PSUR-DATA for Covid-19 vaccines – the most comprehensive global pharmacovigilance data available here
According to EU law, Periodic Safety Update Reports (PSURs) must be submitted by the marketing authorisation holder, i.e. the pharmaceutical company, if the safety of the medicinal product still requires further examination. These reports contain the most comprehensive globally available pharmacovigilance data for a specific time frame, mostly 6 months. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) then evaluates these data in a separate Assessment Report (AR PRAC) for a positive risk-benefit ratio and potential safety signals.
Until 2023, these important Covid-19 vaccine pharmacoviligance data were confidential. In order to obtain EMA’s safety data on Covid vaccines, more than 130 European doctors interested in pharmacovigiliance joined forces across borders and founded the PSUR4doctors initative to request these data sets from EMA according to EU transparency laws. The GHRA provided to the PSUR4ddoctors initative the legal background support and was the common voice to speak to EMA. Since then, Covid-19 vaccine pharmacovigilance data are continuously dispatched. As a result of this unique legal campaign, EMA agreed to the PSUR4doctors‘ request and makes since then the PSURs and accompanying PRAC AR publicly available for download on the respective EMA product page for Covid vaccines.
Below are all data officially released so far by EMA are made accessible and will be further updated on a continuing basis. Please check regularly for updates.
PSUR-DATENARCHIV
Periodische Sicherheitsberichte (PSUR) müssen von den Zulassungsinhabern, also den Pharmafirmen, in besonderen Fällen, in denen die Sicherheit des Arzneimittels noch eingehender Prüfung bedarf, erstellt werden. Diese Berichte enthalten alle global verfügbaren Pharmakovigilanzdaten des betreffenden Arzneimittels für einen bestimmten Zeitraum (meist 6 Monate), die in einem umfangreichen Rohdatensatz angehängt sind.
Dieser PSUR wird dem Ausschuss für Risikobewertung im Bereich der Pharmakovigilanz der Europäischen Arzneimittelbehörde (kurz PRAC) vorgelegt, der in einem Beurteilungsbericht (kurz AR PRAC) das positive Risiko-Nutzen Verhältnis überprüft. Im negativen Beurteilungsfall müsste das Arzneimittel vom Markt genommen werden.
Um die Sicherheitsdaten der EMA betreffend Covid-Impfstoffe zu erhalten, haben sich Anfang 2023 über 130 europäische Ärztinnen und Ärzte über die Grenzen hinweg zusammengeschlossen und diese Datensätze bei der EMA beantragt. Dabei wurde die Initative von der GHRA rechtlich unterstützt. Seither werden diese laufend übermittelt und auf TKP in einem durchsuchbaren OCR Format zur Verfügung gestellt sowie unterstehend verlinkt. Aufgrund dieser Aktion hat sich die EMA im Sommer 2023 bereit erklärt, die PSURs and PRAC AR auf der jeweiligen EMA-Produktseite der Covid-Impfstoffe öffentlich zum Download bereit zu stellen.
Untenstehend finden Sie alle bisher übermittelten Daten zum download – die Sammlung wird laufend erweitert.
Biontech/Pfizer
1. PSUR Comirnaty/Biontech (2020/12/19-2021/06/18)
1. PSUR Comirnaty/Biontech: Zeitraum: 19. Dezember 2020-18. Juni 2021
1.PSUR Comirnaty/Biontech (pp. 1-286) – EMA-PRAC AR of 1.PSUR Biontech (still missing)
APPENDIX 1 REFERENCE INFORMATION (19 MAY 2021) 287APPENDIX 1.1 SAFETY RELATED CHANGES TO RSI 328
APPENDIX 1.2 CORE DATA SHEET (12 FEBRUARY 2021) 343
APPENDIX 1.3 CORE DATA SHEET (02 MARCH 2021) 363
APPENDIX 1.4 CORE DATA SHEET (20 APRIL 2021) 384
APPENDIX 1.5 COMBINED EUA FACT SHEET FOR HEALTHCARE PROVIDERS AND FULL EUA PRESCRIBING INFORMATION (11 DECEMBER 2020) 407
APPENDIX 1.6 COMBINED EUA FACT SHEET FOR HEALTHCARE PROVIDERS AND FULL EUA PRESCRIBING INFORMATION (23 DECEMBER 2020) 436
APPENDIX 1.7 COMBINED EUA FACT SHEET FOR HEALTHCARE PROVIDERS ANDFULL EUA PRESCRIBING INFORMATION (05 JANUARY 2021) 466
APPENDIX 1.8 COMBINED EUA FACT SHEET FOR HEALTHCARE PROVIDERS ANDFULL EUA PRESCRIBING INFORMATION (25 JANUARY 2021) 496
APPENDIX 1.9 EU-SmPC (21 DECEMBER 2020) 526
APPENDIX 1.10 EU-SmPC (08 JANUARY 2021) 558
APPENDIX 1.11 EU-SmPC (28 JANUARY 2021) 593
APPENDIX 2.1 CUMULATIVE SUMMARY TABULATION OF SERIOUS ADVERSE EVENTS FROM CLINICAL TRIALS 626APPENDIX 2.1.1 CUMULATIVE SUMMARY TABULATION OF SERIOUS ADVERSE EVENTS FROM NON-PFIZER (LICENSING PARTNER) CLINICAL TRIALS 653
APPENDIX 2.2 CUMULATIVE AND INTERVAL SUMMARY TABULATION OF SERIOUS AND NON-SERIOUS ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES 655
APPENDIX 2.3 CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA 884
APPENDIX 2.3B CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM BIONTECH DEVELOPMENT PROGRAMS 886
APPENDIX 2.3C CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM FOSUN DEVELOPMENT PROGRAMS 887
APPENDIX 2.3.1 CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM OTHER PFIZER DEVELOPMENT PROGRAMS 888, all pp. 287-888 here
APPENDIX 3 TABULAR SUMMARY OF SAFETY SIGNALS 889
APPENDIX 3.1 SIGNAL EVALUATION NO DATA
APPENDIX 4.1 LISTING OF COMPLETED (CONCLUDED WITH FINAL CLINICAL
STUDY REPORT) INTERVENTIONAL SAFETY STUDIES NO DATA
APPENDIX 4.2 LISTING OF ONGOING (STARTED OR CONCLUDED WITH NO
FINAL CLINICAL STUDY REPORTS) INTERVENTIONAL SAFETY STUDIES
DATA STILL MISSING
2. PSUR Comirnaty/Biontech (2021/06/20 - 2021/12/18)
2.PSUR Comirnaty/Biontech (pp 1-352) – EMA PRAC AR 2.PSUR Biontech
APPENDIX 1 REFERENCE INFORMATION (02 DECEMBER 2021) 353
APPENDIX 1.1 SAFETY RELATED CHANGES TO RSI 417
APPENDIX 1.2 CORE DATA SHEET (19 MAY 2021) 435
APPENDIX 1.3 CORE DATA SHEET (14 JULY 2021) 476
APPENDIX 1.4 CORE DATA SHEET (11 AUGUST 2021) 518
APPENDIX 1.5 CORE DATA SHEET (08 SEPTEMBER 2021) 560
APPENDIX 1.6 CORE DATA SHEET (19 OCTOBER 2021) 607
APPENDIX 2.1 CUMULATIVE SUMMARY TABULATION OF SERIOUS ADVERSE EVENTS FROM CLINICAL TRIALS, pp. 671-709.
APPENDIX 2.1.1 CUMULATIVE SUMMARY TABULATION OF SERIOUS
ADVERSE EVENTS FROM NON-PFIZER (LICENSING PARTNER)
CLINICAL TRIALS 710
APPENDIX 2.2 CUMULATIVE AND INTERVAL SUMMARY TABULATION OF SERIOUS AND NON-SERIOUS ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES, pp. 714- 1050
APPENDIX 2.3 CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA 1051
APPENDIX 2.3B CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM BIONTECH DEVELOPMENT PROGRAMS 1053
APPENDIX 2.3C CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM FOSUN DEVELOPMENT PROGRAMS 1054
APPENDIX 2.3.1 CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM OTHER PFIZER DEVELOPMENT PROGRAMS 1055
APPENDIX 3 TABULAR SUMMARY OF SAFETY SIGNALS 1056
APPENDIX 3.1 SIGNAL EVALUATION NO DATA
APPENDIX 4.1 LISTING OF COMPLETED (CONCLUDED WITH FINAL CLINICAL STUDY REPORT) INTERVENTIONAL SAFETY STUDIES NO DATA
APPENDIX 4.2 LISTING OF ONGOING (STARTED OR CONCLUDED WITH NO FINAL CLINICAL STUDY REPORTS) INTERVENTIONAL SAFETY STUDIES 1078
APPENDIX 4.3 LISTING OF COMPLETED (CONCLUDED WITH FINAL CLINICAL STUDY REPORT) NON-INTERVENTIONAL SAFETY STUDIES NO DATA APPENDIX 4.4
LISTING OF ONGOING (STARTED OR CONCLUDED WITH NO FINAL CLINICAL STUDY REPORTS) NON-INTERVENTIONAL SAFETY STUDIES 1080
APPENDIX 5 LIST OF SOURCES OF INFORMATION USED TO PREPARE THE PSUR (LITERATURE ABS IRACTS) 1085
APPENDIX 6A LIST OF REGULATORY AUTHORITIES REQUEST(S) 1136
APPENDIX 6A.1 EXACERBATION (FLARE-UP) OF PRE-EXISTING AI/INFLAMMATORY DISORDERS 1170
APPENDIX 6A.2 CHRONIC URTICARIA/WORSENING OF PRE-EXISTING CHRONIC URTICARIA 1213
APPENDIX 6A.3 POLYMYALGIA RHEUMATICA CUMULATIVE REVIEW 1224
APPENDIX 6A.4 GLOMERULONEPHRITIS AND NEPHROTIC SYNDROME CUMULATIVE REVIEW 1282
APPENDIX 6A.5 MIS-C / MIS-A 1299
APPENDIX 6B OBSERVED VERSUS EXPECTED ANALYSES FOR ADVERSE EVENTS OF SPECIAL INTEREST 1309
APPENDIX 6C.1 INTERVAL SUMMARY TABULATION OF FATAL REPORTS 1354
APPENDIX 6C.2 CUMULATIVE SUMMARY TABULATION OF FATAL REPORTS 1406, all pp. 352-1406 here
APPENDIX 6.1 PROPOSED PRODUCT INFORMATION (REGIONAL APPENDIX) NO DATA
APPENDIX 6.2 PROPOSED ADDITIONAL PHARMACOVIGILANCE AND RISK MINIMISATION ACTIVITIES (REGIONAL APPENDIX) NO DATA
APPENDIX 6.3 SUMMARY OF ONGOING SAFETY CONCERNS (REGIONAL APPENDIX) NO DATA
APPENDIX 6.4 REPORTING OF RESULTS FROM POST-AUTHORISATION SAFETY STUDIES (REGIONAL APPENDIX) NO DATA
APPENDIX 6.5 EFFECTIVENESS OF RISK MINIMISATION (REGIONAL APPENDIX) NO DATA
APPENDIX 7 CUMULATIVE MARKETING AUTHORISATION STATUS NO DATA
APPENDIX 8 CHARACTERISATION OF IMPORTANT RISKS NO DATA
3. PSUR Comirnaty/Biontech (2021/12/19-2022/06/18)
3.PSUR Biontech (1-622) –EMA-PRAC Assessment Report of 3. PSUR Biontech
APPENDIX 1 REFERENCE INFORMATION (10 MAY 2022), p. 397
APPENDIX 1.1 SAFETY RELATED CHANGES TO RSI, p. 474
APPENDIX 1.2 CORE DATA SHEET (02 DECEMBER 2021), p. 494
APPENDIX 1.3 CORE DATA SHEET (21 DECEMBER 2021), p. 558
APPENDIX 1.4 CORE DATA SHEET (14 JANUARY 2022) , p. 626
APPENDIX 1.5 CORE DATA SHEET (23 MARCH 2022), p. 697 – all pp 397-768 here
APPENDIX 2.1 CUMULATIVE SUMMARY TABULATION OF SERIOUS ADVERSE
EVENTS FROM CLINICAL TRIALS, pp. 769 –815 (only from 774 – some pages missing??)
APPENDIX 2.1.1 CUMULATIVE SUMMARY TABULATION OF SERIOUS ADVERSE EVENTS FROM NON-PFIZER (LICENSING PARTNER)
CLINICAL TRIALS, pp. 816-820
APPENDIX 2.2 CUMULATIVE AND INTERVAL SUMMARY TABULATION OF SERIOUS AND NON-SERIOUS ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES, pp. 821-1213
APPENDIX 2.3 CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA, p. 1214
APPENDIX 2.3B CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM BIONTECH DEVELOPMENT PROGRAMS, p 1217
APPENDIX 2.3C CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM FOSUN DEVELOPMENT PROGRAMS, p. 1218
APPENDIX 2.3.1 CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM OTHER PFIZER DEVELOPMENT PROGRAMS, p. 1219
APPENDIX 3 TABULAR SUMMARY OF SAFETY SIGNALS, p. 1220
APPENDIX 3.1 SIGNAL EVALUATION (NO DATA)
APPENDIX 4.1 LISTING OF COMPLETED (CONCLUDED WITH FINAL CLINICAL
STUDY REPORT) INTERVENTIONAL SAFETY STUDIES (NO DATA)
APPENDIX 4.2 LISTING OF ONGOING (STARTED OR CONCLUDED WITH NO FINAL CLINICAL STUDY REPORTS) INTERVENTIONAL SAFETY STUDIES, p. 1235
APPENDIX 4.3 LISTING OF COMPLETED (CONCLUDED WITH FINAL CLINICAL STUDY REPORT) NON-INTERVENTIONAL SAFETY STUDIES (NO DATA)
APPENDIX 4.4 LISTING OF ONGOING (STARTED OR CONCLUDED WITH NO FINAL CLINICAL STUDY REPORTS) NON-INTERVENTIONAL SAFETY STUDIES, p. 1237
APPENDIX 5 LIST OF SOURCES OF INFORMATION USED TO PREPARE THE PSUR (LITERATURE ABSTRACTS), p. 1243
APPENDIX 6A LIST OF REGULATORY AUTHORITIES REQUEST(S), p. 1251
APPENDIX 6A.1 DIZZINESS CUMULATIVE REVIEW, p. 1261
APPENDIX 6A.2 ACQUIRED HAEMOPHILIA CUMULATIVE REV
APPENDIX 6A.3 HEARING LOSS AND TINNITUS CUMULATIVE REVIEW, p. 1289
APPENDIX 6A.4 MULTISYSTEM INFLAMMATORY SYNDROME, p. 1318
APPENDIX 6A.5 AUTOIMMUNE HEPATITIS CUMULATIVE REVIEW, p. 1345
APPENDIX 6B OBSERVED VERSUS EXPECTED ANALYSES FOR ADVERSE EVENTS OF SPECIAL INTEREST, p. 1400
APPENDIX 6C.1 INTERVAL SUMMARY TABULATION OF FATAL REPORTS, p. 1470, all pp. 1214-1515 here
APPENDIX 6C.2 CUMULATIVE SUMMARY TABULATION OF FATAL REPORTS, pp. 1516 -1598
APPENDIX 6D TABLES SUPPORTING CLINICAL REACTOGENICITY DATA ON INDIVIDUALS PREVIOUSLY EXPOSED OR NOT TO SARS-COV-2, p. 1599
APPENDIX 6.1 PROPOSED PRODUCT INFORMATION (REGIONAL APPENDIX) (NO DATA)
APPENDIX 6.2 PROPOSED ADDITIONAL PHARMACOVIGILANCE AND RISK MINIMISATION ACTIVITIES (REGIONAL APPENDIX) (NO DATA)
APPENDIX 6.3 SUMMARY OF ONGOING SAFETY CONCERNS (REGIONAL APPENDIX) (NO DATA)
APPENDIX 6.4 REPORTING OF RESULTS FROM POST-AUTHORISATION SAFETY STUDIES (REGIONAL APPENDIX) (NO DATA)
APPENDIX 6.5 EFFECTIVENESS OF RISK MINIMISATION (REGIONAL APPENDIX) (NO DATA)
APPENDIX 7 CUMULATIVE MARKETING AUTHORISATION STATUS (NO DATA)
APPENDIX 8 CHARACTERISATION OF IMPORTANT RISKS, p. 1658, all pp. 1599-1662.
4. PSUR Comirnaty/Biontech - 2022/06/19-2022/12/18
4.PSUR Biontech (pp. 1-335) – EMA-PRAC Assessment Report of 3. PSUR Biontech (pp.336-504) one document
All Appendices still missing
APPENDIX 1 REFERENCE INFORMATION (05 DECEMBER 2022) 334
APPENDIX 1.1 SAFETY RELATED CHANGES TO RSI 474
APPENDIX 1.2 CORE DATA SHEET (10 MAY 2022) 572
APPENDIX 1.3 CORE DATA SHEET (26 JULY 2022) 649
APPENDIX 1.4 CORE DATA SHEET (31 AUGUST 2022) 754
APPENDIX 1.5 CORE DATA SHEET (08 SEPTEMBER 2022) 880
APPENDIX 1.6 CORE DATA SHEET (06 OCTOBER 2022) 1006
APPENDIX 2.1 CUMULATIVE SUMMARY TABULATION OF SERIOUS ADVERSE EVENTS FROM CLINICAL TRIALS 1145
APPENDIX 2.1.1 CUMULATIVE SUMMARY TABULATION OF SERIOUS ADVERSE EVENTS FROM NON-PFIZER (LICENSING PARTNER) CLINICAL TRIALS 1200
APPENDIX 2.2 CUMULATIVE AND INTERVAL SUMMARY TABULATION OF
SERIOUS AND NON-SERIOUS ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES 1206
APPENDIX 2.2.1 BNT162B2 ORIGINAL CUMULATIVE AND INTERVAL SUMMARY TABULATION OF SERIOUS AND NON-SERIOUS ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES 1621
APPENDIX 2.2.2 BNT162B2 ORIGINAL/OMICRON BA.1 CUMULATIVE AND
INTERVAL SUMMARY TABULATION OF SERIOUS AND NON-SERIOUS
ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES 2035
APPENDIX 2.2.3 BNT162B2 ORIGINAL/OMICRON BA.4/BA.5 CUMULATIVE AND INTERVAL SUMMARY TABULATION OF SERIOUS AND NON-SERIOUS
ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES 2081
APPENDIX 2.2.4 BNT162B2 ORIGINAL/OMICRON CUMULATIVE AND INTERVAL SUMMARY TABULATION OF SERIOUS AND NON-SERIOUS ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES 2138
APPENDIX 2.2.5 INCREMENTAL DEMOGRAPHY SUMMARY 2139
APPENDIX 2.3 CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA 2146
APPENDIX 2.3B CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM BIONTECH DEVELOPMENT PROGRAMS 2151
APPENDIX 2.3C
CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC
DATA FROM FOSUN DEVELOPMENT PROGRAMS 2153
APPENDIX 2.3.1 CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM OTHER PFIZER DEVELOPMENT PROGRAMS 2154
APPENDIX 3 TABULAR SUMMARY OF SAFETY SIGNALS 2156
APPENDIX 3.1 SIGNAL EVALUATION NO DATA
Spikevax/Moderna
- PSUR Spikevax/Moderna (01/01/2022 – 18/06/2022)
3.PSUR Spikevax/Moderna – AR 3.PSUR Spikevax/Moderna
(EMA provided a set of documents which does not follow the original numbering)
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, pp. 566-914
Appendix 4.2 Signal Evaluation Reports 583, EMA only sent Appendix 4.2f: Signal Evaluation report: Corneal graft rejection, pp. 915-1298.
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
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, EMA sent Appendix 11.5a, Appendix 11.5a Myocarditis/Pericarditis: Patients < 40 years of age after Dose 2 and Dose 3: Case Listings,
Appendix 12 Literature search strategies 791
pp. 667(1269)-1568,
in addition: 1569-1868, 1869-2268, 2269-2734, 2735-3034,
(3035-3417 coming soon).
Vaxzevria/AstraZeneca
3. PSUR Vaxzevria/AstraZeneca (29/12/2021-28/06/2022)
3. PSUR Vaxzevria/AZ (pp. 141-711) and EMA-PRAC Assessment Report of 3. PSUR Vaxzevria/AZ (pp. 1-124)
Appendix 1 Reference Information (AstraZeneca Core Data Sheet)
Appendix 2 Cumulative Summary Tabulation of Serious Adverse Events from Clinical Trials + Interval/Cumulative Summary Tabulations of Serious and Non-Serious Adverse Reactions from Marketed Experience
Appendix 3 Tabular Summary of Validated Safety Signals
Appendix 4 Listings of All Post-Authorisation Safety Studies
Appendix 5 List of the Sources of Information Used to Prepare the PBRER (Not produced as not considered necessary for this report)
Appendix 6 Post-marketing Exposure Data
Appendix 7 Standardised MedDRA Queries (SMQ) and MedDRA search term (MST) lists used for Adverse Events of Special Interest (AESIs) and Safety Concerns in the VAXZEVRIA Risk Management Plan (RMP)
Appendix 8 Observed versus Expected Analyses
Appendix 9 Observed versus Expected Analyses Supporting Information
Appendix 10 Lot Analysis (Not produced as not applicable/Not produced as
no information to report)
Additional Appendix 11 Cases with reported Vaccination error and case level outcome of fatal
Additional Appendix 12 Listing of Myocarditis case reports with Vaxzevria
Additional Appendix 13 Listing of Rhabdomyolysis
Additional Appendix 14 EMA LEG O/E: Incidence rates
Additional Appendix 15 EMA LEG: Sex and age differences, exclusion of previous cases and VTE definition in VTE studies
Additional Appendix 16 Evaluation of Cutaneous vasculitis
Additional Appendix 17 AZ sponsored observational study in relation to Thrombosis with Thrombocytopenic syndrome, request from Health Canada.
Additional Appendix 18 Thrombosis in combination with thrombocytopenia /Thrombosis with Thrombocytopenic syndrome Tables related to evaluation of new information
Additional Appendix 19 Listings of Medically Confirmed Subacute thyroiditis case reports with VAXZEVRIA
Additional Appendix 20 GBS Signal Evaluation and Supporting Document for CDS Changes
Regional Appendices are relevant for submission as follows
European Union (EU)
Regional Appendix R1 Proposed Product Information
Regional Appendix R2 Proposed Additional Pharmacovigilance and Risk Minimisation Activities (Not produced as no proposals to report)
Regional Appendix R3 Summary of Ongoing Safety Concerns in the European Union
Regional Appendix R4
Reporting of Results from Post-Authorisation Safety Studies
(Not produced as no information to report)
Regional Appendix R5 Effectiveness of Risk Minimisation (Not produced as not applicable)
The following Regional Appendices are not required for submission in EU
Regional Appendix R6 Individual Case Safety Reports
Regional Appendix R7 US Prescribing Information
Regional Appendix R8 Combination Product Five-day and Malfunction Report Analysis
4. PSUR Vaxzevria/AstraZeneca (29/06/2022-28/12/2022)
4.PSUR Vaxzevria/AZ (pp. 140-711) and EMA-PRAC Assessment Report of 4.PSUR (pp. 1-139) Vaxzevria/AZ (pp. 1-124) see combined doc here
Appendix 1 Reference Information (AstraZeneca Core Data Sheet)
Appendix 2 Cumulative Summary Tabulation of Serious Adverse Events from Clinical Trials + Interval/Cumulative Summary Tabulations of Serious and Non-Serious Adverse Reactions from Marketed Experience ; Appendices 1 & 2, pp. 1-908 see here
Appendix 3 Tabular Summary of Validated Safety Signals
Appendix 4 Listings of All Post-Authorisation Safety Studies
Appendix 5 List of the Sources of Information Used to Prepare the PBRER (Not produced as not considered necessary for this report) missing
Appendix 6 Post-marketing Exposure Data, Appendices 3, 4, 6, pp. 1-527 see here
Appendix 7 Standardised MedDRA Queries (SMQ) and MedDRA search term (MST) lists used for Adverse Events of Special Interest (AESIs) and Safety Concerns in the VAXZEVRIA Risk Management Plan (RMP)
Appendix 8 Observed versus Expected Analyses
Appendix 9 Observed versus Expected Analyses Supporting Information
Appendix 10 Lot Analysis (Not produced as not applicable/Not produced as no information to report)
Appendix 11 Cases of Acute Disseminated Encephalomyelitis Fulfilling BCC Level 1, 2 and 3 Cumulatively through 28 December 2022
Appendix 12 Search criteria for immunocompromised persons
Appendix 13 Cumulative assessment of events pertaining to New daily persistent headache and VAXZEVRIA
Appendix 14 PBRER Listing of Myositis Cases Cumulatively through 28 December 2022
Regional Appendices are relevant for submission as follows
European Union (EU)
Regional Appendix R1 Proposed Product Information
Regional Appendix R2 Proposed Additional Pharmacovigilance and Risk Minimisation Activities (Not
produced as no proposals to report)
Regional Appendix R3 Summary of Ongoing Safety Concerns in the European Union
Regional Appendix R4 Reporting of Results from Post-Authorisation Safety Studies (Not produced as no information to report)
Regional Appendix R5 Effectiveness of Risk Minimisation (Not produced as not applicable)
The following Regional Appendices are not required for submission in EU
Regional Appendix R6 Individual Case Safety Reports
Regional Appendix R7 US Prescribing Information
Regional Appendix R8 Combination Product Five-day and Malfunction Report Analysis
VALNEVA/Valneva Austria (authorization withdrawn)
1. PSUR Valneva (28/02/2022- 27/08/2022)
1.PSUR Valneva (pp. 17-107)– EMA PRAC 1. PSUR Valneva (pp. 2-16)
1. PSUR Valneva (28/08/2022- 27/02/2023)
2.PSUR Valneva (pp.18 -65)– EMA PRAC 1. PSUR Valneva (pp. 2-17)
NUVAXOVID
Periodic safety update report assessment – 20th June 2022 to 19th December 2022, see here (no OCR)
