# Pharmacovigilance Term Scan

Scanned **6,136 PDFs** (M3 excluded; 6,136 in scope total). **177 files contain at least one matching term**; 2,318 total term occurrences.

Each section lists files containing that term, sorted by hit count. Context snippets are ~80 characters around each match. Click PHMPT (may show one-time Cloudflare challenge) or ICAN (no challenge) to open the PDF.

**Term hit summary:**

| Term | Files | Total occurrences |
| --- | ---: | ---: |
| Pharmacovigilance plan | 105 | 438 |
| Disproportionality analysis | 7 | 24 |
| Risk management plan | 71 | 1,617 |
| PRR | 7 | 25 |
| Proportional Reporting Ratio | 0 | 0 |
| Bayesian | 45 | 214 |

---

## Pharmacovigilance plan

**105 file(s), 438 hit(s).**

| File | Module | Company | License | Hits | Pages | Links |
| --- | --- | --- | --- | ---: | --- | --- |
| `125752_S37_M1_pvp-spikevax-16dec2021-trk.pdf` | M1 | Moderna | BLA | 30 | 1, 2, 3, 4, 5, 6, 7, 8, … (+13) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/07/125752_S37_M1_pvp-spikevax-16dec2021-trk.pdf) |
| `125752_S37_M1_pvp-spikevax-16dec2021.pdf` | M1 | Moderna | BLA | 30 | 1, 2, 3, 4, 5, 6, 7, 8, … (+13) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/07/125752_S37_M1_pvp-spikevax-16dec2021.pdf) |
| `125742_S1_M1_meeting-correspondence.pdf` | M1 | Pfizer | BLA | 29 | 460, 468, 478, 481, 488, 498, 499, 518, … (+4) | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/125742_S1_M1_meeting-correspondence.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/125742_S1_M1_meeting-correspondence.pdf) |
| `27073_S3_M1_pvp.pdf` | M1 | Moderna | EUA | 26 | 1, 2, 3, 4, 5, 6, 7, 8, … (+12) | — |
| `125752_S3_M1_rmp-v2-2.pdf` | M1 | Moderna | BLA | 13 | 1, 3, 67, 106, 115, 227, 485, 486, … (+1) | — |
| `125742_S21_M1_pharmacovigilance-plan.pdf` | M1 | Pfizer | BLA | 12 | 1, 2, 7, 14, 56, 57, 58, 71, … (+1) | [PHMPT](https://phmpt.org/wp-content/uploads/2023/01/125742_S21_M1_pharmacovigilance-plan.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/01/125742_S21_M1_pharmacovigilance-plan.pdf) |
| `125742_S21_M1_pvp-track.pdf` | M1 | Pfizer | BLA | 12 | 1, 2, 7, 14, 56, 57, 58, 71, … (+1) | [PHMPT](https://phmpt.org/wp-content/uploads/2023/01/125742_S21_M1_pvp-track.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/01/125742_S21_M1_pvp-track.pdf) |
| `125742-45_S211_M1_pharmacovigilance-plan.pdf` | M1 | Pfizer | BLA | 12 | 1, 2, 8, 18, 68, 70, 71, 88, … (+1) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M1_pharmacovigilance-plan.pdf) |
| `125742-45_S211_M1_pharmacovigilance-plan-track.pdf` | M1 | Pfizer | BLA | 12 | 1, 2, 8, 18, 73, 75, 77, 96, … (+1) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M1_pharmacovigilance-plan-track.pdf) |
| `125742-45_S314_M1_pharmacovigilance-plan.pdf` | M1 | Pfizer | BLA | 12 | 1, 2, 8, 18, 68, 70, 71, 88, … (+1) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S314_M1_pharmacovigilance-plan.pdf) |
| `125742-45_S314_M1_pharmacovigilance-plan-track.pdf` | M1 | Pfizer | BLA | 12 | 1, 2, 8, 18, 68, 70, 71, 88, … (+1) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S314_M1_pharmacovigilance-plan-track.pdf) |
| `125742_S2_M1_pharmacovigilance-plan.pdf` | M1 | Pfizer | BLA | 12 | 1, 2, 7, 14, 53, 54, 55, 68, … (+1) | [PHMPT](https://phmpt.org/wp-content/uploads/2023/08/125742_S2_M1_pharmacovigilance-plan.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/125742_S2_M1_pharmacovigilance-plan.pdf) |
| `27034_S135_M1_pharmacovigilance-plan-track.pdf` | M1 | Pfizer | EUA | 10 | 1, 2, 7, 16, 57, 78, 102 | — |
| `125742_S69_M1_response-19aug2021.pdf` | M1 | Pfizer | BLA | 10 | 3, 4, 5 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/08/125742_S69_M1_response-19aug2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/125742_S69_M1_response-19aug2021.pdf) |
| `27034_S135_M1_pharmacovigilance-plan-clean.pdf` | M1 | Pfizer | EUA | 9 | 1, 2, 7, 15, 73, 92 | — |
| `51_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Memo-COMIRNATY.pdf` | — | Pfizer | — | 9 | 1, 2, 21, 23, 28 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/11/51_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Memo-COMIRNATY.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/11/51_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Memo-COMIRNATY.pdf) |
| `27034_S1_M1_pharmacovigilance-plan.pdf` | M1 | Pfizer | EUA | 8 | 1, 2, 5, 12, 51, 60 | — |
| `27034_S16_M1_pharmacovigilance-plan-clean.pdf` | M1 | Pfizer | EUA | 8 | 1, 2, 5, 12, 51, 60 | — |
| `27034_S16_M1_pharmacovigilance-plan-track.pdf` | M1 | Pfizer | EUA | 8 | 1, 2, 5, 12, 51, 60 | — |
| `19736_S0214_M1_smsr-01jan2021-31jan2021.pdf` | M1 | Pfizer | BLA | 7 | 3, 9, 42, 1849, 1850 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/19736_S0214_M1_smsr-01jan2021-31jan2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/19736_S0214_M1_smsr-01jan2021-31jan2021.pdf) |
| `101_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Addendum-Memo-COMIRNATY.pdf` | — | Pfizer | — | 7 | 1, 2, 3, 4 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/11/101_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Addendum-Memo-COMIRNATY.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/11/101_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Addendum-Memo-COMIRNATY.pdf) |
| `reissue_5.3.6-postmarketing-experience.pdf` | — | Pfizer | — | 6 | 2, 4, 5, 9, 28 | [PHMPT](https://phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf) |
| `27034_S135_M1_eua-amend-12-15-years.pdf` | M1 | Pfizer | EUA | 4 | 96, 97 | — |
| `27034_S25_M1_response-9-dec-2020-pvp.pdf` | M1 | Pfizer | EUA | 4 | 1, 3, 8 | — |
| `119_Courtesy-Copy_BLA-125742-0_Real-World-Evidence-BLA-Memo-COMIRNATY.pdf` | — | Pfizer | — | 4 | 1, 2, 6, 7 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/11/119_Courtesy-Copy_BLA-125742-0_Real-World-Evidence-BLA-Memo-COMIRNATY.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/11/119_Courtesy-Copy_BLA-125742-0_Real-World-Evidence-BLA-Memo-COMIRNATY.pdf) |
| `124_BLA-125742-0_08-23-2021_Memo_Committee-Memo_SBRA.pdf` | — | Pfizer | — | 4 | 23, 25 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/11/124_BLA-125742-0_08-23-2021_Memo_Committee-Memo_SBRA.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/11/124_BLA-125742-0_08-23-2021_Memo_Committee-Memo_SBRA.pdf) |
| `131_Courtesy-Copy_BLA-125742-0_Clinical-Review-Memo-August-23-2021-COMIRNATY.pdf` | — | Pfizer | — | 4 | 4, 14, 85, 97 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/11/131_Courtesy-Copy_BLA-125742-0_Clinical-Review-Memo-August-23-2021-COMIRNATY.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/11/131_Courtesy-Copy_BLA-125742-0_Clinical-Review-Memo-August-23-2021-COMIRNATY.pdf) |
| `135_Courtesy-Copy_BLA-125742-0_November-8-2021_Summary-Basis-for-Regulatory-Action-COMIRNATY.pdf` | — | Pfizer | — | 4 | 23, 25 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/11/135_Courtesy-Copy_BLA-125742-0_November-8-2021_Summary-Basis-for-Regulatory-Action-COMIRNATY.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/11/135_Courtesy-Copy_BLA-125742-0_November-8-2021_Summary-Basis-for-Regulatory-Action-COMIRNATY.pdf) |
| `23_1_BLA-125742-0_07-15-2021_Telecon_Information-Reques.pdf` | — | Pfizer | — | 4 | 1, 2 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/23_1_BLA-125742-0_07-15-2021_Telecon_Information-Reques.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/09/23_1_BLA-125742-0_07-15-2021_Telecon_Information-Reques.pdf) |
| `27073_S249_M1_pbrer-01-18dec2020-30jun2021.pdf` | M1 | Moderna | BLA | 3 | 5, 54, 57 | — |
| `27073_S3_M1_vrbpac-briefing-doc.pdf` | M1 | Moderna | EUA | 3 | 3, 72 | — |
| `27073_S8_M1_vrbpac-briefing-doc.pdf` | M1 | Moderna | EUA | 3 | 3, 72 | — |
| `27034_S16_M1_cover.pdf` | M1 | Pfizer | EUA | 3 | 1 | — |
| `19736_S0289_M1_smsr-01mar2021-31mar2021.pdf` | M1 | Pfizer | BLA | 3 | 4, 10, 50 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/19736_S0289_M1_smsr-01mar2021-31mar2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/19736_S0289_M1_smsr-01mar2021-31mar2021.pdf) |
| `125742-45_05-19-2022_Memo_Committee-Memo_Postm.pdf` | — | Pfizer | — | 3 | 1, 2, 3 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_05-19-2022_Memo_Committee-Memo_Postm.pdf) |
| `125752_S55_M1_pbrer-2-01jul2021-31dec2021.pdf` | M1 | Moderna | BLA | 2 | 38, 1657 | — |
| `125742-45_S211_M1_priority-review-request.pdf` | M1 | Pfizer | BLA | 2 | 10 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/125742-45_S211_M1_priority-review-request.pdf) |
| `27073_S13_M1_rsp-cmts-ir14.pdf` | M1 | Moderna | EUA | 2 | 1, 3 | — |
| `125742_S2_M5_5354_c4591008-protocol.pdf` | M5 | Pfizer | BLA | 2 | 7, 14 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/04/125742_S2_M5_5354_c4591008-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/04/125742_S2_M5_5354_c4591008-protocol.pdf) |
| `125742-45_S211_M2_clinical-overview.pdf` | M2 | Pfizer | BLA | 2 | 126 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M2_clinical-overview.pdf) |
| `125742-45_S211_M5_cumulative-analysis-post-auth-ae-reports.pdf` | M5 | Pfizer | BLA | 2 | 2, 8 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M5_cumulative-analysis-post-auth-ae-reports.pdf) |
| `27034_S7_M1_cover.pdf` | M1 | Pfizer | EUA | 2 | 1 | — |
| `27034_S7_M1_response-25-nov-2020-pvp.pdf` | M1 | Pfizer | EUA | 2 | 1, 3 | — |
| `27034_S25_M1_cover.pdf` | M1 | Pfizer | EUA | 2 | 1 | — |
| `125742_S41_M5_5354_c4591021-protocol.pdf` | M5 | Pfizer | BLA | 2 | 61, 66 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/08/125742_S41_M5_5354_c4591021-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/125742_S41_M5_5354_c4591021-protocol.pdf) |
| `125742_S71_M1_response-19aug2021.pdf` | M1 | Pfizer | BLA | 2 | 2 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/08/125742_S71_M1_response-19aug2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/125742_S71_M1_response-19aug2021.pdf) |
| `125742_S77_M1_response-21aug2021-pmc.pdf` | M1 | Pfizer | BLA | 2 | 4 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/08/125742_S77_M1_response-21aug2021-pmc.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/125742_S77_M1_response-21aug2021-pmc.pdf) |
| `27034_S4_M1_vrbpac-bd.pdf` | M1 | Pfizer | EUA | 2 | 72, 74 | — |
| `27034_S6_M1_vrbpac-bd.pdf` | M1 | Pfizer | EUA | 2 | 73, 75 | — |
| `019736_S196_M5_c4591008-protocol.pdf` | M5 | Pfizer | BLA | 2 | 7, 14 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S196_M5_c4591008-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S196_M5_c4591008-protocol.pdf) |
| `019736_S387_M5_c4591008-interim-protocol.pdf` | M5 | Pfizer | BLA | 2 | 7, 14 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S387_M5_c4591008-interim-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S387_M5_c4591008-interim-protocol.pdf) |
| `019736_S470_M5_c4591009-protocol.pdf` | M5 | Pfizer | BLA | 2 | 63, 67 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S470_M5_c4591009-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S470_M5_c4591009-protocol.pdf) |
| `125742_S0136_M5_smsr-01sep2021-30sep2021.pdf` | M5 | Pfizer | BLA | 2 | 11, 48 | [PHMPT](https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/100123/125742_S0136_M5_smsr-01sep2021-30sep2021.pdf) · [ICAN](https://ican-public.s3.amazonaws.com/productions/100123/125742_S0136_M5_smsr-01sep2021-30sep2021.pdf) |
| `125742_S31_M1_356h.pdf` | M1 | Pfizer | BLA | 2 | 2, 3 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/125742_S31_M1_356h.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/125742_S31_M1_356h.pdf) |
| `19736_S0366_M1_smsr-30apr2021-31may2021.pdf` | M1 | Pfizer | BLA | 2 | 11, 47 | [PHMPT](https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/100123/19736_S0366_M1_smsr-30apr2021-31may2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/19736_S0366_M1_smsr-30apr2021-31may2021.pdf) |
| `19736_S0408_M1_smsr-01jun2021-30jun2021.pdf` | M1 | Pfizer | BLA | 2 | 11, 46 | [PHMPT](https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/100123/19736_S0408_M1_smsr-01jun2021-30jun2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/19736_S0408_M1_smsr-01jun2021-30jun2021.pdf) |
| `19736_S0453_M1_smsr-01jul2021-31jul2021.pdf` | M1 | Pfizer | BLA | 2 | 10, 47 | [ICAN](https://ican-public.s3.amazonaws.com/productions/100123/19736_S0453_M1_smsr-01jul2021-31jul2021.pdf) |
| `19736_S0491_M1_smsr-01aug2021-31aug2021.pdf` | M1 | Pfizer | BLA | 2 | 10, 46 | [PHMPT](https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/100123/19736_S0491_M1_smsr-01aug2021-31aug2021.pdf) · [ICAN](https://ican-public.s3.amazonaws.com/productions/100123/19736_S0491_M1_smsr-01aug2021-31aug2021.pdf) |
| `125742-45_04-20-2022_Telecon_Information-Reque.pdf` | — | Pfizer | — | 2 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_04-20-2022_Telecon_Information-Reque.pdf) |
| `125742-45_05-06-2022_Meeting-Summary_Committee.pdf` | — | Pfizer | — | 2 | 4, 7 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_05-06-2022_Meeting-Summary_Committee.pdf) |
| `20_1_BLA-125742-0_07-13-2021_Telecon_Information-Reques.pdf` | — | Pfizer | — | 2 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/20_1_BLA-125742-0_07-13-2021_Telecon_Information-Reques.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/09/20_1_BLA-125742-0_07-13-2021_Telecon_Information-Reques.pdf) |
| `35_BLA-125752-0_11-05-2021_Telecon_Information-Reques.pdf` | — | Moderna | — | 2 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2025/05/35_BLA-125752-0_11-05-2021_Telecon_Information-Reques.pdf) |
| `Courtesy-Copy_BLA-125742-45_07-08-2022_Memo_Committee-Memo-Clinical-Review.pdf` | — | Pfizer | — | 2 | 16, 57 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/Courtesy-Copy_BLA-125742-45_07-08-2022_Memo_Committee-Memo-Clinical-Review.pdf) |
| `125752_S22_M1_rsp-fda-cmts-safety-05nov2021.pdf` | M1 | Moderna | BLA | 1 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/07/125752_S22_M1_rsp-fda-cmts-safety-05nov2021.pdf) |
| `125752_S34_M1_rsp-fda-cmts-info-req31-10dec2021.pdf` | M1 | Moderna | BLA | 1 | 4 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/07/125752_S34_M1_rsp-fda-cmts-info-req31-10dec2021.pdf) |
| `125752_S37_M1_cover-0037.pdf` | M1 | Moderna | BLA | 1 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/07/125752_S37_M1_cover-0037.pdf) |
| `125752_S3_M1_cover-0003.pdf` | M1 | Moderna | BLA | 1 | 6 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/06/125752_S3_M1_cover-0003.pdf) |
| `27073_S66_M1_monthly-safety-rpt-18dec2020-17jan2021.pdf` | M1 | Moderna | BLA | 1 | 2 | — |
| `27073_S99_M1_monthly-safety-rpt-18jan2021-17feb2021.pdf` | M1 | Moderna | BLA | 1 | 2 | — |
| `27073_S134_M1_monthly-safety-rpt-18feb2021-31mar2021.pdf` | M1 | Moderna | BLA | 1 | 2 | — |
| `27073_S164_M1_ monthly-safety-rpt-01apr2021-30apr2021.pdf` | M1 | Moderna | BLA | 1 | 2 | — |
| `27073_S198_M1_monthly-safety-rpt-01may2021-31may2021.pdf` | M1 | Moderna | BLA | 1 | 2 | — |
| `125742-45_S211_M1_cover.pdf` | M1 | Pfizer | BLA | 1 | 3 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/125742-45_S211_M1_cover.pdf) |
| `125742-45_S314_M1_cover.pdf` | M1 | Pfizer | BLA | 1 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/125742-45_S314_M1_cover.pdf) |
| `125742-45_S314_M1_356h.pdf` | M1 | Pfizer | BLA | 1 | 2 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/125742-45_S314_M1_356h.pdf) |
| `27073_S3_M1_0003-cover.pdf` | M1 | Moderna | EUA | 1 | 1 | — |
| `27073_S13_M1_core-presentation-draft-slides.pdf` | M1 | Moderna | EUA | 1 | 67 | — |
| `27073_S15_M1_rsp-cmts-ir17-items-1-2.pdf` | M1 | Moderna | EUA | 1 | 1 | — |
| `125742_S1_M1_priority-review-request.pdf` | M1 | Pfizer | BLA | 1 | 14 | [PHMPT](https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M1_priority-review-request.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M1_priority-review-request.pdf) |
| `125742_S2_M1_cover.pdf` | M1 | Pfizer | BLA | 1 | 3 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/04/125742_S2_M1_cover.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/04/125742_S2_M1_cover.pdf) |
| `19745_S63_M1_ eua-pre-sub-mtg-rqst.pdf` | M1 | Moderna | EUA | 1 | 38 | — |
| `125752_S3_M5_53_monthly-safety-rpt-06-01jun-30jun2021.pdf` | M5 | Moderna | BLA | 1 | 2 | — |
| `125742-45_S316_M1_response-22april2022.pdf` | M1 | Pfizer | BLA | 1 | 2 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S316_M1_response-22april2022.pdf) |
| `27034_S1_M1_eua.pdf` | M1 | Pfizer | EUA | 1 | 209 | — |
| `27034_S13_M1_response-2-dec-2020-bp-act-surv.pdf` | M1 | Pfizer | EUA | 1 | 12 | — |
| `27034_S21_M1_cover.pdf` | M1 | Pfizer | EUA | 1 | 1 | — |
| `27034_S21_M1_eua.pdf` | M1 | Pfizer | EUA | 1 | 210 | — |
| `27034_S21_M1_eua-track.pdf` | M1 | Pfizer | EUA | 1 | 210 | — |
| `125742_S21_M1_cover.pdf` | M1 | Pfizer | BLA | 1 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/08/125742_S21_M1_cover.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/125742_S21_M1_cover.pdf) |
| `125742_S31_M1_cover.pdf` | M1 | Pfizer | BLA | 1 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/08/125742_S31_M1_cover.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/125742_S31_M1_cover.pdf) |
| `125742_S41_M1_response-10aug2021.pdf` | M1 | Pfizer | BLA | 1 | 4 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/08/125742_S41_M1_response-10aug2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/125742_S41_M1_response-10aug2021.pdf) |
| `125742_S52_M1_response-13aug2021.pdf` | M1 | Pfizer | BLA | 1 | 3 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/08/125742_S52_M1_response-13aug2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/125742_S52_M1_response-13aug2021.pdf) |
| `125742_S62_M1_response-17aug2021.pdf` | M1 | Pfizer | BLA | 1 | 3 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/08/125742_S62_M1_response-17aug2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/125742_S62_M1_response-17aug2021.pdf) |
| `019736_S387_M5_c4591008-interim-abstract.pdf` | M5 | Pfizer | BLA | 1 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S387_M5_c4591008-interim-abstract.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S387_M5_c4591008-interim-abstract.pdf) |
| `027-2-Declaration-of-Sarah-B.-Kotler-2023-03-31.pdf` | — | — | — | 1 | 7 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/05/027-2-Declaration-of-Sarah-B.-Kotler-2023-03-31.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/027-2-Declaration-of-Sarah-B.-Kotler-2023-03-31.pdf) |
| `125742-45_04-22-2022_Telecon_Information-Reque.pdf` | — | Pfizer | — | 1 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_04-22-2022_Telecon_Information-Reque.pdf) |
| `125742_S1_M1_priority-review-request-1.pdf` | M1 | Pfizer | — | 1 | 14 | [PHMPT](https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M1_priority-review-request-1.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M1_priority-review-request-1.pdf) |
| `127_Courtesy-Copy_BLA-125742-0_CBER-Sentinel-Program-Sufficiency-Memo-COMIRNATY.pdf` | — | Pfizer | — | 1 | 2 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/11/127_Courtesy-Copy_BLA-125742-0_CBER-Sentinel-Program-Sufficiency-Memo-COMIRNATY.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/11/127_Courtesy-Copy_BLA-125742-0_CBER-Sentinel-Program-Sufficiency-Memo-COMIRNATY.pdf) |
| `22_BLA-125742-0_07-15-2021_Meeting-Summary_Committee-.pdf` | — | Pfizer | — | 1 | 8 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/22_BLA-125742-0_07-15-2021_Meeting-Summary_Committee-.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/09/22_BLA-125742-0_07-15-2021_Meeting-Summary_Committee-.pdf) |
| `35_BLA-125742-0_07-28-2021_Telecon_Information-Reques.pdf` | — | Pfizer | — | 1 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/35_BLA-125742-0_07-28-2021_Telecon_Information-Reques.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/09/35_BLA-125742-0_07-28-2021_Telecon_Information-Reques.pdf) |
| `3_BLA-125752-0_09-09-2021_Meeting-Summary_Committee-.pdf` | — | Moderna | — | 1 | 6 | [PHMPT](https://phmpt.org/wp-content/uploads/2025/05/3_BLA-125752-0_09-09-2021_Meeting-Summary_Committee-.pdf) |
| `55_BLA-125752-0_12-10-2021_Telecon_Information-Reques.pdf` | — | Moderna | — | 1 | 3 | [PHMPT](https://phmpt.org/wp-content/uploads/2025/05/55_BLA-125752-0_12-10-2021_Telecon_Information-Reques.pdf) |
| `59_1_BLA-125742-0_08-10-2021_Telecon_Information-Reques.pdf` | — | Pfizer | — | 1 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/59_1_BLA-125742-0_08-10-2021_Telecon_Information-Reques.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/09/59_1_BLA-125742-0_08-10-2021_Telecon_Information-Reques.pdf) |
| `69_1_BLA-125742-0_08-13-2021_Telecon_Information-Reques.pdf` | — | Pfizer | — | 1 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/69_1_BLA-125742-0_08-13-2021_Telecon_Information-Reques.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/09/69_1_BLA-125742-0_08-13-2021_Telecon_Information-Reques.pdf) |
| `80_2_BLA-125742-0_08-17-2021_Telecon_Information-Reques.pdf` | — | Pfizer | — | 1 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/80_2_BLA-125742-0_08-17-2021_Telecon_Information-Reques.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/09/80_2_BLA-125742-0_08-17-2021_Telecon_Information-Reques.pdf) |

<details><summary>Example context snippets (first 3)</summary>

- **`125752_S37_M1_pvp-spikevax-16dec2021-trk.pdf` p1** — *…MODERNATX, INC. MRNA-1273 E2E PHARMACOVIGILANCE PLAN 16 DECEMBER 2021 Confidential Page 1 MODERNATX, INC. Pharmacovigilance Pla…*
- **`125752_S37_M1_pvp-spikevax-16dec2021-trk.pdf` p1** — *…HARMACOVIGILANCE PLAN 16 DECEMBER 2021 Confidential Page 1 MODERNATX, INC. Pharmacovigilance Plan Spikevax (COVID-19 Vaccine mRNA) 16 December 2021 FDA-CBER-2022-1614-1227464…*
- **`125752_S37_M1_pvp-spikevax-16dec2021.pdf` p1** — *…MODERNATX, INC. MRNA-1273 E2E PHARMACOVIGILANCE PLAN DECEMBER 16, 2021 Confidential Page 1 MODERNATX, INC. Pharmacovigilance Pl…*

</details>

## Disproportionality analysis

**7 file(s), 24 hit(s).**

| File | Module | Company | License | Hits | Pages | Links |
| --- | --- | --- | --- | ---: | --- | --- |
| `125752_S3_M5_53_monthly-safety-rpt-06-01jun-30jun2021.pdf` | M5 | Moderna | BLA | 8 | 321, 1237, 1238, 1249, 1250, 1251, 1252 | — |
| `27073_S198_M1_monthly-safety-rpt-01may2021-31may2021.pdf` | M1 | Moderna | BLA | 7 | 668, 864, 866, 873, 874, 875 | — |
| `27073_S134_M1_monthly-safety-rpt-18feb2021-31mar2021.pdf` | M1 | Moderna | BLA | 4 | 644, 660, 667, 682 | — |
| `27073_S164_M1_ monthly-safety-rpt-01apr2021-30apr2021.pdf` | M1 | Moderna | BLA | 2 | 652, 673 | — |
| `27073_S249_M1_pbrer-01-18dec2020-30jun2021.pdf` | M1 | Moderna | BLA | 1 | 102 | — |
| `125752_S55_M1_pbrer-2-01jul2021-31dec2021.pdf` | M1 | Moderna | BLA | 1 | 900 | — |
| `19736_S0491_M1_smsr-01aug2021-31aug2021.pdf` | M1 | Pfizer | BLA | 1 | 11669 | [PHMPT](https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/100123/19736_S0491_M1_smsr-01aug2021-31aug2021.pdf) · [ICAN](https://ican-public.s3.amazonaws.com/productions/100123/19736_S0491_M1_smsr-01aug2021-31aug2021.pdf) |

<details><summary>Example context snippets (first 3)</summary>

- **`125752_S3_M5_53_monthly-safety-rpt-06-01jun-30jun2021.pdf` p321** — *…n Empirica Signal. Review of an external large post-marketing database allowing disproportionality analysis (DPA). 1) Disproportionality scores 2) Case series for predefined topics 3) E…*
- **`125752_S3_M5_53_monthly-safety-rpt-06-01jun-30jun2021.pdf` p1237** — *…...........................................14 3.4 Epidemiological Context and Disproportionality Analysis ................14 3.4.1 Analysis of Observed to Expected Rates for Appendici…*
- **`27073_S198_M1_monthly-safety-rpt-01may2021-31may2021.pdf` p668** — *…n Empirica Signal. Review of an external large post-marketing database allowing disproportionality analysis (DPA). 1) Disproportionality scores 2) Case series for predefined topics 3) E…*

</details>

## Risk management plan

**71 file(s), 1,617 hit(s).**

| File | Module | Company | License | Hits | Pages | Links |
| --- | --- | --- | --- | ---: | --- | --- |
| `125752_S3_M1_rmp-v2-2.pdf` | M1 | Moderna | BLA | 153 | 1, 2, 3, 4, 5, 6, 7, 8, … (+123) | — |
| `125742-45_S211_M1_pharmacovigilance-plan-track.pdf` | M1 | Pfizer | BLA | 142 | 1, 2, 3, 4, 5, 6, 7, 8, … (+133) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M1_pharmacovigilance-plan-track.pdf) |
| `125742-45_S314_M1_pharmacovigilance-plan.pdf` | M1 | Pfizer | BLA | 133 | 1, 2, 3, 4, 5, 6, 7, 8, … (+124) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S314_M1_pharmacovigilance-plan.pdf) |
| `125742-45_S314_M1_pharmacovigilance-plan-track.pdf` | M1 | Pfizer | BLA | 133 | 1, 2, 3, 4, 5, 6, 7, 8, … (+124) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S314_M1_pharmacovigilance-plan-track.pdf) |
| `125742-45_S211_M1_pharmacovigilance-plan.pdf` | M1 | Pfizer | BLA | 132 | 1, 2, 3, 4, 5, 6, 7, 8, … (+123) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M1_pharmacovigilance-plan.pdf) |
| `27034_S135_M1_pharmacovigilance-plan-track.pdf` | M1 | Pfizer | EUA | 110 | 1, 2, 3, 4, 5, 6, 7, 8, … (+102) | — |
| `125742_S21_M1_pharmacovigilance-plan.pdf` | M1 | Pfizer | BLA | 99 | 1, 2, 3, 4, 5, 6, 7, 8, … (+91) | [PHMPT](https://phmpt.org/wp-content/uploads/2023/01/125742_S21_M1_pharmacovigilance-plan.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/01/125742_S21_M1_pharmacovigilance-plan.pdf) |
| `125742_S21_M1_pvp-track.pdf` | M1 | Pfizer | BLA | 99 | 1, 2, 3, 4, 5, 6, 7, 8, … (+91) | [PHMPT](https://phmpt.org/wp-content/uploads/2023/01/125742_S21_M1_pvp-track.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/01/125742_S21_M1_pvp-track.pdf) |
| `27034_S135_M1_pharmacovigilance-plan-clean.pdf` | M1 | Pfizer | EUA | 99 | 1, 2, 3, 4, 5, 6, 7, 8, … (+91) | — |
| `125742_S2_M1_pharmacovigilance-plan.pdf` | M1 | Pfizer | BLA | 93 | 1, 2, 3, 4, 5, 6, 7, 8, … (+85) | [PHMPT](https://phmpt.org/wp-content/uploads/2023/08/125742_S2_M1_pharmacovigilance-plan.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/125742_S2_M1_pharmacovigilance-plan.pdf) |
| `27034_S16_M1_pharmacovigilance-plan-clean.pdf` | M1 | Pfizer | EUA | 77 | 1, 2, 3, 4, 5, 6, 7, 8, … (+69) | — |
| `27034_S16_M1_pharmacovigilance-plan-track.pdf` | M1 | Pfizer | EUA | 77 | 1, 2, 3, 4, 5, 6, 7, 8, … (+69) | — |
| `27034_S1_M1_pharmacovigilance-plan.pdf` | M1 | Pfizer | EUA | 72 | 1, 2, 3, 4, 5, 6, 7, 8, … (+64) | — |
| `125752_S55_M1_pbrer-2-01jul2021-31dec2021.pdf` | M1 | Moderna | BLA | 25 | 5, 33, 37, 38, 70, 71, 73, 106, … (+17) | — |
| `125752_S37_M1_pvp-spikevax-16dec2021-trk.pdf` | M1 | Moderna | BLA | 24 | 4, 5, 6, 7, 10, 11, 20 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/07/125752_S37_M1_pvp-spikevax-16dec2021-trk.pdf) |
| `125752_S37_M1_pvp-spikevax-16dec2021.pdf` | M1 | Moderna | BLA | 24 | 4, 5, 6, 7, 10, 11, 19, 20 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/07/125752_S37_M1_pvp-spikevax-16dec2021.pdf) |
| `27073_S134_M1_monthly-safety-rpt-18feb2021-31mar2021.pdf` | M1 | Moderna | BLA | 11 | 2, 6, 39, 81, 87, 432, 433, 457, … (+3) | — |
| `125752_S3_M5_5351_mrna1273p301-16-1-1.pdf` | M5 | Moderna | BLA | 8 | 116, 254, 391, 530, 671, 809, 969, 1130 | [PHMPT](https://phmpt.org/wp-content/uploads/2025/04/125752_S3_M5_5351_mrna1273p301-16-1-1.pdf) |
| `27073_S249_M1_pbrer-01-18dec2020-30jun2021.pdf` | M1 | Moderna | BLA | 8 | 5, 29, 36, 77, 82, 937, 939, 958 | — |
| `125752_S3_M5_53_monthly-safety-rpt-06-01jun-30jun2021.pdf` | M5 | Moderna | BLA | 7 | 19, 24, 96, 101, 913, 934, 1231 | — |
| `125752_S19_M5_5354_mrna-1273-p904-eu-pass-protocol.pdf` | M5 | Moderna | BLA | 4 | 7, 15, 37, 43 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/12/125752_S19_M5_5354_mrna-1273-p904-eu-pass-protocol.pdf) |
| `27073_S66_M1_monthly-safety-rpt-18dec2020-17jan2021.pdf` | M1 | Moderna | BLA | 4 | 3, 5, 26 | — |
| `125742_S1_M1_meeting-correspondence.pdf` | M1 | Pfizer | BLA | 4 | 468, 518, 543, 592 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/125742_S1_M1_meeting-correspondence.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/125742_S1_M1_meeting-correspondence.pdf) |
| `27073_S164_M1_ monthly-safety-rpt-01apr2021-30apr2021.pdf` | M1 | Moderna | BLA | 3 | 12, 109, 675 | — |
| `125742_S0136_M5_smsr-01sep2021-30sep2021.pdf` | M5 | Pfizer | BLA | 3 | 11, 13140, 13165 | [PHMPT](https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/100123/125742_S0136_M5_smsr-01sep2021-30sep2021.pdf) · [ICAN](https://ican-public.s3.amazonaws.com/productions/100123/125742_S0136_M5_smsr-01sep2021-30sep2021.pdf) |
| `19736_S0214_M1_smsr-01jan2021-31jan2021.pdf` | M1 | Pfizer | BLA | 3 | 3, 9, 87 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/19736_S0214_M1_smsr-01jan2021-31jan2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/19736_S0214_M1_smsr-01jan2021-31jan2021.pdf) |
| `19736_S0289_M1_smsr-01mar2021-31mar2021.pdf` | M1 | Pfizer | BLA | 3 | 10, 4743, 4822 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/19736_S0289_M1_smsr-01mar2021-31mar2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/19736_S0289_M1_smsr-01mar2021-31mar2021.pdf) |
| `125752_S3_M2_25_clinical-overview.pdf` | M2 | Moderna | BLA | 2 | 7, 110 | [PHMPT](https://phmpt.org/wp-content/uploads/2025/04/125752_S3_M2_25_clinical-overview.pdf) |
| `125752_S3_M2_27_summary-clin-safety.pdf` | M2 | Moderna | BLA | 2 | 10, 179 | [PHMPT](https://phmpt.org/wp-content/uploads/2025/04/125752_S3_M2_27_summary-clin-safety.pdf) |
| `125752_S19_M5_5354_mrna-1273-p905-eu-pass-preg-protocol.pdf` | M5 | Moderna | BLA | 2 | 6, 39 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/12/125752_S19_M5_5354_mrna-1273-p905-eu-pass-preg-protocol.pdf) |
| `27073_S285_M5_ mrna-1273-p903-pass-interim-update-3.pdf` | M5 | Moderna | EUA | 2 | 8, 10 | — |
| `27073_S99_M1_monthly-safety-rpt-18jan2021-17feb2021.pdf` | M1 | Moderna | BLA | 2 | 2, 6 | — |
| `27073_S198_M1_monthly-safety-rpt-01may2021-31may2021.pdf` | M1 | Moderna | BLA | 2 | 13, 62 | — |
| `125742_S1_M5_5351_c4591001-fa-interim-report-body.pdf` | M5 | Pfizer | BLA | 2 | 80 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/04/125742_S1_M5_5351_c4591001-fa-interim-report-body.pdf) |
| `125742_S1_M5_5351_c4591001-interim-mth6-report-body.pdf` | M5 | Pfizer | BLA | 2 | 68 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/04/125742_S1_M5_5351_c4591001-interim-mth6-report-body.pdf) |
| `125742_S2_M5_5354_c4591008-protocol.pdf` | M5 | Pfizer | BLA | 2 | 5, 13 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/04/125742_S2_M5_5354_c4591008-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/04/125742_S2_M5_5354_c4591008-protocol.pdf) |
| `125742_S2_M5_5354_c4591011-protocol.pdf` | M5 | Pfizer | BLA | 2 | 10, 25 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/04/125742_S2_M5_5354_c4591011-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/04/125742_S2_M5_5354_c4591011-protocol.pdf) |
| `125742_S2_M5_5354_c4591012-protocol.pdf` | M5 | Pfizer | BLA | 2 | 9, 24 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/04/125742_S2_M5_5354_c4591012-protocol.pdf) |
| `125742-45_S211_M5_c4591001-interim-ado-mth6-report-body.pdf` | M5 | Pfizer | BLA | 2 | 50 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M5_c4591001-interim-ado-mth6-report-body.pdf) |
| `125742-45_S211_M5_c4591001-interim-ado-report-body.pdf` | M5 | Pfizer | BLA | 2 | 43 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M5_c4591001-interim-ado-report-body.pdf) |
| `19736_S136_M5_c4591001-interim-report-body.pdf` | M5 | Pfizer | EUA | 2 | 62 | — |
| `019736_S196_M5_c4591008-protocol.pdf` | M5 | Pfizer | BLA | 2 | 5, 13 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S196_M5_c4591008-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S196_M5_c4591008-protocol.pdf) |
| `019736_S196_M5_c4591011-protocol.pdf` | M5 | Pfizer | BLA | 2 | 10, 25 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S196_M5_c4591011-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S196_M5_c4591011-protocol.pdf) |
| `019736_S196_M5_c4591012-protocol.pdf` | M5 | Pfizer | BLA | 2 | 9, 24 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S196_M5_c4591012-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S196_M5_c4591012-protocol.pdf) |
| `019736_S387_M5_c4591008-interim-protocol.pdf` | M5 | Pfizer | BLA | 2 | 5, 13 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S387_M5_c4591008-interim-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S387_M5_c4591008-interim-protocol.pdf) |
| `019736_S387_M5_c4591012-interim-protocol.pdf` | M5 | Pfizer | BLA | 2 | 9, 24 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S387_M5_c4591012-interim-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S387_M5_c4591012-interim-protocol.pdf) |
| `019736_S470_M5_c4591012-protocol.pdf` | M5 | Pfizer | BLA | 2 | 10, 31 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S470_M5_c4591012-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S470_M5_c4591012-protocol.pdf) |
| `019736_S470_M5_c4591012-protocol-track.pdf` | M5 | Pfizer | BLA | 2 | 10, 34 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S470_M5_c4591012-protocol-track.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S470_M5_c4591012-protocol-track.pdf) |
| `32_BLA-125752-0_11-01-2021_Telecon_Information-Reques.pdf` | — | Moderna | — | 2 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2025/05/32_BLA-125752-0_11-01-2021_Telecon_Information-Reques.pdf) |
| `36_BLA-125752-0_11-05-2021_Telecon_Information-Reques.pdf` | — | Moderna | — | 2 | 1 | [PHMPT](https://phmpt.org/wp-content/uploads/2025/05/36_BLA-125752-0_11-05-2021_Telecon_Information-Reques.pdf) |
| `125752_S19_M5_5354_mrna-1273-p903-covid-19-safety-protocol.pdf` | M5 | Moderna | BLA | 1 | 11 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/07/125752_S19_M5_5354_mrna-1273-p903-covid-19-safety-protocol.pdf) |
| `125752_S3_M1_cover-0003.pdf` | M1 | Moderna | BLA | 1 | 7 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/06/125752_S3_M1_cover-0003.pdf) |
| `125752_S3_M5_5351_mrna1273p301-body.pdf` | M5 | Moderna | BLA | 1 | 93 | [PHMPT](https://phmpt.org/wp-content/uploads/2025/04/125752_S3_M5_5351_mrna1273p301-body.pdf) |
| `125752_S5008_M1_115214_annotated-ref-4-protocol-v3-.pdf` | M1 | Moderna | BLA | 1 | 122 | — |
| `19745_S42_M5_protocol-mrna-1273-p301-amend-4.pdf` | M5 | Moderna | EUA | 1 | 127 | — |
| `19745_S42_M5_protocol-mrna-1273-p301-amend-4-trk(2103076.1).pdf` | M5 | Moderna | EUA | 1 | 128 | — |
| `19745_S42_M5_protocol-mrna-1273-p301-amend-4-trk.pdf` | M5 | Moderna | EUA | 1 | 128 | — |
| `27073_S248_M5_mrna-1273-p903-pass-ni-protocol-v3-1.pdf` | M5 | Moderna | EUA | 1 | 10 | — |
| `27073_S248_M5_mrna-1273-p903-pass-ni-protocol-v3-1-trk.pdf` | M5 | Moderna | EUA | 1 | 11 | — |
| `125742-45_S211_M1_cover.pdf` | M1 | Pfizer | BLA | 1 | 3 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/125742-45_S211_M1_cover.pdf) |
| `27073_S13_M1_core-presentation-draft-slides.pdf` | M1 | Moderna | EUA | 1 | 67 | — |
| `27073_S16_M1_core-presentation-final-slides.pdf` | M1 | Moderna | EUA | 1 | 68 | — |
| `125742_S2_M1_cover.pdf` | M1 | Pfizer | BLA | 1 | 3 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/04/125742_S2_M1_cover.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/04/125742_S2_M1_cover.pdf) |
| `125742_S41_M5_5354_c4591021-protocol.pdf` | M5 | Pfizer | BLA | 1 | 69 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/08/125742_S41_M5_5354_c4591021-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/08/125742_S41_M5_5354_c4591021-protocol.pdf) |
| `019736_S387_M5_c4591008-interim-report-body.pdf` | M5 | Pfizer | BLA | 1 | 12 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S387_M5_c4591008-interim-report-body.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S387_M5_c4591008-interim-report-body.pdf) |
| `19736_S0185_M1_smsr-01dec2020-31dec2020.pdf` | M1 | Pfizer | BLA | 1 | 55 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/19736_S0185_M1_smsr-01dec2020-31dec2020.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/19736_S0185_M1_smsr-01dec2020-31dec2020.pdf) |
| `19736_S0366_M1_smsr-30apr2021-31may2021.pdf` | M1 | Pfizer | BLA | 1 | 11 | [PHMPT](https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/100123/19736_S0366_M1_smsr-30apr2021-31may2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/19736_S0366_M1_smsr-30apr2021-31may2021.pdf) |
| `19736_S0408_M1_smsr-01jun2021-30jun2021.pdf` | M1 | Pfizer | BLA | 1 | 11 | [PHMPT](https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/100123/19736_S0408_M1_smsr-01jun2021-30jun2021.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/19736_S0408_M1_smsr-01jun2021-30jun2021.pdf) |
| `19736_S0453_M1_smsr-01jul2021-31jul2021.pdf` | M1 | Pfizer | BLA | 1 | 10 | [ICAN](https://ican-public.s3.amazonaws.com/productions/100123/19736_S0453_M1_smsr-01jul2021-31jul2021.pdf) |
| `19736_S0491_M1_smsr-01aug2021-31aug2021.pdf` | M1 | Pfizer | BLA | 1 | 11 | [PHMPT](https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/100123/19736_S0491_M1_smsr-01aug2021-31aug2021.pdf) · [ICAN](https://ican-public.s3.amazonaws.com/productions/100123/19736_S0491_M1_smsr-01aug2021-31aug2021.pdf) |
| `3_BLA-125752-0_09-09-2021_Meeting-Summary_Committee-.pdf` | — | Moderna | — | 1 | 6 | [PHMPT](https://phmpt.org/wp-content/uploads/2025/05/3_BLA-125752-0_09-09-2021_Meeting-Summary_Committee-.pdf) |

<details><summary>Example context snippets (first 3)</summary>

- **`125752_S3_M1_rmp-v2-2.pdf` p1** — *…ModernaTX, Inc. EU Risk Management Plan for COVID-19 Vaccine Moderna Page 1 EU Risk Management Plan for Spikevax (COV…*
- **`125752_S3_M1_rmp-v2-2.pdf` p1** — *…dernaTX, Inc. EU Risk Management Plan for COVID-19 Vaccine Moderna Page 1 EU Risk Management Plan for Spikevax (COVID-19mRNA vaccine) Risk Management Plan (RMP) version to…*
- **`125742-45_S211_M1_pharmacovigilance-plan-track.pdf` p1** — *…BNT162b2 1.16 Risk Management Plan (Non-REMS) for Biologic License Application # 125742 CONFIDENTIAL Page 1…*

</details>

## PRR

**7 file(s), 25 hit(s).**

| File | Module | Company | License | Hits | Pages | Links |
| --- | --- | --- | --- | ---: | --- | --- |
| `125752_S3_M5_54_desmet-2012.pdf` | M5 | Moderna | BLA | 16 | 1, 2, 3, 5, 6, 7, 8, 10, … (+1) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/08/125752_S3_M5_54_desmet-2012.pdf) |
| `125752_S3_M5_54_li-2021.pdf` | M5 | Moderna | BLA | 2 | 9, 10 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/08/125752_S3_M5_54_li-2021.pdf) |
| `125752_S3_M5_53_monthly-safety-rpt-06-01jun-30jun2021.pdf` | M5 | Moderna | BLA | 2 | 431, 1250 | — |
| `19736_S105_M4_engelmann-b-2013.pdf` | M4 | Pfizer | EUA | 2 | 4, 6 | — |
| `125752_S3_M5_54_de-wit-2016.pdf` | M5 | Moderna | BLA | 1 | 6 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/08/125752_S3_M5_54_de-wit-2016.pdf) |
| `27073_S198_M1_monthly-safety-rpt-01may2021-31may2021.pdf` | M1 | Moderna | BLA | 1 | 820 | — |
| `19736_S105_M4_dewit-e-2016.pdf` | M4 | Pfizer | EUA | 1 | 6 | — |

<details><summary>Example context snippets (first 3)</summary>

- **`125752_S3_M5_54_desmet-2012.pdf` p1** — *…receptors that are often referred to as pattern-recognition receptors (PRRs). PRR-derived signals are integrated directly or indirectly at the level of antigen…*
- **`125752_S3_M5_54_desmet-2012.pdf` p2** — *…oteins) and extracellular host nucleic acids8. Although some DAMPs bind to non-PRR receptors, most DAMPs were proposed to activate PRRs8. In the context of infec…*
- **`125752_S3_M5_54_li-2021.pdf` p9** — *…the manuscript. RM, AZ, GR, and AS implemented the study. XL, AO, PR, RM, KV, PRR, TDS, and MAS contributed to the study execution (data holders). XL, AO, GH, a…*

</details>

## Proportional Reporting Ratio

*No hits.*

## Bayesian

**45 file(s), 214 hit(s).**

| File | Module | Company | License | Hits | Pages | Links |
| --- | --- | --- | --- | ---: | --- | --- |
| `125742-45_S211_M5_c4591001-interim-ado-mth6-protocol.pdf` | M5 | Pfizer | BLA | 30 | 176, 203, 409, 435, 642, 668, 874, 900, … (+22) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M5_c4591001-interim-ado-mth6-protocol.pdf) |
| `125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf` | M5 | Pfizer | BLA | 22 | 166, 192, 360, 377, 539, 554, 715, 731, … (+14) | [PHMPT](https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf) |
| `125742-45_S211_M5_c4591001-interim-ado-protocol.pdf` | M5 | Pfizer | BLA | 22 | 166, 192, 360, 377, 539, 554, 715, 731, … (+14) | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M5_c4591001-interim-ado-protocol.pdf) |
| `125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf` | M5 | Pfizer | BLA | 12 | 107, 119, 260, 273, 412, 425, 558, 568, … (+4) | [PHMPT](https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M5_5351_c4591001-fa-interim-protocol.pdf) |
| `19736_S136_M5_c4591001-interim-protocol.pdf` | M5 | Pfizer | EUA | 12 | 107, 119, 260, 273, 412, 425, 558, 568, … (+4) | — |
| `125742_S1_M1_meeting-correspondence.pdf` | M1 | Pfizer | BLA | 11 | 19, 38, 39, 40, 71, 73, 75 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/125742_S1_M1_meeting-correspondence.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/125742_S1_M1_meeting-correspondence.pdf) |
| `125752_S3_M1_rmp-v2-2.pdf` | M1 | Moderna | BLA | 10 | 68, 291, 349, 351, 353, 361, 394 | — |
| `125742_S1_M5_5351_c4591001-fa-interim-sap.pdf` | M5 | Pfizer | BLA | 8 | 5, 29, 35, 47, 53, 54 | [PHMPT](https://phmpt.org/wp-content/uploads/2022/07/125742_S1_M5_5351_c4591001-fa-interim-sap.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2022/07/125742_S1_M5_5351_c4591001-fa-interim-sap.pdf) |
| `125742_S1_M5_5351_c4591001-interim-mth6-sap.pdf` | M5 | Pfizer | BLA | 8 | 8, 44, 45, 55, 81, 88, 89 | [PHMPT](https://phmpt.org/wp-content/uploads/2022/07/125742_S1_M5_5351_c4591001-interim-mth6-sap.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2022/07/125742_S1_M5_5351_c4591001-interim-mth6-sap.pdf) |
| `125742-45_S211_M5_c4591001-interim-ado-mth6-sap.pdf` | M5 | Pfizer | BLA | 8 | 8, 45, 47, 58, 84, 91, 92 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M5_c4591001-interim-ado-mth6-sap.pdf) |
| `125742-45_S211_M5_c4591001-interim-ado-sap.pdf` | M5 | Pfizer | BLA | 8 | 8, 44, 45, 55, 81, 88, 89 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M5_c4591001-interim-ado-sap.pdf) |
| `19736_S136_M5_c4591001-interim-sap.pdf` | M5 | Pfizer | EUA | 8 | 5, 29, 35, 47, 53, 54 | — |
| `125752_S1_M4.3_deming-2006.pdf` | M4 | Moderna | BLA | 4 | 4, 6, 16 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/125752_S1_M4.3_deming-2006.pdf) |
| `125752_S3_M5_54_deming-2006.pdf` | M5 | Moderna | BLA | 4 | 4, 6, 16 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/08/125752_S3_M5_54_deming-2006.pdf) |
| `19736_S105_M4_ke-z-2020.pdf` | M4 | Pfizer | EUA | 4 | 10, 20 | — |
| `27034_S1_M5_verity-r-2020.pdf` | M5 | Pfizer | EUA | 4 | 4, 5, 6 | — |
| `125742-45_S211_M5_c4591001-interim-ado-mth6-publications.pdf` | M5 | Pfizer | BLA | 3 | 12, 30, 64 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M5_c4591001-interim-ado-mth6-publications.pdf) |
| `125752_S3_M5_54_miettinen-1985.pdf` | M5 | Moderna | BLA | 2 | 3, 13 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/08/125752_S3_M5_54_miettinen-1985.pdf) |
| `125742_S1_M5_5351_c4591001-fa-interim-report-body.pdf` | M5 | Pfizer | BLA | 2 | 82 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/04/125742_S1_M5_5351_c4591001-fa-interim-report-body.pdf) |
| `125742_S1_M5_5351_c4591001-fa-interim-synopsis.pdf` | M5 | Pfizer | BLA | 2 | 19 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/04/125742_S1_M5_5351_c4591001-fa-interim-synopsis.pdf) |
| `125742_S1_M5_5351_c4591001-interim-mth6-publications.pdf` | M5 | Pfizer | BLA | 2 | 15, 33 | [PHMPT](https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/060122/125742_S1_M5_5351_c4591001-interim-mth6-publications.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2022/06/125742_S1_M5_5351_c4591001-interim-mth6-publications.pdf) |
| `125742-45_S211_M5_c4591001-interim-ado-publications.pdf` | M5 | Pfizer | BLA | 2 | 15, 33 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/01/125742-45_S211_M5_c4591001-interim-ado-publications.pdf) |
| `019736_S414_M5_c4591001-amendment-17-clean.pdf` | M5 | Pfizer | BLA | 2 | 169, 195 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S414_M5_c4591001-amendment-17-clean.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S414_M5_c4591001-amendment-17-clean.pdf) |
| `019736_S414_M5_c4591001-amendment-17-track.pdf` | M5 | Pfizer | BLA | 2 | 170, 197 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/10/019736_S414_M5_c4591001-amendment-17-track.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/019736_S414_M5_c4591001-amendment-17-track.pdf) |
| `027-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-26-Brief-Memorandum-in-Support-of-Motion.pdf` | — | Pfizer | — | 2 | 29, 203 | [PHMPT](https://phmpt.org/wp-content/uploads/2021/12/027-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-26-Brief-Memorandum-in-Support-of-Motion.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2022/03/027-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-26-Brief-Memorandum-in-Support-of-Motion.pdf) |
| `125752_S37_M1_pvp-spikevax-16dec2021-trk.pdf` | M1 | Moderna | BLA | 1 | 9 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/07/125752_S37_M1_pvp-spikevax-16dec2021-trk.pdf) |
| `125752_S37_M1_pvp-spikevax-16dec2021.pdf` | M1 | Moderna | BLA | 1 | 9 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/07/125752_S37_M1_pvp-spikevax-16dec2021.pdf) |
| `125752_S1_M4.3_dinnon-2020.pdf` | M4 | Moderna | BLA | 1 | 14 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/125752_S1_M4.3_dinnon-2020.pdf) |
| `125752_S1_M4.3_mercado-2020.pdf` | M4 | Moderna | BLA | 1 | 20 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/125752_S1_M4.3_mercado-2020.pdf) |
| `125752_S1_M4.3_tostanoski-2020.pdf` | M4 | Moderna | BLA | 1 | 21 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/125752_S1_M4.3_tostanoski-2020.pdf) |
| `125752_S3_M5_54_corbett-2020a.pdf` | M5 | Moderna | BLA | 1 | 19 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/08/125752_S3_M5_54_corbett-2020a.pdf) |
| `125752_S3_M5_54_dinnon-2020.pdf` | M5 | Moderna | BLA | 1 | 14 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/08/125752_S3_M5_54_dinnon-2020.pdf) |
| `125752_S3_M5_54_zhou-2020.pdf` | M5 | Moderna | BLA | 1 | 32 | [PHMPT](https://phmpt.org/wp-content/uploads/2024/08/125752_S3_M5_54_zhou-2020.pdf) |
| `27073_S249_M1_pbrer-01-18dec2020-30jun2021.pdf` | M1 | Moderna | BLA | 1 | 818 | — |
| `125742-45_S211_M5_sah-p-2021.pdf` | M5 | Pfizer | BLA | 1 | 2 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/09/125742-45_S211_M5_sah-p-2021.pdf) |
| `125742_S1_M5_5351_c4591001-fa-interim-publications.pdf` | M5 | Pfizer | BLA | 1 | 15 | [PHMPT](https://phmpt.org/wp-content/uploads/2022/04/125742_S1_M5_5351_c4591001-fa-interim-publications.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2022/04/125742_S1_M5_5351_c4591001-fa-interim-publications.pdf) |
| `125742_S7_M5_5351_bnt162-01-interim3-reports.pdf` | M5 | Pfizer | BLA | 1 | 500 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/04/125742_S7_M5_5351_bnt162-01-interim3-reports.pdf) |
| `125752_S3_M5_53_monthly-safety-rpt-06-01jun-30jun2021.pdf` | M5 | Moderna | BLA | 1 | 1250 | — |
| `19736_S136_M5_c4591001-interim-report-body.pdf` | M5 | Pfizer | EUA | 1 | 63 | — |
| `19736_S105_M4_pallesen-j-2017.pdf` | M4 | Pfizer | EUA | 1 | 10 | — |
| `27034_S1_M5_mulligan-mj-2020.pdf` | M5 | Pfizer | EUA | 1 | 14 | — |
| `27034_S1_M5_pallesen-j-2017.pdf` | M5 | Pfizer | EUA | 1 | 10 | — |
| `27034_S1_M5_sahin-u-2020.pdf` | M5 | Pfizer | EUA | 1 | 14 | — |
| `125742_S1_M5_5351_bnt162-01-interim3-reports.pdf` | M5 | Pfizer | BLA | 1 | 500 | [PHMPT](https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/100123/125742_S1_M5_5351_bnt162-01-interim3-reports.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/10/125742_S1_M5_5351_bnt162-01-interim3-reports.pdf) |
| `51_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Memo-COMIRNATY.pdf` | — | Pfizer | — | 1 | 19 | [PHMPT](https://phmpt.org/wp-content/uploads/2023/11/51_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Memo-COMIRNATY.pdf) · [ICAN](https://icandecide.org/wp-content/uploads/2023/11/51_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Memo-COMIRNATY.pdf) |

<details><summary>Example context snippets (first 3)</summary>

- **`125742-45_S211_M5_c4591001-interim-ado-mth6-protocol.pdf` p176** — *…essment for the primary analysis will be based on posterior probability using a Bayesian model. The secondary objectives regarding VE against asymptomatic SARS-CoV-2 i…*
- **`125742-45_S211_M5_c4591001-interim-ado-mth6-protocol.pdf` p203** — *…ponsor.  Efficacy and futility boundaries will be applied in a nonbinding way. Bayesian approaches require specification of a prior distribution for the possible value…*
- **`125742_S1_M5_5351_c4591001-interim-mth6-protocol.pdf` p166** — *…essment for the primary analysis will be based on posterior probability using a Bayesian model. The secondary objectives regarding VE against asymptomatic SARS-CoV-2 i…*

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