Nuvaxoid (Novavax) PSURs including raw data sets last update 17/02/2025
released by the European Medicines Agency as requested since 2023 by the PSUR4doctors initiative comprising 130 European doctors
The site is updated continuously and grows according to EMA’s speed of disclosure. The annexes with the raw data sets have been requested at EMA and will be published as soon as they are disclosed! (last update 28th December 24’)
1. PSUR Nuvaxoid (20/12/2021-19/06/2022)
EMA PRAC-AR
1.PSUR available here and 1.PRAC Assessment Report available here
Appendix 1: NVX-CoV2373 EU-SmPC Version 1.0; Effective Date: 20-Dec-2021
Appendix 2: NVX-CoV2373 CCDS Version 3.0; Effective Date: 03-ay-2022
Appendix 3: Worldwide Marketing Authorisation Status
Appendix 4: Cumulative Summary Tabulation of SAE from Clinical Trials
Appendix 5: Cumulative and Interval Summary Tabulation of Serious and Non-Serious PT from Post-Authorisation Data Sources
Appendix 6: Summary of Safety Signals New, Ongoing, or Closed During the Reporting Interval
Appendix 7: Listing of all Interventional Clinical Trials for NVX-CoV2373
Appendix 8: Listing of all MAH-Sponsored Non-Interventional Studies for NVX-CoV2373
Appendix 9: Medication Errors
Appendix 10: O/E Analyses and Exposure Tables Assumptions
Appendix 11: Observed-to-Expected Analysis of AESI with Sensitivity Analysis for
Cumulative Cases
Appendix 12: Observed-to-Expected Analysis of AESI with Sensitivity Analysis for Cumulative Cases (Medically Confirmed)
Appendix 13: Search Strategy for AESI
Document (Appendices 1-13) available hereAppendix 14: Search Strategy/Methodology for Safety Topics for Monitoring
Appendix 15: Australia Regional Appendix
Appendix 16: Canada Regional Appendix
Appendix 17: EU Regional Appendix
Appendix 18: UK Regional Appendix
Appendix 19: Line Listing of Fatal Cases
Appendix 20: Signal Evaluation Report of Anaphylaxis
Appendix 21: Signal Evaluation Report of Myocarditis/Pericarditis
Appendix 22: Signal Evaluation Report of Paraesthesia
Appendix 23: Signal Evaluation Report for Encephalitis/Encephalomyelitis
Appendix 24: Signal Evaluation Report for Chest Pain/Chest Discomfort
Appendix 25: Signal Evaluation Report for Dizziness
Appendix 26: Health Authorities Requests Following Review of SSRs
Appendix 27: References/List of Sources of Information Used to Prepare the PBRER
Document (Appendices 14-27) available here
2.PSUR Nuvaxoid (20/06/2022-19/12/2022) & EMA PRAC-AR
Appendix 1: NVX-CoV2373, CCDS Version 6.0; Effective Date, 10-Aug-2022 (p. 166)
Appendix 2: NVX-CoV2373 CCDS Version 3.0; Effective Date: 03-May-2022 (p.190)
Appendix 3: Worldwide Marketing Authorisation (WWMA) Status (p. 213)
Appendix 4: Cumulative Summary Tabulation of Serious Adverse Events (SAE) from Clinical Trials (p. 217)
Appendix 5: Cumulative and Interval Summary Tabulation of Serious and Non-Serious PT from Post-Authorisation Data Sources (p. 277)
Appendix 6: Summary of Safety Signals New, Ongoing, or Closed During the Reporting Interval (p. 326)
Appendix 7: Listing of all Interventional Clinical Trials for NVX-CoV2373 (p. 329)
Appendix 8: Listing of all MAH-Sponsored Non-Interventional Safety Studies for NVX-CoV2373 (p. 341)
Appendix 9: Medication errors (p. 342)
Appendix 10: O/E Analyses and Exposure Tables Assumptions (p. 347)
Appendix 11: Observed-to-Expected Analysis of AESI with Sensitivity Analysis for
Overall Dose Series (p. 369)
Document (Appendices 1-11) availalbe here
Appendix 12: Search Strategy/Methodology for AESI 583
Appendix 13: Search Strategy/Methodology for Safety Topics for Monitoring 585
Appendix 14: Australia Regional Appendix 587
Appendix 15: Canada Regional Appendix 592
Appendix 16: EU Regional Appendix 599Appendix 17: UK Regional Appendix 601
Appendix 18: Line Listing of Fatal Cases 603
Appendix 19: Signal Evaluation Report for Diarrhoea 639
Appendix 20: Signal Evaluation Report for Dyspnoea 674
Appendix 21: Signal Evaluation Report for Tinnitus 720
Appendix 22: Signal Evaluation Report for Tachycardia and Other RhythM
Abnormalities 746
Appendix 23: Signal Evaluation Report for Acute Coronary Syndrome Associated with Allergic Reaction 781Appendix 24: Signal Evaluation Report for Syncope 795
Appendix 25: Signal Evaluation Report for Menstrual Disorders 821
Appendix 26: Health Authority Requests Following Review of SSRs 858
Appendix 27: References/List of Sources of Information Used to Prepare this PBRER 860