New: Jcovden / Janssen PSUR Disclosure Archive
Some PSURs & PRAC AR, with the Annexes still missing...
Welcome
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.
Guidance for New Readers
Structure of the PSUR Data
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!
Urgent Call to the Scientific Community
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.
PSUR Jcovden: 24 August 2021 to 24 February 2022
PSUR body & EMA-PRAC Assessment Report of PSUR
PSUR Jcovden: 25 February 2022 to 24 August 2022
PSUR body & EMA-PRAC Assessment Report (EMA direct link)
PSUR Jcovden: 25 August 2022 to 24 February 2023
PSUR body & EMA-PRAC Assessment Report (EMA direct link)
PSUR Jcovden: 25 February 2023 to 24 February 2024
PSUR body & EMA-PRAC Assessment Report (EMA direct link)