All new releases are integrated into the chronological list below:
PSUR body & EMA PRAC AR for PSUR 25 Feb 2021-24 Aug 2021
LIST OF APPENDICES
Document Appendices 1-7.1 (pp337-833)
Appendix 1: Company Core Data Sheet Current at the End of the Reporting Period 339
Appendix 2.1.1: Cumulative Summary Tabulations of Serious Adverse Events From Clinical Trials (All Protocols) 362
Appendix 2.1.2: Cumulative Summary Tabulations of Serious Adverse Events From Clinical Trials (By Protocol) 386
Appendix 2.2: Cumulative and Interval Summary Tabulations From Post-marketing Sources 426
Appendix 3: Tabular Summary of Safety Signals That Were Ongoing or Closed During the Reporting Interval 615
Appendix 4.1: Listing of Marketing Authorisation Holder-sponsored Interventional Trials 645
Appendix 4.2: Listing of Marketing Authorisation Holder-sponsored Non-interventional Studies 648
Appendix 5: List of Search Criteria for PBRER Sections 649
Appendix 6.1: Methodology Observed versus Expected Analysis 664
Appendix 6.2: Supporting Data: Observed versus Expected Analysis 683
Appendix 7.1: Supporting Data: Multisystem Inflammatory Syndrome 705
Document Appendices 7.1(follow-up)-7.5 (pp834-1347)
Appendix 7.2: Supporting Data: Menstrual Disorders 847
Appendix 7.3: Supporting Data: Blindness 962
Appendix 7.4: Supporting Data: Myocarditis and Pericarditis 1043
Appendix 7.5: Supporting Data: Autoimmune Disorders 1178
Document Appendices 7.5 (follow-up)-7.11 (pp1328-1827)
Appendix 7.6: Supporting Data: Guillain-Barré Syndrome 1342
Appendix 7.7: Supporting Data: Immune Thrombocytopenia 1504
Appendix 7.8: Supporting Data: Capillary Leak Syndrome 1529
Appendix 7.9: Supporting Data: Anxiety-Related Reactions (including Hypotension, Dizziness, and Loss of Consciousness) 1556
Appendix 7.10: Supporting Data: Diarrhoea 1573
Appendix 7.11: Supporting Data: Lymphadenopathy 1593
Document Appendices 7.12-7.14 (pp1828-2311)
Appendix 7.12: Supporting Data: Sensorineural Hearing Loss Including Tinnitus ... 1828
Appendix 7.13: Supporting Data: Cutaneous Sensory Changes 1862
Appendix 7.14: Supporting Data: Vomiting 2263
Document Appendices 7.15-8 (pp.2312-2641)
Appendix 7.15: Supporting Data: Vasculitis 2282
Appendix 7.16: Supporting Data: Transverse Myelitis and Encephalitis including ADEM 2402
Appendix 8: HealthVerity Claims Data Analysis Specifications and Results 2610
PSUR body & EMA-PRAC Assessment Report of PSUR
PSUR body & EMA-PRAC Assessment Report (EMA direct link)
Appendix 1: Company Core Data Sheet Current at the End of the Reporting Period
Appendix 2.1.1: Cumulative Summary Tabulations of Serious Adverse EventsFrom Clinical Trials (All Protocols)...........................................................................
Appendix 2.1.2: Cumulative Summary Tabulations of Serious Adverse EventsFrom Clinical Trials (By Protocol).............................................................................
Appendix 2.2: Cumulative and Interval Summary Tabulations From Post-marketing Sources.......................................................................................................
Appendix 3: Tabular Summary of Safety Signals That Were Ongoing or Closed During the Reporting Interval.....................................................................................
Appendix 4.1: Listing of Marketing Authorisation Holder-sponsored Interventional Trials....................................................................................................
Appendix 4.2: Listing of Marketing Authorisation Holder-sponsored Non- interventional Studies..................................................................................................
Appendix 5: List of Search Criteria for PBRER Sections ..........................................
Appendices 1-5 here (PSUR 25 Feb 2022-24 Aug 2022 - (Appendices 1-5 p.322-835)
Appendix 6.1: CIOMS II Line Listing: Medication Errors ........................................
Appendix 6.2: CIOMS II Line Listing: Use With Concomitant Vaccination ............
Appendix 6.3: CIOMS II Line Listing: Vaccination Anxiety-Related Reactions......
Appendix 6.4: Supporting Data: Vaccination Failure, Lack of Efficacy/Effectiveness
Appendix 6.5: CIOMS II Line Listing: Reactogenicity..............................................
Appendix 6.6: CIOMS II Line Listing: Thrombosis With Thrombocytopenia Syndrome ....................................................................................................................
Appendix 6.7: CIOMS II Line Listing: Guillain-Barré Syndrome.............................
Appendix 6.8.1: Supporting Data: Venous Thromboembolism .................................
Appendix 6.8.2: CIOMS II Line Listing: Venous Thromboembolism.......................
Appendix 6.9.1: Supporting Data: Immune Thrombocytopenia ................................
Appendix 6.9.2: CIOMS II Line Listing: Immune Thrombocytopenia......................
Appendix 6.10: CIOMS II Line Listing: Use During Pregnancy/Use in Breastfeeding Women.................................................................................................
Appendix 6.11: CIOMS II Line Listing: Use in Immunocompromised Patients .......
Appendix 6.12: CIOMS II Line Listing: Use in Patients With Autoimmune or Inflammatory Disorders ..............................................................................................
Appendix 6.13: CIOMS II Line Listing: Use in Frail Patients With Comorbidities (eg, Chronic Obstructive Pulmonary Disease, Diabetes, Chronic Neurological Disease, Cardiovascular Disorders)............................................................................
Appendix 6.14: CIOMS II Line Listing: Long-term Safety .......................................
Appendix 7.1: Methodology: Observed versus Expected Analyses...........................
Appendix 7.2: Supporting Data: Observed versus Expected Analyses ......................
Appendix 8.1: CIOMS II Line Listing: Cardiac Inflammatory Disorder, Including Myocarditis and Pericarditis .......................................................................................
Appendix 8.2: CIOMS II Line Listing: Cardiomyopathy...........................................
Appendix 8.3.1: Supporting Data: Coronary Artery Disease, Including Myocardial Infarction.....................................................................................................................
Appendix 8.3.2: CIOMS II Line Listing: Coronary Artery Disease, Including Myocardial Infarction .................................................................................................
Appendix 8.4: CIOMS II Line Listing: Acute Aseptic Arthritis ................................
Appendix 8.5: CIOMS II Line Listing: Generalised Convulsion...............................
Appendix 8.6: CIOMS II Line Listing: Encephalitis, Including Acute Disseminated Encephalomyelitis and Meningoencephalitis.......................................
Appendix 8.7: CIOMS II Line Listing: Multiple Sclerosis (Including Opti Neuritis)......................................................................................................................
Appendix 8.8: CIOMS II Line Listing: Narcolepsy ...................................................
Appendix 8.9: CIOMS II Line Listing: Sensorineural Hearing Loss .........................
Appendix 8.10: CIOMS II Line Listing: Transverse Myelitis....................................
Appendix 8.11.1: Supporting Data: Cerebrovascular Events .....................................
Appendix 8.11.2: CIOMS II Line Listing: Cerebrovascular Events ..........................
Appendix 8.12: CIOMS II Line Listing: Acute Hepatic Failure ................................
Appendix 8.13: CIOMS II Line Listing: Acute Kidney Failure.................................
Appendix 9.1: Supporting Data: Glomerulonephritis and Nephrotic Syndrome........
Appendix 9.2: Supporting Data: Neuralgic Amyotrophy...........................................
Appendix 9.3: Supporting Data: Vasculitis ................................................................
Appendix 9.4.1: Supporting Data: Thrombosis With Thrombocytopenia Syndrome Batch Analysis Cases..................................................................................................
Appendix 9.4.2: CIOMS II LL: Thrombosis With Thrombocytopenia Syndrome Batch Analysis Cases..................................................................................................
Appendix 9.5: Supporting Data: Coronary Artery Disease Including Myocardial Infarction.....................................................................................................................
Appendix 9.6: Supporting Data: C-VIPER.................................................................
Appendix 9.7: Supporting Data: Real World Data Analytics.....................................
Appendix 9.8: Supporting Data: Quantitative Benefit-Risk Assessment...................
Appendix 9.9: Supporting Data: Death.............
PSUR body & EMA-PRAC Assessment Report (EMA direct link)
PSUR body & EMA-PRAC Assessment Report (EMA direct link)
This archive reveals official EMA safety data the public was never meant to see.
Dive in. Investigate. Share your findings.
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Let’s do the work the regulators didn’t.
This Substack provides a continuously updated archive of the Jcovden Periodic Safety Update Reports (PSURs), as disclosed by the European Medicines Agency (EMA), a lenghty process. Due to this initative, most PSURs are also published by EMA at the product website, but not the appendices with the raw data.
There are three different types of information provided:
– the main PSUR body report for a specific time interval,
– appendices with raw safety data,
– and the Assessment Report (AR) drafted by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) of the PSUR & appendices.
These documents — often disclosed into a single file by EMA — span thousands of pages. Importantly:
– The PSUR contains data and assessments submitted by the marketing authorization holder, Janssen-Cilag.
– The Assessment Report (AR) reflects the EMA’s own interpretation of that data - eventually arriving at the conclusions that the benefits outweigh the risks.
Understanding the difference between aggregated data of the PSUR and raw data of the appendices and eventually EMA’s assessment thereof is essential for analyzing the data!
For the first time, independent scientists and the public have unfiltered access to the full scope of Covid-vaccine safety data submitted to the EMA.
This archive demands critical and independent analysis.
We call on scientists, physicians, and researchers worldwide:
– Analyse the documents.
– Question the conclusions.
– Test the claim that these products were properly assessed as "safe and effective".
Please use the comments section for collaboration, feedback, and sharing your findings.
This data was buried for too long. Now it’s your turn.
Please notice the European Commission Decision issued on 26th July 2024 regarding the withdrawal from the European market. For more information see here.
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