicated the level of SARS-CoV-2 S-2P antigen expression. Evaluation of In Vivo Expression of mRNA-1273 Mice were administered a single IM dose of 2 or 10 \u00b5g of mRNA-1273. Spleens and dLNs ", "likely_table": false }, { "page": 19, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.6.2.2.2 \nEvaluation of Immunogenicity, Protective Capacity, and Safety of", "bates": "FDA-CBER-2022-1614-3018208", "context_preview": "T-cell cytokine responses to in vitro restimulation with pools of overlapping peptides from S proteins (S1 and S2 peptides), as measured by flow cytometry analysis of cell surface and intracellular immunostaining. Lungs and nasal turbinates were collected from mRNA-1273-immunized mice on Day 2 and D", "likely_table": false } ] }, { "filename": "125752_S3_M2_26_toxicology-tabulated-summary.pdf", "module": "M2", "company": "Moderna", "license": "BLA", "total_kept": 23, "table_count": 8, "by_category": { "Pharmacology / toxicology": 11, "Other / uncategorized": 8, "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 23 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "4.2.3.3.1 \nRat, Sprague", "bates": "FDA-CBER-2022-1614-3018343", "context_preview": "at, Sprague Dawley IV (bolus) mRNA-1706a Single dose evaluated at 24 h and 48 h post dose 0, 0.6/6.2 (F), 1.3/13.5, 2.6/27.0, 5.2/54.1 (M) mg/kg mRNA-1706/ SM-102j, k Yes CRL 9800399 4.2.3.3.2 IV (bolus) NPI luciferase mRNAl Single dose evaluated at 24 h and 48 h post-dose 0.32/6.0, 1.07/20, 3.21/60", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "4.2.3.3.1 \nRat, Sprague", "bates": "FDA-CBER-2022-1614-3018343", "context_preview": "gue Dawley IV (bolus) mRNA-1706a Single dose evaluated at 24 h and 48 h post dose 0, 0.6/6.2 (F), 1.3/13.5, 2.6/27.0, 5.2/54.1 (M) mg/kg mRNA-1706/ SM-102j, k Yes CRL 9800399 4.2.3.3.2 IV (bolus) NPI luciferase mRNAl Single dose evaluated at 24 h and 48 h post-dose 0.32/6.0, 1.07/20, 3.21/60 mg/kg N", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "AF87FU.125012NGLPICH.BTL", "bates": "FDA-CBER-2022-1614-3018346", "context_preview": "y NPI luciferase mRNAc MTDS18021 NE NE NE AF87FU.125012NGLPICH.BTL Genotoxicity mRNA-1273 DH-03026 20248897 Reproductive and developmental toxicity mRNA-1273 8520100101 2308-123 Other toxicity Abbreviations: mRNA = messenger RNA; NE = not evaluated; NPI = nascent peptide imaging. a mRNA-based vaccin", "likely_table": true } ] }, { "filename": "125752_S3_M2_26_toxicology-written-summary.pdf", "module": "M2", "company": "Moderna", "license": "BLA", "total_kept": 18, "table_count": 0, "by_category": { "Manufacturing / CMC": 12, "Pharmacology / toxicology": 3, "Clinical safety / adverse events": 1, "Other / uncategorized": 1, "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 18 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.6.6.6 \nReproductive and Developmental Toxicity .......................................................... 45", "bates": "FDA-CBER-2022-1614-3018289", "context_preview": "...................................... 40 2.6.6.4.3.1 Mammalian Erythrocyte Micronucleus Test in Rat ...................................... 40 2.6.6.4.3.2 Mammalian Erythrocyte Micronucleus Test in Rat ...................................... 42 2.6.6.5 Carcinogenicity ................................", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "BRIEF SUMMARY", "bates": "FDA-CBER-2022-1614-3018294", "context_preview": "aggregate GLP repeat-dose rat data is considered to be representative of mRNA vaccines formulated in the same SM-102\u2013containing LNPs and supports the development of mRNA-1273. SM-102, the novel lipid used in mRNA-1273, and the commercially available PEG2000-DMG were evaluated in genotoxicity studies", "likely_table": false }, { "page": 8, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.6.6 Toxicology Written Summary", "bates": "FDA-CBER-2022-1614-3018296", "context_preview": ", 500 \u03bcg/mL SM-102 with or without supplemented rat liver fraction Yes 9601568 PEG2000- Human peripheral blood lymphocytes Incubation for 4 and/or 24 h with 0, 53.3, 93.3, 163, 286, 500 \u03bcg/mL PEG2000-DMG with or without supplemented rat liver fraction Yes 9601036 In Vivo Genotoxicity In vivo mammali", "likely_table": false } ] }, { "filename": "125752_S3_M2_27_summary-clin-safety.pdf", "module": "M2", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 176, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": "2.7.4.6.1 \nDetermination/Identification of Events", "bates": "FDA-CBER-2022-1614-3225669", "context_preview": "reporting rates. The threshold for flagging topics of interest for the PFRR is reporting ratio > 2, minimum 10 events in the RP and Not Classified as Standard Topic, Important Identified Risk, Important Potential Risk, Missing Information, or Adverse Event of Special Interest. For biweekly VAERS dat", "likely_table": false } ] }, { "filename": "125752_S3_M5_5314_21120-10208.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 93, "table_count": 78, "by_category": { "Trade-secret claim": 81, "Other / uncategorized": 10, "Manufacturing / CMC": 1, "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 93 }, "top_examples": [ { "page": 31, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "Appendix A", "bates": "FDA-CBER-2022-1614-1790150", "context_preview": "testing show that all 4 amplicons were detected for replicates tested at the copies/mL concentration. Table 19. Pre-Validation Sensitivity Amplification Approved and current. Effective starting 26-Jan-2021. 21120.10208 (version 1.0) Validation Report for Establishing the Performance Characteristics ", "likely_table": true }, { "page": 31, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "Appendix A", "bates": "FDA-CBER-2022-1614-1790150", "context_preview": "show that all 4 amplicons were detected for replicates tested at the copies/mL concentration. Table 19. Pre-Validation Sensitivity Amplification Approved and current. Effective starting 26-Jan-2021. 21120.10208 (version 1.0) Validation Report for Establishing the Performance Characteristics of the S", "likely_table": true }, { "page": 31, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "Appendix A", "bates": "FDA-CBER-2022-1614-1790150", "context_preview": "at all 4 amplicons were detected for replicates tested at the copies/mL concentration. Table 19. Pre-Validation Sensitivity Amplification Approved and current. Effective starting 26-Jan-2021. 21120.10208 (version 1.0) Validation Report for Establishing the Performance Characteristics of the SARS-CoV", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_21120-10562-wgs-verification-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 235, "table_count": 184, "by_category": { "Trade-secret claim": 204, "Trial design / efficacy": 31 }, "by_marker": { "(b)(4)": 235 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "1.0\nApproved and Current", "bates": "FDA-CBER-2022-1614-1790155", "context_preview": "ith the Twist SARS-CoV2 synthetic RNA positive control material. The LoD for SARS-CoV2 WGS was previously determined by Eurofins Genomics to be 100 copies/ARTIC PCR Assay reaction. This LoD was re- confirmed by Viracor. PASS Approved and current. Effective starting 19-Mar-2021. 21120.10562 (version ", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "1.0\nApproved and Current", "bates": "FDA-CBER-2022-1614-1790155", "context_preview": "Twist SARS-CoV2 synthetic RNA positive control material. The LoD for SARS-CoV2 WGS was previously determined by Eurofins Genomics to be 100 copies/ARTIC PCR Assay reaction. This LoD was re- confirmed by Viracor. PASS Approved and current. Effective starting 19-Mar-2021. 21120.10562 (version 1.0) SAR", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "1.0\nApproved and Current", "bates": "FDA-CBER-2022-1614-1790155", "context_preview": "ARS-CoV2 synthetic RNA positive control material. The LoD for SARS-CoV2 WGS was previously determined by Eurofins Genomics to be 100 copies/ARTIC PCR Assay reaction. This LoD was re- confirmed by Viracor. PASS Approved and current. Effective starting 19-Mar-2021. 21120.10562 (version 1.0) SARS CoV 2", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_21120-8062-matrix-qual-rpt-biofire-film.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 30, "table_count": 14, "by_category": { "Trade-secret claim": 30 }, "by_marker": { "(b)(4)": 30 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790000", "context_preview": "gative target results can be obtained in a time and resource-efficient manner. Approved and current. Effective starting 20-May-2019. 21120.8062 (version 1.0) Matrix Qualification Report to Verify the Performance Characteristics of the BioFire FilmArray\u00ae Respiratory Panel Assay using Nasopharyngeal a", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790000", "context_preview": "arget results can be obtained in a time and resource-efficient manner. Approved and current. Effective starting 20-May-2019. 21120.8062 (version 1.0) Matrix Qualification Report to Verify the Performance Characteristics of the BioFire FilmArray\u00ae Respiratory Panel Assay using Nasopharyngeal and Oroph", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790000", "context_preview": "sults can be obtained in a time and resource-efficient manner. Approved and current. Effective starting 20-May-2019. 21120.8062 (version 1.0) Matrix Qualification Report to Verify the Performance Characteristics of the BioFire FilmArray\u00ae Respiratory Panel Assay using Nasopharyngeal and Oropharyngeal", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_21120-8918-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 102, "table_count": 60, "by_category": { "Trade-secret claim": 92, "Trial design / efficacy": 5, "Other / uncategorized": 5 }, "by_marker": { "(b)(4)": 102 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "1.0\nRetired", "bates": "FDA-CBER-2022-1614-1790017", "context_preview": "and Drug Administration Staff, document issued on February 29, 2020).Table 1 is a summary of the protocol including acceptance criteria, validation results and pass/fail status. The remainder of this page is intentionally left blank. Approved and current. Effective starting 21-Jul-2020. 21120.8918 (", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "1.0\nRetired", "bates": "FDA-CBER-2022-1614-1790017", "context_preview": "Administration Staff, document issued on February 29, 2020).Table 1 is a summary of the protocol including acceptance criteria, validation results and pass/fail status. The remainder of this page is intentionally left blank. Approved and current. Effective starting 21-Jul-2020. 21120.8918 (version 3", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "1.0\nRetired", "bates": "FDA-CBER-2022-1614-1790017", "context_preview": "stration Staff, document issued on February 29, 2020).Table 1 is a summary of the protocol including acceptance criteria, validation results and pass/fail status. The remainder of this page is intentionally left blank. Approved and current. Effective starting 21-Jul-2020. 21120.8918 (version 3.0) SA", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_21120-9204-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 140, "table_count": 122, "by_category": { "Trade-secret claim": 127, "Trial design / efficacy": 13 }, "by_marker": { "(b)(4)": 140 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "SPECIMEN REQUIREMENTS", "bates": "FDA-CBER-2022-1614-1790051", "context_preview": "and specimen conditions required for each assay on Viracor Eurofins test menu. This includes clinical laboratory procedures involved in determining specimen acceptability for samples received for testing in the Clinical Laboratory. Approved and current. Effective starting 05-Oct-2020. 21120.9204 (ve", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "SPECIMEN REQUIREMENTS", "bates": "FDA-CBER-2022-1614-1790051", "context_preview": "cimen conditions required for each assay on Viracor Eurofins test menu. This includes clinical laboratory procedures involved in determining specimen acceptability for samples received for testing in the Clinical Laboratory. Approved and current. Effective starting 05-Oct-2020. 21120.9204 (version 9", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "SPECIMEN REQUIREMENTS", "bates": "FDA-CBER-2022-1614-1790051", "context_preview": "nditions required for each assay on Viracor Eurofins test menu. This includes clinical laboratory procedures involved in determining specimen acceptability for samples received for testing in the Clinical Laboratory. Approved and current. Effective starting 05-Oct-2020. 21120.9204 (version 9.0) Clie", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_21120-9249-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 164, "table_count": 86, "by_category": { "Trade-secret claim": 146, "Inspection / enforcement": 10, "Other / uncategorized": 8 }, "by_marker": { "(b)(4)": 164 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.0\nApproval", "bates": "FDA-CBER-2022-1614-1790072", "context_preview": "anization ViraCor Author Mark Wissel Comments for version 3.0 Addition of results for an and results for RT-PCR comparison. Updated tables for this upload to correct a typo. This version fixes table 25, which was entered incorrectly. Approval and Periodic Review Signatures Type Description Date Vers", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.0\nApproval", "bates": "FDA-CBER-2022-1614-1790072", "context_preview": "n ViraCor Author Mark Wissel Comments for version 3.0 Addition of results for an and results for RT-PCR comparison. Updated tables for this upload to correct a typo. This version fixes table 25, which was entered incorrectly. Approval and Periodic Review Signatures Type Description Date Version Perf", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.0\nApproval", "bates": "FDA-CBER-2022-1614-1790072", "context_preview": "r Author Mark Wissel Comments for version 3.0 Addition of results for an and results for RT-PCR comparison. Updated tables for this upload to correct a typo. This version fixes table 25, which was entered incorrectly. Approval and Periodic Review Signatures Type Description Date Version Performed By", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_b1004-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 413, "table_count": 377, "by_category": { "Other / uncategorized": 413 }, "by_marker": { "(b)(4)": 413 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790211", "context_preview": "3 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790211", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790211", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790211", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790211", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790211", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_biomarker-con-analy-protocol-p301.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 44, "table_count": 15, "by_category": { "Trade-secret claim": 19, "Inspection / enforcement": 16, "Other / uncategorized": 9 }, "by_marker": { "(b)(4)": 44 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "O35ADF27488C419...", "bates": "FDA-CBER-2022-1614-1790245", "context_preview": "As of 09-Mar-2021, there were 885 subjects (1554 observations) that received mRNA-1273 in the 301 clinical trial and had data from all four assays for a given timepoint (Day 29 or Day 57) and met the following constraints: 1) Above the LLOQ for all four assays, 2) below the ULOQ for the two binding ", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "O35ADF27488C419...", "bates": "FDA-CBER-2022-1614-1790245", "context_preview": "d had data from all four assays for a given timepoint (Day 29 or Day 57) and met the following constraints: 1) Above the LLOQ for all four assays, 2) below the ULOQ for the two binding assays, and 3) HIV negative. Table 2 provides a summary of the available data and the number of patients and observ", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "O35ADF27488C419...", "bates": "FDA-CBER-2022-1614-1790245", "context_preview": "ta from all four assays for a given timepoint (Day 29 or Day 57) and met the following constraints: 1) Above the LLOQ for all four assays, 2) below the ULOQ for the two binding assays, and 3) HIV negative. Table 2 provides a summary of the available data and the number of patients and observations f", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_cfar02-a0026-4.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 139, "table_count": 109, "by_category": { "Other / uncategorized": 139 }, "by_marker": { "(b)(4)": 139 }, "top_examples": [ { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3018417", "context_preview": "8 (b) (4) (b) (4) (b) (4) (b) (4) (b) (6) (b) (6) FDA-CBER-2022-1614-3018417", "likely_table": true }, { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3018417", "context_preview": "8 (b) (4) (b) (4) (b) (4) (b) (4) (b) (6) (b) (6) FDA-CBER-2022-1614-3018417", "likely_table": true }, { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3018417", "context_preview": "8 (b) (4) (b) (4) (b) (4) (b) (4) (b) (6) (b) (6) FDA-CBER-2022-1614-3018417", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_clin-pharm-summ-biomarker-assays.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 126, "table_count": 97, "by_category": { "Other / uncategorized": 110, "Trade-secret claim": 9, "Trial design / efficacy": 5, "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 126 }, "top_examples": [ { "page": 15, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.1.1.1.1 Study 101: ELISA S-2P-protein IgG and RBD IgG", "bates": "FDA-CBER-2022-1614-1790282", "context_preview": "on of , or SARS-CoV-2 RBD antigen at a working concentration of were coated onto plates overnight for hours at . Antigen concentrations were defined during assay development and antigen lot titration. Plates were washed and blocked for . serial fold dilutions covering the range of of the test sample", "likely_table": true }, { "page": 15, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.1.1.1.1 Study 101: ELISA S-2P-protein IgG and RBD IgG", "bates": "FDA-CBER-2022-1614-1790282", "context_preview": "or SARS-CoV-2 RBD antigen at a working concentration of were coated onto plates overnight for hours at . Antigen concentrations were defined during assay development and antigen lot titration. Plates were washed and blocked for . serial fold dilutions covering the range of of the test sample (dilute", "likely_table": true }, { "page": 15, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.1.1.1.1 Study 101: ELISA S-2P-protein IgG and RBD IgG", "bates": "FDA-CBER-2022-1614-1790282", "context_preview": "S-CoV-2 RBD antigen at a working concentration of were coated onto plates overnight for hours at . Antigen concentrations were defined during assay development and antigen lot titration. Plates were washed and blocked for . serial fold dilutions covering the range of of the test sample (diluted in )", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_duke-02-mvppr-covid0001-v1-val-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 81, "table_count": 79, "by_category": { "Other / uncategorized": 59, "Trial design / efficacy": 20, "Trade-secret claim": 2 }, "by_marker": { "(b)(4)": 81 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "3.0\nIntro", "bates": "FDA-CBER-2022-1614-1790311", "context_preview": "Proto d Validation P Neutraliz tion Assa Neutralization Ass rsion 1.0) and prov sion 1.0) and pro pu purpose of this ad pose of this ad on on experiment experiment tha t CV CV for for ople who are being ple who are being be b s a protocol for a protocol dum dum applies to the applie of the e \u201cSARS S", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "3.0\nIntro", "bates": "FDA-CBER-2022-1614-1790311", "context_preview": "Validation P Neutraliz tion Assa Neutralization Ass rsion 1.0) and prov sion 1.0) and pro pu purpose of this ad pose of this ad on on experiment experiment tha t CV CV for for ople who are being ple who are being be b s a protocol for a protocol dum dum applies to the applie of the e \u201cSARS SARS-CoV ", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "3.0\nIntro", "bates": "FDA-CBER-2022-1614-1790311", "context_preview": "ion P Neutraliz tion Assa Neutralization Ass rsion 1.0) and prov sion 1.0) and pro pu purpose of this ad pose of this ad on on experiment experiment tha t CV CV for for ople who are being ple who are being be b s a protocol for a protocol dum dum applies to the applie of the e \u201cSARS SARS-CoV C 3T/AC", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_duke-02-mvr-covid0001-v1-1-val-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 86, "table_count": 58, "by_category": { "Other / uncategorized": 86 }, "by_marker": { "(b)(4)": 86 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "MVR-COVID0001) (", "bates": "FDA-CBER-2022-1614-1790321", "context_preview": "tor the SARS-CoV-2 neutralizing antibody response in clinical trials. Assays are needed that are high throughput and rigorously optimized and validated to facilitate vaccine licensure and implementation after completion of phase 3 clinical trials. in the intra-assay, inter-operator and inter-day pre", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "MVR-COVID0001) (", "bates": "FDA-CBER-2022-1614-1790321", "context_preview": "SARS-CoV-2 neutralizing antibody response in clinical trials. Assays are needed that are high throughput and rigorously optimized and validated to facilitate vaccine licensure and implementation after completion of phase 3 clinical trials. in the intra-assay, inter-operator and inter-day precision w", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "MVR-COVID0001) (", "bates": "FDA-CBER-2022-1614-1790321", "context_preview": "-2 neutralizing antibody response in clinical trials. Assays are needed that are high throughput and rigorously optimized and validated to facilitate vaccine licensure and implementation after completion of phase 3 clinical trials. in the intra-assay, inter-operator and inter-day precision was obser", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_duke-02-mvr-covid0002-v1-val-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 232, "table_count": 220, "by_category": { "Other / uncategorized": 232 }, "by_marker": { "(b)(4)": 232 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "11.3\nPositive Control", "bates": "FDA-CBER-2022-1614-1790344", "context_preview": "hase 1 trial of th ase 3 trial se 3 , and e and r e samples e samples were st were st nutes at 56 utes at 56oC on S on e ststored at 4 ored at 4oC untiti wing the samples wing the sample om Drs. Leonidas om Drs. Leonid Research Cent r Research Center WA. This WA. This is a hum is a hum receptor bind", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "11.3\nPositive Control", "bates": "FDA-CBER-2022-1614-1790344", "context_preview": "rial of th ase 3 trial se 3 , and e and r e samples e samples were st were st nutes at 56 utes at 56oC on S on e ststored at 4 ored at 4oC untiti wing the samples wing the sample om Drs. Leonidas om Drs. Leonid Research Cent r Research Center WA. This WA. This is a hum is a hum receptor binding d re", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "11.3\nPositive Control", "bates": "FDA-CBER-2022-1614-1790344", "context_preview": "th ase 3 trial se 3 , and e and r e samples e samples were st were st nutes at 56 utes at 56oC on S on e ststored at 4 ored at 4oC untiti wing the samples wing the sample om Drs. Leonidas om Drs. Leonid Research Cent r Research Center WA. This WA. This is a hum is a hum receptor binding d receptor b", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_r1022-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 71, "table_count": 60, "by_category": { "Other / uncategorized": 71 }, "by_marker": { "(b)(4)": 71 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790393", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790393", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790393", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790393", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790393", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790393", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_r1023-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 76, "table_count": 70, "by_category": { "Other / uncategorized": 61, "Trial design / efficacy": 15 }, "by_marker": { "(b)(4)": 76 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "2.2 The MSD\u00ae 384-well Custom Serology Assay/4-plex SARS-CoV-2 assay is an", "bates": "FDA-CBER-2022-1614-1790405", "context_preview": "s which manifested at the end of 2019 and caused a global pandemic since the beginning of 2020. In the effort to support vaccine development, clinical endpoint testing of vaccine samples and correlate of protection analysis a Meso Scale Discovery (MSD) 4-plex Custom Serology Assay was developed at t", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "2.2 The MSD\u00ae 384-well Custom Serology Assay/4-plex SARS-CoV-2 assay is an", "bates": "FDA-CBER-2022-1614-1790405", "context_preview": "manifested at the end of 2019 and caused a global pandemic since the beginning of 2020. In the effort to support vaccine development, clinical endpoint testing of vaccine samples and correlate of protection analysis a Meso Scale Discovery (MSD) 4-plex Custom Serology Assay was developed at the Vacci", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "2.2 The MSD\u00ae 384-well Custom Serology Assay/4-plex SARS-CoV-2 assay is an", "bates": "FDA-CBER-2022-1614-1790405", "context_preview": "ed at the end of 2019 and caused a global pandemic since the beginning of 2020. In the effort to support vaccine development, clinical endpoint testing of vaccine samples and correlate of protection analysis a Meso Scale Discovery (MSD) 4-plex Custom Serology Assay was developed at the Vaccine Immun", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_r1024-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 95, "table_count": 85, "by_category": { "Other / uncategorized": 95 }, "by_marker": { "(b)(4)": 95 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790418", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790418", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790418", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790418", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790418", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790418", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_sop-18550.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 11, "table_count": 0, "by_category": { "Other / uncategorized": 9, "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SPECIMEN REQUIREMENTS", "bates": "FDA-CBER-2022-1614-1790459", "context_preview": "ed Volume: Special Handling Not Applicable Rejection Criteria Not Applicable Interfering Substances Bilirubin: \u2264 1129 \u03bcmol/L or \u2264 66 mg/dL Hemoglobin: 1000 mg/dL or 10 g/L Intralipid: 2000 mg/dL Biotin: \u2264 4912 nmol/L or \u2264 1200 ng/mL Rheumatoid factors: 1200 IU/mL IgG: 7.0 g/dL or 70 g/L IgA: 1.6 g/d", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SPECIMEN REQUIREMENTS", "bates": "FDA-CBER-2022-1614-1790459", "context_preview": "e: Special Handling Not Applicable Rejection Criteria Not Applicable Interfering Substances Bilirubin: \u2264 1129 \u03bcmol/L or \u2264 66 mg/dL Hemoglobin: 1000 mg/dL or 10 g/L Intralipid: 2000 mg/dL Biotin: \u2264 4912 nmol/L or \u2264 1200 ng/mL Rheumatoid factors: 1200 IU/mL IgG: 7.0 g/dL or 70 g/L IgA: 1.6 g/dL or 16 ", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.1 \nTwo levels of quality control must be run before and after running patients.", "bates": "FDA-CBER-2022-1614-1790461", "context_preview": "umber SG Catalog Number SHA Catalog Number Vendor Sars- Cov-2 Sars-Cov-2 2.0 Quality Control Preparation Sars-Cov (Positive) Preparation Ready to Use Storage 2 \u2013 8 \u2070 C Sars-Cov (Negative) Preparation Ready to Use Storage 2 \u2013 8 \u2070 C 3.0 Quality Control Frequency 3.1 Two levels of quality control must ", "likely_table": false } ] }, { "filename": "125752_S3_M5_5314_sop-21120-10120.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 49, "table_count": 24, "by_category": { "Trade-secret claim": 31, "Inspection / enforcement": 13, "Manufacturing / CMC": 3, "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 49 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.0\nApproval", "bates": "FDA-CBER-2022-1614-1790490", "context_preview": "t Organization Eurofins - Viracor Comments for version 3.0 Removed from SOP because only an is plated for this assay. Approval and Periodic Review Signatures Type Description Date Version Performed By Notes Approval 02-Mar-2021 11:06 3.0 Approval Approval 01-Mar-2021 21:03 3.0 Approval Approval 01-M", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.0\nApproval", "bates": "FDA-CBER-2022-1614-1790490", "context_preview": "zation Eurofins - Viracor Comments for version 3.0 Removed from SOP because only an is plated for this assay. Approval and Periodic Review Signatures Type Description Date Version Performed By Notes Approval 02-Mar-2021 11:06 3.0 Approval Approval 01-Mar-2021 21:03 3.0 Approval Approval 01-Mar-2021 ", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "21120.517 Analytical Quality Control: Quality Control Procedures.", "bates": "FDA-CBER-2022-1614-1790494", "context_preview": "tablished and maintained in accordance with SOP 21120.517 Analytical Quality Control: Quality Control Procedures. Extraction Controls Description Source Part/Cat No. Storage / Expiration* SARS-CoV-2 Whole Virus Positive Control Approved and current. Effective starting 09-Mar-2021. 21120.10120 (versi", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_sop-21120-10517.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 98, "table_count": 63, "by_category": { "Trade-secret claim": 81, "Inspection / enforcement": 17 }, "by_marker": { "(b)(4)": 98 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "SPECIMEN REQUIREMENTS", "bates": "FDA-CBER-2022-1614-1790514", "context_preview": "clients/sites/central lab are the acceptable specimen types for this assay. \uf0b7 NP Swab specimens in UTM/VTM specimens1 are Extracted RNA should be stored frozen immediately following extraction if not preparing for RT-PCR within Approved and current. Effective starting 12-Apr-2021. 21120.10517 (versi", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "SPECIMEN REQUIREMENTS", "bates": "FDA-CBER-2022-1614-1790514", "context_preview": "/sites/central lab are the acceptable specimen types for this assay. \uf0b7 NP Swab specimens in UTM/VTM specimens1 are Extracted RNA should be stored frozen immediately following extraction if not preparing for RT-PCR within Approved and current. Effective starting 12-Apr-2021. 21120.10517 (version 3.0)", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "SPECIMEN REQUIREMENTS", "bates": "FDA-CBER-2022-1614-1790514", "context_preview": "entral lab are the acceptable specimen types for this assay. \uf0b7 NP Swab specimens in UTM/VTM specimens1 are Extracted RNA should be stored frozen immediately following extraction if not preparing for RT-PCR within Approved and current. Effective starting 12-Apr-2021. 21120.10517 (version 3.0) SARS-Co", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_sop-21120-2380.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 15, "table_count": 13, "by_category": { "Trade-secret claim": 14, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 15 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "9.0\nApproval", "bates": "FDA-CBER-2022-1614-1790467", "context_preview": "tion Client Request Organization Eurofins - Viracor Comments for version 9.0 Updated the resulting section to include (NCE# CA-03191) Approval and Periodic Review Signatures Type Description Date Version Performed By Notes Approval 14-May-2021 10:58 9.0 Approval 14-May-2021 10:44 9.0 Approval 12-May", "likely_table": true }, { "page": 10, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "QUALITY CONTROL", "bates": "FDA-CBER-2022-1614-1790476", "context_preview": "isplay Failed and all results will be listed as Invalid. If the controls fail, the sample should be retested using a new pouch. Control Procedure For the Respiratory Panel For the Pneumonia Panel . Approved and current. Effective starting 24-May-2021. 21120.2380 (version 9.0) Procedure for Biofire F", "likely_table": true }, { "page": 10, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "QUALITY CONTROL", "bates": "FDA-CBER-2022-1614-1790476", "context_preview": "ailed and all results will be listed as Invalid. If the controls fail, the sample should be retested using a new pouch. Control Procedure For the Respiratory Panel For the Pneumonia Panel . Approved and current. Effective starting 24-May-2021. 21120.2380 (version 9.0) Procedure for Biofire FilmArray", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_sop-5525.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 132, "table_count": 81, "by_category": { "Other / uncategorized": 132 }, "by_marker": { "(b)(4)": 132 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.1 This SOP describes the necessary steps undertaken to conduct the semi-automated", "bates": "FDA-CBER-2022-1614-1790432", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790432", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.1 This SOP describes the necessary steps undertaken to conduct the semi-automated", "bates": "FDA-CBER-2022-1614-1790432", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790432", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.1 This SOP describes the necessary steps undertaken to conduct the semi-automated", "bates": "FDA-CBER-2022-1614-1790432", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790432", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vrgclus2020065512-val-report-v02.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 63, "table_count": 28, "by_category": { "Other / uncategorized": 63 }, "by_marker": { "(b)(4)": 63 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "APPENDIX 3. IMPRECISION .......ccssssssssssssrssesreressesensesessesesaesssacccccecsacceaaseccacesnassnnauseaausennasennasensessns", "bates": "FDA-CBER-2022-1614-1790536", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790536", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "APPENDIX 3. IMPRECISION .......ccssssssssssssrssesreressesensesessesesaesssacccccecsacceaaseccacesnassnnauseaausennasennasensessns", "bates": "FDA-CBER-2022-1614-1790536", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790536", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "APPENDIX 3. IMPRECISION .......ccssssssssssssrssesreressesensesessesesaesssacccccecsacceaaseccacesnassnnauseaausennasennasensessns", "bates": "FDA-CBER-2022-1614-1790536", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-1790536", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-58-elisa-qual-rpt.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 105, "table_count": 39, "by_category": { "Other / uncategorized": 105 }, "by_marker": { "(b)(4)": 105 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790572", "context_preview": "[SHULPHQW ZDV WR HVWDEOLVK WKH RI WKH 6$56 &R9\u0010\u0015 VSLNH SURWHLQV\u0011 7KH SXUSRVH RI WKLV UHSRUW LV WR GRFXPHQW WKH RSHUDWLQJ FKDUDFWHULVWLFV RI WKH DVVD\\\u0011 7KH 6$56\u0010&R9\u0010\u0015 RSHUDWLQJ FKDUDFWHULVWLFV DUH VXPPDUL]HG EHORZ DQG LQ 7DEOH \u0014\u0011 4XDOLILFDWLRQ 5HVXOWV 6XPPDU\\ $VVD\\ &KDUDFWHULVWLF 4XDOLILFDWLRQ 5HVXOW", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790572", "context_preview": "W ZDV WR HVWDEOLVK WKH RI WKH 6$56 &R9\u0010\u0015 VSLNH SURWHLQV\u0011 7KH SXUSRVH RI WKLV UHSRUW LV WR GRFXPHQW WKH RSHUDWLQJ FKDUDFWHULVWLFV RI WKH DVVD\\\u0011 7KH 6$56\u0010&R9\u0010\u0015 RSHUDWLQJ FKDUDFWHULVWLFV DUH VXPPDUL]HG EHORZ DQG LQ 7DEOH \u0014\u0011 4XDOLILFDWLRQ 5HVXOWV 6XPPDU\\ $VVD\\ &KDUDFWHULVWLF 4XDOLILFDWLRQ 5HVXOWV $VVD\\ ", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790572", "context_preview": "HVWDEOLVK WKH RI WKH 6$56 &R9\u0010\u0015 VSLNH SURWHLQV\u0011 7KH SXUSRVH RI WKLV UHSRUW LV WR GRFXPHQW WKH RSHUDWLQJ FKDUDFWHULVWLFV RI WKH DVVD\\\u0011 7KH 6$56\u0010&R9\u0010\u0015 RSHUDWLQJ FKDUDFWHULVWLFV DUH VXPPDUL]HG EHORZ DQG LQ 7DEOH \u0014\u0011 4XDOLILFDWLRQ 5HVXOWV 6XPPDU\\ $VVD\\ &KDUDFWHULVWLF 4XDOLILFDWLRQ 5HVXOWV $VVD\\ 9DOLGLW\\ ", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-64-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 104, "table_count": 48, "by_category": { "Trade-secret claim": 63, "Other / uncategorized": 41 }, "by_marker": { "(b)(4)": 104 }, "top_examples": [ { "page": 9, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "STATISTICAL METHODS AND RESULTS ..................................................................................... 24", "bates": "FDA-CBER-2022-1614-1790638", "context_preview": "................................................ 28 Table 9 .............................................................................................................................................. 30 Table 10 .....................................................................................", "likely_table": true }, { "page": 9, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "STATISTICAL METHODS AND RESULTS ..................................................................................... 24", "bates": "FDA-CBER-2022-1614-1790638", "context_preview": "........................................ 28 Table 9 .............................................................................................................................................. 30 Table 10 .............................................................................................", "likely_table": true }, { "page": 9, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "STATISTICAL METHODS AND RESULTS ..................................................................................... 24", "bates": "FDA-CBER-2022-1614-1790638", "context_preview": "................................ 28 Table 9 .............................................................................................................................................. 30 Table 10 .....................................................................................................", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-65-adden-5-v2.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 81, "table_count": 2, "by_category": { "Trade-secret claim": 36, "Other / uncategorized": 33, "Manufacturing / CMC": 12 }, "by_marker": { "(b)(4)": 81 }, "top_examples": [ { "page": 11, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EXPERIMENTAL DESIGN", "bates": "FDA-CBER-2022-1614-1790701", "context_preview": "h consisting of (b) (4) per run (b) (4) were performed by (b) (4) on\u2122 separate days. The experimental design, samples used in this experiment, and plate layout are provided in Table 2, Table 3, and Figure 3, respectively. The purpose of (Db) (4) was to evaluate the dilutional linearity of the assay,", "likely_table": true }, { "page": 11, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EXPERIMENTAL DESIGN", "bates": "FDA-CBER-2022-1614-1790701", "context_preview": "ng of (b) (4) per run (b) (4) were performed by (b) (4) on\u2122 separate days. The experimental design, samples used in this experiment, and plate layout are provided in Table 2, Table 3, and Figure 3, respectively. The purpose of (Db) (4) was to evaluate the dilutional linearity of the assay, which is ", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "MODERNA APPROVAL", "bates": "FDA-CBER-2022-1614-1790693", "context_preview": "lient approval of this report may be granted in the form of written communication and will be stored in PPD\u2019s ECM system. Scientific Approver: B (b) (6) ( b ) ( ) : sora ana mas esov sta cral ga ota 29 6 ates he pee eet sat Be oa DocuSzge Bethany Girard, Ph.D. Date Clinical Biomarker Sr. Manager, Cl", "likely_table": false } ] }, { "filename": "125752_S3_M5_5314_vsdvac-65-elisa-method.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 161, "table_count": 129, "by_category": { "Other / uncategorized": 115, "Manufacturing / CMC": 46 }, "by_marker": { "(b)(4)": 161 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "INSTRUMENT PARAMETERS .............................................................................................. 16", "bates": "FDA-CBER-2022-1614-1790717", "context_preview": "BSTRATE (TMB) INCUBATION ............................................................................................... 14 STOPPING AND PLATE DEVELOPMENT ....................................................................................... 14 Figure 1. Recommended Plate Map ......................", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "INSTRUMENT PARAMETERS .............................................................................................. 16", "bates": "FDA-CBER-2022-1614-1790717", "context_preview": "(TMB) INCUBATION ............................................................................................... 14 STOPPING AND PLATE DEVELOPMENT ....................................................................................... 14 Figure 1. Recommended Plate Map ..............................", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "INSTRUMENT PARAMETERS .............................................................................................. 16", "bates": "FDA-CBER-2022-1614-1790717", "context_preview": "CUBATION ............................................................................................... 14 STOPPING AND PLATE DEVELOPMENT ....................................................................................... 14 Figure 1. Recommended Plate Map ......................................", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-65-sop-method-version-1-02.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 184, "table_count": 146, "by_category": { "Other / uncategorized": 117, "Manufacturing / CMC": 67 }, "by_marker": { "(b)(4)": 184 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1 for additional safety notes related to the automated method.", "bates": "FDA-CBER-2022-1614-1790745", "context_preview": "ented in the or in a training Memo saved in ECM. All samples, controls and reagents should be considered potentially infectious. It is recommended they be handled using established universal precautions. Wear personal protective gear (lab coats, gloves and safety glasses) when working with open sera", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1 for additional safety notes related to the automated method.", "bates": "FDA-CBER-2022-1614-1790745", "context_preview": "the or in a training Memo saved in ECM. All samples, controls and reagents should be considered potentially infectious. It is recommended they be handled using established universal precautions. Wear personal protective gear (lab coats, gloves and safety glasses) when working with open sera. Work in", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1 for additional safety notes related to the automated method.", "bates": "FDA-CBER-2022-1614-1790745", "context_preview": "r in a training Memo saved in ECM. All samples, controls and reagents should be considered potentially infectious. It is recommended they be handled using established universal precautions. Wear personal protective gear (lab coats, gloves and safety glasses) when working with open sera. Work in an a", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-65-vp-addend1.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 28, "table_count": 7, "by_category": { "Other / uncategorized": 27, "Pharmacology / toxicology": 1 }, "by_marker": { "(b)(4)": 28 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 65 V1.01", "bates": "FDA-CBER-2022-1614-1790774", "context_preview": "ect Code RPPF following method VSDVAC 65 V 1.01. If additional experiments not covered by the original plan are required, an addendum to the plan can be written. A plan amendment documents an intended change to the plan after the evaluation was initiated. Amendments and addenda to plans must be appr", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 65 V1.01", "bates": "FDA-CBER-2022-1614-1790774", "context_preview": "RPPF following method VSDVAC 65 V 1.01. If additional experiments not covered by the original plan are required, an addendum to the plan can be written. A plan amendment documents an intended change to the plan after the evaluation was initiated. Amendments and addenda to plans must be approved at t", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 65 V1.01", "bates": "FDA-CBER-2022-1614-1790774", "context_preview": "llowing method VSDVAC 65 V 1.01. If additional experiments not covered by the original plan are required, an addendum to the plan can be written. A plan amendment documents an intended change to the plan after the evaluation was initiated. Amendments and addenda to plans must be approved at the same", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-65-vp-addend2.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 128, "table_count": 109, "by_category": { "Other / uncategorized": 89, "Manufacturing / CMC": 32, "Inspection / enforcement": 7 }, "by_marker": { "(b)(4)": 128 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "VSDVAC 65 V1.01", "bates": "FDA-CBER-2022-1614-1790789", "context_preview": "by interpolation from a standard curve analyzed on each assay plate. The method, VSDVAC 65 was previously validated at sample dilutions Based on clinical testing observations, a sample dilution will be evaluated to As such, the objectives of this validation plan are to: Assay runs that are rejected ", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "VSDVAC 65 V1.01", "bates": "FDA-CBER-2022-1614-1790789", "context_preview": "rpolation from a standard curve analyzed on each assay plate. The method, VSDVAC 65 was previously validated at sample dilutions Based on clinical testing observations, a sample dilution will be evaluated to As such, the objectives of this validation plan are to: Assay runs that are rejected or abor", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "VSDVAC 65 V1.01", "bates": "FDA-CBER-2022-1614-1790789", "context_preview": "n from a standard curve analyzed on each assay plate. The method, VSDVAC 65 was previously validated at sample dilutions Based on clinical testing observations, a sample dilution will be evaluated to As such, the objectives of this validation plan are to: Assay runs that are rejected or aborted due ", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-65-vp-addend3.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 16, "table_count": 8, "by_category": { "Other / uncategorized": 12, "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 16 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790811", "context_preview": "n in Human Serum Page 6 of 9 Experimental Design Refer to Figure 1 for proposed plate map. Plate coating will follow VSDVAC 65 v1.01, current version or higher with the following exceptions: Refer to Table 2 for a description of the storage conditions. All samples will be analyzed in as per VSDVAC 6", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790811", "context_preview": "an Serum Page 6 of 9 Experimental Design Refer to Figure 1 for proposed plate map. Plate coating will follow VSDVAC 65 v1.01, current version or higher with the following exceptions: Refer to Table 2 for a description of the storage conditions. All samples will be analyzed in as per VSDVAC 65 v1.01,", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790811", "context_preview": "m Page 6 of 9 Experimental Design Refer to Figure 1 for proposed plate map. Plate coating will follow VSDVAC 65 v1.01, current version or higher with the following exceptions: Refer to Table 2 for a description of the storage conditions. All samples will be analyzed in as per VSDVAC 65 v1.01, curren", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-65-vp-addend4.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 49, "table_count": 25, "by_category": { "Other / uncategorized": 49 }, "by_marker": { "(b)(4)": 49 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 65 V1.01", "bates": "FDA-CBER-2022-1614-1790819", "context_preview": "mple tested showed reproducible low level of cross-reactivity and two samples tested showed non-reproducible low level of cross-reactivity with the spike protein[4]. As such, the objectives of this validation plan addendum is to confirm specificity of the assay. Assay runs that are rejected or abort", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 65 V1.01", "bates": "FDA-CBER-2022-1614-1790819", "context_preview": "ted showed reproducible low level of cross-reactivity and two samples tested showed non-reproducible low level of cross-reactivity with the spike protein[4]. As such, the objectives of this validation plan addendum is to confirm specificity of the assay. Assay runs that are rejected or aborted due t", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 65 V1.01", "bates": "FDA-CBER-2022-1614-1790819", "context_preview": "ed reproducible low level of cross-reactivity and two samples tested showed non-reproducible low level of cross-reactivity with the spike protein[4]. As such, the objectives of this validation plan addendum is to confirm specificity of the assay. Assay runs that are rejected or aborted due to a docu", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-66-report.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 54, "table_count": 8, "by_category": { "Other / uncategorized": 49, "Inspection / enforcement": 5 }, "by_marker": { "(b)(4)": 54 }, "top_examples": [ { "page": 9, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V0.00", "bates": "FDA-CBER-2022-1614-1790837", "context_preview": "section for each of the experiments. When reanalysis runs due to system suitability failure, the same analyst will be used to perform the repeat runs. Experimental plate layouts and schedules detailed below are tentative and may be subject to change to accommodate repeats or additional testing as ne", "likely_table": true }, { "page": 9, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V0.00", "bates": "FDA-CBER-2022-1614-1790837", "context_preview": "for each of the experiments. When reanalysis runs due to system suitability failure, the same analyst will be used to perform the repeat runs. Experimental plate layouts and schedules detailed below are tentative and may be subject to change to accommodate repeats or additional testing as needed. No", "likely_table": true }, { "page": 9, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V0.00", "bates": "FDA-CBER-2022-1614-1790837", "context_preview": "ch of the experiments. When reanalysis runs due to system suitability failure, the same analyst will be used to perform the repeat runs. Experimental plate layouts and schedules detailed below are tentative and may be subject to change to accommodate repeats or additional testing as needed. Note: Al", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-66-sop.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 157, "table_count": 118, "by_category": { "Other / uncategorized": 114, "Manufacturing / CMC": 43 }, "by_marker": { "(b)(4)": 157 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1 for additional safety notes related to the automated method.", "bates": "FDA-CBER-2022-1614-1790858", "context_preview": "ented in the or in a training Memo saved in ECM. All samples, controls and reagents should be considered potentially infectious. It is recommended they be handled using established universal precautions. Wear personal protective gear (lab coats, gloves and safety glasses) when working with open sera", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1 for additional safety notes related to the automated method.", "bates": "FDA-CBER-2022-1614-1790858", "context_preview": "the or in a training Memo saved in ECM. All samples, controls and reagents should be considered potentially infectious. It is recommended they be handled using established universal precautions. Wear personal protective gear (lab coats, gloves and safety glasses) when working with open sera. Work in", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 1 for additional safety notes related to the automated method.", "bates": "FDA-CBER-2022-1614-1790858", "context_preview": "r in a training Memo saved in ECM. All samples, controls and reagents should be considered potentially infectious. It is recommended they be handled using established universal precautions. Wear personal protective gear (lab coats, gloves and safety glasses) when working with open sera. Work in an a", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-66-vp-addend1-amend1.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V0.00", "bates": "FDA-CBER-2022-1614-1790895", "context_preview": "Page 5 of 5 Method Validation Plan Addendum 1 Amendment 1 Amendment to the Addendum to the Validation of an ELISA Method for the Detection of IgG Specific to SARS-CoV-2 Nucleocapsid Protein in Human Serum 1. A typographical error in the Nucleocapsid Antigen Experimental Design[1] section states Refe", "likely_table": false } ] }, { "filename": "125752_S3_M5_5314_vsdvac-66-vp-addend1.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 11, "table_count": 0, "by_category": { "Other / uncategorized": 11 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V0.00", "bates": "FDA-CBER-2022-1614-1790885", "context_preview": "alidated by PPD\u00ae Laboratories, in Richmond, Virginia, USA. The new method, VSDVAC 66[2], will be finalized to version 1.00 after validation. The client specific validation of this method will be conducted under PPD Project Code \u201cRPPF2\u201d[3]. The purpose of this addendum is to detail the experimental d", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V0.00", "bates": "FDA-CBER-2022-1614-1790885", "context_preview": "by PPD\u00ae Laboratories, in Richmond, Virginia, USA. The new method, VSDVAC 66[2], will be finalized to version 1.00 after validation. The client specific validation of this method will be conducted under PPD Project Code \u201cRPPF2\u201d[3]. The purpose of this addendum is to detail the experimental design and", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V0.00", "bates": "FDA-CBER-2022-1614-1790886", "context_preview": "PPD Validation Plan Addendum 1 VSDVAC 66 V0.00 RPPF2: Addendum to the Validation of an ELISA Method for the Detection of IgG Specific to SARS-CoV-2 Nucleocapsid Protein in Human Serum Page 6 of 10 Reference Standard and Critical Reagents The following reference standard and critical reagents will be", "likely_table": false } ] }, { "filename": "125752_S3_M5_5314_vsdvac-66-vp-addend2.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 50, "table_count": 41, "by_category": { "Other / uncategorized": 50 }, "by_marker": { "(b)(4)": 50 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V0.00", "bates": "FDA-CBER-2022-1614-1790900", "context_preview": "is to detail the experimental design and statistical analysis in accordance with SOP LP-PAL-7023[4] to perform additional runs to establish a The purpose of this experiment is to perform additional runs based on preliminary statistical analysis indicating as noted in Figure 1 and Figure 2. As shown ", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V0.00", "bates": "FDA-CBER-2022-1614-1790900", "context_preview": "tail the experimental design and statistical analysis in accordance with SOP LP-PAL-7023[4] to perform additional runs to establish a The purpose of this experiment is to perform additional runs based on preliminary statistical analysis indicating as noted in Figure 1 and Figure 2. As shown in Figur", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V0.00", "bates": "FDA-CBER-2022-1614-1790900", "context_preview": "experimental design and statistical analysis in accordance with SOP LP-PAL-7023[4] to perform additional runs to establish a The purpose of this experiment is to perform additional runs based on preliminary statistical analysis indicating as noted in Figure 1 and Figure 2. As shown in Figure 1, at t", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-66-vp-addend3-amend1.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 0, "by_category": { "Trade-secret claim": 3, "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790932", "context_preview": "d to Version 1.00 post qualification experiments[2]. At the request of Moderna, the PPD proprietary serological method, \u201cAn ELISA Method for the Detection of IgG Specific to SARS-CoV-2 Nucleocapsid Protein in Human Serum\u201d was validated by PPD\u00ae Laboratories, in Richmond, Virginia, USA. The validation", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790932", "context_preview": "sion 1.00 post qualification experiments[2]. At the request of Moderna, the PPD proprietary serological method, \u201cAn ELISA Method for the Detection of IgG Specific to SARS-CoV-2 Nucleocapsid Protein in Human Serum\u201d was validated by PPD\u00ae Laboratories, in Richmond, Virginia, USA. The validation of this", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790932", "context_preview": "00 post qualification experiments[2]. At the request of Moderna, the PPD proprietary serological method, \u201cAn ELISA Method for the Detection of IgG Specific to SARS-CoV-2 Nucleocapsid Protein in Human Serum\u201d was validated by PPD\u00ae Laboratories, in Richmond, Virginia, USA. The validation of this new me", "likely_table": false } ] }, { "filename": "125752_S3_M5_5314_vsdvac-66-vp-addend3.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 56, "table_count": 21, "by_category": { "Other / uncategorized": 56 }, "by_marker": { "(b)(4)": 56 }, "top_examples": [ { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V1.00", "bates": "FDA-CBER-2022-1614-1790914", "context_preview": "uent) CoV Coronavirus ELISA Enzyme-Linked Immunosorbent Assay IgG Immunoglobulin-G NIH National Institute of Health OD Optical Density QA Quality Assurance QC(s) Quality Control Samples Run A group of analytical samples consisting of standard curve, QCs, and test samples processed across a minimum o", "likely_table": true }, { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V1.00", "bates": "FDA-CBER-2022-1614-1790914", "context_preview": "oV Coronavirus ELISA Enzyme-Linked Immunosorbent Assay IgG Immunoglobulin-G NIH National Institute of Health OD Optical Density QA Quality Assurance QC(s) Quality Control Samples Run A group of analytical samples consisting of standard curve, QCs, and test samples processed across a minimum of one p", "likely_table": true }, { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "VSDVAC 66 V1.00", "bates": "FDA-CBER-2022-1614-1790914", "context_preview": "navirus ELISA Enzyme-Linked Immunosorbent Assay IgG Immunoglobulin-G NIH National Institute of Health OD Optical Density QA Quality Assurance QC(s) Quality Control Samples Run A group of analytical samples consisting of standard curve, QCs, and test samples processed across a minimum of one plate SA", "likely_table": true } ] }, { "filename": "125752_S3_M5_5314_vsdvac-66-vs-adden1-antigen-01.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 72, "table_count": 39, "by_category": { "Other / uncategorized": 39, "Trade-secret claim": 29, "Pharmacology / toxicology": 4 }, "by_marker": { "(b)(4)": 72 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790935", "context_preview": "Signatures Statistical Author: Second-Statistician Reviewer: Date Carl Breidenbach Date Scientific Reviewers and Approvers: Marie Bonhomme, Ph.D. Date Quality Assurance Reviewer: Date cc List: Tina Green; Christopher Hammond; (b) (4) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790935", "context_preview": "tician Reviewer: Date Carl Breidenbach Date Scientific Reviewers and Approvers: Marie Bonhomme, Ph.D. Date Quality Assurance Reviewer: Date cc List: Tina Green; Christopher Hammond; (b) (4) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (6) (b) (4) (b) (6) (b) (6) FDA-CBER-2022-1614-1790935", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-1790937", "context_preview": "performed following VSDVAC 66 Version 0.00[3]. Statistical Results: Sample antibody concentrations are provided in Attachment I. QCS antibody concentrations are displayed graphically in Attachment II. The experimental results and their respective pre-specified acceptance criteria are summarized in t", "likely_table": true } ] }, { "filename": "125752_S3_M5_5351_1273p201-16-1-4.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 20, "table_count": 20, "by_category": { "Trial design / efficacy": 10, "Other / uncategorized": 10 }, "by_marker": { "(b)(4)": 20 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": null, "bates": "FDA-CBER-2022-1614-4216574", "context_preview": "merican Society of Bariatric Physicians American College of Physicians Georgia Medical Society Georgia Bariatric Society North American Association for Obesity Research Fibromyalgia Foundation (Savannah), Chairman Research Experience Principal Investigator 2018 \u2013 Protocol: 246707 Paul Simon Bradley,", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": null, "bates": "FDA-CBER-2022-1614-4216574", "context_preview": "Society of Bariatric Physicians American College of Physicians Georgia Medical Society Georgia Bariatric Society North American Association for Obesity Research Fibromyalgia Foundation (Savannah), Chairman Research Experience Principal Investigator 2018 \u2013 Protocol: 246707 Paul Simon Bradley, Md Full", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": null, "bates": "FDA-CBER-2022-1614-4216574", "context_preview": "of Bariatric Physicians American College of Physicians Georgia Medical Society Georgia Bariatric Society North American Association for Obesity Research Fibromyalgia Foundation (Savannah), Chairman Research Experience Principal Investigator 2018 \u2013 Protocol: 246707 Paul Simon Bradley, Md Full Current", "likely_table": true } ] }, { "filename": "125752_S3_M5_5351_mrna1273p301-16-1-10.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "1.2 TOLL FREE PHONE ACCESS", "bates": "FDA-CBER-2022-1614-0666913", "context_preview": "3.0, 10AUG2021 GCL-PM-0093dr00, Effective Date : 01DEC2019 Page 6 of 50 1.2 TOLL FREE PHONE ACCESS The toll-free numbers listed below can be used to contact our Global Site Services help desk. A specific code needs to be used when contacting the help desk- Site Services help desk US (supports North ", "likely_table": false } ] }, { "filename": "125752_S3_M5_5351_mrna1273p301-16-1-4.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 11448, "table_count": 11319, "by_category": { "Other / uncategorized": 10823, "Trial design / efficacy": 623, "Inspection / enforcement": 2 }, "by_marker": { "(b)(4)": 11448 }, "top_examples": [ { "page": 333, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "FDA-CBER-2022-1614 4216918", "bates": "FDA-CBER-2022-1614-4216919", "context_preview": "333 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-4216919", "likely_table": true }, { "page": 333, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "FDA-CBER-2022-1614 4216918", "bates": "FDA-CBER-2022-1614-4216919", "context_preview": "333 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-4216919", "likely_table": true }, { "page": 333, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "FDA-CBER-2022-1614 4216918", "bates": "FDA-CBER-2022-1614-4216919", "context_preview": "333 (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2022-1614-4216919", "likely_table": true } ] }, { "filename": "125752_S3_M5_5351_mrna1273p301-16-6.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 103, "table_count": 89, "by_category": { "Other / uncategorized": 95, "Trial design / efficacy": 4, "Trade-secret claim": 3, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 103 }, "top_examples": [ { "page": 16, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.1.1.1.1 Study 101: ELISA S-2P-protein IgG and RBD IgG", "bates": "FDA-CBER-2022-1614-1790963", "context_preview": "ARS-CoV-2 RBD antigen at a working concentration of were coated onto Immulon plates overnight for hours at Antigen concentrations were defined during assay development and antigen lot titration. Plates were washed and blocked for . serial fold dilutions covering the range of of the test sample (dilu", "likely_table": true }, { "page": 16, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.1.1.1.1 Study 101: ELISA S-2P-protein IgG and RBD IgG", "bates": "FDA-CBER-2022-1614-1790963", "context_preview": "2 RBD antigen at a working concentration of were coated onto Immulon plates overnight for hours at Antigen concentrations were defined during assay development and antigen lot titration. Plates were washed and blocked for . serial fold dilutions covering the range of of the test sample (diluted in w", "likely_table": true }, { "page": 16, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.1.1.1.1 Study 101: ELISA S-2P-protein IgG and RBD IgG", "bates": "FDA-CBER-2022-1614-1790963", "context_preview": "tigen at a working concentration of were coated onto Immulon plates overnight for hours at Antigen concentrations were defined during assay development and antigen lot titration. Plates were washed and blocked for . serial fold dilutions covering the range of of the test sample (diluted in were incu", "likely_table": true } ] }, { "filename": "125752_S3_M5_5354_bimo-iii-a-2.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-0668589", "context_preview": "is Plan Tables, Figures & Listings Clinical Study Report 929 North Front Street Wilmington, NC 28401-3331 Viracor Eurofins Testing of respiratory specimens for SARs-CoV-2 infection 1001 NW Technology Drive Lee's Summit, MO 64086 BioIVT Sample request for COVID serum PO Box 770 Hicksville, NY 11802 C", "likely_table": false } ] }, { "filename": "125752_S3_M5_53_monthly-safety-rpt-06-01jun-30jun2021.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 0, "by_category": { "Other / uncategorized": 3, "Clinical safety / adverse events": 1, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2022-1614-4065585", "context_preview": "VAERS database (utilizing the Empirica \u00ae, Oracle, Austin, TX). Moderna recently reviewed the relative contributions of adverse event reports submitted through VAERS and those submitted directly to the company (through Medical Information utilizing the system). While data initially lagged VAERS in pr", "likely_table": false }, { "page": 277, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "8.1 Summary of Safety Concerns", "bates": "FDA-CBER-2022-1614-4065860", "context_preview": "ing information). The Spikevax summary of product characteristics (SmPC) and its package leaflet provides essential information to healthcare professionals and patients on how Spikevax should be used. This monthly report summary for Spikevax should be reviewed in the context of all these product dat", "likely_table": false }, { "page": 434, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "APPENDIX 3: SUMMARY OF EXPOSURE BY LOT DISTRIBUTION DATA", "bates": "FDA-CBER-2022-1614-4066017", "context_preview": "ly administered in Liechtenstein. [4] Because nearly all doses distributed to Taiwan and South Korea were delivered on 26 May 2021 and 31 May 2021 respectively, it is assumed no doses were administered during the reporting period. Batch Doses distributed 300042460 300042698 300042721 300042722 30004", "likely_table": false } ] }, { "filename": "125752_S3_M5_bimo_D_define2-0-0.pdf", "module": "M5", "company": "Moderna", "license": "BLA", "total_kept": 2, "table_count": 0, "by_category": { "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 36, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3818415", "context_preview": "on/odm:TranslatedText\"/>) \u2010\u2010> (b) (4), (b) (6) FDA-CBE", "likely_table": false }, { "page": 50, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-3818429", "context_preview": "FirstPage)\"/> Page Subject: STN 125742.0.41: Response to DBSQC IR RE testing related limits for established and polydispersity index Charlene, Pfizer submitted amendment 41 on August 11th in response to your August 10th IR, but I don\u2019t see that you mention that in your review (attach", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150381", "context_preview": " Subject: STN 125742.0.41: Response to DBSQC IR RE testing related limits for established and polydispersity index Charlene, Pfizer submitted amendment 41 on August 11th in response to your August 10th IR, but I don\u2019t see that you mention that in your review (attached). Can", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150381", "context_preview": "rancis@fda.hhs.gov> Subject: STN 125742.0.41: Response to DBSQC IR RE testing related limits for established and polydispersity index Charlene, Pfizer submitted amendment 41 on August 11th in response to your August 10th IR, but I don\u2019t see that you mention that in your review (attached). Can you pl", "likely_table": false } ] }, { "filename": "12_BLA-125752-0_09-27-2021_Telecon_Advice.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 32, "table_count": 28, "by_category": { "Inspection / enforcement": 13, "Trade-secret claim": 6, "Manufacturing / CMC": 5, "Trial design / efficacy": 4, "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 32 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "3.2.S.7.1", "bates": "FDA-CBER-2022-1614-3816042", "context_preview": "ropriate. If the information is not confidential, the information should be provided in BLA 125752 no later than October 15, 2021. Catalent Label/Pack Serialization Catalent Additional Automated Visual Inspection Machine (AIM) From Paul\u2019s email dated September 21, 2021, 9:17 PM EST, we infer there w", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "3.2.S.7.1", "bates": "FDA-CBER-2022-1614-3816042", "context_preview": ". If the information is not confidential, the information should be provided in BLA 125752 no later than October 15, 2021. Catalent Label/Pack Serialization Catalent Additional Automated Visual Inspection Machine (AIM) From Paul\u2019s email dated September 21, 2021, 9:17 PM EST, we infer there will be N", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "3.2.S.7.1", "bates": "FDA-CBER-2022-1614-3816042", "context_preview": "information is not confidential, the information should be provided in BLA 125752 no later than October 15, 2021. Catalent Label/Pack Serialization Catalent Additional Automated Visual Inspection Machine (AIM) From Paul\u2019s email dated September 21, 2021, 9:17 PM EST, we infer there will be NO ADDITIO", "likely_table": true } ] }, { "filename": "132_BLA-125742-0_09-13-2021_Memo_Committee-Memo_Review-1.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 6, "table_count": 0, "by_category": { "Other / uncategorized": 3, "Clinical safety / adverse events": 2, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": "STN 125742/0.15", "bates": "FDA-CBER-2021-5683-1150383", "context_preview": "42/0.16 11 7/13/2021 Mike Smith OBE IR to add myocarditis and pericarditis to the PVP and submit to the BLA by July 19, 2021. Deb Thompson STN 125742/0.20 12 7/13/2021 Ram Naik DVP IR regarding exception or alternative to the requirement that products in multiple-dose vials include a preservative. X", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "STN 125742/0.76", "bates": "FDA-CBER-2021-5683-1150388", "context_preview": "ocol (LRP) template and samples & reagents. Marie Anderson (August 18, 2021) Xiao Wang (August 21, 2021) 7/15/2021 125742/0.11 Response to July 13, 2021, DVP IR regarding exception or alternative to the requirement that products in multiple-dose vials include a preservative. Xiao Wang (August 21, 20", "likely_table": false }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "STN 125742/0.76", "bates": "FDA-CBER-2021-5683-1150389", "context_preview": "ods. DBSQC team (August 21, 2021) 07/30/2021 125742/0.22 Response to July 27, 2021, clinical three questions RE vaccine effectiveness. Clinical team (September 2, 2021) 07/30/2021 125742/0.23 Response to July 26, 2021, clinical IR regarding the disposition of participants in safety populations who e", "likely_table": false } ] }, { "filename": "134_Courtesy-Copy_BLA-125742-0_Toxicology-Review-COMIRNATY.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 20, "table_count": 16, "by_category": { "Other / uncategorized": 18, "Trial design / efficacy": 2 }, "by_marker": { "(b)(4)": 20 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BLA 125742", "bates": null, "context_preview": "sing, the favorable safety profile is notable because it results in a higher systemic exposure than the planned IM dosing in this trial. The findings from this study were mild and mostly related to the mode-of-action and the RNA-intrinsic stimulation of innate immune sensors. In rodents, the non-cli", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BLA 125742", "bates": null, "context_preview": "e favorable safety profile is notable because it results in a higher systemic exposure than the planned IM dosing in this trial. The findings from this study were mild and mostly related to the mode-of-action and the RNA-intrinsic stimulation of innate immune sensors. In rodents, the non-clinical sa", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BLA 125742", "bates": null, "context_preview": "ble safety profile is notable because it results in a higher systemic exposure than the planned IM dosing in this trial. The findings from this study were mild and mostly related to the mode-of-action and the RNA-intrinsic stimulation of innate immune sensors. In rodents, the non-clinical safety pro", "likely_table": true } ] }, { "filename": "135_Courtesy-Copy_BLA-125742-0_November-8-2021_Summary-Basis-for-Regulatory-Action-COMIRNATY.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 28, "table_count": 12, "by_category": { "Manufacturing / CMC": 26, "Pharmacology / toxicology": 2 }, "by_marker": { "(b)(4)": 28 }, "top_examples": [ { "page": 10, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SODIUM CHLORIDE", "bates": null, "context_preview": "1>) 6.9 \u2013 7.9 Osmolality Osmometry (USP <785>) LNP Size Dynamic Light Scattering (DLS) LNP Polydispersity Dynamic Light Scattering (DLS) RNA Encapsulation Fluorescence assay RNA content Fluorescence assay ALC-0315 content HPLC-CAD ALC-0159 content HPLC-CAD DSPC content HPLC-CAD Cholesterol content H", "likely_table": true }, { "page": 10, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SODIUM CHLORIDE", "bates": null, "context_preview": "\u2013 7.9 Osmolality Osmometry (USP <785>) LNP Size Dynamic Light Scattering (DLS) LNP Polydispersity Dynamic Light Scattering (DLS) RNA Encapsulation Fluorescence assay RNA content Fluorescence assay ALC-0315 content HPLC-CAD ALC-0159 content HPLC-CAD DSPC content HPLC-CAD Cholesterol content HPLC-CAD ", "likely_table": true }, { "page": 10, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SODIUM CHLORIDE", "bates": null, "context_preview": "Osmolality Osmometry (USP <785>) LNP Size Dynamic Light Scattering (DLS) LNP Polydispersity Dynamic Light Scattering (DLS) RNA Encapsulation Fluorescence assay RNA content Fluorescence assay ALC-0315 content HPLC-CAD ALC-0159 content HPLC-CAD DSPC content HPLC-CAD Cholesterol content HPLC-CAD Vial c", "likely_table": true } ] }, { "filename": "137_BLA_125742_Endotoxin-release-tests-lots-FD7220-FE3592-FF2587.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 79, "table_count": 74, "by_category": { "Other / uncategorized": 79 }, "by_marker": { "(b)(4)": 79 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150740", "context_preview": "James L. Kenney -S Digitally signed by James L Kenney S DN: c US o U S Government ou HHS ou FDA ou People 0 9 2342 19200300 100 1 1 1300431652 cn James L Kenney S Date: 2021 08 18 15:12 10 04 00' Nadine S. Kaelber -S Digitally signed by Nadine S. Kaelber -S DN: c=US, o=U.S. Government, ou=HHS, ou=FD", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150740", "context_preview": "James L. Kenney -S Digitally signed by James L Kenney S DN: c US o U S Government ou HHS ou FDA ou People 0 9 2342 19200300 100 1 1 1300431652 cn James L Kenney S Date: 2021 08 18 15:12 10 04 00' Nadine S. Kaelber -S Digitally signed by Nadine S. Kaelber -S DN: c=US, o=U.S. Government, ou=HHS, ou=FD", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150740", "context_preview": "James L. Kenney -S Digitally signed by James L Kenney S DN: c US o U S Government ou HHS ou FDA ou People 0 9 2342 19200300 100 1 1 1300431652 cn James L Kenney S Date: 2021 08 18 15:12 10 04 00' Nadine S. Kaelber -S Digitally signed by Nadine S. Kaelber -S DN: c=US, o=U.S. Government, ou=HHS, ou=FD", "likely_table": true } ] }, { "filename": "138_BLA_125742_STN125742-release-test-pH-lots-FD7220-FE3592-FF2587.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 82, "table_count": 74, "by_category": { "Other / uncategorized": 82 }, "by_marker": { "(b)(4)": 82 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150747", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1150747", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150747", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1150747", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150747", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1150747", "likely_table": true } ] }, { "filename": "13_BLA-125752-0_09-27-2021_Telecon_Other.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 3, "table_count": 0, "by_category": { "Other / uncategorized": 2, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "ADMINISTRATION", "bates": "FDA-CBER-2022-1614-3816058", "context_preview": ", Robin ; Weir, Jerry P. ; Gagneten, Sara ; Dabrazhynetskaya, Alena ; Peden, Keith ; Resnick, Josephine ; Kulinski, Joseph \u201d) in Table 3.2.S.2.2-4 In-Process Tests (Monitoring) for Co", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.2 Manufacturing Process Andover, it appears that there are multiple", "bates": "FDA-CBER-2021-5683-1150175", "context_preview": "s during the manufacture of DS. 4. Regarding the action limits for bioburden and endotoxin testing listed in document 3.2.S.2.2 Manufacturing Process Andover, it appears that there are multiple typographical errors (\u201c\u2264\u201d instead of \u201c>\u201d) in Table 3.2.S.2.2-4 In-Process Tests (Monitoring) for Control a", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.2 Manufacturing Process Andover, it appears that there are multiple", "bates": "FDA-CBER-2021-5683-1150175", "context_preview": "the manufacture of DS. 4. Regarding the action limits for bioburden and endotoxin testing listed in document 3.2.S.2.2 Manufacturing Process Andover, it appears that there are multiple typographical errors (\u201c\u2264\u201d instead of \u201c>\u201d) in Table 3.2.S.2.2-4 In-Process Tests (Monitoring) for Control and in Tab", "likely_table": true } ] }, { "filename": "15_BLA-125752-0_09-28-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 6, "table_count": 6, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816064", "context_preview": "however, please provide quality data for a representative linear pDNA batch produced at Aldevron. 10. Residual DNA was defined as a Critical Quality Attribute of CX-024414 mRNA in multiple sections of Module 3, and the residual DNA template test by qPCR was performed for release of CX-024414 mRNA du", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816064", "context_preview": "please provide quality data for a representative linear pDNA batch produced at Aldevron. 10. Residual DNA was defined as a Critical Quality Attribute of CX-024414 mRNA in multiple sections of Module 3, and the residual DNA template test by qPCR was performed for release of CX-024414 mRNA during clin", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816064", "context_preview": "provide quality data for a representative linear pDNA batch produced at Aldevron. 10. Residual DNA was defined as a Critical Quality Attribute of CX-024414 mRNA in multiple sections of Module 3, and the residual DNA template test by qPCR was performed for release of CX-024414 mRNA during clinical de", "likely_table": true } ] }, { "filename": "17_BLA-125752-0_10-05-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 13, "table_count": 7, "by_category": { "Manufacturing / CMC": 7, "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 13 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816071", "context_preview": "rden test performed at Lonza Portsmouth to include the test sample volume, , product lot numbers tested, as well as 3. \u25aa \u25aa \u25aa \u2022 Drug Product 1. Bacterial Endotoxin Test (BET) \u25aa Please provide the current Standard Operating Procedure (SOP) and a complete verification report for SPIKEVAX drug product E", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816071", "context_preview": "t performed at Lonza Portsmouth to include the test sample volume, , product lot numbers tested, as well as 3. \u25aa \u25aa \u25aa \u2022 Drug Product 1. Bacterial Endotoxin Test (BET) \u25aa Please provide the current Standard Operating Procedure (SOP) and a complete verification report for SPIKEVAX drug product Endotoxin", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816071", "context_preview": "med at Lonza Portsmouth to include the test sample volume, , product lot numbers tested, as well as 3. \u25aa \u25aa \u25aa \u2022 Drug Product 1. Bacterial Endotoxin Test (BET) \u25aa Please provide the current Standard Operating Procedure (SOP) and a complete verification report for SPIKEVAX drug product Endotoxin testing", "likely_table": true } ] }, { "filename": "18_BLA-125742-0_07-09-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 6, "table_count": 0, "by_category": { "Other / uncategorized": 3, "Trade-secret claim": 3 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND", "bates": "FDA-CBER-2021-5683-1150180", "context_preview": "IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other act", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND", "bates": "FDA-CBER-2021-5683-1150180", "context_preview": "RESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action ba", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND", "bates": "FDA-CBER-2021-5683-1150180", "context_preview": "ND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on t", "likely_table": false } ] }, { "filename": "18_BLA-125752-0_10-06-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 19, "table_count": 15, "by_category": { "Manufacturing / CMC": 15, "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 19 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816074", "context_preview": "73 LNP DP Positive control (working reference material) b. Formulation Buffer (20mM Tris, Sucrose, pH buffer), c. COAs with concentration/dilutions for use along with temperature of storage and expiry date 5. Particle Size a. Test result for each DP lot 6. Polydispersity a. Test result for each DP l", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816074", "context_preview": "P Positive control (working reference material) b. Formulation Buffer (20mM Tris, Sucrose, pH buffer), c. COAs with concentration/dilutions for use along with temperature of storage and expiry date 5. Particle Size a. Test result for each DP lot 6. Polydispersity a. Test result for each DP lot 7. Li", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816074", "context_preview": "ve control (working reference material) b. Formulation Buffer (20mM Tris, Sucrose, pH buffer), c. COAs with concentration/dilutions for use along with temperature of storage and expiry date 5. Particle Size a. Test result for each DP lot 6. Polydispersity a. Test result for each DP lot 7. Lipid Iden", "likely_table": true } ] }, { "filename": "19736_S0185_M1_smsr-01dec2020-31dec2020.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 8, "table_count": 6, "by_category": { "Other / uncategorized": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "ZHUH WDNHQ IURP WKH", "bates": "FDA-CBER-2021-5683-1078887", "context_preview": "LFD 86E &DQDGDE &HQWUDO DQG 6RXWK $PHULFD $VLD -DSDQ 2WKHU &RXQWULHVE 2FHDQLD $XVWUDOLD\u00121HZ =HDODQG 2WKHU &RXQWULHV $IULFD 7RWDO \u0014\u0013\u0013\u0011\u0013\b \u0015\u0019\u0013\u001a \u0016\u0013\u0013 \u0016 3OHDVH QRWH WKDW FXUUHQWO\\ WKHUH ZHUH QR DYDLODEOH GDWD WKDW DOORZ WR HVWLPDWH H[SRVXUH E\\ JHQGHU DQG DJH JURXS\u0011 \u0017 3OHDVH FRQVLGHU WKDW LV WKH PRVW DFFXU", "likely_table": true }, { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "ZHUH WDNHQ IURP WKH", "bates": "FDA-CBER-2021-5683-1078887", "context_preview": "&DQDGDE &HQWUDO DQG 6RXWK $PHULFD $VLD -DSDQ 2WKHU &RXQWULHVE 2FHDQLD $XVWUDOLD\u00121HZ =HDODQG 2WKHU &RXQWULHV $IULFD 7RWDO \u0014\u0013\u0013\u0011\u0013\b \u0015\u0019\u0013\u001a \u0016\u0013\u0013 \u0016 3OHDVH QRWH WKDW FXUUHQWO\\ WKHUH ZHUH QR DYDLODEOH GDWD WKDW DOORZ WR HVWLPDWH H[SRVXUH E\\ JHQGHU DQG DJH JURXS\u0011 \u0017 3OHDVH FRQVLGHU WKDW LV WKH PRVW DFFXUDWH WUDF", "likely_table": true }, { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "ZHUH WDNHQ IURP WKH", "bates": "FDA-CBER-2021-5683-1078887", "context_preview": "&HQWUDO DQG 6RXWK $PHULFD $VLD -DSDQ 2WKHU &RXQWULHVE 2FHDQLD $XVWUDOLD\u00121HZ =HDODQG 2WKHU &RXQWULHV $IULFD 7RWDO \u0014\u0013\u0013\u0011\u0013\b \u0015\u0019\u0013\u001a \u0016\u0013\u0013 \u0016 3OHDVH QRWH WKDW FXUUHQWO\\ WKHUH ZHUH QR DYDLODEOH GDWD WKDW DOORZ WR HVWLPDWH H[SRVXUH E\\ JHQGHU DQG DJH JURXS\u0011 \u0017 3OHDVH FRQVLGHU WKDW LV WKH PRVW DFFXUDWH WUDFNHU RI V", "likely_table": true } ] }, { "filename": "19736_S0214_M1_smsr-01jan2021-31jan2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 15, "table_count": 13, "by_category": { "Other / uncategorized": 15 }, "by_marker": { "(b)(4)": 15 }, "top_examples": [ { "page": 13, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1079271", "context_preview": "ntries Commonwealth of Independent Statesc North Americab US Canada Central and South America Asia Japan Other Countries 3 Currently there are no available data that allow to estimate exposure by gender and age group. 4 The is the most accurate tracker of shipment used as data source for all the Reg", "likely_table": true }, { "page": 13, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1079271", "context_preview": "ommonwealth of Independent Statesc North Americab US Canada Central and South America Asia Japan Other Countries 3 Currently there are no available data that allow to estimate exposure by gender and age group. 4 The is the most accurate tracker of shipment used as data source for all the Regions and", "likely_table": true }, { "page": 13, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1079271", "context_preview": "lth of Independent Statesc North Americab US Canada Central and South America Asia Japan Other Countries 3 Currently there are no available data that allow to estimate exposure by gender and age group. 4 The is the most accurate tracker of shipment used as data source for all the Regions and Countri", "likely_table": true } ] }, { "filename": "19736_S0289_M1_smsr-01mar2021-31mar2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 23, "table_count": 13, "by_category": { "Other / uncategorized": 23 }, "by_marker": { "(b)(4)": 23 }, "top_examples": [ { "page": 14, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1084608", "context_preview": "Independent Statesd North Americab US Canada 5 Currently there are no available data that allow to estimate exposure by gender; for age group data available for some EU-EFTA countries were listed in below in Table 5. 6 The is the most accurate tracker of shipment used as data source for all the Regi", "likely_table": true }, { "page": 14, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1084608", "context_preview": "ent Statesd North Americab US Canada 5 Currently there are no available data that allow to estimate exposure by gender; for age group data available for some EU-EFTA countries were listed in below in Table 5. 6 The is the most accurate tracker of shipment used as data source for all the Regions and ", "likely_table": true }, { "page": 14, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1084608", "context_preview": "esd North Americab US Canada 5 Currently there are no available data that allow to estimate exposure by gender; for age group data available for some EU-EFTA countries were listed in below in Table 5. 6 The is the most accurate tracker of shipment used as data source for all the Regions and Countrie", "likely_table": true } ] }, { "filename": "19736_S0366_M1_smsr-30apr2021-31may2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 27, "table_count": 13, "by_category": { "Other / uncategorized": 26, "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 27 }, "top_examples": [ { "page": 14, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1095424", "context_preview": "11 Currently there are no available data that allow to estimate exposure by gender; for age group data available for some EU-EEA countries see below data in Table 5. 12 The is the most accurate tracker of shipment used as data source for all the Regions and Countries; US shipment data not available ", "likely_table": true }, { "page": 14, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1095424", "context_preview": "11 Currently there are no available data that allow to estimate exposure by gender; for age group data available for some EU-EEA countries see below data in Table 5. 12 The is the most accurate tracker of shipment used as data source for all the Regions and Countries; US shipment data not available ", "likely_table": true }, { "page": 14, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1095424", "context_preview": "11 Currently there are no available data that allow to estimate exposure by gender; for age group data available for some EU-EEA countries see below data in Table 5. 12 The is the most accurate tracker of shipment used as data source for all the Regions and Countries; US shipment data not available ", "likely_table": true } ] }, { "filename": "19736_S0408_M1_smsr-01jun2021-30jun2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 24, "table_count": 12, "by_category": { "Other / uncategorized": 22, "Trade-secret claim": 2 }, "by_marker": { "(b)(4)": 24 }, "top_examples": [ { "page": 15, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1103462", "context_preview": "8 Currently there are no available data that allow to estimate exposure by gender; for age group data available for some EU-EEA countries see below data in Table 6. 9 The is the most accurate tracker of shipment used as data source for all the Regions and Countries; US shipment data not available in", "likely_table": true }, { "page": 15, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1103462", "context_preview": "8 Currently there are no available data that allow to estimate exposure by gender; for age group data available for some EU-EEA countries see below data in Table 6. 9 The is the most accurate tracker of shipment used as data source for all the Regions and Countries; US shipment data not available in", "likely_table": true }, { "page": 15, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1103462", "context_preview": "8 Currently there are no available data that allow to estimate exposure by gender; for age group data available for some EU-EEA countries see below data in Table 6. 9 The is the most accurate tracker of shipment used as data source for all the Regions and Countries; US shipment data not available in", "likely_table": true } ] }, { "filename": "19736_S0453_M1_smsr-01jul2021-31jul2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 25, "table_count": 6, "by_category": { "Other / uncategorized": 21, "Clinical safety / adverse events": 3, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 25 }, "top_examples": [ { "page": 16, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1112236", "context_preview": "11 Currently there were no available data that allow to estimate exposure by gender; for age group data available for some EU-EEA countries see below data in Table 7. 12 The is the most accurate tracker of shipment used as data source for all the Regions and Countries; US shipment data not available", "likely_table": true }, { "page": 16, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1112236", "context_preview": "urrently there were no available data that allow to estimate exposure by gender; for age group data available for some EU-EEA countries see below data in Table 7. 12 The is the most accurate tracker of shipment used as data source for all the Regions and Countries; US shipment data not available in ", "likely_table": true }, { "page": 16, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1112236", "context_preview": "there were no available data that allow to estimate exposure by gender; for age group data available for some EU-EEA countries see below data in Table 7. 12 The is the most accurate tracker of shipment used as data source for all the Regions and Countries; US shipment data not available in the were ", "likely_table": true } ] }, { "filename": "19736_S0491_M1_smsr-01aug2021-31aug2021.pdf", "module": "M1", "company": "Pfizer", "license": "BLA", "total_kept": 26, "table_count": 12, "by_category": { "Other / uncategorized": 24, "Clinical safety / adverse events": 1, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 26 }, "top_examples": [ { "page": 14, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1122605", "context_preview": "9 Currently there are no available data that allow to estimate exposure by gender; for age group data available for some EU-EEA countries see below data in Table 5. 10 The is the most accurate tracker of shipment used as data source for all the Regions and Countries; US shipment data not available i", "likely_table": true }, { "page": 14, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1122605", "context_preview": "urrently there are no available data that allow to estimate exposure by gender; for age group data available for some EU-EEA countries see below data in Table 5. 10 The is the most accurate tracker of shipment used as data source for all the Regions and Countries; US shipment data not available in t", "likely_table": true }, { "page": 14, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1122605", "context_preview": "there are no available data that allow to estimate exposure by gender; for age group data available for some EU-EEA countries see below data in Table 5. 10 The is the most accurate tracker of shipment used as data source for all the Regions and Countries; US shipment data not available in the were t", "likely_table": true } ] }, { "filename": "19736_S105_M2_introduction.pdf", "module": "M2", "company": "Pfizer", "license": "EUA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1777948", "context_preview": "nistration. The RNA drug substance is the only active ingredient in the drug product. The drug product is a concentrate for injection and filled at mg/mL in glass vials and closed with stoppers and flip off crimping cap. 2.6.1.1. Proposed Indications BNT162b2 is indicated for the active immunization", "likely_table": false } ] }, { "filename": "19736_S105_M4_r-20-0085.pdf", "module": "M4", "company": "Pfizer", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Trade-secret claim": 2, "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 12, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "2.4 \nChanges and Deviations", "bates": "FDA-CBER-2021-5683-1778099", "context_preview": "SOP-110-022 Entsorgung von Biostoffabf\u00e4llen 2.4 Changes and Deviations This R&D study was conducted according to R&D plan P-20-0085. A change occurred in the pVNT. It was planned to perform this analysis with an external partner, . However, the CRO had no pVNT or VNT in place when samples were ready", "likely_table": false }, { "page": 59, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "Appendix 2: Certificates of Analysis", "bates": "FDA-CBER-2021-5683-1778146", "context_preview": "R&D Report R-20-0085 Version 03 Page 59 of 94 Strictly Confidential Appendix 2: Certificates of Analysis 090177e19503d895\\Approved\\Approved On: 25-Sep-2020 20:13 (GMT) (b) (4) (b) (6) (b) (6) FDA-CBER-2021-5683-1778146", "likely_table": false }, { "page": 60, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "Appendix 2: Certificates of Analysis", "bates": "FDA-CBER-2021-5683-1778147", "context_preview": "R&D Report R-20-0085 Version 03 Page 60 of 94 Strictly Confidential 090177e19503d895\\Approved\\Approved On: 25-Sep-2020 20:13 (GMT) (b) (4) (b) (6) FDA-CBER-2021-5683-1778147", "likely_table": false } ] }, { "filename": "19736_S105_M4_vr-vtr-10671.pdf", "module": "M4", "company": "Pfizer", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Other / uncategorized": 2, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1778187", "context_preview": "with two proline mutations (P2) to lock the transmembrane protein in an antigenically optimal prefusion conformation.1,2 The vaccine is formulated in lipid nanoparticles (LNPs). BNT162b2 was assessed for immunogenicity and for protection against an infectious SARS-CoV-2 challenge in rhesus macaques.", "likely_table": false }, { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1778189", "context_preview": "aline solution. The diluted modRNA LNP articles were well mixed by gentle swirling and/or inversion to ensure a homogeneous mixture. 3.3.1. RNase Reduction Measures All preparation steps were performed under a laminar flow hood or PCR Dead Air Box. After disinfection with Terralin\u00ae liquid (alcohol-b", "likely_table": false }, { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1778189", "context_preview": "lution. The diluted modRNA LNP articles were well mixed by gentle swirling and/or inversion to ensure a homogeneous mixture. 3.3.1. RNase Reduction Measures All preparation steps were performed under a laminar flow hood or PCR Dead Air Box. After disinfection with Terralin\u00ae liquid (alcohol-based dis", "likely_table": false } ] }, { "filename": "19736_S120_M1_response-05oct2020-clinical.pdf", "module": "M1", "company": "Pfizer", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 3, "Other / uncategorized": 1, "Trial design / efficacy": 1, "Pharmacology / toxicology": 1 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1778214", "context_preview": "cribed in section E of the \u201cEmergency Use Authorization of Medical Products and Related Authorities\u201d guidance (Ref. 2) and typically are part of pre-EUA discussions; and plans for providing such information in an emergency; Response The requested information, draft fact sheets for health care profes", "likely_table": false }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1778215", "context_preview": "imately 2-3M vials of finished product or 10-15M doses should be available and in drug product storage at the site pending release and shipment. Following completion of process validation batches, the anticipated weekly production rate at the Kalamazoo site should increase to approximately 4M doses ", "likely_table": false }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1778215", "context_preview": "2-3M vials of finished product or 10-15M doses should be available and in drug product storage at the site pending release and shipment. Following completion of process validation batches, the anticipated weekly production rate at the Kalamazoo site should increase to approximately 4M doses per week", "likely_table": false } ] }, { "filename": "19736_S141_M4_20gr142-protocol.pdf", "module": "M4", "company": "Pfizer", "license": "EUA", "total_kept": 5, "table_count": 0, "by_category": { "Trade-secret claim": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 550, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1781566", "context_preview": "Report for Study 20GR142 Page 550 PFIZER CONFIDENTIAL 090177e1958479af\\Approved\\Approved On: 13-Nov-2020 15:24 (GMT) (b) (4) FDA-CBER-2021-5683-1781566", "likely_table": false }, { "page": 551, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1781567", "context_preview": "Report for Study 20GR142 Page 551 PFIZER CONFIDENTIAL 090177e1958479af\\Approved\\Approved On: 13-Nov-2020 15:24 (GMT) (b) (4) (b) (4) FDA-CBER-2021-5683-1781567", "likely_table": false }, { "page": 551, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1781567", "context_preview": "Report for Study 20GR142 Page 551 PFIZER CONFIDENTIAL 090177e1958479af\\Approved\\Approved On: 13-Nov-2020 15:24 (GMT) (b) (4) (b) (4) FDA-CBER-2021-5683-1781567", "likely_table": false } ] }, { "filename": "19736_S1_M4_38166.pdf", "module": "M4", "company": "Pfizer", "license": "EUA", "total_kept": 2, "table_count": 0, "by_category": { "Pharmacology / toxicology": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "TO WISTAR HAN RATS", "bates": "FDA-CBER-2021-5683-1773321", "context_preview": "5131 Mainz Germany Study conducted by: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG Redderweg 8 21147 Hamburg Germany Contact person: Contact person: 16 April 2020 This report consists of 910 pages. - page 1 - REPEAT-DOSE TOXICITY STUDY OF THREE LNP-FORMULATED RNA PLATFORMS ENCODING F", "likely_table": false }, { "page": 19, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "1.5 \nFindings and conclusion", "bates": "FDA-CBER-2021-5683-1773339", "context_preview": "ent status End of treatment period. The evaluation of the study is still in progress. Final assessment after availability of all data including histopathology and toxicokinetics. The Quality Assurance Unit (QAU) conducts inspections of the various phases of the study and of certain repetitive operat", "likely_table": false } ] }, { "filename": "19736_S1_M4_r-20-0072.pdf", "module": "M4", "company": "Pfizer", "license": "EUA", "total_kept": 136, "table_count": 104, "by_category": { "Manufacturing / CMC": 64, "Other / uncategorized": 60, "Inspection / enforcement": 6, "Trade-secret claim": 4, "Pharmacology / toxicology": 2 }, "by_marker": { "(b)(4)": 136 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "LIST OF ABBREVIATIONS", "bates": "FDA-CBER-2021-5683-1774237", "context_preview": "ation- related effect rather than a payload or expression level effect. Treatment with modRNA with all tested LNP formulations did not induce the formation of luciferase-specific IgGs on day 9. However, a strong antigen-specific IFN-\u03b3 T-cell response was measured by ELISpot assay on day 9 for and LN", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "LIST OF ABBREVIATIONS", "bates": "FDA-CBER-2021-5683-1774237", "context_preview": "elated effect rather than a payload or expression level effect. Treatment with modRNA with all tested LNP formulations did not induce the formation of luciferase-specific IgGs on day 9. However, a strong antigen-specific IFN-\u03b3 T-cell response was measured by ELISpot assay on day 9 for and LNP8-formu", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "LIST OF ABBREVIATIONS", "bates": "FDA-CBER-2021-5683-1774237", "context_preview": "ffect rather than a payload or expression level effect. Treatment with modRNA with all tested LNP formulations did not induce the formation of luciferase-specific IgGs on day 9. However, a strong antigen-specific IFN-\u03b3 T-cell response was measured by ELISpot assay on day 9 for and LNP8-formulated mo", "likely_table": true } ] }, { "filename": "19736_S33_M4_38166-final.pdf", "module": "M4", "company": "Pfizer", "license": "EUA", "total_kept": 234, "table_count": 3, "by_category": { "Other / uncategorized": 131, "Pharmacology / toxicology": 98, "Manufacturing / CMC": 2, "Trial design / efficacy": 2, "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 234 }, "top_examples": [ { "page": 39, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.5 \nSponsor / Test Facility / Responsible personnel", "bates": "FDA-CBER-2021-5683-1774306", "context_preview": "40 70 20 22 60 E-mail: LPT@LPT-Hamburg.de Branch facility LPT, 24601 L\u00f6hndorf/Post Wankendorf Germany Study Director Until 31 May 2020 As of 01 June 2020 Deputy Study Director Test Facility Management Haematology / Clinical chemistry / Coagulation / Cytokine Analysis / Blood sampling Acute phase pro", "likely_table": true }, { "page": 39, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.5 \nSponsor / Test Facility / Responsible personnel", "bates": "FDA-CBER-2021-5683-1774306", "context_preview": "E-mail: LPT@LPT-Hamburg.de Branch facility LPT, 24601 L\u00f6hndorf/Post Wankendorf Germany Study Director Until 31 May 2020 As of 01 June 2020 Deputy Study Director Test Facility Management Haematology / Clinical chemistry / Coagulation / Cytokine Analysis / Blood sampling Acute phase protein analysis V", "likely_table": true }, { "page": 39, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.5 \nSponsor / Test Facility / Responsible personnel", "bates": "FDA-CBER-2021-5683-1774306", "context_preview": "Hamburg.de Branch facility LPT, 24601 L\u00f6hndorf/Post Wankendorf Germany Study Director Until 31 May 2020 As of 01 June 2020 Deputy Study Director Test Facility Management Haematology / Clinical chemistry / Coagulation / Cytokine Analysis / Blood sampling Acute phase protein analysis Veterinarian / Ma", "likely_table": true } ] }, { "filename": "19736_S77_M1_ib-summ-change.pdf", "module": "M1", "company": "Pfizer", "license": "EUA", "total_kept": 37, "table_count": 15, "by_category": { "Other / uncategorized": 37 }, "by_marker": { "(b)(4)": 37 }, "top_examples": [ { "page": 30, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section of the IB", "bates": "FDA-CBER-2021-5683-1776540", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1776540", "likely_table": true }, { "page": 30, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section of the IB", "bates": "FDA-CBER-2021-5683-1776540", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1776540", "likely_table": true }, { "page": 30, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Section of the IB", "bates": "FDA-CBER-2021-5683-1776540", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1776540", "likely_table": true } ] }, { "filename": "19736_S77_M1_ib-track.pdf", "module": "M1", "company": "Pfizer", "license": "EUA", "total_kept": 71, "table_count": 31, "by_category": { "Other / uncategorized": 64, "Manufacturing / CMC": 6, "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 71 }, "top_examples": [ { "page": 30, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NON-CLINICAL STUDIES", "bates": "FDA-CBER-2021-5683-1776618", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4)(b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1776618", "likely_table": true }, { "page": 30, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NON-CLINICAL STUDIES", "bates": "FDA-CBER-2021-5683-1776618", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4)(b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1776618", "likely_table": true }, { "page": 30, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NON-CLINICAL STUDIES", "bates": "FDA-CBER-2021-5683-1776618", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4)(b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1776618", "likely_table": true } ] }, { "filename": "19736_S77_M1_inv-brochure.pdf", "module": "M1", "company": "Pfizer", "license": "EUA", "total_kept": 34, "table_count": 6, "by_category": { "Other / uncategorized": 30, "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 34 }, "top_examples": [ { "page": 86, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BNT162/PF-07302048", "bates": "FDA-CBER-2021-5683-1776797", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1776797", "likely_table": true }, { "page": 86, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BNT162/PF-07302048", "bates": "FDA-CBER-2021-5683-1776797", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1776797", "likely_table": true }, { "page": 86, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BNT162/PF-07302048", "bates": "FDA-CBER-2021-5683-1776797", "context_preview": "(b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-CBER-2021-5683-1776797", "likely_table": true } ] }, { "filename": "19745_S12_M2_nonclinical-overview.pdf", "module": "M2", "company": "Moderna", "license": "EUA", "total_kept": 25, "table_count": 13, "by_category": { "Other / uncategorized": 14, "Pharmacology / toxicology": 7, "Manufacturing / CMC": 3, "Trial design / efficacy": 1 }, "by_marker": { "(b)(4)": 25 }, "top_examples": [ { "page": 21, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.4.2.1 \nIn Vivo Pharmacology", "bates": "FDA-CBER-2022-1614-5662150", "context_preview": "rast, mice administered 10 \u00b5g SARS-CoV-2 S-2P protein + 250 \u00b5g had high titers of IgG1 and low titers of IgG2a. In mice, the ratio of IgG antibody subclasses can be considered a surrogate to indicate Th1/Th2 response. A ratio of IgG1 subclass with low or no IgG2a is associated with Th2 response, whe", "likely_table": true }, { "page": 21, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.4.2.1 \nIn Vivo Pharmacology", "bates": "FDA-CBER-2022-1614-5662150", "context_preview": "ce administered 10 \u00b5g SARS-CoV-2 S-2P protein + 250 \u00b5g had high titers of IgG1 and low titers of IgG2a. In mice, the ratio of IgG antibody subclasses can be considered a surrogate to indicate Th1/Th2 response. A ratio of IgG1 subclass with low or no IgG2a is associated with Th2 response, whereas bal", "likely_table": true }, { "page": 21, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.4.2.1 \nIn Vivo Pharmacology", "bates": "FDA-CBER-2022-1614-5662150", "context_preview": "istered 10 \u00b5g SARS-CoV-2 S-2P protein + 250 \u00b5g had high titers of IgG1 and low titers of IgG2a. In mice, the ratio of IgG antibody subclasses can be considered a surrogate to indicate Th1/Th2 response. A ratio of IgG1 subclass with low or no IgG2a is associated with Th2 response, whereas balanced Ig", "likely_table": true } ] }, { "filename": "19745_S13_M1_fda-brief-doc-21jul2020.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 181, "table_count": 100, "by_category": { "Manufacturing / CMC": 165, "Other / uncategorized": 12, "Pharmacology / toxicology": 2, "Inspection / enforcement": 1, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 181 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "LIST OF TABLES", "bates": "FDA-CBER-2022-1614-4810283", "context_preview": "................................................................................47 Table 23: Clinical In-Use Compatibility Data for mRNA-1273 LS Injection, Lot 6006820001, 0.10 mg /mL, Post 6 Hour Hold of an Entered Multiple-Dose Vial .................................................................", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "LIST OF TABLES", "bates": "FDA-CBER-2022-1614-4810283", "context_preview": "........................................................................47 Table 23: Clinical In-Use Compatibility Data for mRNA-1273 LS Injection, Lot 6006820001, 0.10 mg /mL, Post 6 Hour Hold of an Entered Multiple-Dose Vial .........................................................................", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "LIST OF TABLES", "bates": "FDA-CBER-2022-1614-4810283", "context_preview": "................................................................47 Table 23: Clinical In-Use Compatibility Data for mRNA-1273 LS Injection, Lot 6006820001, 0.10 mg /mL, Post 6 Hour Hold of an Entered Multiple-Dose Vial .................................................................................", "likely_table": true } ] }, { "filename": "19745_S1_M4_xv-216-report.pdf", "module": "M4", "company": "Moderna", "license": "EUA", "total_kept": 12, "table_count": 8, "by_category": { "Other / uncategorized": 12 }, "by_marker": { "(b)(4)": 12 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BRIEF METHODS", "bates": "FDA-CBER-2022-1614-5662122", "context_preview": "The standard curves are developed using serially-diluted cDNA samples enriched in the transcript of interest (lungs 6 hours post-RSV infection of FI-RSV-immunized animals). The Ct values are plotted against log10 cDNA dilution factor. These curves are used to convert the Ct values obtained for diffe", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BRIEF METHODS", "bates": "FDA-CBER-2022-1614-5662122", "context_preview": "andard curves are developed using serially-diluted cDNA samples enriched in the transcript of interest (lungs 6 hours post-RSV infection of FI-RSV-immunized animals). The Ct values are plotted against log10 cDNA dilution factor. These curves are used to convert the Ct values obtained for different s", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BRIEF METHODS", "bates": "FDA-CBER-2022-1614-5662122", "context_preview": "urves are developed using serially-diluted cDNA samples enriched in the transcript of interest (lungs 6 hours post-RSV infection of FI-RSV-immunized animals). The Ct values are plotted against log10 cDNA dilution factor. These curves are used to convert the Ct values obtained for different samples t", "likely_table": true } ] }, { "filename": "19745_S25_M3_32p1_description-and-composition.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 4, "table_count": 0, "by_category": { "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.1 \nDescription and Composition of the Drug Product", "bates": "FDA-CBER-2022-1614-4622288", "context_preview": "of 0.20 mg/mL mRNA, pH 7.5. mRNA-1273 LS Injection is presented in 10R USP Type I borosilicate glass vials with mRNA-1273 LS Injection is stored (long-term) between -60\u00b0C to -90\u00b0C. Prior to use in the clinical studies, mRNA-1273 LS Injection will be thawed and stored (short-term) at 2\u00b0C to 8\u00b0C. One ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.1 \nDescription and Composition of the Drug Product", "bates": "FDA-CBER-2022-1614-4622288", "context_preview": "mg/mL mRNA, pH 7.5. mRNA-1273 LS Injection is presented in 10R USP Type I borosilicate glass vials with mRNA-1273 LS Injection is stored (long-term) between -60\u00b0C to -90\u00b0C. Prior to use in the clinical studies, mRNA-1273 LS Injection will be thawed and stored (short-term) at 2\u00b0C to 8\u00b0C. One vial of ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.1 \nDescription and Composition of the Drug Product", "bates": "FDA-CBER-2022-1614-4622288", "context_preview": "RNA, pH 7.5. mRNA-1273 LS Injection is presented in 10R USP Type I borosilicate glass vials with mRNA-1273 LS Injection is stored (long-term) between -60\u00b0C to -90\u00b0C. Prior to use in the clinical studies, mRNA-1273 LS Injection will be thawed and stored (short-term) at 2\u00b0C to 8\u00b0C. One vial of mRNA-12", "likely_table": false } ] }, { "filename": "19745_S25_M3_32p3_manufacturers.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.3.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622289", "context_preview": "facturer(s) The facilities and responsibilities for the manufacture, testing and release of the mRNA-1273 LS Injection are summarized in Table 1. Table 1: Facilities and Responsibilities for the Manufacture and Testing of the mRNA-1273 LS Injection Facility Address Responsibility ModernaTX, Inc. One", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.3.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622289", "context_preview": "(s) The facilities and responsibilities for the manufacture, testing and release of the mRNA-1273 LS Injection are summarized in Table 1. Table 1: Facilities and Responsibilities for the Manufacture and Testing of the mRNA-1273 LS Injection Facility Address Responsibility ModernaTX, Inc. One Moderna", "likely_table": false } ] }, { "filename": "19745_S25_M3_32p5_analytical-procedure.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Trade-secret claim": 2, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.S.4.2.13{mRNA-1273 LNP}", "bates": "FDA-CBER-2022-1614-4622293", "context_preview": "(RiboGreen) Section 3.2.S.4.2.5{mRNA-1273 LNP} Mean Particle Size and Polydispersity by Dynamic Light Scattering Section 3.2.S.4.2.6{mRNA-1273 LNP} Lipid Identification by UPLC-CAD Section 3.2.S.4.2.7{mRNA-1273 LNP} Lipid Content by UPLC-CAD Section 3.2.S.4.2.8{mRNA-1273 LNP} Lipid Impurities by UPL", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "3.2.P.5.2.4 Sterility", "bates": "FDA-CBER-2022-1614-4622294", "context_preview": "ModernaTX, Inc. mRNA-1273 3.2.P.5.2 Analytical Procedures IND# 19745 Confidential Page 3 3.2.P.5.2.3 Container Content mRNA-1273 LS Injection container content is tested in accordance with USP <697>. 3.2.P.5.2.4 Sterility mRNA-1273 LS Injection is tested for sterility in accordance with USP <71> and", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "3.2.P.5.2.4 Sterility", "bates": "FDA-CBER-2022-1614-4622294", "context_preview": "ModernaTX, Inc. mRNA-1273 3.2.P.5.2 Analytical Procedures IND# 19745 Confidential Page 3 3.2.P.5.2.3 Container Content mRNA-1273 LS Injection container content is tested in accordance with USP <697>. 3.2.P.5.2.4 Sterility mRNA-1273 LS Injection is tested for sterility in accordance with USP <71> and", "likely_table": false } ] }, { "filename": "19745_S25_M3_32p5_batch-analyses.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 20, "table_count": 20, "by_category": { "Manufacturing / CMC": 20 }, "by_marker": { "(b)(4)": 20 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622296", "context_preview": "A N/A N/A N/A N/A N/A Lipid identification by UPLC-CAD SM-102 Conforms Conforms Conforms Conforms Conforms Conforms Conforms Cholesterol Conforms Conforms Conforms Conforms Conforms Conforms Conforms DSPC Conforms Conforms Conforms Conforms Conforms Conforms Conforms PEG2000-DMG Conforms Conforms Co", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622296", "context_preview": "N/A N/A N/A N/A Lipid identification by UPLC-CAD SM-102 Conforms Conforms Conforms Conforms Conforms Conforms Conforms Cholesterol Conforms Conforms Conforms Conforms Conforms Conforms Conforms DSPC Conforms Conforms Conforms Conforms Conforms Conforms Conforms PEG2000-DMG Conforms Conforms Conforms", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622296", "context_preview": "N/A N/A Lipid identification by UPLC-CAD SM-102 Conforms Conforms Conforms Conforms Conforms Conforms Conforms Cholesterol Conforms Conforms Conforms Conforms Conforms Conforms Conforms DSPC Conforms Conforms Conforms Conforms Conforms Conforms Conforms PEG2000-DMG Conforms Conforms Conforms Conform", "likely_table": true } ] }, { "filename": "19745_S25_M3_32p5_specifications.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 7, "table_count": 7, "by_category": { "Manufacturing / CMC": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622326", "context_preview": "EG2000-DMG Lipid content SM-102 UPLC-CAD Cholesterol DSPC PEG2000-DMG Lipid impurities UPLC-CAD Particle size Dynamic Light Scattering Polydispersity pH USP <791> Osmolality USP <785> Freezing Point Depression Particulate matter \u2265 25 \uf06dm USP <788> Method 2 \u2265 10 \uf06dm Container content USP <697> Bacteria", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622326", "context_preview": "MG Lipid content SM-102 UPLC-CAD Cholesterol DSPC PEG2000-DMG Lipid impurities UPLC-CAD Particle size Dynamic Light Scattering Polydispersity pH USP <791> Osmolality USP <785> Freezing Point Depression Particulate matter \u2265 25 \uf06dm USP <788> Method 2 \u2265 10 \uf06dm Container content USP <697> Bacterial endoto", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622326", "context_preview": "d content SM-102 UPLC-CAD Cholesterol DSPC PEG2000-DMG Lipid impurities UPLC-CAD Particle size Dynamic Light Scattering Polydispersity pH USP <791> Osmolality USP <785> Freezing Point Depression Particulate matter \u2265 25 \uf06dm USP <788> Method 2 \u2265 10 \uf06dm Container content USP <697> Bacterial endotoxin USP", "likely_table": true } ] }, { "filename": "19745_S25_M3_32p5_validation-analytical-procedure.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 5, "table_count": 0, "by_category": { "Manufacturing / CMC": 4, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.3 \nValidation of Analytical Procedures", "bates": "FDA-CBER-2022-1614-4622327", "context_preview": "3 {mRNA-1273 LNP} (% RNA Encapsulation) See Table 5, Section 3.2.S.4.3 {mRNA-1273 LNP} Dynamic Light Scattering (a) (Particle Size and Polydispersity) See Table 6, Section 3.2.S.4.3 {mRNA-1273 LNP} UPLC-CAD (a) (Lipid Content, Lipid Identification and Lipid Impurities) See Table 7, Section 3.2.S.4.3", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.3 \nValidation of Analytical Procedures", "bates": "FDA-CBER-2022-1614-4622327", "context_preview": "1273 LNP} (% RNA Encapsulation) See Table 5, Section 3.2.S.4.3 {mRNA-1273 LNP} Dynamic Light Scattering (a) (Particle Size and Polydispersity) See Table 6, Section 3.2.S.4.3 {mRNA-1273 LNP} UPLC-CAD (a) (Lipid Content, Lipid Identification and Lipid Impurities) See Table 7, Section 3.2.S.4.3 {mRNA-1", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.5.3 \nValidation of Analytical Procedures", "bates": "FDA-CBER-2022-1614-4622327", "context_preview": "} (% RNA Encapsulation) See Table 5, Section 3.2.S.4.3 {mRNA-1273 LNP} Dynamic Light Scattering (a) (Particle Size and Polydispersity) See Table 6, Section 3.2.S.4.3 {mRNA-1273 LNP} UPLC-CAD (a) (Lipid Content, Lipid Identification and Lipid Impurities) See Table 7, Section 3.2.S.4.3 {mRNA-1273 LNP}", "likely_table": false } ] }, { "filename": "19745_S25_M3_32p8_stability-data.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 262, "table_count": 254, "by_category": { "Manufacturing / CMC": 257, "Other / uncategorized": 5 }, "by_marker": { "(b)(4)": 262 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.8.3 Stability Data", "bates": "FDA-CBER-2022-1614-4622332", "context_preview": "nical In-Use Compatibility Data for mRNA-1273 LS Injection, Lot 6006920001, 0.5 mg /mL, Post 6 Hour Hold of Opened Multi-Dose Vial................................................................................................ 31 Table 28: Clinical In-Use Compatibility Data for mRNA-1273 LS Injectio", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.8.3 Stability Data", "bates": "FDA-CBER-2022-1614-4622332", "context_preview": "-Use Compatibility Data for mRNA-1273 LS Injection, Lot 6006920001, 0.5 mg /mL, Post 6 Hour Hold of Opened Multi-Dose Vial................................................................................................ 31 Table 28: Clinical In-Use Compatibility Data for mRNA-1273 LS Injection, Lot 6", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.8.3 Stability Data", "bates": "FDA-CBER-2022-1614-4622332", "context_preview": "patibility Data for mRNA-1273 LS Injection, Lot 6006920001, 0.5 mg /mL, Post 6 Hour Hold of Opened Multi-Dose Vial................................................................................................ 31 Table 28: Clinical In-Use Compatibility Data for mRNA-1273 LS Injection, Lot 600692000", "likely_table": true } ] }, { "filename": "19745_S25_M3_32p8_stability-summary.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 40, "table_count": 15, "by_category": { "Manufacturing / CMC": 32, "Other / uncategorized": 8 }, "by_marker": { "(b)(4)": 40 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.1.2", "bates": "FDA-CBER-2022-1614-4622364", "context_preview": "nitial Use Period for mRNA-1273 LS Injection Development mRNA-1273 LS Injection stability samples used to establish initial use period are tested according to the protocol described in Table 3. Samples stored at the intended condition are evaluated against the specification provided in the stability", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.1.2", "bates": "FDA-CBER-2022-1614-4622364", "context_preview": "se Period for mRNA-1273 LS Injection Development mRNA-1273 LS Injection stability samples used to establish initial use period are tested according to the protocol described in Table 3. Samples stored at the intended condition are evaluated against the specification provided in the stability tables.", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.1.2", "bates": "FDA-CBER-2022-1614-4622364", "context_preview": "d for mRNA-1273 LS Injection Development mRNA-1273 LS Injection stability samples used to establish initial use period are tested according to the protocol described in Table 3. Samples stored at the intended condition are evaluated against the specification provided in the stability tables. Samples", "likely_table": true } ] }, { "filename": "19745_S25_M3_32s1_mrna_nomenclature.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.1.1 Nomenclature", "bates": "FDA-CBER-2022-1614-4622375", "context_preview": "ModernaTX, Inc. mRNA-1273 3.2.S.1.1 Nomenclature {mRNA-1273 LNP} IND# 19745 Confidential Page 1 3.2.S.1.1 Nomenclature Generic Name (USAN, INN, BAN, and JAN): N/A Synonyms: mRNA-1273 LS (Large Scale) Lipid Nanoparticle (LNP) is an mRNA-lipid complex [lipid nanoparticle (LNP)] dispersion that contain", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.1.1 Nomenclature", "bates": "FDA-CBER-2022-1614-4622375", "context_preview": "ModernaTX, Inc. mRNA-1273 3.2.S.1.1 Nomenclature {mRNA-1273 LNP} IND# 19745 Confidential Page 1 3.2.S.1.1 Nomenclature Generic Name (USAN, INN, BAN, and JAN): N/A Synonyms: mRNA-1273 LS (Large Scale) Lipid Nanoparticle (LNP) is an mRNA-lipid complex [lipid nanoparticle (LNP)] dispersion that contain", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.1.1 Nomenclature", "bates": "FDA-CBER-2022-1614-4622375", "context_preview": "ModernaTX, Inc. mRNA-1273 3.2.S.1.1 Nomenclature {mRNA-1273 LNP} IND# 19745 Confidential Page 1 3.2.S.1.1 Nomenclature Generic Name (USAN, INN, BAN, and JAN): N/A Synonyms: mRNA-1273 LS (Large Scale) Lipid Nanoparticle (LNP) is an mRNA-lipid complex [lipid nanoparticle (LNP)] dispersion that contain", "likely_table": false } ] }, { "filename": "19745_S25_M3_32s2_mrna_manufacturer.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622377", "context_preview": "LNP) Facility Address Responsibility ModernaTX, Inc. One Moderna Way Norwood, MA 02062 USA \u2022 Manufacture of mRNA-1273 LS LNP \u2022 Release testing of mRNA-1273 LS LNP (excluding bacterial endotoxin testing) \u2022 Lot release of mRNA-1273 LS LNP \u2022 Stability testing of mRNA-1273 LNP (excluding bacterial endot", "likely_table": false } ] }, { "filename": "19745_S25_M3_32s4_coa-cx-024414.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 5, "table_count": 0, "by_category": { "Manufacturing / CMC": 3, "Trade-secret claim": 2 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622378", "context_preview": "re-Main Peak % Post Main Peak % 5' Capped SOP-0467 Cap1 % PolyA tailed RNA / % Tailless RNA SOP-0291 Main Peak Area Pre-Main Peak Area Residual DNA template SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFI", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622381", "context_preview": "uct Related Impurities SOP-0321 Main Peak Area % Pre-Main Peak % Post Main Peak % 5' Capped SOP-0467 Cap1 % PolyA tailed RNA / % Tailless RNA SOP-0291 Main Peak Area Pre-Main Peak Area Residual DNA template SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622383", "context_preview": "uct Related Impurities SOP-0321 Main Peak Area % Pre-Main Peak % Post Main Peak % 5' Capped SOP-0467 Cap1 % PolyA tailed RNA / % Tailless RNA SOP-0291 Main Peak Area Pre-Main Peak Area Residual DNA template SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false } ] }, { "filename": "19745_S25_M3_32s4_mrna_coa-mrna-1273-lnp.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 8, "table_count": 0, "by_category": { "Manufacturing / CMC": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622393", "context_preview": "rance - Color Appearance - Particulates Identity SOP-0544 Identity Concentration SOP-0235 Concentration Purity SOP-0383 Purity % IG1 % IG2 % IG3 % Total Impurities % RNA Encapsulation SOP-0298 % Encapsulation Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-050", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622394", "context_preview": "Method Parameter Specification Result Lipid Content SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 RRT 1 RRT 2 RRT 3 RRT 4 pH SOP-0288 pH Osmolality SOP-0279 Osmolality USP <467> Advantar MRNA- C0000-GTM0018 Ethanol Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622397", "context_preview": "rance - Color Appearance - Particulates Identity SOP-0544 Identity Concentration SOP-0235 Concentration Purity SOP-0383 Purity % IG1 % IG2 % IG3 % Total Impurities % RNA Encapsulation SOP-0298 % Encapsulation Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-050", "likely_table": false } ] }, { "filename": "19745_S25_M3_32s4_mrna_specification.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622408", "context_preview": "Sanger Sequencing Total RNA content Anion Exchange HPLC Purity RP- HPLC Product-related impurities % RNA encapsulation Mean particle size Dynamic Light Scattering Polydispersity Lipid identification SM-102 UPLC-CAD Cholesterol DSPC PEG2000-DMG Lipid content SM-102 UPLC-CAD Cholesterol DSPC PEG2000-D", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622408", "context_preview": "equencing Total RNA content Anion Exchange HPLC Purity RP- HPLC Product-related impurities % RNA encapsulation Mean particle size Dynamic Light Scattering Polydispersity Lipid identification SM-102 UPLC-CAD Cholesterol DSPC PEG2000-DMG Lipid content SM-102 UPLC-CAD Cholesterol DSPC PEG2000-DMG Lipid", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622408", "context_preview": "g Total RNA content Anion Exchange HPLC Purity RP- HPLC Product-related impurities % RNA encapsulation Mean particle size Dynamic Light Scattering Polydispersity Lipid identification SM-102 UPLC-CAD Cholesterol DSPC PEG2000-DMG Lipid content SM-102 UPLC-CAD Cholesterol DSPC PEG2000-DMG Lipid impurit", "likely_table": false } ] }, { "filename": "19745_S30_M1_fda-brief-doc-04sept2020.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 296, "table_count": 59, "by_category": { "Other / uncategorized": 223, "Manufacturing / CMC": 72, "Trial design / efficacy": 1 }, "by_marker": { "(b)(4)": 296 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "LIST OF FIGURES", "bates": "FDA-CBER-2022-1614-4993166", "context_preview": "d will be part of PPQ activities. scale manufacture will not be conducted at ModernaTX, Inc. b) Initial scale at Moderna will be at to gain manufacturing experience (Initial Norwood Scale B) and will be part of PPQ activities. scale manufacture will not be conducted at Lonza. c) Initial scale at Mod", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "LIST OF FIGURES", "bates": "FDA-CBER-2022-1614-4993166", "context_preview": "e part of PPQ activities. scale manufacture will not be conducted at ModernaTX, Inc. b) Initial scale at Moderna will be at to gain manufacturing experience (Initial Norwood Scale B) and will be part of PPQ activities. scale manufacture will not be conducted at Lonza. c) Initial scale at Moderna wil", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "LIST OF FIGURES", "bates": "FDA-CBER-2022-1614-4993166", "context_preview": "f PPQ activities. scale manufacture will not be conducted at ModernaTX, Inc. b) Initial scale at Moderna will be at to gain manufacturing experience (Initial Norwood Scale B) and will be part of PPQ activities. scale manufacture will not be conducted at Lonza. c) Initial scale at Moderna will be at ", "likely_table": true } ] }, { "filename": "19745_S39_M1_0039-cover.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 18, "table_count": 15, "by_category": { "Manufacturing / CMC": 17, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 18 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.4.1\nSpecifications", "bates": "FDA-CBER-2022-1614-4622492", "context_preview": ".P.3.5 Process Validation Administrative Change to remove \u201cLS\u201d from mRNA-1273 nomenclature Addition of process performance qualification for Addition of Aseptic Manufacturing Validation for at Catalent Indiana LLC Addition of environmental monitoring program at Catalent Indiana, LLC 3.2.P.4.1 Specif", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.4.1\nSpecifications", "bates": "FDA-CBER-2022-1614-4622492", "context_preview": "rocess Validation Administrative Change to remove \u201cLS\u201d from mRNA-1273 nomenclature Addition of process performance qualification for Addition of Aseptic Manufacturing Validation for at Catalent Indiana LLC Addition of environmental monitoring program at Catalent Indiana, LLC 3.2.P.4.1 Specifications", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.4.1\nSpecifications", "bates": "FDA-CBER-2022-1614-4622492", "context_preview": "alidation Administrative Change to remove \u201cLS\u201d from mRNA-1273 nomenclature Addition of process performance qualification for Addition of Aseptic Manufacturing Validation for at Catalent Indiana LLC Addition of environmental monitoring program at Catalent Indiana, LLC 3.2.P.4.1 Specifications Adminis", "likely_table": true } ] }, { "filename": "19745_S39_M3_32p1_description-and-composition.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 2, "table_count": 0, "by_category": { "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.1 \nDescription and Composition of the Drug Product", "bates": "FDA-CBER-2022-1614-4622498", "context_preview": "oduct Presentation mRNA strength 0.20 mg/mL Vial 10R Type 1 glass (Ompi) Stopper 4432-50 Gray B240 Westar Seal Aluminum Seal with Flip-off Plastic cap Color: Red Matte Target Fill Volume/Vial 6.3 mL Nominal (= Label) Fill Volume 5.0 mL Nominal Doses/Vial 10 (target) Site of Manufacture Catalent Indi", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.P.1 \nDescription and Composition of the Drug Product", "bates": "FDA-CBER-2022-1614-4622498", "context_preview": "esentation mRNA strength 0.20 mg/mL Vial 10R Type 1 glass (Ompi) Stopper 4432-50 Gray B240 Westar Seal Aluminum Seal with Flip-off Plastic cap Color: Red Matte Target Fill Volume/Vial 6.3 mL Nominal (= Label) Fill Volume 5.0 mL Nominal Doses/Vial 10 (target) Site of Manufacture Catalent Indiana, LLC", "likely_table": false } ] }, { "filename": "19745_S39_M3_32p3_manufacturers.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.3.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622500", "context_preview": "diary of Catalent Pharma Solutions, Inc. (FEI# 3005949964) (DUNS# 172209277) 1300 South Patterson Drive Bloomington, IN 47403 USA EUA and Clinical Supply \u2022 Fill/Finish \u2022 Packaging \u2022 Labelling \u2022 Release Testing (Sterility) \u2022 Stability Testing (Sterility) Catalent Pharma Solutions Associates of Cape C", "likely_table": false } ] }, { "filename": "19745_S39_M3_32p51_specifications.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 9, "table_count": 9, "by_category": { "Manufacturing / CMC": 9 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622501", "context_preview": "ight Scattering (SOP-0107) Polydispersity pH USP <791> (SOP-0288) Osmolality USP <785> Freezing Point Depression (SOP-0279) Particulate matter \u2265 25 \uf06dm USP <788> Method 2 (SOP-0509) \u2265 10 \uf06dm Container content USP <697> (SOP-0950) \u2265 5.0 mL (\u2265 10 doses of 0.5 mL from 1 vial) Bacterial endotoxin USP <85>", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622501", "context_preview": "ttering (SOP-0107) Polydispersity pH USP <791> (SOP-0288) Osmolality USP <785> Freezing Point Depression (SOP-0279) Particulate matter \u2265 25 \uf06dm USP <788> Method 2 (SOP-0509) \u2265 10 \uf06dm Container content USP <697> (SOP-0950) \u2265 5.0 mL (\u2265 10 doses of 0.5 mL from 1 vial) Bacterial endotoxin USP <85>, EP 2.6", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622501", "context_preview": "(SOP-0107) Polydispersity pH USP <791> (SOP-0288) Osmolality USP <785> Freezing Point Depression (SOP-0279) Particulate matter \u2265 25 \uf06dm USP <788> Method 2 (SOP-0509) \u2265 10 \uf06dm Container content USP <697> (SOP-0950) \u2265 5.0 mL (\u2265 10 doses of 0.5 mL from 1 vial) Bacterial endotoxin USP <85>, EP 2.6.14 (M-C", "likely_table": true } ] }, { "filename": "19745_S39_M3_32p54_batch-analyses.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 21, "table_count": 21, "by_category": { "Manufacturing / CMC": 21 }, "by_marker": { "(b)(4)": 21 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622503", "context_preview": "Particulate matter (SOP-0509) \u2265 25 \u00b5m \u2265 10 \u00b5m Container content (SOP-0950) \u2265 5.0 mL (\u2265 10 doses of 0.5 mL from 1 vial) N/A N/A N/A N/A N/A N/A N/A Bacterial endotoxin (M-CTS-CS-0929) Sterility (Moderna: SOP -0378) (Catalent: A-SOP-09-07-015) a) The stability Acceptance Criteria for %purity is as pre", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622503", "context_preview": "Particulate matter (SOP-0509) \u2265 25 \u00b5m \u2265 10 \u00b5m Container content (SOP-0950) \u2265 5.0 mL (\u2265 10 doses of 0.5 mL from 1 vial) N/A N/A N/A N/A N/A N/A N/A Bacterial endotoxin (M-CTS-CS-0929) Sterility (Moderna: SOP -0378) (Catalent: A-SOP-09-07-015) a) The stability Acceptance Criteria for %purity is as pre", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622503", "context_preview": "Particulate matter (SOP-0509) \u2265 25 \u00b5m \u2265 10 \u00b5m Container content (SOP-0950) \u2265 5.0 mL (\u2265 10 doses of 0.5 mL from 1 vial) N/A N/A N/A N/A N/A N/A N/A Bacterial endotoxin (M-CTS-CS-0929) Sterility (Moderna: SOP -0378) (Catalent: A-SOP-09-07-015) a) The stability Acceptance Criteria for %purity is as pre", "likely_table": true } ] }, { "filename": "19745_S39_M3_32p54_coa-various-lots.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 10, "table_count": 0, "by_category": { "Manufacturing / CMC": 10 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 23, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622526", "context_preview": "terility SOP-0378 Sterility This material meets specification: Yes 1.0 - Original 2.0 - Corrected SOP-0509 . No changes to reported results, incorrectly started at instead of for impurity tracking in version 1.0. Corrected batch date from 07Jul2021 to 08Jul2020 and expiry date from 07Jan2021 to 08Ja", "likely_table": false }, { "page": 23, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622526", "context_preview": "SOP-0378 Sterility This material meets specification: Yes 1.0 - Original 2.0 - Corrected SOP-0509 . No changes to reported results, incorrectly started at instead of for impurity tracking in version 1.0. Corrected batch date from 07Jul2021 to 08Jul2020 and expiry date from 07Jan2021 to 08Jan2021 Rev", "likely_table": false }, { "page": 23, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622526", "context_preview": "8 Sterility This material meets specification: Yes 1.0 - Original 2.0 - Corrected SOP-0509 . No changes to reported results, incorrectly started at instead of for impurity tracking in version 1.0. Corrected batch date from 07Jul2021 to 08Jul2020 and expiry date from 07Jan2021 to 08Jan2021 Revision H", "likely_table": false } ] }, { "filename": "19745_S39_M3_32p8_stability-data.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 307, "table_count": 287, "by_category": { "Manufacturing / CMC": 307 }, "by_marker": { "(b)(4)": 307 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.3 Stability Data", "bates": "FDA-CBER-2022-1614-4622546", "context_preview": "ble 30: Clinical In-Use Compatibility Data for mRNA-1273 Drug Product, Lot 6007520007, 0.20 mg/mL, , Post-7 Hour Hold of Opened Multiple-Dose Vial ............................................................................. 34 Table 31: Clinical In-Use Compatibility Data for mRNA-1273 Drug Product,", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.3 Stability Data", "bates": "FDA-CBER-2022-1614-4622546", "context_preview": "Clinical In-Use Compatibility Data for mRNA-1273 Drug Product, Lot 6007520007, 0.20 mg/mL, , Post-7 Hour Hold of Opened Multiple-Dose Vial ............................................................................. 34 Table 31: Clinical In-Use Compatibility Data for mRNA-1273 Drug Product, Lot 600", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.3 Stability Data", "bates": "FDA-CBER-2022-1614-4622546", "context_preview": "al In-Use Compatibility Data for mRNA-1273 Drug Product, Lot 6007520007, 0.20 mg/mL, , Post-7 Hour Hold of Opened Multiple-Dose Vial ............................................................................. 34 Table 31: Clinical In-Use Compatibility Data for mRNA-1273 Drug Product, Lot 600752000", "likely_table": true } ] }, { "filename": "19745_S39_M3_32p8_stability-summary.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 36, "table_count": 14, "by_category": { "Manufacturing / CMC": 36 }, "by_marker": { "(b)(4)": 36 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.P.3.3. One development lot was prepared with a total RNA content of", "bates": "FDA-CBER-2022-1614-4622582", "context_preview": "content (final total RNA content was established as mRNA). Therefore, the stability of mRNA-1273 Drug Product at dosage strength of 0.10 mg/mL and 0.5 mg/mL is a suitable bracket to establish the initial long-term (storage between -60\u00b0C to -90\u00b0C) and short-term (storage between 2\u00b0C to 8\u00b0C) use perio", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.P.3.3. One development lot was prepared with a total RNA content of", "bates": "FDA-CBER-2022-1614-4622582", "context_preview": "(final total RNA content was established as mRNA). Therefore, the stability of mRNA-1273 Drug Product at dosage strength of 0.10 mg/mL and 0.5 mg/mL is a suitable bracket to establish the initial long-term (storage between -60\u00b0C to -90\u00b0C) and short-term (storage between 2\u00b0C to 8\u00b0C) use periods for m", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.P.3.3. One development lot was prepared with a total RNA content of", "bates": "FDA-CBER-2022-1614-4622582", "context_preview": "otal RNA content was established as mRNA). Therefore, the stability of mRNA-1273 Drug Product at dosage strength of 0.10 mg/mL and 0.5 mg/mL is a suitable bracket to establish the initial long-term (storage between -60\u00b0C to -90\u00b0C) and short-term (storage between 2\u00b0C to 8\u00b0C) use periods for mRNA-1273", "likely_table": true } ] }, { "filename": "19745_S39_M3_32s44_mrna_coa-mrna-1273-lnp.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 12, "table_count": 0, "by_category": { "Manufacturing / CMC": 12 }, "by_marker": { "(b)(4)": 12 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622597", "context_preview": "rance - Color Appearance - Particulates Identity SOP-0544 Identity Concentration SOP-0235 Concentration Purity SOP-0383 Purity % IG1 % IG2 % IG3 % Total Impurities % RNA Encapsulation SOP-0298 % Encapsulation Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-050", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622598", "context_preview": "Method Parameter Specification Result Lipid Content SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 RRT 1 RRT 2 RRT 3 RRT 4 pH SOP-0288 pH Osmolality SOP-0279 Osmolality USP <467> Advantar MRNA- C0000-GTM0018 Ethanol Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622601", "context_preview": "rance - Color Appearance - Particulates Identity SOP-0544 Identity Concentration SOP-0235 Concentration Purity SOP-0383 Purity % IG1 % IG2 % IG3 % Total Impurities % RNA Encapsulation SOP-0298 % Encapsulation Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-050", "likely_table": false } ] }, { "filename": "19745_S41_M1_0041-cover.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 5, "table_count": 0, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.A.1", "bates": "FDA-CBER-2022-1614-4622624", "context_preview": "leachable information for the CX-024414 container closure 3.2.S.7.1 {CX-024414} Stability Summary and Conclusions Revision of extension of use period strategy Addition of Lot 4007220003, 4007220004, 400722005, 4007520001, 4007520002, 4007520003 and 4007520004 to scope of stability program 3.2.S.7.3 ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.A.1", "bates": "FDA-CBER-2022-1614-4622624", "context_preview": "le information for the CX-024414 container closure 3.2.S.7.1 {CX-024414} Stability Summary and Conclusions Revision of extension of use period strategy Addition of Lot 4007220003, 4007220004, 400722005, 4007520001, 4007520002, 4007520003 and 4007520004 to scope of stability program 3.2.S.7.3 {CX-024", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.A.1", "bates": "FDA-CBER-2022-1614-4622624", "context_preview": "mation for the CX-024414 container closure 3.2.S.7.1 {CX-024414} Stability Summary and Conclusions Revision of extension of use period strategy Addition of Lot 4007220003, 4007220004, 400722005, 4007520001, 4007520002, 4007520003 and 4007520004 to scope of stability program 3.2.S.7.3 {CX-024414} Sta", "likely_table": false } ] }, { "filename": "19745_S41_M3_32s2_cx_manufacturer.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622626", "context_preview": "024414 are summarized in Table 1. Table 1: Facilities and Responsibilities for Manufacture, Testing and Release of CX-024414 Facility Address Responsibility ModernaTX, Inc. One Moderna Way Norwood, MA 02062 USA \u2022 Manufacture of CX-024414 \u2022 Release and stability testing of CX-024414 \u2022 Lot release Lon", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622626", "context_preview": "re summarized in Table 1. Table 1: Facilities and Responsibilities for Manufacture, Testing and Release of CX-024414 Facility Address Responsibility ModernaTX, Inc. One Moderna Way Norwood, MA 02062 USA \u2022 Manufacture of CX-024414 \u2022 Release and stability testing of CX-024414 \u2022 Lot release Lonza Biolo", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622626", "context_preview": "arized in Table 1. Table 1: Facilities and Responsibilities for Manufacture, Testing and Release of CX-024414 Facility Address Responsibility ModernaTX, Inc. One Moderna Way Norwood, MA 02062 USA \u2022 Manufacture of CX-024414 \u2022 Release and stability testing of CX-024414 \u2022 Lot release Lonza Biologics, I", "likely_table": false } ] }, { "filename": "19745_S41_M3_32s44_cx_coa-cx-024414.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 10, "table_count": 0, "by_category": { "Trade-secret claim": 6, "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622627", "context_preview": "Pre-Main Peak % Post Main Peak % 5' Capped SOP-0467 Cap1 % PolyA tailed RNA / % Tailless RNA SOP-0291 Main Peak Area Pre-Main Peak Area Residual DNA template SOP-0491 Residual DNA Templat pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFI", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622630", "context_preview": "uct Related Impurities SOP-0321 Main Peak Area % Pre-Main Peak % Post Main Peak % 5' Capped SOP-0467 Cap1 % PolyA tailed RNA / % Tailless RNA SOP-0291 Main Peak Area Pre-Main Peak Area Residual DNA template SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622632", "context_preview": "uct Related Impurities SOP-0321 Main Peak Area % Pre-Main Peak % Post Main Peak % 5' Capped SOP-0467 Cap1 % PolyA tailed RNA / % Tailless RNA SOP-0291 Main Peak Area Pre-Main Peak Area Residual DNA template SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false } ] }, { "filename": "19745_S63_M1_ eua-pre-sub-mtg-rqst.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 51, "table_count": 42, "by_category": { "Manufacturing / CMC": 28, "Other / uncategorized": 15, "Pharmacology / toxicology": 8 }, "by_marker": { "(b)(4)": 51 }, "top_examples": [ { "page": 13, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "5.3.5.1 \nPhase 2 and 3 Protocols, Ph3 SAP, DSMB meeting", "bates": "FDA-CBER-2022-1614-5662178", "context_preview": "ad of EUA Submission Module 4 4.2.1.3 Safety Pharmacology Report SN0001 Available now in IND to review ahead of EUA Submission Module 4 4.2.3.7.2 Immunotoxicity Study SN0012 Available now in IND to review ahead of EUA Submission Module 5 5.3.5.1 Phase 2 and 3 Protocols, Ph3 SAP, DSMB meeting minutes", "likely_table": true }, { "page": 13, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "5.3.5.1 \nPhase 2 and 3 Protocols, Ph3 SAP, DSMB meeting", "bates": "FDA-CBER-2022-1614-5662178", "context_preview": "A Submission Module 4 4.2.1.3 Safety Pharmacology Report SN0001 Available now in IND to review ahead of EUA Submission Module 4 4.2.3.7.2 Immunotoxicity Study SN0012 Available now in IND to review ahead of EUA Submission Module 5 5.3.5.1 Phase 2 and 3 Protocols, Ph3 SAP, DSMB meeting minutes SN0033-", "likely_table": true }, { "page": 13, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "5.3.5.1 \nPhase 2 and 3 Protocols, Ph3 SAP, DSMB meeting", "bates": "FDA-CBER-2022-1614-5662178", "context_preview": "ssion Module 4 4.2.1.3 Safety Pharmacology Report SN0001 Available now in IND to review ahead of EUA Submission Module 4 4.2.3.7.2 Immunotoxicity Study SN0012 Available now in IND to review ahead of EUA Submission Module 5 5.3.5.1 Phase 2 and 3 Protocols, Ph3 SAP, DSMB meeting minutes SN0033-Ph2 Pro", "likely_table": true } ] }, { "filename": "19745_S66_M1_0066-cover.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 46, "table_count": 43, "by_category": { "Manufacturing / CMC": 43, "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 46 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.3", "bates": "FDA-CBER-2022-1614-4622653", "context_preview": "024414} Manufacturer(s) Addition of of CX-024414 manufacturing process to ModernaTX, Inc.\u2019s responsibility 3.2.S.2.2 {CX-024414} Description of Manufacturing Process and Process Controls Addition of of CX-024414 manufacturing process and process controls Addition of Item Numbers 3.2.S.2.3 {CX-024414", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.3", "bates": "FDA-CBER-2022-1614-4622653", "context_preview": "Manufacturer(s) Addition of of CX-024414 manufacturing process to ModernaTX, Inc.\u2019s responsibility 3.2.S.2.2 {CX-024414} Description of Manufacturing Process and Process Controls Addition of of CX-024414 manufacturing process and process controls Addition of Item Numbers 3.2.S.2.3 {CX-024414} Contro", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.3", "bates": "FDA-CBER-2022-1614-4622653", "context_preview": "urer(s) Addition of of CX-024414 manufacturing process to ModernaTX, Inc.\u2019s responsibility 3.2.S.2.2 {CX-024414} Description of Manufacturing Process and Process Controls Addition of of CX-024414 manufacturing process and process controls Addition of Item Numbers 3.2.S.2.3 {CX-024414} Control of Mat", "likely_table": true } ] }, { "filename": "19745_S66_M3_32s2_cx_manufacturer.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 4, "table_count": 0, "by_category": { "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622663", "context_preview": "nd release of CX-024414 are summarized in Table 1. Table 1: Facilities and Responsibilities for Manufacture, Testing and Release of CX-024414 Facility Address Responsibility ModernaTX, Inc. One Moderna Way Norwood, MA 02062 USA \u2022 Manufacture of CX-024414 \u2022 Release and stability testing of CX-024414 ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622663", "context_preview": "se of CX-024414 are summarized in Table 1. Table 1: Facilities and Responsibilities for Manufacture, Testing and Release of CX-024414 Facility Address Responsibility ModernaTX, Inc. One Moderna Way Norwood, MA 02062 USA \u2022 Manufacture of CX-024414 \u2022 Release and stability testing of CX-024414 \u2022 Lot re", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622663", "context_preview": "-024414 are summarized in Table 1. Table 1: Facilities and Responsibilities for Manufacture, Testing and Release of CX-024414 Facility Address Responsibility ModernaTX, Inc. One Moderna Way Norwood, MA 02062 USA \u2022 Manufacture of CX-024414 \u2022 Release and stability testing of CX-024414 \u2022 Lot release Lo", "likely_table": false } ] }, { "filename": "19745_S66_M3_32s41_mrna_specification.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622664", "context_preview": "rities % RNA encapsulation (SOP-0298) Mean particle size Dynamic Light Scattering (SOP-0107) Polydispersity Lipid identification SM-102 UPLC-CAD (SOP-0502) Cholesterol DSPC PEG2000-DMG Lipid content SM-102 UPLC-CAD (SOP-0502) Cholesterol DSPC PEG2000-DMG Lipid impurities UPLC-CAD (SOP-0502 pH USP <7", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622664", "context_preview": "% RNA encapsulation (SOP-0298) Mean particle size Dynamic Light Scattering (SOP-0107) Polydispersity Lipid identification SM-102 UPLC-CAD (SOP-0502) Cholesterol DSPC PEG2000-DMG Lipid content SM-102 UPLC-CAD (SOP-0502) Cholesterol DSPC PEG2000-DMG Lipid impurities UPLC-CAD (SOP-0502 pH USP <791> (SO", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622664", "context_preview": "capsulation (SOP-0298) Mean particle size Dynamic Light Scattering (SOP-0107) Polydispersity Lipid identification SM-102 UPLC-CAD (SOP-0502) Cholesterol DSPC PEG2000-DMG Lipid content SM-102 UPLC-CAD (SOP-0502) Cholesterol DSPC PEG2000-DMG Lipid impurities UPLC-CAD (SOP-0502 pH USP <791> (SOP-0288) ", "likely_table": false } ] }, { "filename": "19745_S66_M3_32s44_cx_coa-cx-024414.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 13, "table_count": 0, "by_category": { "Trade-secret claim": 8, "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 13 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622695", "context_preview": "re-Main Peak % Post Main Peak % 5' Capped SOP-0467 Cap1 % PolyA tailed RNA / % Tailless RNA SOP-0291 Main Peak Area Pre-Main Peak Area Residual DNA template SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotoxins Bioburden SOP-0480 TAMC TYMC Page 1 of 2 CONFI", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622698", "context_preview": "uct Related Impurities SOP-0321 Main Peak Area % Pre-Main Peak % Post Main Peak % 5' Capped SOP-0467 Cap1 % PolyA tailed RNA / % Tailless RNA SOP-0291 Main Peak Area Pre-Main Peak Area Residual DNA template SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622700", "context_preview": "uct Related Impurities SOP-0321 Main Peak Area % Pre-Main Peak % Post Main Peak % 5' Capped SOP-0467 Cap1 % PolyA tailed RNA / % Tailless RNA SOP-0291 Main Peak Area Pre-Main Peak Area Residual DNA template SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false } ] }, { "filename": "19745_S66_M3_32s44_mrna_coa-mrna-1273-lnp.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 16, "table_count": 0, "by_category": { "Manufacturing / CMC": 16 }, "by_marker": { "(b)(4)": 16 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622665", "context_preview": "rance - Color Appearance - Particulates Identity SOP-0544 Identity Concentration SOP-0235 Concentration Purity SOP-0383 Purity % IG1 % IG2 % IG3 % Total Impurities % RNA Encapsulation SOP-0298 % Encapsulation Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-050", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622666", "context_preview": "Method Parameter Specification Result Lipid Content SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 RRT 1 RRT 2 RRT 3 RRT 4 pH SOP-0288 pH Osmolality SOP-0279 Osmolality USP <467> Advantar MRNA- C0000-GTM0018 Ethanol Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622669", "context_preview": "rance - Color Appearance - Particulates Identity SOP-0544 Identity Concentration SOP-0235 Concentration Purity SOP-0383 Purity % IG1 % IG2 % IG3 % Total Impurities % RNA Encapsulation SOP-0298 % Encapsulation Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-050", "likely_table": false } ] }, { "filename": "19745_S67_M1_0067-cover.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 1, "table_count": 1, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-4622727", "context_preview": "en prepared by PPD Development, Inc. in full compliance with ICH and FDA guidance. The eCTD has been verified and confirmed to be virus and spyware free. PPD utilizes Palo Alto Traps v4.2.2. All technical questions should be directed to at PPD or email at Yours Sincerely, Carlota Vinals VP, Regulato", "likely_table": true } ] }, { "filename": "19745_S67_M1_rsp-fda-rfi-26oct2020.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 43, "table_count": 15, "by_category": { "Manufacturing / CMC": 22, "Other / uncategorized": 12, "Inspection / enforcement": 7, "Trade-secret claim": 2 }, "by_marker": { "(b)(4)": 43 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.A.1.2 Drug Product Systems, 3.2.1 HVAC Systems", "bates": "FDA-CBER-2022-1614-4810339", "context_preview": "ntrolled by each Air Handling Unit are provided in the Catalent , Section 3.2.A.1.2 Drug Product Systems, 3.2.1 HVAC Systems Table 3, Rooms Controlled by AHU. Room classifications which could be used for mRNA-1273 manufacturing activities are provided in Table 3. Table 3: Manufacturing Rooms A compl", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.A.1.2 Drug Product Systems, 3.2.1 HVAC Systems", "bates": "FDA-CBER-2022-1614-4810339", "context_preview": "by each Air Handling Unit are provided in the Catalent , Section 3.2.A.1.2 Drug Product Systems, 3.2.1 HVAC Systems Table 3, Rooms Controlled by AHU. Room classifications which could be used for mRNA-1273 manufacturing activities are provided in Table 3. Table 3: Manufacturing Rooms A complete list ", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 3.2.A.1.2 Drug Product Systems, 3.2.1 HVAC Systems", "bates": "FDA-CBER-2022-1614-4810339", "context_preview": "Air Handling Unit are provided in the Catalent , Section 3.2.A.1.2 Drug Product Systems, 3.2.1 HVAC Systems Table 3, Rooms Controlled by AHU. Room classifications which could be used for mRNA-1273 manufacturing activities are provided in Table 3. Table 3: Manufacturing Rooms A complete list of manuf", "likely_table": true } ] }, { "filename": "19745_S68_M5_5351_data-blinding-plan.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 2, "table_count": 0, "by_category": { "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "LOCATION OF UNBLINDED DATA / UNBLINDED DATA FLOW", "bates": "FDA-CBER-2022-1614-4624665", "context_preview": "the Primary Analysis and the unblinded IA analysis to support regulatory submissions, following approval from the Sponsor\u2019s Head of Biostatistics (or delegate) and the Therapeutic Area Head (or delegate), the CRO Lead Biostatistician will notify the CRO Unblinded Statistician. The CRO Unblinded Stat", "likely_table": false }, { "page": 8, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "LOCATION OF UNBLINDED DATA / UNBLINDED DATA FLOW", "bates": "FDA-CBER-2022-1614-4624665", "context_preview": "mary Analysis and the unblinded IA analysis to support regulatory submissions, following approval from the Sponsor\u2019s Head of Biostatistics (or delegate) and the Therapeutic Area Head (or delegate), the CRO Lead Biostatistician will notify the CRO Unblinded Statistician. The CRO Unblinded Statisticia", "likely_table": false } ] }, { "filename": "19745_S69_M5_5351_data-blinding-plan.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 2, "table_count": 0, "by_category": { "Trial design / efficacy": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 8, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2022-1614-4624679", "context_preview": "post IA or Primary Analysis will then upload the Analysis data to the Sponsor unblinded folder and only provide access to the subject-level unblinded Sponsor study team members as specified in this document (Section 9). Upon the time of unblinding, the unblinded team will cease participation of cond", "likely_table": false }, { "page": 8, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "CONFIDENTIAL", "bates": "FDA-CBER-2022-1614-4624679", "context_preview": "or Primary Analysis will then upload the Analysis data to the Sponsor unblinded folder and only provide access to the subject-level unblinded Sponsor study team members as specified in this document (Section 9). Upon the time of unblinding, the unblinded team will cease participation of conduct and ", "likely_table": false } ] }, { "filename": "19745_S70_M1_0070-cover.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 23, "table_count": 20, "by_category": { "Manufacturing / CMC": 23 }, "by_marker": { "(b)(4)": 23 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.4.1", "bates": "FDA-CBER-2022-1614-4622732", "context_preview": "process information and PPQ protocols for manufacturing (ModernaTX, Inc. Norwood, MA), (Scale B) of mRNA-1273 LNP manufacturing (ModernaTX, Inc. Norwood, MA) and (Scale B) of fill/finish manufacturing (Catalent Biologics, LLC Bloomington, IN) processes have also been provided. The revised Module 3 C", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.4.1", "bates": "FDA-CBER-2022-1614-4622732", "context_preview": "information and PPQ protocols for manufacturing (ModernaTX, Inc. Norwood, MA), (Scale B) of mRNA-1273 LNP manufacturing (ModernaTX, Inc. Norwood, MA) and (Scale B) of fill/finish manufacturing (Catalent Biologics, LLC Bloomington, IN) processes have also been provided. The revised Module 3 CTD secti", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.4.1", "bates": "FDA-CBER-2022-1614-4622732", "context_preview": "tion and PPQ protocols for manufacturing (ModernaTX, Inc. Norwood, MA), (Scale B) of mRNA-1273 LNP manufacturing (ModernaTX, Inc. Norwood, MA) and (Scale B) of fill/finish manufacturing (Catalent Biologics, LLC Bloomington, IN) processes have also been provided. The revised Module 3 CTD sections, as", "likely_table": true } ] }, { "filename": "19745_S70_M3_32p3_manufacturers.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.3.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622740", "context_preview": "son Drive Bloomington, IN 47403 USA EUA and Clinical Supply \u2022 Fill/Finish \u2022 Packaging \u2022 Labelling \u2022 Release Testing (Sterility) \u2022 Stability Testing (Sterility) Catalent Pharma Solutions RxCrossroads 3PL LLC (McKesson) 5101 Jeff Commerce Drive Louisville, KY 40219 EUA Supply ONLY \u2022 Distribution Assoc", "likely_table": false } ] }, { "filename": "19745_S70_M3_32p51_specifications.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 9, "table_count": 9, "by_category": { "Manufacturing / CMC": 9 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622741", "context_preview": "(SOP-1001) Particle size Dynamic Light Scattering (SOP-0998) Polydispersity pH USP <791> (SOP-0288) Osmolality USP <785> Freezing Point Depression (SOP-0279) Particulate matter \u2265 25 \uf06dm USP <788> Method 2 (SOP-0509) \u2265 10 \uf06dm Container content USP <697> (SOP-0950) \u2265 5.0 mL (\u2265 10 doses of 0.5 mL from 1 ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622741", "context_preview": "001) Particle size Dynamic Light Scattering (SOP-0998) Polydispersity pH USP <791> (SOP-0288) Osmolality USP <785> Freezing Point Depression (SOP-0279) Particulate matter \u2265 25 \uf06dm USP <788> Method 2 (SOP-0509) \u2265 10 \uf06dm Container content USP <697> (SOP-0950) \u2265 5.0 mL (\u2265 10 doses of 0.5 mL from 1 vial) ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622741", "context_preview": "rticle size Dynamic Light Scattering (SOP-0998) Polydispersity pH USP <791> (SOP-0288) Osmolality USP <785> Freezing Point Depression (SOP-0279) Particulate matter \u2265 25 \uf06dm USP <788> Method 2 (SOP-0509) \u2265 10 \uf06dm Container content USP <697> (SOP-0950) \u2265 5.0 mL (\u2265 10 doses of 0.5 mL from 1 vial) Bacteri", "likely_table": true } ] }, { "filename": "19745_S70_M3_32p54_batch-analyses.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 46, "table_count": 46, "by_category": { "Manufacturing / CMC": 46 }, "by_marker": { "(b)(4)": 46 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SPC-1063,", "bates": "FDA-CBER-2022-1614-4622743", "context_preview": "tity by Rev Transcription/Sanger Sequencing (SOP-0544) Purity by RP-HPLC (SOP-0383) N/A N/A N/A N/A N/A N/A N/A N/A Product-related impurities by RP-HPLC (SOP-0383) % RNA encapsulation by Fluorescence (RiboGreen) (SOP-0298) In vitro Translation (SOP-0937) pH (SOP-0288) Osmolality (SOP-0279) Particle", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SPC-1063,", "bates": "FDA-CBER-2022-1614-4622743", "context_preview": "y Rev Transcription/Sanger Sequencing (SOP-0544) Purity by RP-HPLC (SOP-0383) N/A N/A N/A N/A N/A N/A N/A N/A Product-related impurities by RP-HPLC (SOP-0383) % RNA encapsulation by Fluorescence (RiboGreen) (SOP-0298) In vitro Translation (SOP-0937) pH (SOP-0288) Osmolality (SOP-0279) Particle size ", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SPC-1063,", "bates": "FDA-CBER-2022-1614-4622743", "context_preview": "anscription/Sanger Sequencing (SOP-0544) Purity by RP-HPLC (SOP-0383) N/A N/A N/A N/A N/A N/A N/A N/A Product-related impurities by RP-HPLC (SOP-0383) % RNA encapsulation by Fluorescence (RiboGreen) (SOP-0298) In vitro Translation (SOP-0937) pH (SOP-0288) Osmolality (SOP-0279) Particle size by Dynam", "likely_table": true } ] }, { "filename": "19745_S70_M3_32p54_coa-various-lots.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 11, "table_count": 0, "by_category": { "Manufacturing / CMC": 11 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 33, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622779", "context_preview": "ty SOP-0544 Identity Purity SOP-0383 Purity % IG1 % IG2 % IG3 % RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0937 Result pH SOP-0288 pH Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 C", "likely_table": false }, { "page": 35, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622781", "context_preview": ", 20mm Cap Product Attribute Method Parameter Specification Result Container Content SOP-0950 Container Content >= 5.0 mL (>=10 doses of 0.5 mL from one vial) Bacterial Endotoxins USP <85> Bacterial Endotoxins Sterility SOP-0378 Sterility This material meets specification: Yes 1.0 - Original Revisio", "likely_table": false }, { "page": 37, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622783", "context_preview": "ty SOP-0544 Identity Purity SOP-0383 Purity % IG1 % IG2 % IG3 % RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0937 Result pH SOP-0288 pH Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 C", "likely_table": false } ] }, { "filename": "19745_S70_M3_32p8_stability-data.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 376, "table_count": 353, "by_category": { "Manufacturing / CMC": 376 }, "by_marker": { "(b)(4)": 376 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.3 Stability Data", "bates": "FDA-CBER-2022-1614-4622802", "context_preview": "38: Clinical In-Use Compatibility Data for mRNA-1273 Drug Product, Lot 6007520007, 0.20 mg/mL, Luer-Lok Post-7 Hour Hold of Opened Multiple-Dose Vial ............................................................................. 42 Table 39: Clinical In-Use Compatibility Data for mRNA-1273 Drug Produ", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.3 Stability Data", "bates": "FDA-CBER-2022-1614-4622802", "context_preview": "linical In-Use Compatibility Data for mRNA-1273 Drug Product, Lot 6007520007, 0.20 mg/mL, Luer-Lok Post-7 Hour Hold of Opened Multiple-Dose Vial ............................................................................. 42 Table 39: Clinical In-Use Compatibility Data for mRNA-1273 Drug Product, L", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.3 Stability Data", "bates": "FDA-CBER-2022-1614-4622802", "context_preview": "In-Use Compatibility Data for mRNA-1273 Drug Product, Lot 6007520007, 0.20 mg/mL, Luer-Lok Post-7 Hour Hold of Opened Multiple-Dose Vial ............................................................................. 42 Table 39: Clinical In-Use Compatibility Data for mRNA-1273 Drug Product, Lot 60075", "likely_table": true } ] }, { "filename": "19745_S70_M3_32p8_stability-summary.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 42, "table_count": 23, "by_category": { "Manufacturing / CMC": 39, "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 42 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.1.1 \nStability Summary", "bates": "FDA-CBER-2022-1614-4622845", "context_preview": "-performance liquid chromatography with charged aerosol detection (UPLC-CAD) have been demonstrated to be stability-indicating (refer to Section 3.2.P.5.2 for analytical procedures). The stability profiles for all the stability-indicating attributes are being evaluated and monitored, but the primary", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.1.1 \nStability Summary", "bates": "FDA-CBER-2022-1614-4622845", "context_preview": "ance liquid chromatography with charged aerosol detection (UPLC-CAD) have been demonstrated to be stability-indicating (refer to Section 3.2.P.5.2 for analytical procedures). The stability profiles for all the stability-indicating attributes are being evaluated and monitored, but the primary focus o", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.P.8.1.1 \nStability Summary", "bates": "FDA-CBER-2022-1614-4622845", "context_preview": "uid chromatography with charged aerosol detection (UPLC-CAD) have been demonstrated to be stability-indicating (refer to Section 3.2.P.5.2 for analytical procedures). The stability profiles for all the stability-indicating attributes are being evaluated and monitored, but the primary focus of modeli", "likely_table": true } ] }, { "filename": "19745_S70_M3_32s41_cx_specification.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "RP-UPLC-UV", "bates": "FDA-CBER-2022-1614-4622858", "context_preview": "uencing (SOP-1019) Total RNA content UV (SOP-0995) Purity RP-HPLC (SOP-0996) Product-related impurities RP-HPLC (SOP-0996) % 5\u2019 Capped RP-UPLC-UV (SOP-0997) % PolyA tailed RNA (% Tailless RNA) RP-HPLC (SOP-0994) Residual DNA template qPCR (SOP-1020) pH USP <791> (SOP-0288) Bacterial endotoxin USP <8", "likely_table": false } ] }, { "filename": "19745_S70_M3_32s41_mrna_specification.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622859", "context_preview": "ities % RNA encapsulation (SOP-1000) Mean particle size Dynamic Light Scattering (SOP-0998) Polydispersity Lipid identification SM-102 UPLC-CAD (SOP-1001) Cholesterol DSPC PEG2000-DMG Lipid content SM-102 UPLC-CAD (SOP-1001) Cholesterol DSPC PEG2000-DMG Lipid impurities UPLC-CAD (SOP-1001) pH USP <7", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622859", "context_preview": "RNA encapsulation (SOP-1000) Mean particle size Dynamic Light Scattering (SOP-0998) Polydispersity Lipid identification SM-102 UPLC-CAD (SOP-1001) Cholesterol DSPC PEG2000-DMG Lipid content SM-102 UPLC-CAD (SOP-1001) Cholesterol DSPC PEG2000-DMG Lipid impurities UPLC-CAD (SOP-1001) pH USP <791> (SOP", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622859", "context_preview": "apsulation (SOP-1000) Mean particle size Dynamic Light Scattering (SOP-0998) Polydispersity Lipid identification SM-102 UPLC-CAD (SOP-1001) Cholesterol DSPC PEG2000-DMG Lipid content SM-102 UPLC-CAD (SOP-1001) Cholesterol DSPC PEG2000-DMG Lipid impurities UPLC-CAD (SOP-1001) pH USP <791> (SOP-0288) ", "likely_table": false } ] }, { "filename": "19745_S73_M1_rsp-cber-regard-diagn-assays.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 55, "table_count": 25, "by_category": { "Other / uncategorized": 33, "Manufacturing / CMC": 12, "Inspection / enforcement": 5, "Trade-secret claim": 4, "Trial design / efficacy": 1 }, "by_marker": { "(b)(4)": 55 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EUA200124.", "bates": "FDA-CBER-2022-1614-4992774", "context_preview": "NC 004718 and Bat SARS MG77293 with only the Bat SARS yielding a Ct value of 35.1. We note that in your analysis of results you indicated that additional work is required and will be reported as an addendum. Please provide an update on specificity assessments when available. Moderna Response: Please", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EUA200124.", "bates": "FDA-CBER-2022-1614-4992774", "context_preview": "8 and Bat SARS MG77293 with only the Bat SARS yielding a Ct value of 35.1. We note that in your analysis of results you indicated that additional work is required and will be reported as an addendum. Please provide an update on specificity assessments when available. Moderna Response: Please see \u201cWe", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "EUA200124.", "bates": "FDA-CBER-2022-1614-4992774", "context_preview": "t SARS MG77293 with only the Bat SARS yielding a Ct value of 35.1. We note that in your analysis of results you indicated that additional work is required and will be reported as an addendum. Please provide an update on specificity assessments when available. Moderna Response: Please see \u201cWet testin", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_21120-517-report.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 7, "table_count": 5, "by_category": { "Other / uncategorized": 5, "Trade-secret claim": 2 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.2\nRetired", "bates": "FDA-CBER-2022-1614-4806173", "context_preview": "Status Type Date Added Date Effective Date Retired 4.3 Approved and Current Minor revision 16-Oct-2020 16-Oct-2020 Indefinite 4.2 Retired Minor revision 13-Oct-2020 13-Oct-2020 16-Oct-2020 4.1 Retired Minor revision 13-Jul-2018 13-Jul-2018 13-Oct-2020 4.0 Retired Major revision 03-Jul-2018 13-Jul-20", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.2\nRetired", "bates": "FDA-CBER-2022-1614-4806173", "context_preview": "Type Date Added Date Effective Date Retired 4.3 Approved and Current Minor revision 16-Oct-2020 16-Oct-2020 Indefinite 4.2 Retired Minor revision 13-Oct-2020 13-Oct-2020 16-Oct-2020 4.1 Retired Minor revision 13-Jul-2018 13-Jul-2018 13-Oct-2020 4.0 Retired Major revision 03-Jul-2018 13-Jul-2018 13-J", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.2\nRetired", "bates": "FDA-CBER-2022-1614-4806173", "context_preview": "e Added Date Effective Date Retired 4.3 Approved and Current Minor revision 16-Oct-2020 16-Oct-2020 Indefinite 4.2 Retired Minor revision 13-Oct-2020 13-Oct-2020 16-Oct-2020 4.1 Retired Minor revision 13-Jul-2018 13-Jul-2018 13-Oct-2020 4.0 Retired Major revision 03-Jul-2018 13-Jul-2018 13-Jul-2018 ", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_21120-554-report.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 31, "table_count": 31, "by_category": { "Trade-secret claim": 26, "Other / uncategorized": 5 }, "by_marker": { "(b)(4)": 31 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "1.3\nRetired", "bates": "FDA-CBER-2022-1614-4806184", "context_preview": "ncorrect version was uploaded). This version of the document was approved by correct approvers and training was completed by appropriate associates. Version History Version Status Type Date Added Date Effective Date Retired 2.0 Approved and Current Major revision 27-May-2019 10-Jun-2019 Indefinite 1", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "1.3\nRetired", "bates": "FDA-CBER-2022-1614-4806184", "context_preview": "version was uploaded). This version of the document was approved by correct approvers and training was completed by appropriate associates. Version History Version Status Type Date Added Date Effective Date Retired 2.0 Approved and Current Major revision 27-May-2019 10-Jun-2019 Indefinite 1.3 Retire", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "1.3\nRetired", "bates": "FDA-CBER-2022-1614-4806184", "context_preview": "was uploaded). This version of the document was approved by correct approvers and training was completed by appropriate associates. Version History Version Status Type Date Added Date Effective Date Retired 2.0 Approved and Current Major revision 27-May-2019 10-Jun-2019 Indefinite 1.3 Retired Minor ", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_21120-578-approved.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 44, "table_count": 42, "by_category": { "Trade-secret claim": 44 }, "by_marker": { "(b)(4)": 44 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806190", "context_preview": "ptance Criteria When Acceptance Criteria is not met\u2026 NTC to evaluate the signal for the pathogen target detector in NTC If Then NEC to evaluate the signal for the pathogen target detector in NEC If Then Positive Control If Then Approved and current. Effective starting 16-Oct-2020. 21120.578 (version", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806190", "context_preview": "riteria When Acceptance Criteria is not met\u2026 NTC to evaluate the signal for the pathogen target detector in NTC If Then NEC to evaluate the signal for the pathogen target detector in NEC If Then Positive Control If Then Approved and current. Effective starting 16-Oct-2020. 21120.578 (version 16.2) P", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806190", "context_preview": "When Acceptance Criteria is not met\u2026 NTC to evaluate the signal for the pathogen target detector in NTC If Then NEC to evaluate the signal for the pathogen target detector in NEC If Then Positive Control If Then Approved and current. Effective starting 16-Oct-2020. 21120.578 (version 16.2) PCR and R", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_21120-705-report.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 132, "table_count": 82, "by_category": { "Trade-secret claim": 119, "Manufacturing / CMC": 9, "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 132 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "21.0\nApproval", "bates": "FDA-CBER-2022-1614-4806197", "context_preview": "ded verbiage for use of Pre Evo automation for pipetting swabs for SARS-CoV-2 extraction. Comments for version 21.2 (this revision) Updated Warnings per FDA guidance Approval and Periodic Review Signatures Type Description Date Version Performed By Notes Approval 29- Jun-2020 15:21 21.0 Approval App", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "21.0\nApproval", "bates": "FDA-CBER-2022-1614-4806197", "context_preview": "iage for use of Pre Evo automation for pipetting swabs for SARS-CoV-2 extraction. Comments for version 21.2 (this revision) Updated Warnings per FDA guidance Approval and Periodic Review Signatures Type Description Date Version Performed By Notes Approval 29- Jun-2020 15:21 21.0 Approval Approval 29", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "21.0\nApproval", "bates": "FDA-CBER-2022-1614-4806197", "context_preview": "use of Pre Evo automation for pipetting swabs for SARS-CoV-2 extraction. Comments for version 21.2 (this revision) Updated Warnings per FDA guidance Approval and Periodic Review Signatures Type Description Date Version Performed By Notes Approval 29- Jun-2020 15:21 21.0 Approval Approval 29- Jun-202", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_21120-9037-report.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 41, "table_count": 32, "by_category": { "Trial design / efficacy": 40, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 41 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "1.0\nApproved and Current", "bates": "FDA-CBER-2022-1614-4806235", "context_preview": "on 04-Nov-2020 17:03 Printed By Organization ViraCor Comments for version 1.0 Updated (clean) version - added extraction platform Approval and Periodic Review Signatures Type Description Date Version Performed By Notes Approval 04-May-2020 7:23 1.0 Approval Approver - 03-May-2020 22:50 1.0 Version H", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806238", "context_preview": "cid extraction Nucleic acid extraction for respiratory specimens will be performed for each sample following instructions in SOP 21120.705 NucliSens easyMAG Total Nucleic Acid Extraction with the following modifications: Approved and current. Effective starting 04-May-2020. 21120.9037 (version 1.0) ", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806238", "context_preview": "action Nucleic acid extraction for respiratory specimens will be performed for each sample following instructions in SOP 21120.705 NucliSens easyMAG Total Nucleic Acid Extraction with the following modifications: Approved and current. Effective starting 04-May-2020. 21120.9037 (version 1.0) SARS CoV", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_21120-9109-report.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 123, "table_count": 39, "by_category": { "Trade-secret claim": 123 }, "by_marker": { "(b)(4)": 123 }, "top_examples": [ { "page": 9, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "21120.705 NucliSens easyMAG Total Nucleic Acid Extraction.", "bates": "FDA-CBER-2022-1614-4806252", "context_preview": "leic acid amplification and detection Nucleic acid amplification was performed as described in SOP 21120.461 Real-Time PCR and RT-PCR Using Instruments with the following modifications. Approved and current. Effective starting 15-Oct-2020. 21120.9109 (version 3.0) SARS CoV 2 RT qPCR NW, NP SWAB, BAL", "likely_table": true }, { "page": 9, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "21120.705 NucliSens easyMAG Total Nucleic Acid Extraction.", "bates": "FDA-CBER-2022-1614-4806252", "context_preview": "d amplification and detection Nucleic acid amplification was performed as described in SOP 21120.461 Real-Time PCR and RT-PCR Using Instruments with the following modifications. Approved and current. Effective starting 15-Oct-2020. 21120.9109 (version 3.0) SARS CoV 2 RT qPCR NW, NP SWAB, BAL and SER", "likely_table": true }, { "page": 9, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "21120.705 NucliSens easyMAG Total Nucleic Acid Extraction.", "bates": "FDA-CBER-2022-1614-4806252", "context_preview": "ication and detection Nucleic acid amplification was performed as described in SOP 21120.461 Real-Time PCR and RT-PCR Using Instruments with the following modifications. Approved and current. Effective starting 15-Oct-2020. 21120.9109 (version 3.0) SARS CoV 2 RT qPCR NW, NP SWAB, BAL and SERUM (usin", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_21120-9142-report.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 84, "table_count": 47, "by_category": { "Trade-secret claim": 84 }, "by_marker": { "(b)(4)": 84 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806297", "context_preview": "acid extraction Nucleic acid extraction for respiratory specimens will be performed for each sample following instructions in SOP 21120.705 NucliSens easyMAG Total Nucleic Acid Extraction with the following modifications: Approved and current. Effective starting 27-Jul-2020. 21120.9142 (version 2.1)", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806297", "context_preview": "raction Nucleic acid extraction for respiratory specimens will be performed for each sample following instructions in SOP 21120.705 NucliSens easyMAG Total Nucleic Acid Extraction with the following modifications: Approved and current. Effective starting 27-Jul-2020. 21120.9142 (version 2.1) SARS Co", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806297", "context_preview": "Nucleic acid extraction for respiratory specimens will be performed for each sample following instructions in SOP 21120.705 NucliSens easyMAG Total Nucleic Acid Extraction with the following modifications: Approved and current. Effective starting 27-Jul-2020. 21120.9142 (version 2.1) SARS CoV 2 RT q", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_21120-9152-report.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 61, "table_count": 57, "by_category": { "Trade-secret claim": 61 }, "by_marker": { "(b)(4)": 61 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "21120.369 Analytical Quality Control: Assay Calibration and Calibration Verification.", "bates": "FDA-CBER-2022-1614-4806319", "context_preview": "on and Calibration Verification. Quality control specimens are prepared and control ranges are established and maintained in accordance with 21120.369 Analytical Quality Control: Assay Calibration and Calibration Verification. Approved and current. Effective starting 16-Oct-2020. 21120.9152 (version", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "21120.369 Analytical Quality Control: Assay Calibration and Calibration Verification.", "bates": "FDA-CBER-2022-1614-4806319", "context_preview": "alibration Verification. Quality control specimens are prepared and control ranges are established and maintained in accordance with 21120.369 Analytical Quality Control: Assay Calibration and Calibration Verification. Approved and current. Effective starting 16-Oct-2020. 21120.9152 (version 2.2) Ki", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "21120.369 Analytical Quality Control: Assay Calibration and Calibration Verification.", "bates": "FDA-CBER-2022-1614-4806319", "context_preview": "on Verification. Quality control specimens are prepared and control ranges are established and maintained in accordance with 21120.369 Analytical Quality Control: Assay Calibration and Calibration Verification. Approved and current. Effective starting 16-Oct-2020. 21120.9152 (version 2.2) KingFisher", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_21120-9184-report.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 68, "table_count": 43, "by_category": { "Trial design / efficacy": 61, "Manufacturing / CMC": 7 }, "by_marker": { "(b)(4)": 68 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "4.0\nApproval", "bates": "FDA-CBER-2022-1614-4806326", "context_preview": "fective Date 07-Oct-2020 Uncontrolled Copy printed on 04-Nov-2020 16:48 Printed By Organization ViraCor Author Comments for version 4.0 This version changes the number of concentrations of samples in stability and the number of replicates at each time point per client request. Approval and Periodic ", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "1.0\nRetired", "bates": "FDA-CBER-2022-1614-4806328", "context_preview": "Time PCR assay in Human Swab and Saliva Specimens. It is possible that this was due to an anomalously high value. The study will be repeated in this amendment using the swab that is in use in the clinical study (Table 1d). Approved and current. Effective starting 07-Oct-2020. 21120.9184 (version 4.0", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "1.0\nRetired", "bates": "FDA-CBER-2022-1614-4806328", "context_preview": "assay in Human Swab and Saliva Specimens. It is possible that this was due to an anomalously high value. The study will be repeated in this amendment using the swab that is in use in the clinical study (Table 1d). Approved and current. Effective starting 07-Oct-2020. 21120.9184 (version 4.0) SARS Co", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_21120-9201-worksheet.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 19, "table_count": 19, "by_category": { "Trade-secret claim": 19 }, "by_marker": { "(b)(4)": 19 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806351", "context_preview": "____ Run Map _____ Map _____ Other Comments: Positive Control Lot Exp. 2 SD Range (CT Value) 3 SD Range (CT Value) COVID Curve Controls Range ( CT value) Acceptable: Yes or No \uf072 Yes \uf072 No \uf072 Yes \uf072 No Approved and current. Effective starting 30-Sep-2020. 21120.9201 (version 3.5) Client Specific COVID K", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806351", "context_preview": "n Map _____ Map _____ Other Comments: Positive Control Lot Exp. 2 SD Range (CT Value) 3 SD Range (CT Value) COVID Curve Controls Range ( CT value) Acceptable: Yes or No \uf072 Yes \uf072 No \uf072 Yes \uf072 No Approved and current. Effective starting 30-Sep-2020. 21120.9201 (version 3.5) Client Specific COVID King Fis", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806351", "context_preview": "___ Map _____ Other Comments: Positive Control Lot Exp. 2 SD Range (CT Value) 3 SD Range (CT Value) COVID Curve Controls Range ( CT value) Acceptable: Yes or No \uf072 Yes \uf072 No \uf072 Yes \uf072 No Approved and current. Effective starting 30-Sep-2020. 21120.9201 (version 3.5) Client Specific COVID King Fisher qPCR", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_21120-9457-worksheet.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 19, "table_count": 19, "by_category": { "Trade-secret claim": 19 }, "by_marker": { "(b)(4)": 19 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806352", "context_preview": "ther Comments: Positive Control Lot Exp. 2 SD Range (CT Value) 3 SD Range (CT Value) COVID Curve Control COVID Range Acceptable: Yes or No \uf072 Yes \uf072 No \uf072 Yes \uf072 No Approved and current. Effective starting 30-Oct-2020. 21120.9457 (version 2.5) Client Specific COVID qPCR Worksheet EasyMag ONLY (CVID ONLY", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806352", "context_preview": "Comments: Positive Control Lot Exp. 2 SD Range (CT Value) 3 SD Range (CT Value) COVID Curve Control COVID Range Acceptable: Yes or No \uf072 Yes \uf072 No \uf072 Yes \uf072 No Approved and current. Effective starting 30-Oct-2020. 21120.9457 (version 2.5) Client Specific COVID qPCR Worksheet EasyMag ONLY (CVID ONLY 8639", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806352", "context_preview": "Comments: Positive Control Lot Exp. 2 SD Range (CT Value) 3 SD Range (CT Value) COVID Curve Control COVID Range Acceptable: Yes or No \uf072 Yes \uf072 No \uf072 Yes \uf072 No Approved and current. Effective starting 30-Oct-2020. 21120.9457 (version 2.5) Client Specific COVID qPCR Worksheet EasyMag ONLY (CVID ONLY 8639", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_covid-pcr-control.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 10, "table_count": 10, "by_category": { "Other / uncategorized": 10 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806353", "context_preview": "35627 nfectious Disease /Molecular PCR; COV2 Unbuff Hi Pos Ctrl-16 35627 /Infectious Disease /Molecular PCR; COV2 Unbuff Hi Pos Ctrl-16 35627 /Infectious Disease /Molecular PCR; COV2 Unbuff Hi Pos Ctrl-16 35627 Infectious Disease /Molecular PCR; COV2 Unbuff Hi Pos Ctrl-16 35627 /Infectious Disease /", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806353", "context_preview": "fectious Disease /Molecular PCR; COV2 Unbuff Hi Pos Ctrl-16 35627 /Infectious Disease /Molecular PCR; COV2 Unbuff Hi Pos Ctrl-16 35627 /Infectious Disease /Molecular PCR; COV2 Unbuff Hi Pos Ctrl-16 35627 Infectious Disease /Molecular PCR; COV2 Unbuff Hi Pos Ctrl-16 35627 /Infectious Disease /Molecul", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-4806353", "context_preview": "Disease /Molecular PCR; COV2 Unbuff Hi Pos Ctrl-16 35627 /Infectious Disease /Molecular PCR; COV2 Unbuff Hi Pos Ctrl-16 35627 /Infectious Disease /Molecular PCR; COV2 Unbuff Hi Pos Ctrl-16 35627 Infectious Disease /Molecular PCR; COV2 Unbuff Hi Pos Ctrl-16 35627 /Infectious Disease /Molecular PCR; C", "likely_table": true } ] }, { "filename": "19745_S73_M5_5314_vsdvac-65-elisa-val-rpt.pdf", "module": "M5", "company": "Moderna", "license": "EUA", "total_kept": 80, "table_count": 35, "by_category": { "Other / uncategorized": 44, "Trade-secret claim": 36 }, "by_marker": { "(b)(4)": 80 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "EXPERIMENT BACKGROUND AND PURPOSE", "bates": "FDA-CBER-2022-1614-4806358", "context_preview": "validity of individual test samples within that assay run. The purpose of this report is to document the operating characteristics of the assay. The SARS-CoV-2 Spike IgG ELISA operating characteristics are summarized below and in Table 1. Validation Results Summary Assay Characteristic Validation Re", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "EXPERIMENT BACKGROUND AND PURPOSE", "bates": "FDA-CBER-2022-1614-4806358", "context_preview": "y of individual test samples within that assay run. The purpose of this report is to document the operating characteristics of the assay. The SARS-CoV-2 Spike IgG ELISA operating characteristics are summarized below and in Table 1. Validation Results Summary Assay Characteristic Validation Results A", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "EXPERIMENT BACKGROUND AND PURPOSE", "bates": "FDA-CBER-2022-1614-4806358", "context_preview": "ividual test samples within that assay run. The purpose of this report is to document the operating characteristics of the assay. The SARS-CoV-2 Spike IgG ELISA operating characteristics are summarized below and in Table 1. Validation Results Summary Assay Characteristic Validation Results Assay Val", "likely_table": true } ] }, { "filename": "19745_S77_M1_rsp-fda-rfi-06oct2020-09nov2020.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 60, "table_count": 52, "by_category": { "Manufacturing / CMC": 59, "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 60 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "LIST OF FIGURES", "bates": "FDA-CBER-2022-1614-4992799", "context_preview": "wing Major Lipid Components and Impurities ........................................................................ 12 Figure 2: LC-CAD (top trace) and LC-MS (bottom trace) Chromatograms of Showing Retention Time Alignment Based on Relative Retention Time ............................................", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "LIST OF FIGURES", "bates": "FDA-CBER-2022-1614-4992799", "context_preview": "or Lipid Components and Impurities ........................................................................ 12 Figure 2: LC-CAD (top trace) and LC-MS (bottom trace) Chromatograms of Showing Retention Time Alignment Based on Relative Retention Time ....................................................", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "LIST OF FIGURES", "bates": "FDA-CBER-2022-1614-4992799", "context_preview": "d Components and Impurities ........................................................................ 12 Figure 2: LC-CAD (top trace) and LC-MS (bottom trace) Chromatograms of Showing Retention Time Alignment Based on Relative Retention Time ...........................................................", "likely_table": true } ] }, { "filename": "19745_S81_M1_0081-cover.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 30, "table_count": 30, "by_category": { "Manufacturing / CMC": 19, "Other / uncategorized": 11 }, "by_marker": { "(b)(4)": 30 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.2", "bates": "FDA-CBER-2022-1614-4622860", "context_preview": "3.2.S.2.1 {CX-024414} Manufacturer(s) Addition of (Final Scale B) production at Lonza Biologics, Inc. 3.2.S.2.2 {CX-024414} Description of Manufacturing Process and Process Controls Addition of (Lonza Biologics, Inc.) CX-024414 mRNA item number Revision to reflect ability to perform step to adjust R", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.2", "bates": "FDA-CBER-2022-1614-4622860", "context_preview": ".1 {CX-024414} Manufacturer(s) Addition of (Final Scale B) production at Lonza Biologics, Inc. 3.2.S.2.2 {CX-024414} Description of Manufacturing Process and Process Controls Addition of (Lonza Biologics, Inc.) CX-024414 mRNA item number Revision to reflect ability to perform step to adjust RNA conc", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.2", "bates": "FDA-CBER-2022-1614-4622860", "context_preview": "24414} Manufacturer(s) Addition of (Final Scale B) production at Lonza Biologics, Inc. 3.2.S.2.2 {CX-024414} Description of Manufacturing Process and Process Controls Addition of (Lonza Biologics, Inc.) CX-024414 mRNA item number Revision to reflect ability to perform step to adjust RNA concentratio", "likely_table": true } ] }, { "filename": "19745_S81_M1_rsp-cmnts-proposed-pre-eau-pkg.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 19, "table_count": 17, "by_category": { "Manufacturing / CMC": 17, "Trial design / efficacy": 2 }, "by_marker": { "(b)(4)": 19 }, "top_examples": [ { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 19745", "bates": "FDA-CBER-2022-1614-4810352", "context_preview": "for manufacture at both ModernaTX, Inc. and Lonza. Please note that ModernaTX, Inc. has transferred all manufacturing activities for linearized plasmid DNA template to Aldevron (Fargo, ND), as mention in IND 19745 SN0077 (November 24, 2020). Information concerning the manufacture of the linearized p", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 19745", "bates": "FDA-CBER-2022-1614-4810352", "context_preview": "facture at both ModernaTX, Inc. and Lonza. Please note that ModernaTX, Inc. has transferred all manufacturing activities for linearized plasmid DNA template to Aldevron (Fargo, ND), as mention in IND 19745 SN0077 (November 24, 2020). Information concerning the manufacture of the linearized plasmid D", "likely_table": true }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "IND 19745", "bates": "FDA-CBER-2022-1614-4810352", "context_preview": "at both ModernaTX, Inc. and Lonza. Please note that ModernaTX, Inc. has transferred all manufacturing activities for linearized plasmid DNA template to Aldevron (Fargo, ND), as mention in IND 19745 SN0077 (November 24, 2020). Information concerning the manufacture of the linearized plasmid DNA templ", "likely_table": true } ] }, { "filename": "19745_S81_M3_32p51_specifications.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 8, "table_count": 8, "by_category": { "Manufacturing / CMC": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622868", "context_preview": "Particle size Dynamic Light Scattering (SOP-0998) Polydispersity pH USP <791> (SOP-0288) Osmolality USP <785> Freezing Point Depression (SOP-0279) Particulate matter \u2265 25 \uf06dm USP <788> Method 2 (SOP-0509) \u2265 10 \uf06dm Container content USP <697> (SOP-0950) \u2265 5.0 mL (\u2265 10 doses of 0.5 mL from 1 vial) Bacte", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622868", "context_preview": "e size Dynamic Light Scattering (SOP-0998) Polydispersity pH USP <791> (SOP-0288) Osmolality USP <785> Freezing Point Depression (SOP-0279) Particulate matter \u2265 25 \uf06dm USP <788> Method 2 (SOP-0509) \u2265 10 \uf06dm Container content USP <697> (SOP-0950) \u2265 5.0 mL (\u2265 10 doses of 0.5 mL from 1 vial) Bacterial en", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "PEG2000-DMG", "bates": "FDA-CBER-2022-1614-4622868", "context_preview": "Dynamic Light Scattering (SOP-0998) Polydispersity pH USP <791> (SOP-0288) Osmolality USP <785> Freezing Point Depression (SOP-0279) Particulate matter \u2265 25 \uf06dm USP <788> Method 2 (SOP-0509) \u2265 10 \uf06dm Container content USP <697> (SOP-0950) \u2265 5.0 mL (\u2265 10 doses of 0.5 mL from 1 vial) Bacterial endotoxin", "likely_table": true } ] }, { "filename": "19745_S81_M3_32s2_cx_manufacturer.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 7, "table_count": 7, "by_category": { "Manufacturing / CMC": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622870", "context_preview": "ufacture of CX-024414 \u2022 Release and stability testing of CX-024414 (excluding Bacterial endotoxin and bioburden for manufactured at Lonza Biologics Inc.) \u2022 Lot release \u2022 Storage of CX-024414 Lonza Biologics, Inc. 101 International Drive Portsmouth, NH 03801 USA \u2022 Manufacture of CX-024414 \u2022 Release t", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622870", "context_preview": "of CX-024414 \u2022 Release and stability testing of CX-024414 (excluding Bacterial endotoxin and bioburden for manufactured at Lonza Biologics Inc.) \u2022 Lot release \u2022 Storage of CX-024414 Lonza Biologics, Inc. 101 International Drive Portsmouth, NH 03801 USA \u2022 Manufacture of CX-024414 \u2022 Release testing (B", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1 Manufacturer(s)", "bates": "FDA-CBER-2022-1614-4622870", "context_preview": "24414 \u2022 Release and stability testing of CX-024414 (excluding Bacterial endotoxin and bioburden for manufactured at Lonza Biologics Inc.) \u2022 Lot release \u2022 Storage of CX-024414 Lonza Biologics, Inc. 101 International Drive Portsmouth, NH 03801 USA \u2022 Manufacture of CX-024414 \u2022 Release testing (Bacteria", "likely_table": true } ] }, { "filename": "19745_S81_M3_32s2_mrna_manufacturer.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1 MANUFACTURER(S)", "bates": "FDA-CBER-2022-1614-4622869", "context_preview": "tability testing of mRNA-1273 LNP (excluding bacterial endotoxin testing) \u2022 Lot release of mRNA-1273 LNP \u2022 Storage of mRNA-1273 LNP Lonza Biologics, Inc. 101 International Drive Portsmouth, NH 03801 USA \u2022 Manufacture of mRNA-1273 LNP \u2022 Release testing (Bioburden testing of mRNA-1273 LNP manufactured", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.1 MANUFACTURER(S)", "bates": "FDA-CBER-2022-1614-4622869", "context_preview": "testing of mRNA-1273 LNP (excluding bacterial endotoxin testing) \u2022 Lot release of mRNA-1273 LNP \u2022 Storage of mRNA-1273 LNP Lonza Biologics, Inc. 101 International Drive Portsmouth, NH 03801 USA \u2022 Manufacture of mRNA-1273 LNP \u2022 Release testing (Bioburden testing of mRNA-1273 LNP manufactured at site)", "likely_table": false } ] }, { "filename": "19745_S81_M3_32s44_cx_coa-cx-024414.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 14, "table_count": 0, "by_category": { "Manufacturing / CMC": 14 }, "by_marker": { "(b)(4)": 14 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622922", "context_preview": "uct Related Impurities SOP-0321 Main Peak Area % Pre-Main Peak % Post Main Peak % 5' Capped SOP-0467 Cap1 % PolyA tailed RNA / % Tailless RNA SOP-0291 Main Peak Area Pre-Main Peak Area Residual DNA template SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622925", "context_preview": "uct Related Impurities SOP-0321 Main Peak Area % Pre-Main Peak % Post Main Peak % 5' Capped SOP-0467 Cap1 % PolyA tailed RNA / % Tailless RNA SOP-0291 Main Peak Area Pre-Main Peak Area Residual DNA template SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622927", "context_preview": "uct Related Impurities SOP-0321 Main Peak Area % Pre-Main Peak % Post Main Peak % 5' Capped SOP-0467 Cap1 % PolyA tailed RNA / % Tailless RNA SOP-0291 Main Peak Area Pre-Main Peak Area Residual DNA template SOP-0491 Residual DNA Template pH SOP-0288 pH Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false } ] }, { "filename": "19745_S81_M3_32s44_mrna_coa-mrna-1273-lnp.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 28, "table_count": 0, "by_category": { "Manufacturing / CMC": 28 }, "by_marker": { "(b)(4)": 28 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622872", "context_preview": "rance - Color Appearance - Particulates Identity SOP-0544 Identity Concentration SOP-0235 Concentration Purity SOP-0383 Purity % IG1 % IG2 % IG3 % Total Impurities % RNA Encapsulation SOP-0298 % Encapsulation Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-050", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622873", "context_preview": "Method Parameter Specification Result Lipid Content SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 RRT 1 RRT 2 RRT 3 RRT 4 pH SOP-0288 pH Osmolality SOP-0279 Osmolality USP <467> Advantar MRNA- C0000-GTM0018 Ethanol Bacterial Endotoxins USP <85> Bacterial Endotox", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622876", "context_preview": "rance - Color Appearance - Particulates Identity SOP-0544 Identity Concentration SOP-0235 Concentration Purity SOP-0383 Purity % IG1 % IG2 % IG3 % Total Impurities % RNA Encapsulation SOP-0298 % Encapsulation Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-050", "likely_table": false } ] }, { "filename": "19745_S82_M1_initial-ped-study-plan-trk.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 23, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "7.0 \n AGE-APPROPRIATE FORMULATION DEVELOPMENT", "bates": "FDA-CBER-2022-1614-5476903", "context_preview": "on Detailed instructions for dilution of the drug product with the diluent and administration in a short time window have been established and are summarised below. In the pediatric population from birth to <18 years, the applicant proposes to investigate the safety, reactogenicity and effectiveness", "likely_table": false } ] }, { "filename": "19745_S84_M1_0084-cover.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 1, "table_count": 1, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.S.4.2", "bates": "FDA-CBER-2022-1614-4622964", "context_preview": "ry obligations (TORO) is included in this submission. If FDA has any questions, please do not hesitate to contact me directly at or at @modernatx.com. This eCTD submission has been prepared by PPD Development, Inc. in full compliance with ICH and FDA guidance. The eCTD has been verified and confirme", "likely_table": true } ] }, { "filename": "19745_S84_M1_resp-fda-rfi-20nov2020.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 17, "table_count": 13, "by_category": { "Manufacturing / CMC": 15, "Trade-secret claim": 1, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 17 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 8.5.6 in", "bates": "FDA-CBER-2022-1614-4622975", "context_preview": "a reference to an SOP describing this step (e.g., similar to that described in SOP-1032 (mRNA sequence by RT-PCR/Sanger). Sponsor Response: Sample preparation for SOP-0999 is described in Section 8.2.3.1 in SOP-0999. A combination of Section 8.2.3.1 in SOP-0999 states Section 8.1.9 in SOP-0999. Samp", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 8.5.6 in", "bates": "FDA-CBER-2022-1614-4622975", "context_preview": "nce to an SOP describing this step (e.g., similar to that described in SOP-1032 (mRNA sequence by RT-PCR/Sanger). Sponsor Response: Sample preparation for SOP-0999 is described in Section 8.2.3.1 in SOP-0999. A combination of Section 8.2.3.1 in SOP-0999 states Section 8.1.9 in SOP-0999. Sample prepa", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Section 8.5.6 in", "bates": "FDA-CBER-2022-1614-4622975", "context_preview": "n SOP describing this step (e.g., similar to that described in SOP-1032 (mRNA sequence by RT-PCR/Sanger). Sponsor Response: Sample preparation for SOP-0999 is described in Section 8.2.3.1 in SOP-0999. A combination of Section 8.2.3.1 in SOP-0999 states Section 8.1.9 in SOP-0999. Sample preparation f", "likely_table": true } ] }, { "filename": "19745_S84_M2_pharmacol-tabulated-summary.pdf", "module": "M2", "company": "Moderna", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Pharmacology / toxicology": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "4.2.3.7.7 \nProtection from WT", "bates": "FDA-CBER-2022-1614-5476962", "context_preview": "utes of Health Building 40, Room 2608 Bethesda, MD 20892 VRC02 4.2.1.1 Five-week (2 doses: prime/boost) repeat dose immunogenicity with safety endpoints Rat, Sprague Dawley IM Charles River Laboratories, Inc. 54943 North Main Street Mattawan, MI 49071 2308-123 4.2.3.7.7 Protection from WT SARS-CoV-2", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "4.2.1.1 \nAbbreviations: eCTD = electronic common technical document; GLP = Good Laboratory Practice; IM = intramuscular; NHP = non", "bates": "FDA-CBER-2022-1614-5476963", "context_preview": "valuation of immunogenicity and efficacy from expanded dose range in NHPs NHP, rhesus macaque (Indian-origin) IM Viral Pathogenesis Laboratory, Vaccine Research Center, National Institutes of Health Building 40 Room 2608 Bethesda, MD 20892 Vaccine Immunology Program 9 West Watkins Mill Road Gaithers", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "4.2.1.1 \nAbbreviations: eCTD = electronic common technical document; GLP = Good Laboratory Practice; IM = intramuscular; NHP = non", "bates": "FDA-CBER-2022-1614-5476963", "context_preview": "n of immunogenicity and efficacy from expanded dose range in NHPs NHP, rhesus macaque (Indian-origin) IM Viral Pathogenesis Laboratory, Vaccine Research Center, National Institutes of Health Building 40 Room 2608 Bethesda, MD 20892 Vaccine Immunology Program 9 West Watkins Mill Road Gaithersburg, MD", "likely_table": false } ] }, { "filename": "19745_S84_M2_pharmacol-written-summary.pdf", "module": "M2", "company": "Moderna", "license": "EUA", "total_kept": 20, "table_count": 0, "by_category": { "Other / uncategorized": 9, "Pharmacology / toxicology": 6, "Manufacturing / CMC": 4, "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 20 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "2.6.2 Pharmacology Written Summary", "bates": "FDA-CBER-2022-1614-5476970", "context_preview": "heptad repeat 1 domain SARS severe acute respiratory syndrome SARS-CoV severe acute respiratory syndrome coronavirus SARS-CoV-1 severe acute respiratory syndrome coronavirus-1 SARS-CoV-1 DIV double-inactivated severe acute respiratory syndrome coronavirus-1 SARS-CoV-2 2019 novel coronavirus SD stand", "likely_table": false }, { "page": 12, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "2.6.2.2.1 \nEvaluation of Immunogenicity, Protective Capacity, and Safety of", "bates": "FDA-CBER-2022-1614-5476975", "context_preview": "activated severe acute respiratory syndrome coronavirus-1; SARS-CoV-2 = 2019 novel coronavirus; S-2P = spike protein modified with 2 proline substitutions within the heptad repeat 1 domain; WT = wild-type. 2.6.2.2 PRIMARY PHARMACODYNAMICS 2.6.2.2.1 Evaluation of Immunogenicity, Protective Capacity, ", "likely_table": false }, { "page": 13, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "2.6.2 Pharmacology Written Summary", "bates": "FDA-CBER-2022-1614-5476976", "context_preview": "al IgG) BALB/cJ C57BL/6J B6C3F1/J 2 (10) 0.1 or 1 \u00b5g of mRNA-1273 Week 0 (Day 1) Week 3 (Day 22) NA Week 2 (Day 15) and Week 5 (Day 36); sera for nAbs (pseudovirus) BALB/cJ 3 (3) 1 \u00b5g of SARS-CoV-2 S-2P with Week 0 (Day 1) Week 3 (Day 22) NA Week 5 (Day 36); sera for nAbs (WT virus) BALB/cJ C57/B/6 ", "likely_table": false } ] }, { "filename": "19745_S84_M2_toxicology-tabulated-summary.pdf", "module": "M2", "company": "Moderna", "license": "EUA", "total_kept": 14, "table_count": 0, "by_category": { "Pharmacology / toxicology": 7, "Manufacturing / CMC": 5, "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 14 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "4.2.3.3.2 \nOther toxicity", "bates": "FDA-CBER-2022-1614-5664686", "context_preview": "7.0, 5.2/54.1 (M) mg/kg mRNA-1706/ SM-102i, j Yes CRL 9800399 4.2.3.3.2 IV (bolus) NPI luciferase mRNAk Single dose evaluated at 24 h and 48 h post-dose 0.32/6.0, 1.07/20, 3.21/60 mg/kg NPI luciferase mRNA/SM-102 No BioReliance Corporation Rockville, MD, USA AF87FU. 125012N GLPICH. BTL 4.2.3.3.2 Oth", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "4.2.3.3.2 \nOther toxicity", "bates": "FDA-CBER-2022-1614-5664686", "context_preview": "2/54.1 (M) mg/kg mRNA-1706/ SM-102i, j Yes CRL 9800399 4.2.3.3.2 IV (bolus) NPI luciferase mRNAk Single dose evaluated at 24 h and 48 h post-dose 0.32/6.0, 1.07/20, 3.21/60 mg/kg NPI luciferase mRNA/SM-102 No BioReliance Corporation Rockville, MD, USA AF87FU. 125012N GLPICH. BTL 4.2.3.3.2 Other toxi", "likely_table": false }, { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "2.6.7 Toxicology Tabulated Summary", "bates": "FDA-CBER-2022-1614-5664687", "context_preview": "ay 2017). The change in the reported mRNA content for mRNA-1706 was k NPI luciferase mRNA is combined in a mixture of 4 lipids (SM-102, PEG2000-DMG, cholesterol, and DSPC) and formulated in 25 mM Tris, 123 g/L sucrose, 1 mM DTPA, pH 7.5. l mRNA-1273 contains a single mRNA sequence that encodes for t", "likely_table": false } ] }, { "filename": "19745_S84_M2_toxicology-written-summary.pdf", "module": "M2", "company": "Moderna", "license": "EUA", "total_kept": 8, "table_count": 0, "by_category": { "Manufacturing / CMC": 5, "Other / uncategorized": 2, "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 8, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "2.6.6 Toxicology Written Summary", "bates": "FDA-CBER-2022-1614-5477058", "context_preview": "2017). The change in the reported mRNA content for mRNA-1706 was k The NPI luciferase mRNA is combined in a mixture of 4 lipids (SM-102, PEG2000-DMG, cholesterol, and DSPC) and formulated in 25 mM Tris, 123 g/L sucrose, 1 mM DTPA, pH 7.5. l mRNA-1273 contains a single mRNA sequence that encodes the ", "likely_table": false }, { "page": 8, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "2.6.6 Toxicology Written Summary", "bates": "FDA-CBER-2022-1614-5477058", "context_preview": "he change in the reported mRNA content for mRNA-1706 was k The NPI luciferase mRNA is combined in a mixture of 4 lipids (SM-102, PEG2000-DMG, cholesterol, and DSPC) and formulated in 25 mM Tris, 123 g/L sucrose, 1 mM DTPA, pH 7.5. l mRNA-1273 contains a single mRNA sequence that encodes the full-len", "likely_table": false }, { "page": 8, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "2.6.6 Toxicology Written Summary", "bates": "FDA-CBER-2022-1614-5477058", "context_preview": "e in the reported mRNA content for mRNA-1706 was k The NPI luciferase mRNA is combined in a mixture of 4 lipids (SM-102, PEG2000-DMG, cholesterol, and DSPC) and formulated in 25 mM Tris, 123 g/L sucrose, 1 mM DTPA, pH 7.5. l mRNA-1273 contains a single mRNA sequence that encodes the full-length SARS", "likely_table": false } ] }, { "filename": "19745_S84_M4_20248897-report.pdf", "module": "M4", "company": "Moderna", "license": "EUA", "total_kept": 2, "table_count": 0, "by_category": { "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 771, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 39", "bates": "FDA-CBER-2022-1614-5477863", "context_preview": "a GD 1 a GD 13 a GD21 b LD 21 b 1-2 1 X X X X X - 1-2 2 X X X X - X Unscheduled euthanasia (when possible) X X = Sample to be collected ; - = Not applicable a Sample collected prior to dose administration b Terminal blood sample collection 4. MATERIALS AND METHODS Table 3: Equipment Equipment Manufa", "likely_table": false }, { "page": 774, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Appendix 39", "bates": "FDA-CBER-2022-1614-5477866", "context_preview": "st Facility Study No. 20248897 Test Site Reference No. BS-3858 Page 9 4.5. Computerized Systems Table 6: Computerized Systems System Name Version No. Description of Data Collected and/or Analyzed \u2022 Collection of Absorbance Values at 650 nm \u2022 Calculations of \u201cAntibody Units/mL\u201d (X) based on Absorbanc", "likely_table": false } ] }, { "filename": "19745_S85_M3_32p1_description-and-composition.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 2, "table_count": 0, "by_category": { "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT", "bates": "FDA-CBER-2022-1614-4622409", "context_preview": "ce) Stopper 20 mm West 4432-50 GY S10-F451* B240 Westar Seal Aluminum Seal with Flip-off Plastic cap Color: Red Matte Target Fill Volume/Vial 6.3 mL Nominal (= Label) Fill Volume 5.0 mL Nominal Doses/Vial 10 (target) Site of Manufacture Catalent Indiana, LLC 1300 South Patterson Drive Bloomington, I", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT", "bates": "FDA-CBER-2022-1614-4622409", "context_preview": "pper 20 mm West 4432-50 GY S10-F451* B240 Westar Seal Aluminum Seal with Flip-off Plastic cap Color: Red Matte Target Fill Volume/Vial 6.3 mL Nominal (= Label) Fill Volume 5.0 mL Nominal Doses/Vial 10 (target) Site of Manufacture Catalent Indiana, LLC 1300 South Patterson Drive Bloomington, Indiana ", "likely_table": false } ] }, { "filename": "19745_S85_M3_32p5_batch-analyses.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 51, "table_count": 51, "by_category": { "Manufacturing / CMC": 51 }, "by_marker": { "(b)(4)": 51 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SPC-1063,", "bates": "FDA-CBER-2022-1614-4622412", "context_preview": "-HPLC (SOP-0235) Identity by Rev Transcription/Sanger Sequencing (SOP-0544) Purity by RP-HPLC (SOP-0383) N/A N/A N/A N/A N/A N/A N/A N/A Product-related impurities by RP-HPLC (SOP-0383) % RNA encapsulation by (SOP-0298) In vitro Translation (SOP-0937) pH (SOP-0288) Osmolality (SOP-0279) Particle siz", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SPC-1063,", "bates": "FDA-CBER-2022-1614-4622412", "context_preview": "SOP-0235) Identity by Rev Transcription/Sanger Sequencing (SOP-0544) Purity by RP-HPLC (SOP-0383) N/A N/A N/A N/A N/A N/A N/A N/A Product-related impurities by RP-HPLC (SOP-0383) % RNA encapsulation by (SOP-0298) In vitro Translation (SOP-0937) pH (SOP-0288) Osmolality (SOP-0279) Particle size by Dy", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "SPC-1063,", "bates": "FDA-CBER-2022-1614-4622412", "context_preview": ") Identity by Rev Transcription/Sanger Sequencing (SOP-0544) Purity by RP-HPLC (SOP-0383) N/A N/A N/A N/A N/A N/A N/A N/A Product-related impurities by RP-HPLC (SOP-0383) % RNA encapsulation by (SOP-0298) In vitro Translation (SOP-0937) pH (SOP-0288) Osmolality (SOP-0279) Particle size by Dynamic Li", "likely_table": true } ] }, { "filename": "19745_S85_M3_32p5_coa-various-lots.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 17, "table_count": 0, "by_category": { "Manufacturing / CMC": 17 }, "by_marker": { "(b)(4)": 17 }, "top_examples": [ { "page": 34, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622449", "context_preview": "ty SOP-0544 Identity Purity SOP-0383 Purity % IG1 % IG2 % IG3 % RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0937 Result pH SOP-0288 pH Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 C", "likely_table": false }, { "page": 36, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622451", "context_preview": ", 20mm Cap Product Attribute Method Parameter Specification Result Container Content SOP-0950 Container Content >= 5.0 mL (>=10 doses of 0.5 mL from one vial) Bacterial Endotoxins USP <85> Bacterial Endotoxins Sterility SOP-0378 Sterility This material meets specification: Yes 1.0 - Original Revisio", "likely_table": false }, { "page": 38, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622453", "context_preview": "ty SOP-0544 Identity Purity SOP-0383 Purity % IG1 % IG2 % IG3 % RNA Encapsulation SOP-0298 % Encapsulation In vitro Translation (Potency) SOP-0937 Result pH SOP-0288 pH Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 C", "likely_table": false } ] }, { "filename": "19745_S85_M3_32s2_cx_manufacturer.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 7, "table_count": 7, "by_category": { "Manufacturing / CMC": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MANUFACTURER(S)", "bates": "FDA-CBER-2022-1614-4622477", "context_preview": "\u2022 Release and stability testing of CX-024414 (excluding Bacterial endotoxin and bioburden for manufactured at Lonza Biologics Inc.) \u2022 Lot release \u2022 Storage of CX-024414 Lonza Biologics, Inc. 101 International Drive Portsmouth, NH 03801 USA \u2022 Manufacture of CX-024414 \u2022 Release testing (Bacterial endo", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MANUFACTURER(S)", "bates": "FDA-CBER-2022-1614-4622477", "context_preview": "se and stability testing of CX-024414 (excluding Bacterial endotoxin and bioburden for manufactured at Lonza Biologics Inc.) \u2022 Lot release \u2022 Storage of CX-024414 Lonza Biologics, Inc. 101 International Drive Portsmouth, NH 03801 USA \u2022 Manufacture of CX-024414 \u2022 Release testing (Bacterial endotoxin a", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MANUFACTURER(S)", "bates": "FDA-CBER-2022-1614-4622477", "context_preview": "tability testing of CX-024414 (excluding Bacterial endotoxin and bioburden for manufactured at Lonza Biologics Inc.) \u2022 Lot release \u2022 Storage of CX-024414 Lonza Biologics, Inc. 101 International Drive Portsmouth, NH 03801 USA \u2022 Manufacture of CX-024414 \u2022 Release testing (Bacterial endotoxin and Biobu", "likely_table": true } ] }, { "filename": "19745_S87_M1_rsp-rfi-08dec2020.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 61, "table_count": 50, "by_category": { "Manufacturing / CMC": 34, "Other / uncategorized": 21, "Trade-secret claim": 6 }, "by_marker": { "(b)(4)": 61 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "RECEIVED ON DECEMBER 08, 2020", "bates": "FDA-CBER-2022-1614-4993156", "context_preview": "lease for GMP use through 30Nov20. The scale CX-024414 mRNA manufacturing is no longer used in mRNA manufacturing activities. Request 2 Regarding your manufacturing equipment: a. According to cross-referenced , mRNA manufacturing areas are equipped with the following equipment not listed in your IND", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "RECEIVED ON DECEMBER 08, 2020", "bates": "FDA-CBER-2022-1614-4993156", "context_preview": "r GMP use through 30Nov20. The scale CX-024414 mRNA manufacturing is no longer used in mRNA manufacturing activities. Request 2 Regarding your manufacturing equipment: a. According to cross-referenced , mRNA manufacturing areas are equipped with the following equipment not listed in your IND: Please", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "RECEIVED ON DECEMBER 08, 2020", "bates": "FDA-CBER-2022-1614-4993156", "context_preview": "e through 30Nov20. The scale CX-024414 mRNA manufacturing is no longer used in mRNA manufacturing activities. Request 2 Regarding your manufacturing equipment: a. According to cross-referenced , mRNA manufacturing areas are equipped with the following equipment not listed in your IND: Please clarify", "likely_table": true } ] }, { "filename": "19745_S89_M1_quality-info-amendment.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 2, "table_count": 0, "by_category": { "Inspection / enforcement": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "1.11.1 \nQuality Information Amendment", "bates": "FDA-CBER-2022-1614-4622981", "context_preview": "oundary had been breached. No product had been filled at the time of the detection of the leak. Per a teleconference on December 16, 2020 with FDA , the CofA for Lot 7006520014, the deviation investigation from Catalent (REC 283121), and the technical summary are being provided. The CofA will also b", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "1.11.1 \nQuality Information Amendment", "bates": "FDA-CBER-2022-1614-4622981", "context_preview": "had been breached. No product had been filled at the time of the detection of the leak. Per a teleconference on December 16, 2020 with FDA , the CofA for Lot 7006520014, the deviation investigation from Catalent (REC 283121), and the technical summary are being provided. The CofA will also be submit", "likely_table": false } ] }, { "filename": "19745_S89_M3_32p54_coa-7006520014.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622982", "context_preview": "Translation SOP-0937 Result pH SOP-0288 pH Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622984", "context_preview": "rility USP <71> Sterility This material meets specification: Yes 1.0 - Original Unlabeled Drug Product Lot 6007320011 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 1", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622984", "context_preview": "SP <71> Sterility This material meets specification: Yes 1.0 - Original Unlabeled Drug Product Lot 6007320011 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-20", "likely_table": false } ] }, { "filename": "19745_S91_M1_quality-info-amendment-lot-6008620003.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 2, "table_count": 0, "by_category": { "Inspection / enforcement": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "1.11.1 \nQuality Information Amendment", "bates": "FDA-CBER-2022-1614-4622992", "context_preview": "ched. No product had been filled at the time of the detection of the leak. Per a teleconference on December 16, 2020 with FDA , the CofA for Lot 6008620003 (Catalent Lot 027L20), the deviation investigation from Catalent (REC 284379), and the technical summary are being provided. The CofA will also ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "1.11.1 \nQuality Information Amendment", "bates": "FDA-CBER-2022-1614-4622992", "context_preview": "product had been filled at the time of the detection of the leak. Per a teleconference on December 16, 2020 with FDA , the CofA for Lot 6008620003 (Catalent Lot 027L20), the deviation investigation from Catalent (REC 284379), and the technical summary are being provided. The CofA will also be submit", "likely_table": false } ] }, { "filename": "19745_S91_M3_32pcoa-lot-6008620003.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622993", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622993", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4622994", "context_preview": "% Area 2 % Area 3 % Area 4 % Area 5 RRT 1 RRT 2 RRT 3 RRT 4 RRT 5 % Total Impurities Particulate Matter SOP-0509 10 \u00b5m particles per container Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Dec-2020 Generated Date: Steven Anderson ", "likely_table": false } ] }, { "filename": "20_BLA-125752-0_10-14-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 5, "table_count": 0, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816079", "context_preview": "and cumulative process durations of about may impact overall product consistency over the life-cycle of the product and increase the risk of releasing vaccine with RNA purity and impurity levels which are not representative of those of the clinical lots used to demonstrate effectiveness. Any changes", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816079", "context_preview": "ulative process durations of about may impact overall product consistency over the life-cycle of the product and increase the risk of releasing vaccine with RNA purity and impurity levels which are not representative of those of the clinical lots used to demonstrate effectiveness. Any changes in the", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816079", "context_preview": "process durations of about may impact overall product consistency over the life-cycle of the product and increase the risk of releasing vaccine with RNA purity and impurity levels which are not representative of those of the clinical lots used to demonstrate effectiveness. Any changes in the specifi", "likely_table": false } ] }, { "filename": "22_BLA-125742-0_07-15-2021_Meeting-Summary_Committee-.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "2.3.3 \nDBSQC (Hsiaoling Wang, Emnet Yitbarek, Karla Garcia, Anil Choudhary,", "bates": "FDA-CBER-2021-5683-1024846", "context_preview": "ng Wang, Emnet Yitbarek, Karla Garcia, Anil Choudhary, Esmeralda Alvarado and Marie Anderson): \u2022 The DBSQC reviewers provided updates that the reagents and lots for testing were received last week. IRs regarding the lot release protocol templates as well as the number of freeze/thaws allowed for the", "likely_table": false } ] }, { "filename": "24_BLA-125752-0_10-20-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 7, "table_count": 6, "by_category": { "Manufacturing / CMC": 6, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816087", "context_preview": "linearized pDNA template. a. Please clarify if is involved with the manufacture of the linearized pDNA template for SPIKEVAX, including but not limited to release testing, stability testing and storage unit operations. 2. Please describe the primary container closure system used in storing and shipp", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816087", "context_preview": "ed pDNA template. a. Please clarify if is involved with the manufacture of the linearized pDNA template for SPIKEVAX, including but not limited to release testing, stability testing and storage unit operations. 2. Please describe the primary container closure system used in storing and shipping the ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816087", "context_preview": "template. a. Please clarify if is involved with the manufacture of the linearized pDNA template for SPIKEVAX, including but not limited to release testing, stability testing and storage unit operations. 2. Please describe the primary container closure system used in storing and shipping the linear D", "likely_table": true } ] }, { "filename": "25_BLA-125752-0_10-21-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816089", "context_preview": "e communications we will refer to the \u201cmRNA-1273 LNP\u201d as the Drug Substance (DS); the \u201cCX-024414\u201d (i.e., mRNA-1273) and the ; and the lipids \u201cmPEG2000-DMG\u201d (from as Raw Materials. Please use this terminology in future communications with the FDA. Please confirm your receipt of this information, and ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816089", "context_preview": "ications we will refer to the \u201cmRNA-1273 LNP\u201d as the Drug Substance (DS); the \u201cCX-024414\u201d (i.e., mRNA-1273) and the ; and the lipids \u201cmPEG2000-DMG\u201d (from as Raw Materials. Please use this terminology in future communications with the FDA. Please confirm your receipt of this information, and let me k", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816089", "context_preview": "we will refer to the \u201cmRNA-1273 LNP\u201d as the Drug Substance (DS); the \u201cCX-024414\u201d (i.e., mRNA-1273) and the ; and the lipids \u201cmPEG2000-DMG\u201d (from as Raw Materials. Please use this terminology in future communications with the FDA. Please confirm your receipt of this information, and let me know if yo", "likely_table": false } ] }, { "filename": "26_2_BLA-125742-0_07-16-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 8, "table_count": 8, "by_category": { "Trade-secret claim": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN", "bates": "FDA-CBER-2021-5683-1150186", "context_preview": "OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, disseminatio", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN", "bates": "FDA-CBER-2021-5683-1150186", "context_preview": "PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copy", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN", "bates": "FDA-CBER-2021-5683-1150186", "context_preview": "WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or o", "likely_table": true } ] }, { "filename": "27034_S13_M1_response-2-dec-2020-bp-act-surv.pdf", "module": "M1", "company": "Pfizer", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 10, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1789155", "context_preview": "d. Work with the DoD will be coordinated via Health ResearchTx, LLC (HRTX). HRTX has over a decade of experience working within and with the DoD, an established infrastructure for the conduct of scientific research, and have served as a valued research partner on government and industry-sponsored re", "likely_table": false }, { "page": 10, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1789155", "context_preview": "with the DoD will be coordinated via Health ResearchTx, LLC (HRTX). HRTX has over a decade of experience working within and with the DoD, an established infrastructure for the conduct of scientific research, and have served as a valued research partner on government and industry-sponsored research p", "likely_table": false }, { "page": 10, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1789155", "context_preview": "DoD will be coordinated via Health ResearchTx, LLC (HRTX). HRTX has over a decade of experience working within and with the DoD, an established infrastructure for the conduct of scientific research, and have served as a valued research partner on government and industry-sponsored research projects. ", "likely_table": false } ] }, { "filename": "27034_S18_M1_response-4-dec-2020-biostat.pdf", "module": "M1", "company": "Pfizer", "license": "EUA", "total_kept": 1, "table_count": 0, "by_category": { "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 11, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": null, "bates": "FDA-CBER-2021-5683-1789482", "context_preview": "Document Approval Record Document Name: \u0005\u0006\u0007\b \u000e \u000e \u000f\u0010\u0011\u0012\u0013\u0014\u0011\u0010 \u0015\u0013 \u000e\u0016 \u0010\u0017 \u000e \u0005\u0018\u0019\u000f \u000f\u0010\u0011\u0012\u0013\u0014\u0011\u0010 \u001a\u0015\u001a\u0011\u0010\u0015 \u0007\u001a\u001b \u001a \u0010\u0011 Document Title: \u0005\u0006\u0007\b \u000e \u000e \u000f\u0010\u0011\u0012\u0013\u0014\u0011\u0010 \u0015\u0013 \u000e\u0016 \u0010\u0017 \u000e \u0005\u0018\u0019\u000f \u000f\u0010\u0011\u0012\u0013\u0014\u0011\u0010 \u001a\u0015\u001a\u0011\u0010\u0015 \u0007\u001a\u001b \u001a \u0010\u0011 Signed By: Date(GMT) Signing Capacity \u000e% \u0010\u0017 \u000e \u000e &\u000e\u0016&' \u0018(\u0011 \u0014\u0010\u0011\u0011 # \u0014\u0010 )\u0012\u0012\u001b\u0013*\u0010\u001b 090177e195b7d33e\\Approved\\Approved On: 07-Dec-202", "likely_table": false } ] }, { "filename": "27034_S1_M1_c4591011-draft-protocol.pdf", "module": "M1", "company": "Pfizer", "license": "EUA", "total_kept": 13, "table_count": 0, "by_category": { "Trial design / efficacy": 12, "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 13 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1781648", "context_preview": ". Secondary objective \uf0b7 Evaluate whether the vaccine recipients experience increased risk of AESI post-vaccination. \uf0b7 Estimate the incidence rates of AESI among subcohorts of interest such as women of childbearing age, immunocompromised people, and stratified by age. Characterize utilization pattern", "likely_table": false }, { "page": 6, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1781652", "context_preview": "L STUDY PROTOCOL DRAFT FOR FDA REVIEW V1.0 (Draft), 18 November 2020 PFIZER CONFIDENTIAL CT24-WI-GL02-RF02 2.0 Non-Interventional Study Protocol Template For Secondary Data Collection Study 01-Jun-2020 Page 6 of 26 3. RESPONSIBLE PARTIES Principal Investigator(s) of the Protocol Name, degree(s) Job ", "likely_table": false }, { "page": 17, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1781663", "context_preview": "could reflect changes in care delivery. The investigators will evaluate any anomalies and contact DoD for resolution. These analyses will supplement the already extensive data integration and quality checking conducted by DoD. 9.7.2. Analyses for Formal Comparisons Two study designs are discussed be", "likely_table": false } ] }, { "filename": "27034_S1_M1_eua.pdf", "module": "M1", "company": "Pfizer", "license": "EUA", "total_kept": 15, "table_count": 13, "by_category": { "Manufacturing / CMC": 15 }, "by_marker": { "(b)(4)": 15 }, "top_examples": [ { "page": 12, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL AND PROPRIETARY", "bates": "FDA-CBER-2021-5683-1781730", "context_preview": ". Back-up sterility test sites may be employed. d. Select tests may be performed on DS release and stability for EUA supplies at Pfizer or BioNTech (BNT). Drug Substance Sites that have responsibilities in the production of RNA drug substance and their specified functions are listed in Table 2. Manu", "likely_table": true }, { "page": 12, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL AND PROPRIETARY", "bates": "FDA-CBER-2021-5683-1781730", "context_preview": "p sterility test sites may be employed. d. Select tests may be performed on DS release and stability for EUA supplies at Pfizer or BioNTech (BNT). Drug Substance Sites that have responsibilities in the production of RNA drug substance and their specified functions are listed in Table 2. Manufacturin", "likely_table": true }, { "page": 12, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL AND PROPRIETARY", "bates": "FDA-CBER-2021-5683-1781730", "context_preview": "ity test sites may be employed. d. Select tests may be performed on DS release and stability for EUA supplies at Pfizer or BioNTech (BNT). Drug Substance Sites that have responsibilities in the production of RNA drug substance and their specified functions are listed in Table 2. Manufacturing, testi", "likely_table": true } ] }, { "filename": "27034_S21_M1_eua-track.pdf", "module": "M1", "company": "Pfizer", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 12, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL AND PROPRIETARY", "bates": "FDA-CBER-2021-5683-1789721", "context_preview": "support the EUA is provided in Table 1. Table 1. Emergency and Commercial Supply Chain Manufacturing Nodes Emergency Supply Commercial/Emergency Drug Substance Sites that have responsibilities in the production of RNA drug substance and their specified functions are listed in Table 2. Manufacturing,", "likely_table": false }, { "page": 13, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "FEI / DUNS", "bates": "FDA-CBER-2021-5683-1789722", "context_preview": "Pfizer-BioNTech EUA for Pfizer-BioNTech COVID-19 Vaccine CONFIDENTIAL AND PROPRIETARY 13 Table 2. Sites and Responsibilities for Manufacture and Testing of BNT162b2 Drug Substance Site FEI / DUNS Responsibility Drug Product Manufacturing, testing, release and bulk packaging for emergency supply are ", "likely_table": false }, { "page": 14, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL AND PROPRIETARY", "bates": "FDA-CBER-2021-5683-1789723", "context_preview": "Pfizer-BioNTech EUA for Pfizer-BioNTech COVID-19 Vaccine CONFIDENTIAL AND PROPRIETARY 14 Table 3. Manufacturing Sites Involved in Drug Product Manufacturing and Testing for Emergency Supply Additional information regarding GMP status of the manufacturing sites has been filed to the IND; please refer", "likely_table": false } ] }, { "filename": "27034_S21_M1_eua.pdf", "module": "M1", "company": "Pfizer", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 12, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL AND PROPRIETARY", "bates": "FDA-CBER-2021-5683-1789506", "context_preview": "support the EUA is provided in Table 1. Table 1. Emergency and Commercial Supply Chain Manufacturing Nodes Emergency Supply Commercial/Emergency Supply Drug Substance Sites that have responsibilities in the production of RNA drug substance and their specified functions are listed in Table 2. Manufac", "likely_table": false }, { "page": 13, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "FEI / DUNS", "bates": "FDA-CBER-2021-5683-1789507", "context_preview": "Pfizer-BioNTech EUA for Pfizer-BioNTech COVID-19 Vaccine CONFIDENTIAL AND PROPRIETARY 13 Table 2. Sites and Responsibilities for Manufacture and Testing of BNT162b2 Drug Substance Site FEI / DUNS Responsibility Drug Product Manufacturing, testing, release and bulk packaging for emergency supply are ", "likely_table": false }, { "page": 14, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL AND PROPRIETARY", "bates": "FDA-CBER-2021-5683-1789508", "context_preview": "Pfizer-BioNTech EUA for Pfizer-BioNTech COVID-19 Vaccine CONFIDENTIAL AND PROPRIETARY 14 Table 3. Manufacturing Sites Involved in Drug Product Manufacturing and Testing for Emergency Supply Additional information regarding GMP status of the manufacturing sites has been filed to the IND; please refer", "likely_table": false } ] }, { "filename": "27034_S5_M1_response-24-nov-2020.pdf", "module": "M1", "company": "Pfizer", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Clinical safety / adverse events": 2, "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 9, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1788598", "context_preview": "g). We have 320 subjects with ADAE.AECAT = \u201cMEDICATION ERROR\u201d. The breakdown for the preferred term is as follows. None of these medication errors subjects had an SAE. For the same 320 subjects as per ADDS, breakdown for the disposition term are as shown below: Based on ADDS.DSPHASE = \"VACCINATION\",", "likely_table": false }, { "page": 9, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": "PFIZER CONFIDENTIAL", "bates": "FDA-CBER-2021-5683-1788598", "context_preview": "ave 320 subjects with ADAE.AECAT = \u201cMEDICATION ERROR\u201d. The breakdown for the preferred term is as follows. None of these medication errors subjects had an SAE. For the same 320 subjects as per ADDS, breakdown for the disposition term are as shown below: Based on ADDS.DSPHASE = \"VACCINATION\", 37 subj", "likely_table": false }, { "page": 28, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "ADSL.TRT01A", "bates": "FDA-CBER-2021-5683-1788617", "context_preview": "Document Approval Record Document Name: \u0005\u0006\u0007\b \u000e \u000e \u000f\u0010\u0011\u0012\u0013\u0014\u0011\u0010 \u0015\u0013 \u0016\u0017\u0013\u0018 \u000e \u0005\u0019\u001a\u000f \u0005\u0013\u001b\u001b\u0010\u0014\u0015\u0011 \u0015 \u0011\u0010\u0015\u0011 Document Title: \u0005\u0006\u0007\b \u000e \u000e \u000f\u0010\u0011\u0012\u0013\u0014\u0011\u0010 \u0015\u0013 \u0016\u0017\u0013\u0018 \u000e \u0005\u0019\u001a\u000f \u0005\u0013\u001b\u001b\u0010\u0014\u0015\u0011 \u0015 \u0011\u0010\u0015\u0011 Signed By: Date(GMT) Signing Capacity % \u0017\u0013\u0018 \u000e \u000e \u000e\u000e& &\u000e \u0019'\u0011\"\u0014\u0010\u0011\u0011 !\"\u0014\u0010 (\u0012\u0012)\u0013\u0018\u0010) *\u0010)\u0010# +\u0013 \u0014 % \u0017\u0013\u0018 \u000e \u000e \u000e &\u000e,&\u000e\u000e -\"\u0014 $ (\u0012\u0012)\u0013\u0018 $ 090177e1959f4bcf\\Approv", "likely_table": false } ] }, { "filename": "27034_S9_M1_response-01-dec-2020-stat.pdf", "module": "M1", "company": "Pfizer", "license": "EUA", "total_kept": 1, "table_count": 0, "by_category": { "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "TABLE OF CONTENTS", "bates": "FDA-CBER-2021-5683-1789046", "context_preview": "Document Approval Record Document Name: \u0005\u0006\u0007\b \u000e \u000e \u000f\u0010\u0011\u0012\u0013\u0014\u0011\u0010 \u0015\u0013 \u0005\u0016\u0017\u000f \u000e \u0010\u0018 \u000e \b\u0014\u0019\u0013\u001a\u001b \u0015 \u0013\u0014 \u000f\u0010 \u0010\u0011\u0015 \u0015 \u0011\u0010\u0015\u0011 Document Title: \u0005\u0006\u0007\b \u000e \u000e \u000f\u0010\u0011\u0012\u0013\u0014\u0011\u0010 \u0015\u0013 \u0005\u0016\u0017\u000f \u000e \u0010\u0018 \u000e \b\u0014\u0019\u0013\u001a\u001b \u0015 \u0013\u0014 \u000f\u0010 \u0010\u0011\u0015 \u0015 \u0011\u0010\u0015\u0011 Signed By: Date(GMT) Signing Capacity \u000e \u0010\u0018 \u000e \u000e (\u000e\u000e( ) \u0016 \u0011 \u0014\u0010\u0011\u0011 $ \u0014\u0010 *\u0012\u0012\u001a\u0013+\u0010\u001a 090177e195ad52ac\\Approved\\Approved On: 02-Dec-202", "likely_table": false } ] }, { "filename": "27073_S10_M1_clin-study-audit-plan.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 1, "table_count": 0, "by_category": { "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "2.0 \nThis plan version", "bates": "FDA-CBER-2022-1614-4433098", "context_preview": "e and additional comments (please provide justification regarding decision to conduct/not to conduct an oversight audit) Due to the importance of this study in terms of its contribution and significance to the biologics license application for mRNA-1273 and likelihood of regulatory authority inspect", "likely_table": false } ] }, { "filename": "27073_S11_M1_submission-plan-eua.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 40, "table_count": 32, "by_category": { "Manufacturing / CMC": 30, "Other / uncategorized": 8, "Trial design / efficacy": 2 }, "by_marker": { "(b)(4)": 40 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.A.1", "bates": "FDA-CBER-2022-1614-4805332", "context_preview": "conducted at Catalent Biologics, LLC (Bloomington, IN) representing a fill/finish output of SN0039 Available now in IND to review ahead of EUA Submission IND Module 3 3.2.A.1 3.2.A.1- Facilities and Equipment (ModernaTX, Inc) SN0039 Available IND Module 3 3.2.A.1 Letter of authorization to cross ref", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.A.1", "bates": "FDA-CBER-2022-1614-4805332", "context_preview": "ed at Catalent Biologics, LLC (Bloomington, IN) representing a fill/finish output of SN0039 Available now in IND to review ahead of EUA Submission IND Module 3 3.2.A.1 3.2.A.1- Facilities and Equipment (ModernaTX, Inc) SN0039 Available IND Module 3 3.2.A.1 Letter of authorization to cross reference ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "3.2.A.1", "bates": "FDA-CBER-2022-1614-4805332", "context_preview": "atalent Biologics, LLC (Bloomington, IN) representing a fill/finish output of SN0039 Available now in IND to review ahead of EUA Submission IND Module 3 3.2.A.1 3.2.A.1- Facilities and Equipment (ModernaTX, Inc) SN0039 Available IND Module 3 3.2.A.1 Letter of authorization to cross reference 3.2.A.1", "likely_table": true } ] }, { "filename": "27073_S12_M1_rsp-cmts-cmc-ir12.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 23, "table_count": 23, "by_category": { "Other / uncategorized": 23 }, "by_marker": { "(b)(4)": 23 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RECEIVED ON DECEMBER 08, 2020 FOR EUA 27073", "bates": "FDA-CBER-2022-1614-4433116", "context_preview": "eral different mechanisms to remove residue as part of the cleaning systems. If necessary, Item 2 from December 08, 2020: You stated in your submission that all the product-contact equipment is supplied pre-sterilized, single-use and disposable including the . However, in document 3.2.P.3.5, Process", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RECEIVED ON DECEMBER 08, 2020 FOR EUA 27073", "bates": "FDA-CBER-2022-1614-4433116", "context_preview": "ferent mechanisms to remove residue as part of the cleaning systems. If necessary, Item 2 from December 08, 2020: You stated in your submission that all the product-contact equipment is supplied pre-sterilized, single-use and disposable including the . However, in document 3.2.P.3.5, Process Validat", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "RECEIVED ON DECEMBER 08, 2020 FOR EUA 27073", "bates": "FDA-CBER-2022-1614-4433116", "context_preview": "echanisms to remove residue as part of the cleaning systems. If necessary, Item 2 from December 08, 2020: You stated in your submission that all the product-contact equipment is supplied pre-sterilized, single-use and disposable including the . However, in document 3.2.P.3.5, Process Validation and/", "likely_table": true } ] }, { "filename": "27073_S134_M1_monthly-safety-rpt-18feb2021-31mar2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 11, "table_count": 7, "by_category": { "Pharmacology / toxicology": 7, "Manufacturing / CMC": 3, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 672, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.5 Non-clinical Data", "bates": "FDA-CBER-2022-1614-4220567", "context_preview": "ous adverse reaction, rash, plaque, dermatologic adverse reaction, blister, bullae, skin necrosis, skin exfoliation, drug eruption, hypersensitivity, sensitization, erythema, edema, dermatitis, pruritis, exanthem, irritation, and injection site reaction. 2.4 External Databases Not applicable 2.5 Non", "likely_table": true }, { "page": 672, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.5 Non-clinical Data", "bates": "FDA-CBER-2022-1614-4220567", "context_preview": "rse reaction, rash, plaque, dermatologic adverse reaction, blister, bullae, skin necrosis, skin exfoliation, drug eruption, hypersensitivity, sensitization, erythema, edema, dermatitis, pruritis, exanthem, irritation, and injection site reaction. 2.4 External Databases Not applicable 2.5 Non-clinica", "likely_table": true }, { "page": 672, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "2.5 Non-clinical Data", "bates": "FDA-CBER-2022-1614-4220567", "context_preview": "tion, rash, plaque, dermatologic adverse reaction, blister, bullae, skin necrosis, skin exfoliation, drug eruption, hypersensitivity, sensitization, erythema, edema, dermatitis, pruritis, exanthem, irritation, and injection site reaction. 2.4 External Databases Not applicable 2.5 Non-clinical Data A", "likely_table": true } ] }, { "filename": "27073_S13_M1_submission-plan-eua.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 47, "table_count": 47, "by_category": { "Trial design / efficacy": 17, "Manufacturing / CMC": 17, "Other / uncategorized": 13 }, "by_marker": { "(b)(4)": 47 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "5.3.1.4\nQualification and Validation of ELISA Method", "bates": "FDA-CBER-2022-1614-4992413", "context_preview": "ion IND Module 5 5.3.5.1 Phase 2 and 3 Protocols, Ph3 SAP, DSMB meeting minutes SN0033-Ph2 Protocol Amd3 SN0036-Ph3 SAP SN0042-Ph3 Protocol Amd4 SN0047-DSMB minutes SN0055-DSMB minutes Available now in IND to review ahead of EUA Submission IND Module 5 5.3.1.4 Qualification and Validation of ELISA M", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "5.3.1.4\nQualification and Validation of ELISA Method", "bates": "FDA-CBER-2022-1614-4992413", "context_preview": "Module 5 5.3.5.1 Phase 2 and 3 Protocols, Ph3 SAP, DSMB meeting minutes SN0033-Ph2 Protocol Amd3 SN0036-Ph3 SAP SN0042-Ph3 Protocol Amd4 SN0047-DSMB minutes SN0055-DSMB minutes Available now in IND to review ahead of EUA Submission IND Module 5 5.3.1.4 Qualification and Validation of ELISA Method SN", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "5.3.1.4\nQualification and Validation of ELISA Method", "bates": "FDA-CBER-2022-1614-4992413", "context_preview": "5.3.5.1 Phase 2 and 3 Protocols, Ph3 SAP, DSMB meeting minutes SN0033-Ph2 Protocol Amd3 SN0036-Ph3 SAP SN0042-Ph3 Protocol Amd4 SN0047-DSMB minutes SN0055-DSMB minutes Available now in IND to review ahead of EUA Submission IND Module 5 5.3.1.4 Qualification and Validation of ELISA Method SN0036 Avai", "likely_table": true } ] }, { "filename": "27073_S14_M1_rsp-cmts-cmc-ir16.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 108, "table_count": 84, "by_category": { "Other / uncategorized": 47, "Inspection / enforcement": 25, "Manufacturing / CMC": 25, "Trade-secret claim": 11 }, "by_marker": { "(b)(4)": 108 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "RESPONSE TO CBER COMMUNICATION REGARDING CMC QUESTIONS", "bates": "FDA-CBER-2022-1614-4992419", "context_preview": "Major Defect: Fibers or Intrinsic Particulate Matter). Similarly, of Lot 6007920001 (Catalent lot 025J20) and of Lot 6007920002 (Catalent lot 025J20-2) were rejected during visual inspection (Minor Defect: Foreign Matter (External)). Vials which passed 100% visual inspection were then subjected to a", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "RESPONSE TO CBER COMMUNICATION REGARDING CMC QUESTIONS", "bates": "FDA-CBER-2022-1614-4992419", "context_preview": "fect: Fibers or Intrinsic Particulate Matter). Similarly, of Lot 6007920001 (Catalent lot 025J20) and of Lot 6007920002 (Catalent lot 025J20-2) were rejected during visual inspection (Minor Defect: Foreign Matter (External)). Vials which passed 100% visual inspection were then subjected to a Normal ", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "RESPONSE TO CBER COMMUNICATION REGARDING CMC QUESTIONS", "bates": "FDA-CBER-2022-1614-4992419", "context_preview": "bers or Intrinsic Particulate Matter). Similarly, of Lot 6007920001 (Catalent lot 025J20) and of Lot 6007920002 (Catalent lot 025J20-2) were rejected during visual inspection (Minor Defect: Foreign Matter (External)). Vials which passed 100% visual inspection were then subjected to a Normal Level II", "likely_table": true } ] }, { "filename": "27073_S164_M1_ monthly-safety-rpt-01apr2021-30apr2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 3, "table_count": 0, "by_category": { "Other / uncategorized": 2, "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 135, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "8.1 Summary of Safety Concerns", "bates": "FDA-CBER-2022-1614-4220716", "context_preview": "ed disease (VAED) including vaccine-associated enhanced respiratory disease (VAERD) Missing information Use in pregnancy and while breastfeeding Long-term safety Use in immunocompromised subjects Interaction with other vaccines Use in frail subjects with unstable health conditions and comorbidities ", "likely_table": false }, { "page": 159, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "APPENDIX 2: SUMMARY OF EXPOSURE BY LOT DISTRIBUTION DATA", "bates": "FDA-CBER-2022-1614-4220740", "context_preview": "e than 0.1% of the total estimated doses administered, data have been presented as they were originally obtained. Batch Doses distributed 3001943 3001939 3001937 3001938 3001531 3001177 3000493 Netherlands 308,985 Norway 91,120 Poland 967,591 Portugal 214,724 Qatar* 360,360 Romania 417,436 Singapore", "likely_table": false }, { "page": 560, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "APPENDIX 10: Sudden Unexpected Death Narratives", "bates": "FDA-CBER-2022-1614-4221141", "context_preview": ": not provided not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not appl", "likely_table": false } ] }, { "filename": "27073_S198_M1_monthly-safety-rpt-01may2021-31may2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 192, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "APPENDIX 2: SUMMARY OF EXPOSURE BY LOT DISTRIBUTION DATA", "bates": "FDA-CBER-2022-1614-4221449", "context_preview": "ed on data from ECDC exceeds the number of doses distributed based on internal supply chain data. The proportion of doses distributed administered per the ECDC website ) was used to approximate the number of doses administered to avoid inflation of the administered dose count. Batch Doses Distribute", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-6007320001.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 5, "table_count": 0, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433307", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433307", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433308", "context_preview": "3 % Area 4 RRT 1 RRT 2 RRT 3 RRT 4 % Total Impurities Particulate Matter SOP-0509 10 \u00b5m particles per container 25 \u00b5m particles per container Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson N", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-6007320002.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 5, "table_count": 0, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433311", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433311", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433312", "context_preview": "3 % Area 4 RRT 1 RRT 2 RRT 3 RRT 4 % Total Impurities Particulate Matter SOP-0509 10 \u00b5m particles per container 25 \u00b5m particles per container Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson N", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-6007320004.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 5, "table_count": 0, "by_category": { "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433315", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433315", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433316", "context_preview": "3 % Area 4 RRT 1 RRT 2 RRT 3 RRT 4 % Total Impurities Particulate Matter SOP-0509 10 \u00b5m particles per container 25 \u00b5m particles per container Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson N", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-6007320005.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433319", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433319", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0107 Particle Size Polydispersity Lipid Identification SOP-0502 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433320", "context_preview": "ntent SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 % Area 5 % Area 6 RRT 1 RRT 2 RRT 3 RRT 4 RRT 5 RRT 6 Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-7006520006.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433323", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433323", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433324", "context_preview": "SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 % Area 5 % Area 6 % Area 7 % Area 8 RRT 1 RRT 2 RRT 3 RRT 4 Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-7006520007.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433327", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433327", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433328", "context_preview": "SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 % Area 5 % Area 6 % Area 7 % Area 8 RRT 1 RRT 2 RRT 3 RRT 4 Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-7006520008.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433331", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433331", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433332", "context_preview": "nt SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 % Area 5 % Area 6 % Area 7 RRT 1 RRT 2 RRT 3 RRT 4 RRT 5 Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-7006520009.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433335", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433335", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433336", "context_preview": "ntent SM102 Cholesterol DSPC PEG-DMG Lipid Impurities % Area 1 % Area 2 % Area 3 % Area 4 % Area 5 % Area 6 RRT 1 RRT 2 RRT 3 RRT 4 RRT 5 RRT 6 Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-7006520010.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433339", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433339", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433340", "context_preview": "% Area 2 % Area 3 % Area 4 % Area 5 RRT 1 RRT 2 RRT 3 RRT 4 RRT 5 % Total Impurities Particulate Matter SOP-0509 10 \u00b5m particles per container Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson ", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-7006520011.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433343", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433343", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433344", "context_preview": "% Area 2 % Area 3 % Area 4 % Area 5 RRT 1 RRT 2 RRT 3 RRT 4 RRT 5 % Total Impurities Particulate Matter SOP-0509 10 \u00b5m particles per container Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson ", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-7006520012.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433347", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433347", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433348", "context_preview": "% Area 2 % Area 3 % Area 4 % Area 5 RRT 1 RRT 2 RRT 3 RRT 4 RRT 5 % Total Impurities Particulate Matter SOP-0509 10 \u00b5m particles per container Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-2020 Generated Date: Steven Anderson ", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-7006520013.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433351", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433351", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433352", "context_preview": "% Area 2 % Area 3 % Area 4 % Area 5 RRT 1 RRT 2 RRT 3 RRT 4 RRT 5 % Total Impurities Particulate Matter SOP-0509 10 \u00b5m particles per container Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson ", "likely_table": false } ] }, { "filename": "27073_S19_M3_32p5_coa-lot-7006520015.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433355", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433355", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433356", "context_preview": "% Area 2 % Area 3 % Area 4 % Area 5 RRT 1 RRT 2 RRT 3 RRT 4 RRT 5 % Total Impurities Particulate Matter SOP-0509 10 \u00b5m particles per container Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 16-Dec-2020 Generated Date: Steven Anderson ", "likely_table": false } ] }, { "filename": "27073_S1_M1_eua-request-moderna-covid-19-vaccine.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 57, "table_count": 42, "by_category": { "Manufacturing / CMC": 28, "Pharmacology / toxicology": 22, "Other / uncategorized": 4, "Clinical safety / adverse events": 2, "Trial design / efficacy": 1 }, "by_marker": { "(b)(4)": 57 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MANUFACTURING SITE/CGMP STATUS", "bates": "FDA-CBER-2022-1614-4805166", "context_preview": "CX-024414 \u2022 Lot release of CX-024414 mRNA-1273 LNP \u2022 Manufacture of mRNA-1273 LNP \u2022 Release and stability testing of mRNA-1273 LNP (excludes bacterial endotoxin testing) \u2022 Lot release of mRNA-1273 LNP mRNA-1273 Drug Product \u2022 Release and stability testing of mRNA-1273 Drug Product (excludes bacteria", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MANUFACTURING SITE/CGMP STATUS", "bates": "FDA-CBER-2022-1614-4805166", "context_preview": "4 \u2022 Lot release of CX-024414 mRNA-1273 LNP \u2022 Manufacture of mRNA-1273 LNP \u2022 Release and stability testing of mRNA-1273 LNP (excludes bacterial endotoxin testing) \u2022 Lot release of mRNA-1273 LNP mRNA-1273 Drug Product \u2022 Release and stability testing of mRNA-1273 Drug Product (excludes bacterial endoto", "likely_table": true }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "MANUFACTURING SITE/CGMP STATUS", "bates": "FDA-CBER-2022-1614-4805166", "context_preview": "release of CX-024414 mRNA-1273 LNP \u2022 Manufacture of mRNA-1273 LNP \u2022 Release and stability testing of mRNA-1273 LNP (excludes bacterial endotoxin testing) \u2022 Lot release of mRNA-1273 LNP mRNA-1273 Drug Product \u2022 Release and stability testing of mRNA-1273 Drug Product (excludes bacterial endotoxin and ", "likely_table": true } ] }, { "filename": "27073_S20_M1_mrna-1273-deviation-283121-tech-summ.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 165, "table_count": 160, "by_category": { "Trade-secret claim": 58, "Inspection / enforcement": 54, "Manufacturing / CMC": 40, "Other / uncategorized": 13 }, "by_marker": { "(b)(4)": 165 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "section of the MBR were issued for Lot 038K20 to document the re-filtration.", "bates": "FDA-CBER-2022-1614-4805394", "context_preview": "(only of the batch was able to be filtered during the subsequent filtration). 3.2. Long Term Actions \u2022 vendor investigation initiated by Catalent \u2022 Conduct awareness communication of this issue per A-SOP-03-01-008 Event and Deviation Reporting to remind operators to handle with care and to inspect f", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "section of the MBR were issued for Lot 038K20 to document the re-filtration.", "bates": "FDA-CBER-2022-1614-4805394", "context_preview": "of the batch was able to be filtered during the subsequent filtration). 3.2. Long Term Actions \u2022 vendor investigation initiated by Catalent \u2022 Conduct awareness communication of this issue per A-SOP-03-01-008 Event and Deviation Reporting to remind operators to handle with care and to inspect for dam", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "section of the MBR were issued for Lot 038K20 to document the re-filtration.", "bates": "FDA-CBER-2022-1614-4805394", "context_preview": "batch was able to be filtered during the subsequent filtration). 3.2. Long Term Actions \u2022 vendor investigation initiated by Catalent \u2022 Conduct awareness communication of this issue per A-SOP-03-01-008 Event and Deviation Reporting to remind operators to handle with care and to inspect for damaged pr", "likely_table": true } ] }, { "filename": "27073_S20_M1_quality-info-amendment.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 2, "table_count": 0, "by_category": { "Inspection / enforcement": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "1.11.1 \nQuality Information Amendment", "bates": "FDA-CBER-2022-1614-4433359", "context_preview": "ile boundary had been breached. No product had been filled at the time of the detection of the leak. Per a teleconference on December 16, 2020 with FDA , the CofA for Lot 7006520014, the deviation investigation from Catalent (REC 283121), and the technical summary are being provided. The CofA will a", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "1.11.1 \nQuality Information Amendment", "bates": "FDA-CBER-2022-1614-4433359", "context_preview": "dary had been breached. No product had been filled at the time of the detection of the leak. Per a teleconference on December 16, 2020 with FDA , the CofA for Lot 7006520014, the deviation investigation from Catalent (REC 283121), and the technical summary are being provided. The CofA will also be s", "likely_table": false } ] }, { "filename": "27073_S20_M3_32p5_coa-lot-7006520014.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433361", "context_preview": "Translation SOP-0937 Result pH SOP-0288 pH Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433363", "context_preview": "rility USP <71> Sterility This material meets specification: Yes 1.0 - Original Unlabeled Drug Product Lot 6007320011 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 1", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433363", "context_preview": "SP <71> Sterility This material meets specification: Yes 1.0 - Original Unlabeled Drug Product Lot 6007320011 Drug Substance Manufacturer: Moderna, Norwood, MA Revision History: Page 3 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 15-Dec-20", "likely_table": false } ] }, { "filename": "27073_S21_M1_mrna-1273-deviation-284379-tech-summ.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 144, "table_count": 133, "by_category": { "Trade-secret claim": 61, "Other / uncategorized": 44, "Inspection / enforcement": 22, "Manufacturing / CMC": 17 }, "by_marker": { "(b)(4)": 144 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "REC 284379", "bates": "FDA-CBER-2022-1614-4805429", "context_preview": "for ~9 hours. 3.1.3. Manufacturing Technology Specialist reviewed the The appeared to be fully engaged when they performed a visual review of the connection. 3.1.4. A second filtration pathway was setup. Bioburden and were resampled, and the batch was re-filtered (only of the batch was able to be fi", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "REC 284379", "bates": "FDA-CBER-2022-1614-4805429", "context_preview": "hours. 3.1.3. Manufacturing Technology Specialist reviewed the The appeared to be fully engaged when they performed a visual review of the connection. 3.1.4. A second filtration pathway was setup. Bioburden and were resampled, and the batch was re-filtered (only of the batch was able to be filtered ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "REC 284379", "bates": "FDA-CBER-2022-1614-4805429", "context_preview": "3.1.3. Manufacturing Technology Specialist reviewed the The appeared to be fully engaged when they performed a visual review of the connection. 3.1.4. A second filtration pathway was setup. Bioburden and were resampled, and the batch was re-filtered (only of the batch was able to be filtered during ", "likely_table": true } ] }, { "filename": "27073_S21_M1_quality-info-amendment-lot-6008620003.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 2, "table_count": 0, "by_category": { "Inspection / enforcement": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "1.11.1 \nQuality Information Amendment", "bates": "FDA-CBER-2022-1614-4433365", "context_preview": "ched. No product had been filled at the time of the detection of the leak. Per a teleconference on December 16, 2020 with FDA , the CofA for Lot 6008620003 (Catalent Lot 027L20), the deviation investigation from Catalent (REC 284379), and the technical summary are being provided. The CofA will also ", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": "1.11.1 \nQuality Information Amendment", "bates": "FDA-CBER-2022-1614-4433365", "context_preview": "product had been filled at the time of the detection of the leak. Per a teleconference on December 16, 2020 with FDA , the CofA for Lot 6008620003 (Catalent Lot 027L20), the deviation investigation from Catalent (REC 284379), and the technical summary are being provided. The CofA will also be submit", "likely_table": false } ] }, { "filename": "27073_S21_M3_32p5_coa-lot-6008620003.pdf", "module": "M3", "company": "Moderna", "license": "EUA", "total_kept": 6, "table_count": 0, "by_category": { "Manufacturing / CMC": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433368", "context_preview": "H Osmolality SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Dec-2020 Generated Date: Steven Anderson", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433368", "context_preview": "lity SOP-0279 Osmolality Dynamic Light Scattering SOP-0998 Particle Size Polydispersity Lipid Identification SOP-1001 SM102 Cholesterol Page 1 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Dec-2020 Generated Date: Steven Anderson Number:", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION", "bates": "FDA-CBER-2022-1614-4433369", "context_preview": "% Area 2 % Area 3 % Area 4 % Area 5 RRT 1 RRT 2 RRT 3 RRT 4 RRT 5 % Total Impurities Particulate Matter SOP-0509 10 \u00b5m particles per container Page 2 of 3 CONFIDENTIAL - DO NOT DISTRIBUTE OUTSIDE OF MODERNATX, INC. WITHOUT WRITTEN PERMISSION Generated By: 17-Dec-2020 Generated Date: Steven Anderson ", "likely_table": false } ] }, { "filename": "27073_S249_M1_pbrer-01-18dec2020-30jun2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 5, "table_count": 0, "by_category": { "Manufacturing / CMC": 2, "Other / uncategorized": 2, "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 5 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": "EXECUTIVE SUMMARY", "bates": "FDA-CBER-2022-1614-4222285", "context_preview": "TX, Inc has subsequently conducted weekly downloads from the VAERS website of all mRNA-1273 cases reported to VAERS in addition to conducting routine signal detection of the entire VAERS database (utilising the Empirica\u00ae, Oracle, Austin, TX). ModernaTX, Inc recently reviewed the relative contributio", "likely_table": false }, { "page": 32, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "INTRODUCTION", "bates": "FDA-CBER-2022-1614-4222314", "context_preview": "ed with N-methyl-pseudouridine, a naturally-occurring pyrimidine base present in mammalian transfer RNAs [1,2]. This nucleoside is included in mRNA-1273 drug substance in place of the normal uridine base to minimise the indiscriminate recognition of the mRNA-1273 by pathogen-associated molecular pat", "likely_table": false }, { "page": 42, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "73.4 \nEuropean Economic Area", "bates": "FDA-CBER-2022-1614-4222324", "context_preview": "ontrol (ECDC) [8], Health Canada [9], Swiss Federal Office of Public Health [10], and Our World in Data [6]. These estimates reflect an additional 27,194,595 doses administered since the last monthly report. Table 5-7. Vaccine Doses Distributed and Administered through the reporting period and cumul", "likely_table": false } ] }, { "filename": "27073_S267_M1_rsp-fda-cmts-clinical-29jul2021.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 3, "table_count": 0, "by_category": { "Clinical safety / adverse events": 2, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": "RESPONSE TO FDA COMMENTS ON CLINICAL RECEIVED ON JULY 29, 2021", "bates": "FDA-CBER-2022-1614-4992541", "context_preview": "er self-report (with valid documentation). Because external COVID-19 vaccination can be captured in the KPSC EHR data by manual entry and automated updates from mechanisms such as CAIR and claims, assessment of vaccination via the KPSC system is thorough and as complete as possible in a pandemic set", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": "RESPONSE TO FDA COMMENTS ON CLINICAL RECEIVED ON JULY 29, 2021", "bates": "FDA-CBER-2022-1614-4992541", "context_preview": "report (with valid documentation). Because external COVID-19 vaccination can be captured in the KPSC EHR data by manual entry and automated updates from mechanisms such as CAIR and claims, assessment of vaccination via the KPSC system is thorough and as complete as possible in a pandemic setting. To", "likely_table": false }, { "page": 10, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "0.82 \n \nBased on Moderna COVID-19 vaccine implementation plan and anticipated uptake, we expected", "bates": "FDA-CBER-2022-1614-4992550", "context_preview": "act with a COVID-19- positive individual, residents or employees of congregate living facilities, employment (e.g., healthcare workers, first responders, essential workers, or any others who require testing for workplace), school or daycare, or any other reason. In addition, asymptomatic individuals", "likely_table": false } ] }, { "filename": "27073_S3_M1_submission-plan-eua.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 38, "table_count": 33, "by_category": { "Manufacturing / CMC": 25, "Pharmacology / toxicology": 8, "Trial design / efficacy": 5 }, "by_marker": { "(b)(4)": 38 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "4.2.3.7.2\nImmunotoxicity Study", "bates": "FDA-CBER-2022-1614-4805316", "context_preview": "now in IND to review ahead of EUA Submission IND Module 3 3.2.S and 3.2.P Analytical methods descriptions, validation summaries and documentation to support CX-024414 mRNA, mRNA-1273 LNP SN0053 Available now in IND to review ahead of EUA Submission IND Module 4 4.2.1.3 Safety Pharmacology Report SN0", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "4.2.3.7.2\nImmunotoxicity Study", "bates": "FDA-CBER-2022-1614-4805316", "context_preview": "IND to review ahead of EUA Submission IND Module 3 3.2.S and 3.2.P Analytical methods descriptions, validation summaries and documentation to support CX-024414 mRNA, mRNA-1273 LNP SN0053 Available now in IND to review ahead of EUA Submission IND Module 4 4.2.1.3 Safety Pharmacology Report SN0001 Ava", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Pharmacology / toxicology", "section_heading": "4.2.3.7.2\nImmunotoxicity Study", "bates": "FDA-CBER-2022-1614-4805316", "context_preview": "review ahead of EUA Submission IND Module 3 3.2.S and 3.2.P Analytical methods descriptions, validation summaries and documentation to support CX-024414 mRNA, mRNA-1273 LNP SN0053 Available now in IND to review ahead of EUA Submission IND Module 4 4.2.1.3 Safety Pharmacology Report SN0001 Available ", "likely_table": true } ] }, { "filename": "27073_S6_M1_list-vrbpac-mtg-attendees.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 1, "table_count": 1, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2022-1614-4432996", "context_preview": "@moderntx.com Robert Paris Moderna @moderntx.com Darin Edwards Moderna @moderntx.com Melissa Rossi Moderna @moderntx.com Barbara Kuter Moderna @moderntx.com Moderna @moderntx.com Carla Vinals Moderna @moderntx.com Michelle Olsen Moderna Michelle.Olsen@moderntx.com Rodrigo Laureano Moderna modernatx.", "likely_table": true } ] }, { "filename": "27073_S7_M1_draft-702195-eua-vial-label-new-line.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NDC 80777-273-10", "bates": "FDA-CBER-2022-1614-4805320", "context_preview": "1273 Vial Label Size DATE: JOB: DIE# APPROVED BY: PART # INSTRUCTIONS: VERSION: Moderna US, Inc. Cambridge, MA 02139 12/04/20 Layout Number: LN00025085 P/N 702195 Version R1_V1 2D Datamatrix code encoded P/N 702195 QR code encoded with https://www.modernatx.com/covid19vaccine-eua Varnish line Varnis", "likely_table": false } ] }, { "filename": "27073_S7_M1_draft-702208-eua-carton-manual.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "CARTON LEGEND", "bates": "FDA-CBER-2022-1614-4805324", "context_preview": "702208 After \ufb01rst use, hold at 2\u00b0-25\u00b0C (36\u00b0-77\u00b0F). Discard after 6 hours. Do not refreeze. NDC 80777-273-99 NDC 80777-273-99 702208 mRNA-1273 10ct Vial Carton Size DATE: JOB: DIE# APPROVED BY: PART # INSTRUCTIONS: VERSION: Moderna US, Inc. Cambridge, MA 02139 12/03/20 201974 Rev. 2 P/N 702208 Versio", "likely_table": false } ] }, { "filename": "27073_S7_M1_draft-702210-eua-vial-label.pdf", "module": "M1", "company": "Moderna", "license": "EUA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "NDC 80777-273-10", "bates": "FDA-CBER-2022-1614-4805331", "context_preview": "1273 Vial Label Size DATE: JOB: DIE# APPROVED BY: PART # INSTRUCTIONS: VERSION: Moderna US, Inc. Cambridge, MA 02139 12/03/20 Layout Number: LN00025085 P/N 702210 Version R7_V1 2D Datamatrix code encoded P/N 702210 QR code encoded with https://www.modernatx.com/covid19vaccine-eua Varnish line Varnis", "likely_table": false } ] }, { "filename": "27073_S99_M1_monthly-safety-rpt-18jan2021-17feb2021.pdf", "module": "M1", "company": "Moderna", "license": "BLA", "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 10, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "5.2 \nTraceability", "bates": "FDA-CBER-2022-1614-4219232", "context_preview": "administered vaccine to improve traceability. Moderna has also developed Traceability and Vaccination Reminder cards (printed cards to vaccinators as of March 2021), that may be completed at the time of vaccination when necessary for individual member states. The card will be also accessible electro", "likely_table": false } ] }, { "filename": "27_BLA-125752-0_10-22-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 32, "table_count": 32, "by_category": { "Manufacturing / CMC": 23, "Other / uncategorized": 9 }, "by_marker": { "(b)(4)": 32 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "QC-MVR-0009.", "bates": "FDA-CBER-2022-1614-3816093", "context_preview": "information provided for the qualification of a new lot of to verify its suitability before using in release testing. Please provide the qualification procedure for new lots. 2. Regarding determination of % RNA Encapsulation by (SOP# 1000): a) Per SOP 1000, a Response Factor (RF) of is used for dete", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "QC-MVR-0009.", "bates": "FDA-CBER-2022-1614-3816093", "context_preview": "tion provided for the qualification of a new lot of to verify its suitability before using in release testing. Please provide the qualification procedure for new lots. 2. Regarding determination of % RNA Encapsulation by (SOP# 1000): a) Per SOP 1000, a Response Factor (RF) of is used for determinati", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "QC-MVR-0009.", "bates": "FDA-CBER-2022-1614-3816093", "context_preview": "vided for the qualification of a new lot of to verify its suitability before using in release testing. Please provide the qualification procedure for new lots. 2. Regarding determination of % RNA Encapsulation by (SOP# 1000): a) Per SOP 1000, a Response Factor (RF) of is used for determination of fr", "likely_table": true } ] }, { "filename": "28_BLA-125742-0_07-20-2021_Memo_Review.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 1, "table_count": 0, "by_category": { "Trial design / efficacy": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": null, "bates": "FDA-CBER-2021-5683-1058205", "context_preview": ": \u2022 Reactogenicity events that begin within the prespecified assessment period but are currently reported in the AE dataset should be transferred from AE to FACE, or be flagged in AE so that we know that it is being included in the CE dataset. \u2022 Records covering the entire event duration (which coul", "likely_table": false } ] }, { "filename": "2_IND_19736_214_03-Mar-2021_KERRY_KERRY__RO_-.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150399", "context_preview": "EH D ULVN\u0011 \u001b ,PPXQH WKURPERF\\WRSHQLD ZDV HYDOXDWHG DQG GHWHUPLQHG QRW WR EH D ULVN\u0011 2YHUGRVH ZDV HYDOXDWHG\u0011 7KH VSRQVRU GHWHUPLQHG QR XSGDWH WR WKH ODEHO ZDV QHHGHG\u0011 \u0014\u0013 (\\H SDLQ DQG VZHOOLQJ ZHUH HYDOXDWHG DQG GHWHUPLQHG QRW WR EH ULVNV\u0011 \u0014\u0014 'L]]LQHVV HYDOXDWLRQ LV RQJRLQJ\u0011 \u0014\u0015 )DFLDO SDUDO\\VLV HYDOXD", "likely_table": false } ] }, { "filename": "31_BLA-125752-0_11-01-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 8, "table_count": 0, "by_category": { "Manufacturing / CMC": 8 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816771", "context_preview": "fication studies conducted as part of process performance qualification (PPQ) batches [Section 3.2.P.3.5.1.3.5 Process Validation and/or Evaluation {Catalent} and PPQ report VPPQ-256-100-00003-S for DP manufacture at Catalent]. Table \u2013 DP cumulative process durations Process Parameter PAR Criticalit", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816771", "context_preview": "studies conducted as part of process performance qualification (PPQ) batches [Section 3.2.P.3.5.1.3.5 Process Validation and/or Evaluation {Catalent} and PPQ report VPPQ-256-100-00003-S for DP manufacture at Catalent]. Table \u2013 DP cumulative process durations Process Parameter PAR Criticality Designa", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816771", "context_preview": "conducted as part of process performance qualification (PPQ) batches [Section 3.2.P.3.5.1.3.5 Process Validation and/or Evaluation {Catalent} and PPQ report VPPQ-256-100-00003-S for DP manufacture at Catalent]. Table \u2013 DP cumulative process durations Process Parameter PAR Criticality Designation Tot", "likely_table": false } ] }, { "filename": "32_1_BLA-125742-0_07-26-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 53, "table_count": 53, "by_category": { "Manufacturing / CMC": 47, "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 53 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150188", "context_preview": "nufacturing, please provide the in-process action limit for bioburden and endotoxin. 5. Please clarify that bioburden sampling for the is taken at the . 6. Please provide the shipping validation for shipments of Additionally, clarify if all shipments of will be temperature monitored and shipped via ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150188", "context_preview": "ing, please provide the in-process action limit for bioburden and endotoxin. 5. Please clarify that bioburden sampling for the is taken at the . 6. Please provide the shipping validation for shipments of Additionally, clarify if all shipments of will be temperature monitored and shipped via validate", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150188", "context_preview": "ase provide the in-process action limit for bioburden and endotoxin. 5. Please clarify that bioburden sampling for the is taken at the . 6. Please provide the shipping validation for shipments of Additionally, clarify if all shipments of will be temperature monitored and shipped via validated shippi", "likely_table": true } ] }, { "filename": "37_BLA-125752-0_11-10-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 14, "table_count": 6, "by_category": { "Manufacturing / CMC": 13, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 14 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816784", "context_preview": "will be used post licensure for lot release and stability studies. The following comments pertain to the implementation of SOP 1142. Different nomenclatures were used for the identification of mRNA purity and product- related impurity peaks in each SOP. In this communication, we will use the followi", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816784", "context_preview": "used post licensure for lot release and stability studies. The following comments pertain to the implementation of SOP 1142. Different nomenclatures were used for the identification of mRNA purity and product- related impurity peaks in each SOP. In this communication, we will use the following nomen", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816784", "context_preview": "t licensure for lot release and stability studies. The following comments pertain to the implementation of SOP 1142. Different nomenclatures were used for the identification of mRNA purity and product- related impurity peaks in each SOP. In this communication, we will use the following nomenclature ", "likely_table": true } ] }, { "filename": "38_1_BLA-125742-0_08-02-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 38, "table_count": 38, "by_category": { "Other / uncategorized": 27, "Trade-secret claim": 11 }, "by_marker": { "(b)(4)": 38 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND", "bates": "FDA-CBER-2021-5683-1024725", "context_preview": "for Biologics Evaluation & Research Office of Vaccines Research & Review Division of Vaccines and Related Products Applications Tel: 301-796-2640 michael.smith2@fda.hhs.gov THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, ", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND", "bates": "FDA-CBER-2021-5683-1024725", "context_preview": "logics Evaluation & Research Office of Vaccines Research & Review Division of Vaccines and Related Products Applications Tel: 301-796-2640 michael.smith2@fda.hhs.gov THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDE", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND", "bates": "FDA-CBER-2021-5683-1024725", "context_preview": "valuation & Research Office of Vaccines Research & Review Division of Vaccines and Related Products Applications Tel: 301-796-2640 michael.smith2@fda.hhs.gov THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, A", "likely_table": true } ] }, { "filename": "39_2_BLA-125742-0_08-02-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 21, "table_count": 18, "by_category": { "Manufacturing / CMC": 17, "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 21 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150194", "context_preview": "added. Please confirm that this method will be used for lot release testing by the PSG-KZO laboratory and that the container volume specification \u201cNot less than mL\u201d is the same regardless of test site/method. 4. Regarding your response (in STN 125742/0.16 dated July 23, 2021) to our IR dated July 9,", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150194", "context_preview": "confirm that this method will be used for lot release testing by the PSG-KZO laboratory and that the container volume specification \u201cNot less than mL\u201d is the same regardless of test site/method. 4. Regarding your response (in STN 125742/0.16 dated July 23, 2021) to our IR dated July 9, 2021, about t", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150194", "context_preview": "that this method will be used for lot release testing by the PSG-KZO laboratory and that the container volume specification \u201cNot less than mL\u201d is the same regardless of test site/method. 4. Regarding your response (in STN 125742/0.16 dated July 23, 2021) to our IR dated July 9, 2021, about the valid", "likely_table": true } ] }, { "filename": "3_BLA-125742-0_05-20-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 3, "table_count": 0, "by_category": { "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150169", "context_preview": "Please provide this information by Monday May 24, 2021, and please provide a time early next week, preferably Tuesday, May 25, 2021, or Wednesday, May 26, 2021, for a teleconference to discuss production schedules and the shutdown activities planned for the Puurs, Belgium site. Regards, Mike - Pleas", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150169", "context_preview": "e provide this information by Monday May 24, 2021, and please provide a time early next week, preferably Tuesday, May 25, 2021, or Wednesday, May 26, 2021, for a teleconference to discuss production schedules and the shutdown activities planned for the Puurs, Belgium site. Regards, Mike - Please con", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150169", "context_preview": "e this information by Monday May 24, 2021, and please provide a time early next week, preferably Tuesday, May 25, 2021, or Wednesday, May 26, 2021, for a teleconference to discuss production schedules and the shutdown activities planned for the Puurs, Belgium site. Regards, Mike - Please confirm rec", "likely_table": false } ] }, { "filename": "3_IND_19736_243_19-Mar-2021_KERRY_KERRY__RO_-.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "FXPXODWLYH GRVHV", "bates": "FDA-CBER-2021-5683-1150401", "context_preview": "D ULVN\u000f EXW ZLOO EH UH\u0010HYDOXDWHG RQFH ILQDO VDIHW\\ GDWD IURP 6WXG\\ &\u0017\u0018 \u0014\u0013\u0013\u0014 LV DYDLODEOH LQ PLG\u0010$SULO \u0015\u0013\u0015\u0014 +HUSHV =RVWHU HYDOXDWLRQ LV RQJRLQJ \u0014\u0013 3DUDHVWKHVLD DQG G\\VDHVWKHVLD HYDOXDWLRQ LV RQJRLQJ \u0014\u0014 7DFK\\FDUGLD HYDOXDWLRQ LV RQJRLQJ \u0014\u0015 *XLOODLQ\u0010%DUUH V\\QGURPH ZDV GHWHUPLQHG QRW WR EH D VLJQDO \u0014\u0016 0", "likely_table": false } ] }, { "filename": "40_2_BLA-125742-0_08-03-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 24, "table_count": 24, "by_category": { "Manufacturing / CMC": 24 }, "by_marker": { "(b)(4)": 24 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.5 Process Validation and/or Evaluation \u2013 Additional Process", "bates": "FDA-CBER-2021-5683-1150197", "context_preview": "s\u201d in Section 3.2.S.2.5 Process Validation and/or Evaluation \u2013 Additional Process Evaluation to include the acceptance criteria/action limit for the performance-related parameters based on the results from the initial validation studies and the experience from commercial production. 3. In document I", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.5 Process Validation and/or Evaluation \u2013 Additional Process", "bates": "FDA-CBER-2021-5683-1150197", "context_preview": "ction 3.2.S.2.5 Process Validation and/or Evaluation \u2013 Additional Process Evaluation to include the acceptance criteria/action limit for the performance-related parameters based on the results from the initial validation studies and the experience from commercial production. 3. In document INX100433", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.S.2.5 Process Validation and/or Evaluation \u2013 Additional Process", "bates": "FDA-CBER-2021-5683-1150197", "context_preview": ".2.S.2.5 Process Validation and/or Evaluation \u2013 Additional Process Evaluation to include the acceptance criteria/action limit for the performance-related parameters based on the results from the initial validation studies and the experience from commercial production. 3. In document INX100433827: CO", "likely_table": true } ] }, { "filename": "42_1_BLA-125742-0_08-04-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 20, "table_count": 17, "by_category": { "Manufacturing / CMC": 17, "Trade-secret claim": 3 }, "by_marker": { "(b)(4)": 20 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150201", "context_preview": "in vitro expression test template (Attachment 5) to report the drug product test results \u2022 RNA integrity Please provide that are RNA for each sample replicate and insert the reference standard above this line so that the sample lines are not obscured. Please include clear labels for product and that", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150201", "context_preview": "o expression test template (Attachment 5) to report the drug product test results \u2022 RNA integrity Please provide that are RNA for each sample replicate and insert the reference standard above this line so that the sample lines are not obscured. Please include clear labels for product and that were i", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150201", "context_preview": "sion test template (Attachment 5) to report the drug product test results \u2022 RNA integrity Please provide that are RNA for each sample replicate and insert the reference standard above this line so that the sample lines are not obscured. Please include clear labels for product and that were included ", "likely_table": true } ] }, { "filename": "43A_STN-125742.0-4AUG21-LRP-FU-IR-2.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 11, "table_count": 6, "by_category": { "Manufacturing / CMC": 10, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "20100001.P0 \n \nSample Status", "bates": "FDA-CBER-2021-5683-1150205", "context_preview": "License Name of Product RNA encapsulation and content test Test date Test method __________________ Sample/Control Specification Result R2 for Standard A R2 for Standard B RNA (mg/mL) Total RNA (mg/mL) Encapsulated RNA (mg/mL) Encapsulated RNA ( ) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "20100001.P0 \n \nSample Status", "bates": "FDA-CBER-2021-5683-1150205", "context_preview": "License Name of Product RNA encapsulation and content test Test date Test method __________________ Sample/Control Specification Result R2 for Standard A R2 for Standard B RNA (mg/mL) Total RNA (mg/mL) Encapsulated RNA (mg/mL) Encapsulated RNA ( ) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "20100001.P0 \n \nSample Status", "bates": "FDA-CBER-2021-5683-1150205", "context_preview": "License Name of Product RNA encapsulation and content test Test date Test method __________________ Sample/Control Specification Result R2 for Standard A R2 for Standard B RNA (mg/mL) Total RNA (mg/mL) Encapsulated RNA (mg/mL) Encapsulated RNA ( ) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) FDA-", "likely_table": true } ] }, { "filename": "43_2_BLA-125742-0_08-04-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 18, "table_count": 14, "by_category": { "Manufacturing / CMC": 18 }, "by_marker": { "(b)(4)": 18 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1024822", "context_preview": "ne so that the sample lines are not obscured. Please include clear labels for product and that were included in the analysis of each Include the name of the test method, the specification, date of test and the result on the same page as the \u2022 Bacterial endotoxin Please use the Limulus Amebocyte Lysa", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1024822", "context_preview": "at the sample lines are not obscured. Please include clear labels for product and that were included in the analysis of each Include the name of the test method, the specification, date of test and the result on the same page as the \u2022 Bacterial endotoxin Please use the Limulus Amebocyte Lysate Test ", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1024822", "context_preview": "ample lines are not obscured. Please include clear labels for product and that were included in the analysis of each Include the name of the test method, the specification, date of test and the result on the same page as the \u2022 Bacterial endotoxin Please use the Limulus Amebocyte Lysate Test template", "likely_table": true } ] }, { "filename": "44_3_BLA-125742-0_08-04-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 7, "table_count": 7, "by_category": { "Inspection / enforcement": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150209", "context_preview": "w you calculated the overall %RSD for 2. We note that, in Tables 14-1 and 14-2 on Page 21 of the report, the mean S1+ (%) results from compared to the results from . This trend becomes more , which may indicate some systematic difference between . Please comment and explain why you consider reproduc", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150209", "context_preview": "alculated the overall %RSD for 2. We note that, in Tables 14-1 and 14-2 on Page 21 of the report, the mean S1+ (%) results from compared to the results from . This trend becomes more , which may indicate some systematic difference between . Please comment and explain why you consider reproducibility", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Inspection / enforcement", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150209", "context_preview": "d the overall %RSD for 2. We note that, in Tables 14-1 and 14-2 on Page 21 of the report, the mean S1+ (%) results from compared to the results from . This trend becomes more , which may indicate some systematic difference between . Please comment and explain why you consider reproducibility to be a", "likely_table": true } ] }, { "filename": "46_2_BLA-125742-0_08-05-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 39, "table_count": 36, "by_category": { "Manufacturing / CMC": 28, "Other / uncategorized": 8, "Trade-secret claim": 3 }, "by_marker": { "(b)(4)": 39 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.A.1", "bates": "FDA-CBER-2021-5683-1150212", "context_preview": "owing information: a. Provide the cleaning validation results (or rationale for lack thereof) for the following equipment - - b. Specify the maximum clean hold times and provide clean hold time validation results for each equipment. c. Specify the equipment cleaning verification frequency and the pa", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.A.1", "bates": "FDA-CBER-2021-5683-1150212", "context_preview": "nformation: a. Provide the cleaning validation results (or rationale for lack thereof) for the following equipment - - b. Specify the maximum clean hold times and provide clean hold time validation results for each equipment. c. Specify the equipment cleaning verification frequency and the parameter", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "3.2.A.1", "bates": "FDA-CBER-2021-5683-1150212", "context_preview": "on: a. Provide the cleaning validation results (or rationale for lack thereof) for the following equipment - - b. Specify the maximum clean hold times and provide clean hold time validation results for each equipment. c. Specify the equipment cleaning verification frequency and the parameters to be ", "likely_table": true } ] }, { "filename": "46_BLA-125752-0_11-29-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 29, "table_count": 29, "by_category": { "Other / uncategorized": 15, "Manufacturing / CMC": 14 }, "by_marker": { "(b)(4)": 29 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816858", "context_preview": "ModernaTX, Inc. Email: Michelle.Olsen@modernatx.com From: Joseph Kulinski, Ph.D. DVRPA/OVRR/CBER Email: Joseph.Kulinski@fda.hhs.gov Product: COVID-19 Vaccine, mRNA (SPIKEVAX) Subject: CMC Information We are reviewing the CMC information submitted in the BLA STN 125752 regarding the , mRNA-1273 LNP D", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816858", "context_preview": "X, Inc. Email: Michelle.Olsen@modernatx.com From: Joseph Kulinski, Ph.D. DVRPA/OVRR/CBER Email: Joseph.Kulinski@fda.hhs.gov Product: COVID-19 Vaccine, mRNA (SPIKEVAX) Subject: CMC Information We are reviewing the CMC information submitted in the BLA STN 125752 regarding the , mRNA-1273 LNP DS and mR", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816858", "context_preview": "Email: Michelle.Olsen@modernatx.com From: Joseph Kulinski, Ph.D. DVRPA/OVRR/CBER Email: Joseph.Kulinski@fda.hhs.gov Product: COVID-19 Vaccine, mRNA (SPIKEVAX) Subject: CMC Information We are reviewing the CMC information submitted in the BLA STN 125752 regarding the , mRNA-1273 LNP DS and mRNA-1273 ", "likely_table": true } ] }, { "filename": "47_BLA-125752-0_12-01-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 8, "table_count": 7, "by_category": { "Manufacturing / CMC": 7, "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 8 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816860", "context_preview": "ease provide data from a dilution study of samples that includes the percent positive product control (PPC %) recovery at each dilution of DP, up to the Maximum Valid Dilution (MVD). 3. From the data generated in the preceding request, we ask that you identify a dilution for testing DP within the ra", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816860", "context_preview": "ovide data from a dilution study of samples that includes the percent positive product control (PPC %) recovery at each dilution of DP, up to the Maximum Valid Dilution (MVD). 3. From the data generated in the preceding request, we ask that you identify a dilution for testing DP within the range of ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816860", "context_preview": "ta from a dilution study of samples that includes the percent positive product control (PPC %) recovery at each dilution of DP, up to the Maximum Valid Dilution (MVD). 3. From the data generated in the preceding request, we ask that you identify a dilution for testing DP within the range of 50-200% ", "likely_table": true } ] }, { "filename": "50_BLA-125752-0_12-07-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 7, "table_count": 0, "by_category": { "Manufacturing / CMC": 7 }, "by_marker": { "(b)(4)": 7 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816875", "context_preview": "nclude additional information as stated in the proposed template below: Page 11 of 12: 8. Sterility test \u2013 please include the test method and test result details. Include the information as stated in the proposed template below: SOP number: On Test Date Medium/Temperature Number of vials tested Off ", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816875", "context_preview": "dditional information as stated in the proposed template below: Page 11 of 12: 8. Sterility test \u2013 please include the test method and test result details. Include the information as stated in the proposed template below: SOP number: On Test Date Medium/Temperature Number of vials tested Off Test Dat", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816875", "context_preview": "l information as stated in the proposed template below: Page 11 of 12: 8. Sterility test \u2013 please include the test method and test result details. Include the information as stated in the proposed template below: SOP number: On Test Date Medium/Temperature Number of vials tested Off Test Date Result", "likely_table": false } ] }, { "filename": "51_BLA-125752-0_12-09-2021_Telecon_Advice.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 3, "table_count": 0, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "section 1), the immunobridging benchmark population will consist of the PP", "bates": "FDA-CBER-2022-1614-3816885", "context_preview": "ariants of concern. Does CBER concur? 3) Assessment of and Clinical Development in Pediatrics 6m to <2 years and to 2 to <6 years a. The Sponsor acknowledges the Agency\u2019s comments to consider changes to the clinical development plan for 6m to <2 years and 2 to <6 years and shares that plans to explo", "likely_table": false }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "section 1), the immunobridging benchmark population will consist of the PP", "bates": "FDA-CBER-2022-1614-3816885", "context_preview": "of concern. Does CBER concur? 3) Assessment of and Clinical Development in Pediatrics 6m to <2 years and to 2 to <6 years a. The Sponsor acknowledges the Agency\u2019s comments to consider changes to the clinical development plan for 6m to <2 years and 2 to <6 years and shares that plans to explore the f", "likely_table": false }, { "page": 7, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "section 1), the immunobridging benchmark population will consist of the PP", "bates": "FDA-CBER-2022-1614-3816885", "context_preview": "rn. Does CBER concur? 3) Assessment of and Clinical Development in Pediatrics 6m to <2 years and to 2 to <6 years a. The Sponsor acknowledges the Agency\u2019s comments to consider changes to the clinical development plan for 6m to <2 years and 2 to <6 years and shares that plans to explore the feasibili", "likely_table": false } ] }, { "filename": "51_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Memo-COMIRNATY.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 1, "table_count": 0, "by_category": { "Clinical safety / adverse events": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Clinical safety / adverse events", "section_heading": "Module 1.16.1, dated July 28, 2021; received July 29, 2021)", "bates": null, "context_preview": "se in individuals 12 through 15 years of age with addition of following warning in Fact Sheet for Healthcare Providers: \u201cSyncope (fainting) may occur in association with administration of injectable vaccines, in particular adolescents. Procedures should be in place to avoid injury from fainting.\u201d Ma", "likely_table": false } ] }, { "filename": "52_1_BLA-125742-0_08-06-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 11, "table_count": 11, "by_category": { "Manufacturing / CMC": 11 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150222", "context_preview": "21). However, the process validation for the batch size was not executed with this step. Please clarify that during the routine commercial-scale manufacturing process, the step is only applied to the batch scale at Pfizer Puurs. Please also update the document 3.2.P.3.3 Description of Manufacturing ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150222", "context_preview": "ever, the process validation for the batch size was not executed with this step. Please clarify that during the routine commercial-scale manufacturing process, the step is only applied to the batch scale at Pfizer Puurs. Please also update the document 3.2.P.3.3 Description of Manufacturing Process ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150222", "context_preview": "e process validation for the batch size was not executed with this step. Please clarify that during the routine commercial-scale manufacturing process, the step is only applied to the batch scale at Pfizer Puurs. Please also update the document 3.2.P.3.3 Description of Manufacturing Process and Proc", "likely_table": true } ] }, { "filename": "52_BLA-125752-0_12-09-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 16, "table_count": 16, "by_category": { "Manufacturing / CMC": 9, "Other / uncategorized": 7 }, "by_marker": { "(b)(4)": 16 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "section 3.2.S.2.6 Manufacturing Process Development {Comparability Scale A to", "bates": "FDA-CBER-2022-1614-3816886", "context_preview": "for all DS or DP lots for which quantitative data are available at release or as part of stability studies together with data for RNA content (by AEX-HPLC), and RNA purity and product-related impurities (by RPIP-HPLC) from corresponding lots and time points. 2. Please include a description of the me", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "section 3.2.S.2.6 Manufacturing Process Development {Comparability Scale A to", "bates": "FDA-CBER-2022-1614-3816886", "context_preview": "DS or DP lots for which quantitative data are available at release or as part of stability studies together with data for RNA content (by AEX-HPLC), and RNA purity and product-related impurities (by RPIP-HPLC) from corresponding lots and time points. 2. Please include a description of the method (or", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "section 3.2.S.2.6 Manufacturing Process Development {Comparability Scale A to", "bates": "FDA-CBER-2022-1614-3816886", "context_preview": "P lots for which quantitative data are available at release or as part of stability studies together with data for RNA content (by AEX-HPLC), and RNA purity and product-related impurities (by RPIP-HPLC) from corresponding lots and time points. 2. Please include a description of the method (or any ot", "likely_table": true } ] }, { "filename": "53_2_BLA-125742-0_08-06-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 25, "table_count": 25, "by_category": { "Manufacturing / CMC": 25 }, "by_marker": { "(b)(4)": 25 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150224", "context_preview": "is the usual approach to . Please provide data from a ). 3. From the data generated in the preceding request, we ask that you identify a for testing DP within the , . Please use this information to establish the endotoxin limit and establish a specification for DP endotoxin activity levels for sampl", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150224", "context_preview": "usual approach to . Please provide data from a ). 3. From the data generated in the preceding request, we ask that you identify a for testing DP within the , . Please use this information to establish the endotoxin limit and establish a specification for DP endotoxin activity levels for samples that", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150224", "context_preview": "proach to . Please provide data from a ). 3. From the data generated in the preceding request, we ask that you identify a for testing DP within the , . Please use this information to establish the endotoxin limit and establish a specification for DP endotoxin activity levels for samples that are . P", "likely_table": true } ] }, { "filename": "53_BLA-125752-0_12-10-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816888", "context_preview": "con if you would like to discuss this request. 2. Please provide the positive product control (PPC) recovery for drug product (beginning, middle and end samples) tested under Associates of Cape Cod (ACC) report numbers# 0121-012TESVR, 0421-290TESCVR, 0421- 290TESCVR, 0521-099TESCVR, 0820-082TESVR an", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816888", "context_preview": "ou would like to discuss this request. 2. Please provide the positive product control (PPC) recovery for drug product (beginning, middle and end samples) tested under Associates of Cape Cod (ACC) report numbers# 0121-012TESVR, 0421-290TESCVR, 0421- 290TESCVR, 0521-099TESCVR, 0820-082TESVR and 1220-2", "likely_table": false } ] }, { "filename": "54A_BLA-125752-0_12-10-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 4, "table_count": 0, "by_category": { "Other / uncategorized": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility", "bates": "FDA-CBER-2022-1614-3816903", "context_preview": "oval of \u201cnano\u201d from the description. Commented [A5]: SPONSOR COMMENT: Moderna proposes to delete this phrase. Mutagenic potential of the was evaluated and deemed a very low risk. Sources: BLA 125752 SN0001 4.2.3.3.1 9601567 Main Report Final BLA 125752 SN0001 4.2.3.3.1 9601568 Main Report Final Comm", "likely_table": false }, { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility", "bates": "FDA-CBER-2022-1614-3816903", "context_preview": "\u201cnano\u201d from the description. Commented [A5]: SPONSOR COMMENT: Moderna proposes to delete this phrase. Mutagenic potential of the was evaluated and deemed a very low risk. Sources: BLA 125752 SN0001 4.2.3.3.1 9601567 Main Report Final BLA 125752 SN0001 4.2.3.3.1 9601568 Main Report Final Commented [A", "likely_table": false }, { "page": 12, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility", "bates": "FDA-CBER-2022-1614-3816903", "context_preview": "rom the description. Commented [A5]: SPONSOR COMMENT: Moderna proposes to delete this phrase. Mutagenic potential of the was evaluated and deemed a very low risk. Sources: BLA 125752 SN0001 4.2.3.3.1 9601567 Main Report Final BLA 125752 SN0001 4.2.3.3.1 9601568 Main Report Final Commented [A6R5]: CB", "likely_table": false } ] }, { "filename": "54_BLA-125742-0_08-09-2021_Inspection-Related_Inspect.pdf.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 21, "table_count": 17, "by_category": { "Manufacturing / CMC": 21 }, "by_marker": { "(b)(4)": 21 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150228", "context_preview": "ual inspection, capping, labeling and packaging into vial boxes, loading / unloading of ultralow temperature freezers, and packaging of the packed vial boxes into styrofoam boxes for distribution. Additionally, for filling Lines , the inspectors reviewed the routine media fills and the three specifi", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150228", "context_preview": "pection, capping, labeling and packaging into vial boxes, loading / unloading of ultralow temperature freezers, and packaging of the packed vial boxes into styrofoam boxes for distribution. Additionally, for filling Lines , the inspectors reviewed the routine media fills and the three specific BNT16", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150228", "context_preview": "capping, labeling and packaging into vial boxes, loading / unloading of ultralow temperature freezers, and packaging of the packed vial boxes into styrofoam boxes for distribution. Additionally, for filling Lines , the inspectors reviewed the routine media fills and the three specific BNT162b2 media", "likely_table": true } ] }, { "filename": "55_BLA-125742-0_08-09-2021_Telecon_Advice.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 20, "table_count": 17, "by_category": { "Manufacturing / CMC": 15, "Other / uncategorized": 5 }, "by_marker": { "(b)(4)": 20 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150233", "context_preview": "confirm that this method will be used for lot release testing by the PSG-KZO laboratory and that the container volume specification \u201cNot less than mL\u201d is the same regardless of test site/method. 4. Regarding your response (in STN 125742/0.16 dated July 23, 2021) to our IR dated July 9, 2021, about t", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150233", "context_preview": "that this method will be used for lot release testing by the PSG-KZO laboratory and that the container volume specification \u201cNot less than mL\u201d is the same regardless of test site/method. 4. Regarding your response (in STN 125742/0.16 dated July 23, 2021) to our IR dated July 9, 2021, about the valid", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150233", "context_preview": "s method will be used for lot release testing by the PSG-KZO laboratory and that the container volume specification \u201cNot less than mL\u201d is the same regardless of test site/method. 4. Regarding your response (in STN 125742/0.16 dated July 23, 2021) to our IR dated July 9, 2021, about the validation of", "likely_table": true } ] }, { "filename": "58_2_BLA-125742-0_08-10-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 1, "table_count": 0, "by_category": { "Trade-secret claim": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trade-secret claim", "section_heading": "ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND", "bates": "FDA-CBER-2021-5683-1150236", "context_preview": "HS Senior Regulatory Review Officer Food and Drug Administration Center for Biologics Evaluation & Research Office of Vaccines Research & Review Division of Vaccines and Related Products Applications Tel: 301-796-2640 michael.smith2@fda.hhs.gov THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY ", "likely_table": false } ] }, { "filename": "59_BLA-125752-0_12-15-2021_Telecon_Advice.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 3, "table_count": 3, "by_category": { "Manufacturing / CMC": 3 }, "by_marker": { "(b)(4)": 3 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3816918", "context_preview": "dotoxin testing on the final drug product (DP) of LNPs) to be implemented as a release test. FDA responded that although not required prior to the regulatory action on the SPIKEVAX BLA, FDA would like to request that the endotoxin testing on the complete DP be submitted as a PAS. Moderna agreed. In ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3816918", "context_preview": "testing on the final drug product (DP) of LNPs) to be implemented as a release test. FDA responded that although not required prior to the regulatory action on the SPIKEVAX BLA, FDA would like to request that the endotoxin testing on the complete DP be submitted as a PAS. Moderna agreed. In the inte", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2022-1614-3816918", "context_preview": "on the final drug product (DP) of LNPs) to be implemented as a release test. FDA responded that although not required prior to the regulatory action on the SPIKEVAX BLA, FDA would like to request that the endotoxin testing on the complete DP be submitted as a PAS. Moderna agreed. In the interim, Mod", "likely_table": true } ] }, { "filename": "61_BLA-125742-0_08-11-2021_Telecon_Other.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "STN 125742/0", "bates": "FDA-CBER-2021-5683-1150241", "context_preview": "ation is delayed, Pfizer has the flexibility to continue manufacturing frozen formulation as it will be licensed and will be under Pfizer\u2019s control, including distribution. Pfizer is planning to file EUA amendment for RTU formulation (for use in individuals 12 years of age and older) at the end of A", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "STN 125742/0", "bates": "FDA-CBER-2021-5683-1150241", "context_preview": "delayed, Pfizer has the flexibility to continue manufacturing frozen formulation as it will be licensed and will be under Pfizer\u2019s control, including distribution. Pfizer is planning to file EUA amendment for RTU formulation (for use in individuals 12 years of age and older) at the end of August 202", "likely_table": false } ] }, { "filename": "62_BLA-125742-0_08-12-2021_Memo_Committee-Memo_Requir.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 36, "table_count": 36, "by_category": { "Manufacturing / CMC": 35, "Internal FDA deliberation": 1 }, "by_marker": { "(b)(4)": 34, "(b)(7)(E)": 1, "(b)(5)": 1 }, "top_examples": [ { "page": 2, "marker": "(b)(7)(E)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150415", "context_preview": "l include a requirement for a justification as to why the batch is being enrolled on stability, including whether the stability data is required for drug substance batch release. \u2022 Relevant individuals will be trained per site procedures. The committed deadline for this action is September 15, 2021.", "likely_table": true }, { "page": 2, "marker": "(b)(5)", "category": "Internal FDA deliberation", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150415", "context_preview": "requirement for a justification as to why the batch is being enrolled on stability, including whether the stability data is required for drug substance batch release. \u2022 Relevant individuals will be trained per site procedures. The committed deadline for this action is September 15, 2021. Reviewer\u2019s ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150414", "context_preview": "ty prior to the release of BNT162b2 drug substance (DS) batch manufactured at Pfizer Andover on . was derived from batch and a deviation ( ) was initiated due to the multiple control limit excursions during the of The were below the control limits and the between and overall both exceeded the contro", "likely_table": true } ] }, { "filename": "62_BLA-125752-0_12-16-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 39, "table_count": 39, "by_category": { "Other / uncategorized": 27, "Inspection / enforcement": 9, "Trial design / efficacy": 3 }, "by_marker": { "(b)(4)": 39 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816922", "context_preview": "rovide data from a protocol- driven validation study using samples generated by spiking DS/DP with stressed samples. Spiking should span the appropriate range for Please note, we do not agree with using the as a surrogate for Please evaluate linearity of independently, using in place of 2. In commen", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816922", "context_preview": "ata from a protocol- driven validation study using samples generated by spiking DS/DP with stressed samples. Spiking should span the appropriate range for Please note, we do not agree with using the as a surrogate for Please evaluate linearity of independently, using in place of 2. In comment 7, we ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816922", "context_preview": "a protocol- driven validation study using samples generated by spiking DS/DP with stressed samples. Spiking should span the appropriate range for Please note, we do not agree with using the as a surrogate for Please evaluate linearity of independently, using in place of 2. In comment 7, we requested", "likely_table": true } ] }, { "filename": "63_BLA-125742-0_08-12-2021_Telecon_Other.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 9, "table_count": 5, "by_category": { "Other / uncategorized": 5, "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BLA STN 125742/0", "bates": "FDA-CBER-2021-5683-1024779", "context_preview": "l on, and how practicably it can be accomplished? \u2022 how Pfizer can relabel vials/cartons without compromising storage conditions? Pfizer replied that all vials are packaged in vial carton pizza boxes. Pfizer cannot place sticker on the vials or cartons because they are frozen and relabeling vials an", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BLA STN 125742/0", "bates": "FDA-CBER-2021-5683-1024779", "context_preview": "d how practicably it can be accomplished? \u2022 how Pfizer can relabel vials/cartons without compromising storage conditions? Pfizer replied that all vials are packaged in vial carton pizza boxes. Pfizer cannot place sticker on the vials or cartons because they are frozen and relabeling vials and carton", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BLA STN 125742/0", "bates": "FDA-CBER-2021-5683-1024779", "context_preview": "racticably it can be accomplished? \u2022 how Pfizer can relabel vials/cartons without compromising storage conditions? Pfizer replied that all vials are packaged in vial carton pizza boxes. Pfizer cannot place sticker on the vials or cartons because they are frozen and relabeling vials and cartons would", "likely_table": true } ] }, { "filename": "63_BLA-125752-0_12-16-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 17, "table_count": 12, "by_category": { "Other / uncategorized": 12, "Manufacturing / CMC": 5 }, "by_marker": { "(b)(4)": 17 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "section 3.2.S.7.3 Stability Data {", "bates": "FDA-CBER-2022-1614-3816925", "context_preview": "dment to the BLA. We request that the implementation of this change be submitted as a prior approval supplement, post regulatory action on the BLA. Please confirm your receipt of this request and submit your response as an amendment to STN 125752 as soon as possible but no later than December 28, 20", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "section 3.2.S.7.3 Stability Data {", "bates": "FDA-CBER-2022-1614-3816925", "context_preview": "the BLA. We request that the implementation of this change be submitted as a prior approval supplement, post regulatory action on the BLA. Please confirm your receipt of this request and submit your response as an amendment to STN 125752 as soon as possible but no later than December 28, 2021. Pleas", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "section 3.2.S.7.3 Stability Data {", "bates": "FDA-CBER-2022-1614-3816925", "context_preview": ". We request that the implementation of this change be submitted as a prior approval supplement, post regulatory action on the BLA. Please confirm your receipt of this request and submit your response as an amendment to STN 125752 as soon as possible but no later than December 28, 2021. Please conta", "likely_table": true } ] }, { "filename": "65_BLA-125742-0_08-13-2021_Memo_Request-For-Complianc.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 17, "table_count": 13, "by_category": { "Manufacturing / CMC": 17 }, "by_marker": { "(b)(4)": 17 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150244", "context_preview": "oduct formulation Fill and finish Primary packaging Secondary packaging Drug Product Release and Stability testing Facility: Pharmacia & Upjohn Company LLCb 7000 Portage Road Kalamazoo, MI 49001 FEI#: 1810189 Waiver Yes Yes ORA/OBPO surveillance inspection VAI, 05/11/2021 \u2013 05/20/2021 LNP production", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150244", "context_preview": "rmulation Fill and finish Primary packaging Secondary packaging Drug Product Release and Stability testing Facility: Pharmacia & Upjohn Company LLCb 7000 Portage Road Kalamazoo, MI 49001 FEI#: 1810189 Waiver Yes Yes ORA/OBPO surveillance inspection VAI, 05/11/2021 \u2013 05/20/2021 LNP production and bul", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150244", "context_preview": "n Fill and finish Primary packaging Secondary packaging Drug Product Release and Stability testing Facility: Pharmacia & Upjohn Company LLCb 7000 Portage Road Kalamazoo, MI 49001 FEI#: 1810189 Waiver Yes Yes ORA/OBPO surveillance inspection VAI, 05/11/2021 \u2013 05/20/2021 LNP production and bulk drug p", "likely_table": true } ] }, { "filename": "66_4_BLA-125742-0_08-13-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 10, "table_count": 6, "by_category": { "Other / uncategorized": 6, "Inspection / enforcement": 4 }, "by_marker": { "(b)(4)": 10 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150247", "context_preview": ". Regarding the recent Information Request (IR) responses (Response to FDA 26 Jul 2021 and Response to the August 5, 2021 FDA IR) STN 125742/0.24 and STN 125742/0.43, the Agency has additional inquiries for the Kalamazoo facility. You provided Table 8 (appended in the Response to August 5, 2021 FDA ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150247", "context_preview": "ing the recent Information Request (IR) responses (Response to FDA 26 Jul 2021 and Response to the August 5, 2021 FDA IR) STN 125742/0.24 and STN 125742/0.43, the Agency has additional inquiries for the Kalamazoo facility. You provided Table 8 (appended in the Response to August 5, 2021 FDA IR), whi", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150247", "context_preview": "recent Information Request (IR) responses (Response to FDA 26 Jul 2021 and Response to the August 5, 2021 FDA IR) STN 125742/0.24 and STN 125742/0.43, the Agency has additional inquiries for the Kalamazoo facility. You provided Table 8 (appended in the Response to August 5, 2021 FDA IR), which lists", "likely_table": true } ] }, { "filename": "66_BLA-125752-0_12-21-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816930", "context_preview": "n to support the revised PARs for CPD and TOR such as the information provided to support the same changes under EUA 27073; e.g., release testing results, CPDs and TORS for all Catalent DP lots manufactured with exceeded or non-exceeded process durations up to September 2021. b. Available informatio", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816930", "context_preview": "port the revised PARs for CPD and TOR such as the information provided to support the same changes under EUA 27073; e.g., release testing results, CPDs and TORS for all Catalent DP lots manufactured with exceeded or non-exceeded process durations up to September 2021. b. Available information on pro", "likely_table": false } ] }, { "filename": "67_BLA-125752-0_12-23-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 2, "table_count": 0, "by_category": { "Other / uncategorized": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816932", "context_preview": "u plan on submitting the additional method development/expanded endotoxin testing on whole DP ( procedure). Please confirm your receipt of this request and submit your response as an amendment to STN 125752 as soon as possible but no later than December 29, 2021. If clarification is needed, please r", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816932", "context_preview": "n submitting the additional method development/expanded endotoxin testing on whole DP ( procedure). Please confirm your receipt of this request and submit your response as an amendment to STN 125752 as soon as possible but no later than December 29, 2021. If clarification is needed, please request a", "likely_table": false } ] }, { "filename": "68A_5_BLA-125742-0_08-13-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 22, "table_count": 14, "by_category": { "Other / uncategorized": 16, "Pharmacology / toxicology": 4, "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 22 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150254", "context_preview": "ay has a limit as acceptance criterion and indicate if the assay results meet the criterion. Regarding the RNA integrity assay (TM100010392): The SOP does not provide instructions on how the In addition, the provided suggest the could be subjective. Hence, please provide the in your LRPs as requeste", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150254", "context_preview": "limit as acceptance criterion and indicate if the assay results meet the criterion. Regarding the RNA integrity assay (TM100010392): The SOP does not provide instructions on how the In addition, the provided suggest the could be subjective. Hence, please provide the in your LRPs as requested in our ", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150254", "context_preview": "as acceptance criterion and indicate if the assay results meet the criterion. Regarding the RNA integrity assay (TM100010392): The SOP does not provide instructions on how the In addition, the provided suggest the could be subjective. Hence, please provide the in your LRPs as requested in our previo", "likely_table": true } ] }, { "filename": "68B_5_BLA-125742-0_08-13-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 22, "table_count": 14, "by_category": { "Other / uncategorized": 16, "Pharmacology / toxicology": 4, "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 22 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150258", "context_preview": "ay has a limit as acceptance criterion and indicate if the assay results meet the criterion. Regarding the RNA integrity assay (TM100010392): The SOP does not provide instructions on how the In addition, the provided suggest the could be subjective. Hence, please provide the in your LRPs as requeste", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150258", "context_preview": "limit as acceptance criterion and indicate if the assay results meet the criterion. Regarding the RNA integrity assay (TM100010392): The SOP does not provide instructions on how the In addition, the provided suggest the could be subjective. Hence, please provide the in your LRPs as requested in our ", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150258", "context_preview": "as acceptance criterion and indicate if the assay results meet the criterion. Regarding the RNA integrity assay (TM100010392): The SOP does not provide instructions on how the In addition, the provided suggest the could be subjective. Hence, please provide the in your LRPs as requested in our previo", "likely_table": true } ] }, { "filename": "73_BLA-125752-0_01-04-2022_Memo_Test-Results.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 22, "table_count": 22, "by_category": { "Manufacturing / CMC": 22 }, "by_marker": { "(b)(4)": 22 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "BLA 125752/0", "bates": "FDA-CBER-2022-1614-3816996", "context_preview": "they were both within their proposed specification. Table 1: BET Results Moderna Lot Number (Manufacturer Lot) BET Test Dilution CBER % Spike Recovery CBER Results (EU/mL) Moderna\u2019s Results (EU/mL) Specification EU/mL) met 7006521151 (031H21A by Catalent) 1:1000 80 yes (both CBER and Moderna) 700652", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "BLA 125752/0", "bates": "FDA-CBER-2022-1614-3816996", "context_preview": "e both within their proposed specification. Table 1: BET Results Moderna Lot Number (Manufacturer Lot) BET Test Dilution CBER % Spike Recovery CBER Results (EU/mL) Moderna\u2019s Results (EU/mL) Specification EU/mL) met 7006521151 (031H21A by Catalent) 1:1000 80 yes (both CBER and Moderna) 7006521143 (06", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "BLA 125752/0", "bates": "FDA-CBER-2022-1614-3816996", "context_preview": "ithin their proposed specification. Table 1: BET Results Moderna Lot Number (Manufacturer Lot) BET Test Dilution CBER % Spike Recovery CBER Results (EU/mL) Moderna\u2019s Results (EU/mL) Specification EU/mL) met 7006521151 (031H21A by Catalent) 1:1000 80 yes (both CBER and Moderna) 7006521143 (064H21A by", "likely_table": true } ] }, { "filename": "75_1_BLA-125742-0_08-16-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 6, "table_count": 1, "by_category": { "Other / uncategorized": 6 }, "by_marker": { "(b)(4)": 6 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "BLA STN 125742/0", "bates": "FDA-CBER-2021-5683-1150263", "context_preview": "Technical Services, Pfizer Global Supply, Pfizer Inc. Background/Purpose of this call: CBER sent Pfizer an Information Request (IR) containing three questions regarding measurement of endotoxins using the LAL procedures on August 6, 2021. Pfizer responded in STN 125742/0.48 that was submitted on Aug", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "STN 125742/0", "bates": "FDA-CBER-2021-5683-1150264", "context_preview": "the product. Once the commitment is acceptable to CBER, Pfizer will submit an official commitment in an amendment to the BLA. Pfizer stated that they envision this taking about a month to work out the testing procedures and another 2-3 months to validate the assay and CBER understood. Pfizer asked i", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "STN 125742/0", "bates": "FDA-CBER-2021-5683-1150264", "context_preview": "roduct. Once the commitment is acceptable to CBER, Pfizer will submit an official commitment in an amendment to the BLA. Pfizer stated that they envision this taking about a month to work out the testing procedures and another 2-3 months to validate the assay and CBER understood. Pfizer asked if the", "likely_table": false } ] }, { "filename": "7_BLA-125752-0_09-22-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816027", "context_preview": "se provide the updated SOP-1142 and full validation of the method or confirm your intent to use the original method as described in SOP-0996. \u2022 If you intend to use the original method (SOP-0996) for Drug Substances (DS) and Drug Product (DP) release testing, please provide that were used in the val", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "DVRPA/OVRR/CBER", "bates": "FDA-CBER-2022-1614-3816027", "context_preview": "de the updated SOP-1142 and full validation of the method or confirm your intent to use the original method as described in SOP-0996. \u2022 If you intend to use the original method (SOP-0996) for Drug Substances (DS) and Drug Product (DP) release testing, please provide that were used in the validation ", "likely_table": false } ] }, { "filename": "81_1_BLA-125742-0_08-17-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 11, "table_count": 11, "by_category": { "Other / uncategorized": 11 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150267", "context_preview": "rocess control parameter in all the documents based on your validation study results. 2. Please update the Tables 3.2.P.3.4-1 in Sections 3.2.P.3.4 Process Step \u2013 \u2013 Puurs and Kalamazoo, to include the validated for DS using based on your qualification/validation data submitted to BLA 125742 amendmen", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150267", "context_preview": "ontrol parameter in all the documents based on your validation study results. 2. Please update the Tables 3.2.P.3.4-1 in Sections 3.2.P.3.4 Process Step \u2013 \u2013 Puurs and Kalamazoo, to include the validated for DS using based on your qualification/validation data submitted to BLA 125742 amendment 33 in ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150267", "context_preview": "arameter in all the documents based on your validation study results. 2. Please update the Tables 3.2.P.3.4-1 in Sections 3.2.P.3.4 Process Step \u2013 \u2013 Puurs and Kalamazoo, to include the validated for DS using based on your qualification/validation data submitted to BLA 125742 amendment 33 in response", "likely_table": true } ] }, { "filename": "83_BLA-125742-0_08-17-2021_Telecon_Other.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 83, "table_count": 83, "by_category": { "Other / uncategorized": 44, "Manufacturing / CMC": 22, "Clinical safety / adverse events": 17 }, "by_marker": { "(b)(4)": 83 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "STN 125742/0", "bates": "FDA-CBER-2021-5683-1150417", "context_preview": "form 483 item 2c: CBER asked about Pfizer\u2019s response and Pfizer explained that the was a target, not a control limit and not a critical parameter process at that time. Pfizer explained this was a retrospective review in of batch records regarding the less than target. CBER asked if there were any co", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "STN 125742/0", "bates": "FDA-CBER-2021-5683-1150417", "context_preview": "3 item 2c: CBER asked about Pfizer\u2019s response and Pfizer explained that the was a target, not a control limit and not a critical parameter process at that time. Pfizer explained this was a retrospective review in of batch records regarding the less than target. CBER asked if there were any correctiv", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "STN 125742/0", "bates": "FDA-CBER-2021-5683-1150417", "context_preview": "c: CBER asked about Pfizer\u2019s response and Pfizer explained that the was a target, not a control limit and not a critical parameter process at that time. Pfizer explained this was a retrospective review in of batch records regarding the less than target. CBER asked if there were any corrective action", "likely_table": true } ] }, { "filename": "84_BLA-125742-0_08-18-2021_Memo_Committee-Memo_Review.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 2, "table_count": 0, "by_category": { "Manufacturing / CMC": 2 }, "by_marker": { "(b)(4)": 2 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "OCBQ/DMPQ/PRB.", "bates": "FDA-CBER-2021-5683-1150271", "context_preview": "e e-mail) was submitted to 125742/0.50 on August 16, 2021. This response and LRP template were reviewed by DBSQC. There were no changes from the e-mail submission of August 14, 2021. 3 Conclusions The LRP template for COVID-19 mRNA Vaccine submitted in amendment 125742/0.50 on August 16, 2021 is acc", "likely_table": false }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "OCBQ/DMPQ/PRB.", "bates": "FDA-CBER-2021-5683-1150271", "context_preview": ") was submitted to 125742/0.50 on August 16, 2021. This response and LRP template were reviewed by DBSQC. There were no changes from the e-mail submission of August 14, 2021. 3 Conclusions The LRP template for COVID-19 mRNA Vaccine submitted in amendment 125742/0.50 on August 16, 2021 is acceptable ", "likely_table": false } ] }, { "filename": "85_BLA-125752-0_01-14-2022_Telecon_Information-Reques.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 4, "table_count": 0, "by_category": { "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Appendix 1, for endotoxin test details for the CX-024414 mRNA:", "bates": "FDA-CBER-2022-1614-3818215", "context_preview": "Page 1 of 12 Please change \u201cProtocol #:\u201d to \u201cElectronic Filename:\u201d to facilitate future submissions to FDA\u2019s electronic gateway. Page 9 of 12 Appendix 1, for endotoxin test details for the CX-024414 mRNA: \u2022 Please correct the unit of standard endotoxin concentration to EU/mL (not ). \u2022 Please use EU/", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Appendix 1, for endotoxin test details for the CX-024414 mRNA:", "bates": "FDA-CBER-2022-1614-3818215", "context_preview": "f 12 Please change \u201cProtocol #:\u201d to \u201cElectronic Filename:\u201d to facilitate future submissions to FDA\u2019s electronic gateway. Page 9 of 12 Appendix 1, for endotoxin test details for the CX-024414 mRNA: \u2022 Please correct the unit of standard endotoxin concentration to EU/mL (not ). \u2022 Please use EU/mL for e", "likely_table": false }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Appendix 1, for endotoxin test details for the CX-024414 mRNA:", "bates": "FDA-CBER-2022-1614-3818215", "context_preview": "Please change \u201cProtocol #:\u201d to \u201cElectronic Filename:\u201d to facilitate future submissions to FDA\u2019s electronic gateway. Page 9 of 12 Appendix 1, for endotoxin test details for the CX-024414 mRNA: \u2022 Please correct the unit of standard endotoxin concentration to EU/mL (not ). \u2022 Please use EU/mL for endoto", "likely_table": false } ] }, { "filename": "85_Courtesy-Copy_BLA-125742-0_Statistical-Review-COMIRNATY.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 45, "table_count": 27, "by_category": { "Other / uncategorized": 30, "Trial design / efficacy": 11, "Manufacturing / CMC": 4 }, "by_marker": { "(b)(4)": 45 }, "top_examples": [ { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Module 3.2.R of BLA125741/0.19, which have not been reviewed previously.", "bates": null, "context_preview": "rt\u00ae Xpress PCR Assay to Detect SARS-CoV-2 (VR-MVR-10080, Version 3.0), \u2022 Method Validation Report for the Elecsys Anti-SARS-CoV-2 Assay (VR-MVR- 10081, Version 2.0), \u2022 Qualification Report for a Direct Luminex Assay (dLIA) for Quantitation of IgG Antibodies to SARS-CoV-2 S1 Protein in Human Sera (VR", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Module 3.2.R of BLA125741/0.19, which have not been reviewed previously.", "bates": null, "context_preview": "ss PCR Assay to Detect SARS-CoV-2 (VR-MVR-10080, Version 3.0), \u2022 Method Validation Report for the Elecsys Anti-SARS-CoV-2 Assay (VR-MVR- 10081, Version 2.0), \u2022 Qualification Report for a Direct Luminex Assay (dLIA) for Quantitation of IgG Antibodies to SARS-CoV-2 S1 Protein in Human Sera (VR-MQR-102", "likely_table": true }, { "page": 4, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "Module 3.2.R of BLA125741/0.19, which have not been reviewed previously.", "bates": null, "context_preview": "ssay to Detect SARS-CoV-2 (VR-MVR-10080, Version 3.0), \u2022 Method Validation Report for the Elecsys Anti-SARS-CoV-2 Assay (VR-MVR- 10081, Version 2.0), \u2022 Qualification Report for a Direct Luminex Assay (dLIA) for Quantitation of IgG Antibodies to SARS-CoV-2 S1 Protein in Human Sera (VR-MQR-10211, Vers", "likely_table": true } ] }, { "filename": "86_BLA-125742-0_08-18-2021_Telecon_Advice.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 33, "table_count": 31, "by_category": { "Manufacturing / CMC": 33 }, "by_marker": { "(b)(4)": 33 }, "top_examples": [ { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF PFIZER INC.", "bates": "FDA-CBER-2021-5683-1150274", "context_preview": "s parameter for the was validated to be within the range of . However, in your documents Section 3.2.S.2.2 Manufacturing Process, the is described as . Please align the acceptance range of this process control parameter in all the documents based on your validation study results. 2. Please update th", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF PFIZER INC.", "bates": "FDA-CBER-2021-5683-1150274", "context_preview": "er for the was validated to be within the range of . However, in your documents Section 3.2.S.2.2 Manufacturing Process, the is described as . Please align the acceptance range of this process control parameter in all the documents based on your validation study results. 2. Please update the Tables ", "likely_table": true }, { "page": 3, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF PFIZER INC.", "bates": "FDA-CBER-2021-5683-1150274", "context_preview": "the was validated to be within the range of . However, in your documents Section 3.2.S.2.2 Manufacturing Process, the is described as . Please align the acceptance range of this process control parameter in all the documents based on your validation study results. 2. Please update the Tables 3.2.P.3", "likely_table": true } ] }, { "filename": "87_3_BLA-125742-0_08-18-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 1, "table_count": 0, "by_category": { "Manufacturing / CMC": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150276", "context_preview": "ntent is safe. Mike, Mike, Can you clarify what CBER has in mind by \u201creal time\u201d? Taken literally that might be interpreted as reporting each time point, of each lot in the stability program (more than lots at this point. We would not be prepared to make updates that frequently. Updates within a reas", "likely_table": false } ] }, { "filename": "87_BLA-125752-0_01-18-2022_Memo_Test-Results.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 47, "table_count": 47, "by_category": { "Manufacturing / CMC": 33, "Other / uncategorized": 14 }, "by_marker": { "(b)(4)": 47 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "DBSQC/OCBQ ANALYTICAL METHOD TEST MEMO", "bates": "FDA-CBER-2022-1614-3818217", "context_preview": "The test was performed per DBSQC Doc000482 \u201cpH Determination\u201d on December 10, 2021. pH values of three DP sample lots were measured in duplicate with a pH standard of as the assay control. The result of the control was , which met the acceptance criterion of 7.00 \u00b1 0.05. The test results by DBSQC an", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "DBSQC/OCBQ ANALYTICAL METHOD TEST MEMO", "bates": "FDA-CBER-2022-1614-3818217", "context_preview": "was performed per DBSQC Doc000482 \u201cpH Determination\u201d on December 10, 2021. pH values of three DP sample lots were measured in duplicate with a pH standard of as the assay control. The result of the control was , which met the acceptance criterion of 7.00 \u00b1 0.05. The test results by DBSQC and those f", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "DBSQC/OCBQ ANALYTICAL METHOD TEST MEMO", "bates": "FDA-CBER-2022-1614-3818217", "context_preview": "formed per DBSQC Doc000482 \u201cpH Determination\u201d on December 10, 2021. pH values of three DP sample lots were measured in duplicate with a pH standard of as the assay control. The result of the control was , which met the acceptance criterion of 7.00 \u00b1 0.05. The test results by DBSQC and those from the", "likely_table": true } ] }, { "filename": "89_1_BLA-125742-0_08-18-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 11, "table_count": 9, "by_category": { "Manufacturing / CMC": 9, "Trade-secret claim": 2 }, "by_marker": { "(b)(4)": 11 }, "top_examples": [ { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150279", "context_preview": "(TM100010392). Please acknowledge that you will submit the revised SOP to your IND 19736. The difference in used in assay validation and Lot Release Protocols submitted to CBER recently (lots FD7220, FE3592 and FF2587) indicates that a requirement for a specific has not been established, giving the ", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150279", "context_preview": "010392). Please acknowledge that you will submit the revised SOP to your IND 19736. The difference in used in assay validation and Lot Release Protocols submitted to CBER recently (lots FD7220, FE3592 and FF2587) indicates that a requirement for a specific has not been established, giving the appear", "likely_table": true }, { "page": 1, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": null, "bates": "FDA-CBER-2021-5683-1150279", "context_preview": "Please acknowledge that you will submit the revised SOP to your IND 19736. The difference in used in assay validation and Lot Release Protocols submitted to CBER recently (lots FD7220, FE3592 and FF2587) indicates that a requirement for a specific has not been established, giving the appearance that", "likely_table": true } ] }, { "filename": "8_1_BLA-125742-0_06-25-2021_Telecon_Information-Reques.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 9, "table_count": 6, "by_category": { "Manufacturing / CMC": 6, "Other / uncategorized": 3 }, "by_marker": { "(b)(4)": 9 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "TM100010407", "bates": "FDA-CBER-2021-5683-1150172", "context_preview": "uence 50 vials of each reagent OR enough to perform 50 tests i. Positive PCR Control: PF-07305885 DS or equivalent as stated in TM100010407 ii. Positive Control: PF-07302048 DP or equivalent as stated in TM100010407 5. In Vitro Expression Potency assay i. ii. Reference Standards, Qualified - 50 vial", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "TM100010407", "bates": "FDA-CBER-2021-5683-1150172", "context_preview": "50 vials of each reagent OR enough to perform 50 tests i. Positive PCR Control: PF-07305885 DS or equivalent as stated in TM100010407 ii. Positive Control: PF-07302048 DP or equivalent as stated in TM100010407 5. In Vitro Expression Potency assay i. ii. Reference Standards, Qualified - 50 vials of e", "likely_table": true }, { "page": 2, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "TM100010407", "bates": "FDA-CBER-2021-5683-1150172", "context_preview": "als of each reagent OR enough to perform 50 tests i. Positive PCR Control: PF-07305885 DS or equivalent as stated in TM100010407 ii. Positive Control: PF-07302048 DP or equivalent as stated in TM100010407 5. In Vitro Expression Potency assay i. ii. Reference Standards, Qualified - 50 vials of each o", "likely_table": true } ] }, { "filename": "92_BLA-125742-0_08-19-2021_Inspection-Related_Inspect.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 2407, "table_count": 2401, "by_category": { "Other / uncategorized": 1021, "Manufacturing / CMC": 1005, "Inspection / enforcement": 233, "Trial design / efficacy": 148 }, "by_marker": { "(b)(4)": 2258, "(b)(7)(C)": 149 }, "top_examples": [ { "page": 3, "marker": "(b)(7)(C)", "category": "Manufacturing / CMC", "section_heading": "BACKGROUND AND HISTORY", "bates": "FDA-CBER-2021-5683-1150422", "context_preview": "ns have been implemented, which include the in 2011. In 2015, a was implemented. \u2022 In 1998 a was built for the manufacturing and packaging of was used for manufacturing at that time \u2022 In 2013 the was finished was performed in 2014/2015 and started in 2015. \u2022 In 1999 technology was introduced and In ", "likely_table": true }, { "page": 3, "marker": "(b)(7)(C)", "category": "Manufacturing / CMC", "section_heading": "BACKGROUND AND HISTORY", "bates": "FDA-CBER-2021-5683-1150422", "context_preview": "nted, which include the in 2011. In 2015, a was implemented. \u2022 In 1998 a was built for the manufacturing and packaging of was used for manufacturing at that time \u2022 In 2013 the was finished was performed in 2014/2015 and started in 2015. \u2022 In 1999 technology was introduced and In this area Xalatan ma", "likely_table": true }, { "page": 3, "marker": "(b)(7)(C)", "category": "Manufacturing / CMC", "section_heading": "BACKGROUND AND HISTORY", "bates": "FDA-CBER-2021-5683-1150422", "context_preview": "the in 2011. In 2015, a was implemented. \u2022 In 1998 a was built for the manufacturing and packaging of was used for manufacturing at that time \u2022 In 2013 the was finished was performed in 2014/2015 and started in 2015. \u2022 In 1999 technology was introduced and In this area Xalatan manufactured. Xalatan ", "likely_table": true } ] }, { "filename": "93_BLA-125752-0_01-26-2022_Inspection-Related_Inspect.pdf", "module": null, "company": "Moderna", "license": null, "total_kept": 78, "table_count": 70, "by_category": { "Manufacturing / CMC": 29, "Other / uncategorized": 20, "Trial design / efficacy": 12, "Internal FDA deliberation": 10, "Inspection / enforcement": 7 }, "by_marker": { "(b)(4)": 58, "(b)(5)": 10, "(b)(7)(E)": 10 }, "top_examples": [ { "page": 2, "marker": "(b)(5)", "category": "Internal FDA deliberation", "section_heading": "RECOMMENDATION", "bates": "FDA-CBER-2022-1614-3818225", "context_preview": "rds pending review. Recognizing that the majority of deviations are identified during batch documentation review, delays in initiating the review process led to identification and initiation of investigations weeks after occurrence. This is reflected in the deviation management system ( where the \u201cD", "likely_table": true }, { "page": 2, "marker": "(b)(7)(E)", "category": "Manufacturing / CMC", "section_heading": "RECOMMENDATION", "bates": "FDA-CBER-2022-1614-3818225", "context_preview": "ng review. Recognizing that the majority of deviations are identified during batch documentation review, delays in initiating the review process led to identification and initiation of investigations weeks after occurrence. This is reflected in the deviation management system ( where the \u201cDate of Oc", "likely_table": true }, { "page": 2, "marker": "(b)(5)", "category": "Internal FDA deliberation", "section_heading": "RECOMMENDATION", "bates": "FDA-CBER-2022-1614-3818225", "context_preview": "Recognizing that the majority of deviations are identified during batch documentation review, delays in initiating the review process led to identification and initiation of investigations weeks after occurrence. This is reflected in the deviation management system ( where the \u201cDate of Occurrence\u201d a", "likely_table": true } ] }, { "filename": "93_Courtesy-Copy_2_BLA-125742-0_Statistical-Review-COMIRNATY.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 1, "table_count": 0, "by_category": { "Other / uncategorized": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 10, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "6.1.7 Surveillance/Monitoring", "bates": null, "context_preview": "0 \u03bcg Based upon the preliminary results, the vaccine candidate selected for further evaluation in the Phase 2/3 studies was BNT162b2 [BNT162 RNA-LNP vaccine utilizing modRNA mcg/0.5 mL] at a dose of 30 \u03bcg. 6.1.6 Sites and Centers The study was conducted in a total of 153 sites: 131 in the U.S., 9 in", "likely_table": false } ] }, { "filename": "95_BLA-125742-0_08-19-2021_Memo_Compliance-Check-Acce.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 35, "table_count": 27, "by_category": { "Manufacturing / CMC": 27, "Inspection / enforcement": 8 }, "by_marker": { "(b)(4)": 35 }, "top_examples": [ { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "OCBQ/DCM/BDDCB", "bates": "FDA-CBER-2021-5683-1150285", "context_preview": "uildings and Drug Product Release and Stability Testing (Buildings and Facility: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCa 1 Burtt Road Andover, MA 01810 FEI#: 1222181 Inspection Yes Yes CBER pre-license inspection July 19 \u2013 23, 2021 LNP production and bulk drug product formulation Fill", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "OCBQ/DCM/BDDCB", "bates": "FDA-CBER-2021-5683-1150285", "context_preview": "and Drug Product Release and Stability Testing (Buildings and Facility: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCa 1 Burtt Road Andover, MA 01810 FEI#: 1222181 Inspection Yes Yes CBER pre-license inspection July 19 \u2013 23, 2021 LNP production and bulk drug product formulation Fill and fini", "likely_table": true }, { "page": 5, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "OCBQ/DCM/BDDCB", "bates": "FDA-CBER-2021-5683-1150285", "context_preview": "rug Product Release and Stability Testing (Buildings and Facility: Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCa 1 Burtt Road Andover, MA 01810 FEI#: 1222181 Inspection Yes Yes CBER pre-license inspection July 19 \u2013 23, 2021 LNP production and bulk drug product formulation Fill and finish Pr", "likely_table": true } ] }, { "filename": "99_BLA-125742-0_08-20-2021_Memo_Committee-Memo_Labeli.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 4, "table_count": 0, "by_category": { "Other / uncategorized": 2, "Manufacturing / CMC": 1, "Inspection / enforcement": 1 }, "by_marker": { "(b)(4)": 4 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "DEPARTMENT OF HEALTH & HUMAN SERVICES", "bates": "FDA-CBER-2021-5683-1150289", "context_preview": "ner label for their Diluent 0.9% Sodium Chloride Injection, USP Vial Carton Label \u2013 Hospira to CBER on August 17, 2021, and again on August 19, 2021. This label is acceptable for approval. Please see Appendix 4 for full review. Fresenius Kabi Diluent Stamp (No NDC): The original label did not includ", "likely_table": false }, { "page": 2, "marker": "(b)(4)", "category": "Other / uncategorized", "section_heading": "DEPARTMENT OF HEALTH & HUMAN SERVICES", "bates": "FDA-CBER-2021-5683-1150289", "context_preview": "l for their Diluent 0.9% Sodium Chloride Injection, USP Vial Carton Label \u2013 Hospira to CBER on August 17, 2021, and again on August 19, 2021. This label is acceptable for approval. Please see Appendix 4 for full review. Fresenius Kabi Diluent Stamp (No NDC): The original label did not include the di", "likely_table": false }, { "page": 11, "marker": "(b)(4)", "category": "Manufacturing / CMC", "section_heading": "Appendix 3: Review Checklist for Multiple-Dose 10 mL (25 Doses) Diluent 0.9% Sodium Chloride", "bates": "FDA-CBER-2021-5683-1150298", "context_preview": "ufacture, and, where applicable, the production medium and the method of inactivation, or reference to an enclosed circular containing appropriate information X r. Minimum potency of product expressed in terms of official standard of potency or, if potency is a factor and no U.S. standard of potency", "likely_table": false } ] }, { "filename": "9_IND_19736_491_29-Sep-2021_DEBORAH_DEBORAH__RO_-The-Summary-Monthly-Safety-Report-has-been-reviewed.-No-furthe.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 1, "table_count": 0, "by_category": { "Trial design / efficacy": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 2, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "19736.491\nProcess track #907079", "bates": "FDA-CBER-2021-5683-1150413", "context_preview": "tigated efficacy and safety of the 2-dose BNT162b2 regimen in adults with autoimmune inflammatory rheumatic diseases (AIIRD; n=686) compared to controls (n=121); two cases of uveitis were reported in AIIRD patients. An IR was sent asking the sponsor in the next SMSR to provide a descriptive summary ", "likely_table": false } ] }, { "filename": "Courtesy-Copy_BLA-125742-45_04-11-2022_Memo_Committee-Memo-Statistical-Review-.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 1, "table_count": 0, "by_category": { "Trial design / efficacy": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 11, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "6.1.11.2 Analyses of Efficacy Endpoints", "bates": null, "context_preview": "%). These analyses were based on a median follow-up of 4.4 months post Dose 2. Figure 1 shows the cumulative incidence of COVID-19 in the Dose 1 All-Available Efficacy Population, where 48 cases in the placebo group and 3 cases in the BNT162b2 group were observed during blinded follow-up starting af", "likely_table": false } ] }, { "filename": "Courtesy-Copy_BLA-125742-45_07-08-2022_Memo_Committee-Memo-Clinical-Review.pdf", "module": null, "company": "Pfizer", "license": null, "total_kept": 1, "table_count": 0, "by_category": { "Trial design / efficacy": 1 }, "by_marker": { "(b)(4)": 1 }, "top_examples": [ { "page": 35, "marker": "(b)(4)", "category": "Trial design / efficacy", "section_heading": "6.1.11.1 Analyses of Secondary Endpoint", "bates": null, "context_preview": "s from that analysis time point. Updated efficacy analyses Updated efficacy analyses were performed with additional confirmed COVID-19 cases accrued during blinded placebo-controlled follow-up through September 2, 2021, representing a median of 6 months of follow-up after Dose 2 for participants in ", "likely_table": false } ] } ] }