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          "term": "Risk management plan",
          "context": "uss the need for any potential amendment to the product information and/or the risk management plan and make accordingly a proposal for the changes to the relevant sections withi"
        },
        {
          "page": 82,
          "term": "Risk management plan",
          "context": "as refuted. No changes to labeling, other reference safety information or the risk management plan were warranted. Hearing Loss / Deafness will continue to be monitored through"
        },
        {
          "page": 102,
          "term": "Disproportionality analysis",
          "context": "for the occurrence of appendicitis and exposure to SPIKEVAX. Epidemiology and disproportionality analysis found a reporting rate of Appendicitis in the GSDB (0.87 cases per 100,000 per"
        },
        {
          "page": 818,
          "term": "Bayesian",
          "context": "iBase. The information component (IC), an indicator value for disproportionate Bayesian reporting comparingly observed and expected values to find signals for associa"
        },
        {
          "page": 937,
          "term": "Risk management plan",
          "context": "linical trial conduct, labeling, other reference safety information or the risk management plan. Hypoaesthesia / Paraesthesia 12 Mar 2021 Closed 6 Apr 2021 Health Autho"
        },
        {
          "page": 939,
          "term": "Risk management plan",
          "context": "rna SMT. No changes to labeling, other reference safety information or the risk management plan warranted. Hypoaesthesia/P araesthesia will continue to be monitored 939 FD"
        },
        {
          "page": 958,
          "term": "Risk management plan",
          "context": "refuted. No changes to labeling, other reference safety information or the risk management plan. Appendicitis will continue to be monitored through routine pharmacovigila"
        }
      ]
    },
    {
      "filename": "125752_S3_M5_5351_1273p201-16-1-4.pdf",
      "id": 1983,
      "module": "M5",
      "batch_code": "md",
      "company": "Moderna",
      "license": "BLA",
      "individual_url": null,
      "ican_url": null,
      "total_pages": 16,
      "matches": []
    },
    {
      "filename": "125752_S3_M5_5351_mrna1273p301-16-1-4.pdf",
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      "module": "M5",
      "batch_code": "md",
      "company": "Moderna",
      "license": "BLA",
      "individual_url": null,
      "ican_url": null,
      "total_pages": 1614,
      "matches": []
    },
    {
      "filename": "125752_S53_M1_12_cover-0053.pdf",
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      "module": "M1",
      "batch_code": "md",
      "company": "Moderna",
      "license": "BLA",
      "individual_url": null,
      "ican_url": null,
      "total_pages": 1,
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    },
    {
      "filename": "125752_S53_M1_11423_final-labeling-text-full-prescribing-info.pdf",
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      "batch_code": "md",
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      "individual_url": null,
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      "total_pages": 17,
      "matches": []
    },
    {
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      "matches": []
    },
    {
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      "module": "M1",
      "batch_code": "md",
      "company": "Moderna",
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      "individual_url": null,
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      "matches": []
    },
    {
      "filename": "125752_S55_M1_12_cover-0055.pdf",
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      "module": "M1",
      "batch_code": "md",
      "company": "Moderna",
      "license": "BLA",
      "individual_url": null,
      "ican_url": null,
      "total_pages": 1,
      "matches": []
    },
    {
      "filename": "125752_S55_M1_form-356h-0055.pdf",
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      "module": "M1",
      "batch_code": "md",
      "company": "Moderna",
      "license": "BLA",
      "individual_url": null,
      "ican_url": null,
      "total_pages": 6,
      "matches": []
    },
    {
      "filename": "125752_S55_M1_pbrer-2-01jul2021-31dec2021.pdf",
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      "module": "M1",
      "batch_code": "md",
      "company": "Moderna",
      "license": "BLA",
      "individual_url": null,
      "ican_url": null,
      "total_pages": 13123,
      "matches": [
        {
          "page": 5,
          "term": "Risk management plan",
          "context": "of this report (closed on 19 Jan 2022). During the reporting period, SPIKEVAX risk management plan (RMP) was updated to RMP v2.1 to include myocarditis and pericarditis as new i"
        },
        {
          "page": 33,
          "term": "Risk management plan",
          "context": "riodic Safety Update Report PT Preferred Term RA Rheumatoid Arthritis RMP Risk Management Plan ROR Rate of Return RSI Reference Safety Information RTX Rituximab RWE R"
        },
        {
          "page": 37,
          "term": "Risk management plan",
          "context": "s, for whom dosing has not been completed. On 31 Jul 2021, as per category 2 Risk Management Plan (RMP) commitment, the interim clinical study report for protocol mRNA 1273 P30"
        },
        {
          "page": 38,
          "term": "Pharmacovigilance plan",
          "context": "ngoing. o All interventional and observational studies listed in the SPIKEVAX pharmacovigilance plan were updated to better characterize the risks of myocarditis and pericarditis"
        },
        {
          "page": 38,
          "term": "Risk management plan",
          "context": "m the MAH for the administration of the second dose submitted 02 Aug 2021 \u2022 A risk management plan update including measures to further characterize the risk: RMP version 2.1 wi"
        },
        {
          "page": 70,
          "term": "Risk management plan",
          "context": "tiforme. The MAH should discuss the need to update the product information and risk management plan and submit proposals as appropriate Background Erythema multiforme is immune-"
        },
        {
          "page": 71,
          "term": "Risk management plan",
          "context": "to clinical trial conduct, labelling, other reference safety information or the risk management plan. The topic of EM will be monitored through routine PV activities. 16.2.4. Gl"
        },
        {
          "page": 73,
          "term": "Risk management plan",
          "context": "erulonephritis, the MAH does not plan to update the product information and/or risk management plan, including relevant risk minimization measures. Similarly, the MAH does not se"
        },
        {
          "page": 106,
          "term": "Risk management plan",
          "context": "ion of the MAH\u2019s CCDS and it is considered an important identified risk in the risk management plan of SPIKEVAX. Based on the analysis of all the safety data available as of 31 D"
        },
        {
          "page": 191,
          "term": "Risk management plan",
          "context": "ne and inflammatory disorders (AI/ID) is an area of missing information in the Risk Management Plan (RMP). There are limited data from clinical trials on the use of SPIKEVAX in i"
        },
        {
          "page": 484,
          "term": "Risk management plan",
          "context": "se 3 mRNA-1273-P301 harm monitoring at the time of the data lock point for the risk management plan where safety follow-up is based on a median duration of follow-up after the se"
        },
        {
          "page": 513,
          "term": "Risk management plan",
          "context": "of this report (closed on 19 Jan 2022). During the reporting period SPIKEVAX risk management plan was updated to RMP v2.1 to include myocarditis and pericarditis as new importa"
        },
        {
          "page": 724,
          "term": "Risk management plan",
          "context": "a sources reviewed. MAH did not plan to update the product information and/or risk management plan, including relevant risk minimization measures. EM will be monitored through"
        },
        {
          "page": 725,
          "term": "Risk management plan",
          "context": "a sources reviewed. MAH did not plan to update the product information and/or risk management plan, FDA-CBER-2022-1614-4234598"
        },
        {
          "page": 727,
          "term": "Risk management plan",
          "context": "clinical trial conduct, labelling, other reference safety information or the risk management plan. Events of serious hypertension will continue to be monitored through routine"
        },
        {
          "page": 729,
          "term": "Risk management plan",
          "context": "a sources reviewed. MAH did not plan to update the product information and/or risk management plan, including relevant risk minimization measures. MIS will be monitored through"
        },
        {
          "page": 730,
          "term": "Risk management plan",
          "context": "a sources reviewed. MAH did not plan to update the product information and/or risk management plan, including relevant risk minimization measures. TM will continue to be monito"
        },
        {
          "page": 732,
          "term": "Risk management plan",
          "context": "a sources reviewed. MAH did not plan to update the product information and/or risk management plan, including relevant risk minimization measures. CLS will continue to be monit"
        },
        {
          "page": 733,
          "term": "Risk management plan",
          "context": "ources reviewed. MAH did not plan to update the product information and/or risk management plan, including relevant risk minimization measures. CVST will continue to be moni"
        },
        {
          "page": 734,
          "term": "Risk management plan",
          "context": "a sources reviewed. MAH did not plan to update the product information and/or risk management plan, including relevant risk minimization measures. AIH will continue to be monit"
        },
        {
          "page": 779,
          "term": "Risk management plan",
          "context": "tiforme. The MAH should discuss the need to update the product information and risk management plan and submit proposals as appropriate.\" FDA-CBER-2022-1614-4234652"
        },
        {
          "page": 792,
          "term": "Risk management plan",
          "context": "to clinical trial conduct, labeling, other reference safety information or the risk management plan. The topic of Erythema multiforme will be monitored through routine PV activit"
        },
        {
          "page": 834,
          "term": "Risk management plan",
          "context": "merulonephritis, the MAH does not plan to update the product information and/or risk management plan, including relevant risk minimization measures. Similarly, the MAH does not s"
        },
        {
          "page": 900,
          "term": "Disproportionality analysis",
          "context": "tension (5.82%), hypotension (3.60%) and peripheral coldness (2.41%). Based on disproportionality analysis (IC025 values), acute myocardial infarction, cardiac arrest, and circulatory c"
        },
        {
          "page": 905,
          "term": "Risk management plan",
          "context": "s, clinical trial conduct, labeling, other reference safety information or the risk management plan. Events of serious hypertension will continue to be monitored through routine"
        },
        {
          "page": 913,
          "term": "Risk management plan",
          "context": "uss the need for any potential amendment to the product information and/or the risk management plan and make accordingly a proposal for the changes to the relevant sections withi"
        },
        {
          "page": 916,
          "term": "Risk management plan",
          "context": "urrent local labels, nor is it identified as a safety concern in the mRNA-1273 risk management plan. 3 REVIEW OF DATA FROM ALL SOURCES 3.1 REVIEW OF CLINICAL STUDY SAFETY DATA"
        },
        {
          "page": 1657,
          "term": "Pharmacovigilance plan",
          "context": "nging of SPIKEVAX in children 6 months to 12 years of age, Please refer to the Pharmacovigilance plan (PVP) for the pediatric indication (6 to 12 years). In addition, the following"
        }
      ]
    },
    {
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    {
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      "individual_url": null,
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      "total_pages": 6,
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    },
    {
      "filename": "125752_S57_M1_rsp-fda-derm-24feb2022.pdf",
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      "batch_code": "md",
      "company": "Moderna",
      "license": "BLA",
      "individual_url": null,
      "ican_url": null,
      "total_pages": 10,
      "matches": []
    },
    {
      "filename": "125752_S5000_M1_115_form-2253-5000.pdf",
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      "batch_code": "md",
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      "license": "BLA",
      "individual_url": null,
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      "total_pages": 2,
      "matches": []
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    {
      "filename": "125752_S5000_M1_1146_spikevax-product-labeling.pdf",
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      "individual_url": null,
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    {
      "filename": "125752_S5000_M1_115211_us-cov-2100322-clean.pdf",
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    {
      "filename": "125752_S5000_M1_115212_us-cov-2100322-annotated.pdf",
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    {
      "filename": "125752_S5001_M1_115_form-2253-5001.pdf",
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      "batch_code": "md",
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    {
      "filename": "125752_S5001_M1_1146_spikevax-product-labeling.pdf",
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    {
      "filename": "125752_S5001_M1_115211_us-cov-2100318-annotated.pdf",
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    {
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    {
      "filename": "125752_S5003_M1_115_form-2253-5003.pdf",
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    {
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      "batch_code": "md",
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    },
    {
      "filename": "125752_S5003_M1_115211_us-cov-2200037-clean.pdf",
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      "module": "M1",
      "batch_code": "md",
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    {
      "filename": "125752_S5003_M1_115212_us-cov-2200037-annotated.pdf",
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    },
    {
      "filename": "125752_S5004_M1_115_form-2253-5004.pdf",
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    {
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    {
      "filename": "125752_S5004_M1_115211_us-cov-2200059-clean.pdf",
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      "filename": "125752_S5004_M1_115212_us-cov-2200059-annotated.pdf",
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    {
      "filename": "125752_S5005_M1_115_form-2253-5005.pdf",
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    },
    {
      "filename": "125752_S5005_M1_115211_us-cov-2200008-clean.pdf",
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    },
    {
      "filename": "125752_S5005_M1_115211_us-cov-2200042-clean.pdf",
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    {
      "filename": "125752_S5005_M1_115212_us-cov-2200008-annotated.pdf",
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      "batch_code": "md",
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      "total_pages": 4,
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    },
    {
      "filename": "125752_S5006_M1_115_form-2253-5006.pdf",
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      "batch_code": "md",
      "company": "Moderna",
      "license": "BLA",
      "individual_url": null,
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      "total_pages": 2,
      "matches": []
    },
    {
      "filename": "125752_S5006_M1_1146_spikevax-product-labeling.pdf",
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      "batch_code": "md",
      "company": "Moderna",
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    },
    {
      "filename": "125752_S5006_M1_115211_us-cov-2100410-clean.pdf",
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      "module": "M1",
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    },
    {
      "filename": "125752_S5006_M1_115211_us-cov-2200060-clean.pdf",
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      "batch_code": "md",
      "company": "Moderna",
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          "context": "ModernaTX, Inc. EU Risk Management Plan for COVID-19 Vaccine Moderna Page 120 REFERENCES Agrawal AS, Tao X, Algaissi"
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          "context": "freedom and P value noted Give P values as exact values whenever suitable. For Bayesian analysis, information on the choice of priors and Markov chain Monte Carlo sett"
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        {
          "page": 349,
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          "context": "ate backwards from observed deaths to the number of infections. We introduce a Bayesian mechanistic model linking the infection cycle to observed deaths, inferring th"
        },
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          "context": "tervals on Rt show the self-consistent behaviour that is a hallmark of a fully Bayesian analysis throughout the entire period we study, exhibiting appropriate shrinka"
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          "context": "the infection process associated with COVID-19 using a semi-mechanistic, joint Bayesian hierarchical model, we can reproduce trends observed in the data relating to d"
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        {
          "page": 353,
          "term": "Bayesian",
          "context": "hich interventions are modelled as piecewise constant functions. Following the Bayesian hierarchy from bottom to top gives us a full framework to see how intervention"
        },
        {
          "page": 353,
          "term": "Bayesian",
          "context": "ect of all interventions (Supplementary Fig. 3). We evaluate the effect of our Bayesian prior distribution choices and evaluate our Bayesian posterior calibration to"
        },
        {
          "page": 353,
          "term": "Bayesian",
          "context": "valuate the effect of our Bayesian prior distribution choices and evaluate our Bayesian posterior calibration to ensure our results are statistically robust. We perfo"
        },
        {
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          "term": "Bayesian",
          "context": "freedom and P value noted Give P values as exact values whenever suitable. For Bayesian analysis, information on the choice of priors and Markov chain Monte Carlo sett"
        },
        {
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          "term": "Bayesian",
          "context": "freedom and P value noted Give P values as exact values whenever suitable. For Bayesian analysis, information on the choice of priors and Markov chain Monte Carlo sett"
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          "term": "Pharmacovigilance plan",
          "context": "[ENTER PROCEDURE NUMBER] Initial version Safety concerns: Not applicable. Pharmacovigilance Plan: Not applicable. Post-authorisation efficacy plan: Not applicable. Risk min"
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          "page": 485,
          "term": "Pharmacovigilance plan",
          "context": "nd Use in participants with autoimmune or inflammatory disorders) - - - Pharmacovigilance Plan: The details have been updated to meet the request in Part III.1 (Specific ad"
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          "context": "ModernaTX, Inc. EU Risk Management Plan for COVID-19 Vaccine Moderna Page 126 Annex 8 Summary of Changes to the Risk"
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          "page": 488,
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          "context": "You propose to include pregnancy and lactation as missing information in your pharmacovigilance plan. We recommend a pregnancy registry for your product. Pregnancy registries prov"
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        {
          "page": 488,
          "term": "Pharmacovigilance plan",
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        {
          "page": 488,
          "term": "Pharmacovigilance plan",
          "context": "ce plan submitted with your BLA contains the elements specified in the ICH E2E Pharmacovigilance Planning Guidance (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs- gen/"
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          "page": 499,
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        {
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          "context": ". You propose to include pregnancy and lactation as missing information in your pharmacovigilance plan. We recommend a pregnancy registry for your product. Pregnancy registries provi"
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          "page": 499,
          "term": "Pharmacovigilance plan",
          "context": "view of the clinical and safety data related to your product. Please ensure the pharmacovigilance plan submitted with your BLA contains the elements specified in the ICH E2E Pharma"
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        {
          "page": 499,
          "term": "Pharmacovigilance plan",
          "context": "e plan submitted with your BLA contains the elements specified in the ICH E2E Pharmacovigilance Planning Guidance (https://www.fda.gov/ucm/groups/fdagov- public/@fdagov-drugsgen/do"
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