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Last release by EMA: 7th February 25’: 4.PSUR: Document (Appendices 1.6-2.2)
1.PSUR Body Comirnaty/Biontech (pp. 1-286) –
*EMA-PRAC AR of 1.PSUR Biontech (still missing)
Appendix 1: Reference Information (19 May 2021) 287
Appendix 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 and Full EUA Prescribing Information (05 January 2021) 466
Appendix 1.8: Combined EUA Fact Sheet for Healthcare Providers and Full 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 626
Appendix 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, Appendix 3: Tabular Summary of Safety Signals 889
Appendix 3.1: Signal Evaluation No Data
Document (Appendices 1-2.3.1) available 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
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 904
Appendix 5 List of Sources of Information Used to Prepare the PSUR No Data
Appendix 6A Regulatory Authorities Request(s) Following Review of SMSR (Not Considered as a Signal) 906
Appendix 6A.1 Lymphopenia Cumulative Review 908
Appendix 6A.2 Hypoglycaemia Cumulative Review 914
Appendix 6A.3 Serious Hypertension Cumulative Review 920
Appendix 6A.4 Haemophagocytic Syndrome Cumulative Review 926
Appendix 6B Regulatory Authorities Request(s) Following Review of SMSR 933
Appendix 6B.1 Immune Thrombocytopenia 935
Appendix 6B.2-1 Hearing Loss (Serious Cases) 955
Appendix 6B.2-2 Tinnitus 966
Appendix 6B.3 Serious Arrhythmias 984
Appendix 6B.4 Pancreatitis 990
Appendix 6B.5 Acquired Haemophilia 1000
Appendix 6B.6 Menstrual Disorders 1011
Appendix 6C Observed Versus Expected Analyses for Adverse Events of Special Interest 1029
Appendix 6D.1 Interval Summary Tabulation of Fatal Reports 1058
Appendix 6D.2 Cumulative Summary Tabulation of Fatal Reports 1088
Appendix 6E Safety Effects of Mixed Schedule No Data
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
Document (Appendices 3-8) available here
2.PSUR Body 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 Abstracts) 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
Document (Appendices 1-6C) available here pp. 352-1406
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 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
Document (Appendices 1-1.5) available here (pp 397-768)
Appendix 2.1 Cumulative summary tabulation of serious adverse events from clinical trials
Document (Appendix 2.1) available here (pp. 769–815)
Appendix 2.1.1 Cumulative summary tabulation of serious adverse events from non-Pfizer (licensing partner) clinical trials
Document (Appendix 2.1.1.) available here (pp. 816-820)
Appendix 2.2 Cumulative and interval summary tabulation of serious and non-serious adverse reactions from post-marketing data sources
Appendix 2.2. pp. 821-1213 available here
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 review
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
Document (Appendices 2.3-6C.1) available here (pp. 1214-1515)
Appendix 6C.2 Cumulative summary tabulation of fatal reports
Document (Appendices 6C.1) available here (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
Document (Appendices 6D-8, pp. 1599-1662) available here
4.PSUR Biontech (pp. 1-335) – EMA-PRAC Assessment Report of 4. PSUR Biontech (pp.336-504)
Appendix 1 Reference information (05 December 2022) 334
Appendix 1
Appendix 1.1 Safety related changes to RSI 474
Document (Appendix 1.1) available here
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
Document (Appendices 1.2-1.5) available here
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
Document (Appendices 1.6-2.2) available here
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
5.PSUR Biontech (pp. 144-351) – EMA-PRAC Assessment Report of 5. PSUR Biontech (pp. 1-143)
6.PSUR Biontech (pp. 74 -274) – EMA-PRAC Assessment Report of 6. PSUR Biontech (pp. 1-73)
7.PSUR Biontech (pp. ) – EMA-PRAC Assessment Report of 7. PSUR Biontech (pp.) (not available yet)
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