Datensammlung der Juristin Dr, Silvia Behrendt über EMA - Wichtige Indizien für die Beweisaufnahme

Im Substack der österreichischen Juristin und EMA-Expertin Frau Dr. Silvia Behrendt finden sich die veröffentlichten Daten der EMA, die nach langer Forderung entweder gut lesbar oder auch geschwärzt veröffentlicht wurden. In unserem Interview bei CSmedicus wird sie einiges dazu vorstellen, warum sie der EMA bewusste Vertuschung vorwirft. ab 3.7.26, 18.30 Uhr: https://www.youtube.com/@csmedicus/videos

Spikevax (Moderna) PSURs including raw data sets updated 17/03/2025
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 (last document 2.EMA PSUR) 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)