Spikevax (Moderna) PSURs including raw data sets

released on an ongoing basis by the European Medicines Agency as requested since 2023 by the PSUR4doctors initiative comprising 130 European doctors

…is updated continuously and grows according to EMA’s speed…

6. PSUR Spikevax: 18 June 2023 to 17 December 2023

EMA-PRAC Assessment Report of 6. PSUR Spikevax (available soon) & PSUR body

5. PSUR Spikevax: 18 December 2022 to 17 June 2023

EMA-PRAC Assessment Report of 5. PSUR Spikevax & PSUR body

4.PSUR Spikevax – 19 June 2022 to 17 December 2022

EMA-PRAC Assessment Report of 4. PSUR Spikevax & PSUR body

All Appendices requested at EMA, still pending

3. PSUR Spikevax (01/01/2022 – 18/06/2022)

3.PSUR Spikevax – *EMA-PRAC Spikevax

Appendix 1 Reference Safety Information 567
Appendix 2 Cumulative Summary Tabulations of Serious Adverse Events from Clinical Trials 568
Appendix 3 Cumulative and Interval Summary Tabulations of Serious and Non-Serious Adverse Reactions from Post-marketing Data Sources 569
Appendix 4.1 Tabular Summary of Safety Signals 570
Appendix 4.2a Signal Evaluation report: Autoimmune hepatitis
Appendix 4.2b Signal Evaluation report: Giant Cell Arteritis
Appendix 4.2c Signal Evaluation report: Amenorrhea (additional signal evaluation report) 586
Appendix 4.2d Signal Evaluation report: Heavy menstrual bleeding (additional signal evaluation report) 587
Appendix 4.2e Signal Evaluation report: Urticaria (additional signal evaluation report) 588

Document with Appendices 1-4.2 (pp. 566-914) available here

Appendix 4.2f A Signal Evaluation report: Corneal graft rejection (additional signal evaluation report) 589
Appendix 4.2g Signal Evaluation report: IgA Nephropathy (additional signal evaluation report) 590
Appendix 5 Listing of all MAH-Sponsored Interventional Trials with the Primary Aim of Identifying, Characterising, or Quantifying a Safety Hazard or Confirming the Safety Profile of the Medicinal Product 591

Dokument with Appendices 4.2f-5 (pp.915-1268) available here

Appendix 6 Listing of all the MAH-sponsored Non-interventional Studies with the Primary Aim of Identifying, Characterising, or Quantifying a Safety Hazard; Confirming the Safety Profile of the Medicinal Product; or Measuring the Effectiveness of Risk Management Measures 611
Appendix 7 List of the Sources of Information Used to Prepare the PBRER (if desired by the MAH) 616
Appendix 8 EU Regional Appendices 639
Appendix 9 US Regional Appendices 641
Appendix 10 Canada Regional appendix 642
Appendix 11 Other Appendices Supporting PBRER 647
Appendix 11.1 Worldwide Marketing Authorization status 648
Appendix 11.2 Summary of Exposure from Marketing Experience and
Distribution and Administration Data
Appendix 11.3 Observed Expected Appendix
Appendix 11.4a Anaphylaxis Adolescents ages 12 to 17 years_Medical Review
Appendix 11.4b Anaphylaxis: Adolescents ages 12 to 17 years_Medical Review with Brighton Collaboration -Narratives
Appendix 11.4c Anaphylaxis: Literature Search Methodology with Brighton Collaboration

Document with Appendices 6-11.4c available here (pp. 915-1268)

Appendix 11.5a Myocarditis/Pericarditis: Patients < 40 years of age after Dose 2 (additional signal evaluation report) 667
Appendix 11.5b Myocarditis/Pericarditis: Patients < 40 years of age after Dose 2 and Dose 3: Case Narratives and Dose 3: Case Listings) 668

Documents with Appendices 11.5a-11.5b available here (pp. 1269-1568) and prolonged Appendix 11.5b from pp. 1569-1697 available here (pp.1569-1868)

Appendix 11.5c Myocarditis/Pericarditis Patients less than 18 of age after Dose 2 and Dose 3-Case listings 669
Appendix 11.5d Myocarditis/Pericarditis Patients less than 18 of age after Dose 2 and Dose 3-Case narratives 670
Appendix 11.5e Myocarditis-Pericarditis Fatal reports Case Listings 671
Appendix 11.5f Myocarditis-Pericarditis Fatal reports Case Narratives 672
Appendix 11.5g Myocarditis: Literature search Methodology 673
Appendix 11.6a Pregnancy: Distribution of Case and Event Counts by
SOC/HLT/PT Stratified by Event seriousness for Interval and Cumulative 675
Appendix 11.6b Pregnancy: Summary of pregnancy outcomes by trimester of exposure, and retrospective/prospective case classification, Reporting Period 676
Appendix 11.6c Pregnancy: Summary of pregnancy outcomes by trimester of exposure, and retrospective/prospective case classification, Cumulative 677
Appendix 11.6d Pregnancy: Sun nary of reported congenital anomalies by HLT and PT that occurred in fetuses and neonates, Cumulative 678
Appendix 11.6e Pregnancy: Distribution of Case and Event Counts by SOC/HLT/PT Stratified by Event Seriousness for Adolescents, Interval and Cumulative 679
Appendix 11.6f Pregnancy: Targeted Literature Search Strategy for Pregnancy and Lactation for The Reporting Period (01 Jan 2022-18 Jun 2022 680
Appendix 11.7 Lactation-related Cases Under 5 years of Age with Serious Lactation-related events, Cumulative 681
Appendix 11.8 Use in immunocompromised subjects: Literature search methodology 682
Appendix 11.9a Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Literature search 683
Appendix 11.9b Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Various Synonyms terms of SPIKEVAX 684
Appendix 11.9c Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Articles/Abstracts Appendix 11.9c Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Articles/Abstracts 685
Appendix 11.9d Interaction with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Fatal cases: Case Listings and Case Narratives) 686

Documents with Appendices 5.c-11.9d available here (pp.1569-1868) and prolonged Appendix 11.9 from pp. 1868-2050 available here (pp. 1869-2268)

Appendix 11.9e Interaction: with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Immunocompromised co-morbidities Dose 3 & 4 688

Documents with Appendix 11.9e available here 2269-2734 and prolonged pp. 2735- 2862 available here (pp. 2735-3034)

Appendix 11.9f Interaction: with Other COVID-19 vaccines (Heterologous Vaccine Schedule): Immunocompromised co-morbidities Dose 3 & 4

Appendix 11.10 Narratives-RP Use in frail subjects: Fatal cases: Case Listings and Case 689

Document with Appendices 11.9f -11.10 available here (pp. 2735-3034)

Appendix 11.11a Use in Patients with Autoimmune or Inflammatory Disorders:
Literature Search Methodology
Appendix 11.11b Use in patients with Autoimmune or Inflammatory Disorders:
Fatal cases: Case Listings and Case Narratives
Appendix 11.11c Use in Patients with Autoimmune or Inflammatory Disorders: PTs of Autoimmune/Inflammatory Disorder (AI/M) SMQ in Reports with Past MIHX of AI/ID, representing a subset of potential flares (Cumulative)
Appendix 11.12a Myasthenia gravis: New Onset MG-Case Listings
Appendix 11.12b Myasthenia gravis: New Onset MG-Case Narratives
Appendix 11.12c Myasthenia gravis: MG flare-Case Listings
Appendix 11.12d Myasthenia gravis: MG flare-Case Narratives
Appendix 11.12e Myasthenia gravis: Literature Search Methodology
Appendix 11.13a Use in Patients with Autoimmune c• Irlammatory Disorders
(Autoimmune Hemolytic Anemia): Cumulative Evaluation-Case listings
Appendix 11.13b Use in Patients with Autoimmune or Inflammatory Disorders
(Autoimmune Hemolytic Anemia): Cumulative Evaluation-Case Narratives

Document with Appendices 11.11a-11.13b available here (pp. 3035-3417)

(*3418-3764)

Appendix 11.17c Acute Disseminated Encephalomyelitis (ADEM): Detailed Summary of Cumulative Data Concerning ADEM and Brighton's CollaborationLevel of diagnostic certainty 1 to 3 and their WHO-UMC Causality Assessment: Case Listings 731
Appendix 11.17d Acute Disseminated Encephilc -myelitis (ADEM): Detailed Summary of Cumulative Data Concerning ADEM and Brighton's Collaboration Level of diagnostic certainty 1 to 3 and their WHO-UMC Causality Assessment: Case Narratives 732
Appendix 11.17e Acute Disseminated Encephalomyelitis (ADEM): Various synonymous terms of SPIKEVAX
Appendix 11.17f Acute Dissemitfted Encephalomyelitis (ADEM): Literature Search Methodology 734
Appendix 11.18a Neuralgic Amyotrophy: Cumulative reports of Neuralgic amyotrophy with Case Assessment and WHO Causality information 735
Appendix 11.18b Neuralgic Amyotrophy: Cumulative reports of Neuralgic Amyotrophy with Case Assessment and WHO Causality information: Casenarratives 736
Appendix 11.18c Neuralgic Amyotrophy: Cumulative reports of Neuralgic Amyotrophy with Case Assessment and WHO Causality infermation: Case listings 737
Appendix 11.18d Neuralgic Amyotrophy: Literature Search Methodology 738

Document Appendices 11.17.c-11.18d available here (pp. 3765-4087)

Appendix 11.19a Multisystem Inflaming'ory Syndrome (MIS): Summary Informs_ on on the Reported Evens Eiring the Reporting Period with a Fatal Outcome: Case Listings
Appendix 11.19b Multisystem Inflan )ry Syndrome (MIS): Summary Inform c on the Reported Evens Eiring the Reporting Period will) a Fatal Outcome: Narratives Appendix 11.19c Multisystem Inflammatory Syndrome (MIS): Information on MIS-C Related Events for the reporting period: Case Listings
Appendix 11.19d Multisystem Inflammatory Syndrome (MIS): Information on MIS-C Related Events for the reporting period: Narratives
Appendix 11.19e Multisystem Inflammatory Syndrome (MIS): Brighton Collaboration Summary Information Level 1 to 3 for the Reporting Period: Case Listings
Appendix 11.19f Multisystem Inflammatory Syndrome (MIS): Brighton Collaboration Summary Information Level 1 to 3 for the Reporting Period: Narratives
Appendix 11.19g Multisystem Inflammatory Syndrome (MIS): Summary Information for all MIS-C/A related cases for the reporting period: Case Listings Appendix 11.19h Multisystem Inflammatory Syndrome (MIS): Summary Information on all MIS-C/A related cases for the reporting period: Narratives Appendix 11.19i Multisystem Inflammatory Syndrome (MIS): Various synonymous terms of SPIKEVAX
Appendix 11.20a Chronic Urticaria: Cases classified by the MAH as Chronic Urtica is Flare/Worsening (n=9) Appendix 11.20b Chronic Urticaria: Case Narratives for "Definite" cases of Chronic Urticaria (N=35)
Appendix 11.20c Chronic Urticaria: Literature Search Methodology

Document Appendices 11.19a-11.20c available here (pp. 4088-4371)

Appendix 11.21a Autoimmune Hepatitis: Cumulative Cases with WHO Causality and Confounders-Case listings 751
Appendix 11.21b Autoimmune Hepatitis: Cumulative Cases with WHO Causality and Confounders-Case narratives 752
Appendix 11.21c Autoimmune Hepatitis: AIH confirmed case-Case listings 753
Appendix 11.21d Autoimmune Hepatitis: AIH confirmed case-Case narratives 754
Appendix 11.21e Autoimmune Hepatitis: Summary of Fatal Cases 755
Appendix 11.21f Autoimmune Hepatitis: tabular Overview of Fatal cases with
WHO Causality-Case listings 756
Appendix 11.21g Autoimmune Hepatitis: tabular Overview of Fatal cases with WHO Causality-Case narratives 757
Appendix 11.21h Autoimmune Hepatitis: Literature Search Methodology 758
Appendix 11.22a SOCV: Detailed summary of Cumulative cases that met Brighon's Collaboration Level of diagnostic certainty 1 to 3, and their WHO-UMC causality assessment 759
Appendix 11.22b SOCV: Literature Search Methodology 760
Appendix 11.23a Polymyalgia Rheumatica and exacerbation or flar:-up- Overview of Flare/Aggravated and New-Onset PMR cases with case summaries andcompany comments- Reporting Period 01 Jan 2022 to 18 Jun 2022 761
Appendix 11.23b Polymyalgia Rheumatica and exacerbation or flare-up: Re-evaluation of the causality assessment of the 22 possible cases presented in PBRER#2 762
Appendix 11.23c Polymyalgia Rheumatica and exacerbation or flare-up: Literature Search Methodology 763

Document Appendices 11.21a-11.23c available here (pp. 4372-4685)

Appendix 11.25a Overdose: Reporting Period Case Listings
Appendix 11.25b Overdose: Reporting Period Case Narratives
Appendix 11.25c Overdose: Literature Search Methodology
Appendix 11.26a Off-label use: Reporting Period Case Listing
Appendix 11.26b Off-label use: Reporting Period Case Narratives
Appendix 11.26c Off-label use: Literature Search Methodology
Appendix 11.27a Interactions with Other Vaccines: Literature cases
Appendix 11.27b Interactions with Other Vaccines: Literature Search Methodology
Appendix 11.28a Lack of Efficacy/Vaccine failure: Variant cases
Appendix 11.28b Lack of Efficacy/Vaccine failure: Fatal case listings-RP
Appendix 11.28c Lack of Efficacy/Vaccine failure: Fatal case narratives-RP
Appendix 11.28d Lack of Efficacy/Vaccine failure: Fatal case listings after Booster
Appendix 11.28e Lack of Efficacy/Vaccine failure: Fatal case narratives after Booster
Appendix 11.28e Lack of Efficacy/Vaccine failure: literature Search Vaccine Inefficacy cases
Appendix 11.28f Lack of Efficacy/Vaccine failure: Scientific abstracts
Appendix 11.28g Lack of Efficacy/Vaccine failure: Additional literature search strategy
Appendix 11.29a Elderly: Fatal case listings
Appendix 11.29b Elderly: Fatal case narratives

Document Appendices 11.25a-11.28g available here (pp. 5472-5848)

Appendix 11.29c. Elderly: Fatal case listings after Booster
Appendix 11.29d. Elderly: Fatal case narratives after Booster
Appendix 11.29e Elderly: Literature Search Methodology
Appendix 11.30a Children: Cumulative event counts in the < 18 years age group
Appendix 11.30b Children: Summary of Serious cases in children 2-11 years of age
Appendix 11.30c Children: Details on event counts during the reporting period in
the 0-5 years age group
Appendix 11.30d Children: Details on event counts during the reporting period in the 5-11 years age group
Appendix 11.30e Children: Details on event counts during the reporting period in the 12-17 years age group
Appendix 12 Literature search strategies

Document Appendices 11.29c-12 available here (pp. 5849-6053)

2. PSUR Spikevax

2.PSUR Body – EMA PRAC AR 2.PSUR

1. PSUR Spikevax

1.PSUR Body – EMA PRAC AR 2.PSUR

Appendix 1 Reference Information (02 December 2021) 353

1. PSUR Spikevax

1.PSUR Spikevax – EMA-PRAC Spikevax