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Official Releases from the European Medicines Agency

This substack is devoted to make official releases from the European Medicines Agency (EMA), particularly regarding Covid vaccines, publicly available. It is a project by the Global Health Responsiblity Agency (GHRA) due to the EMAs inability to do so.

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Update Aug 26': CTD-Comirnaty: New Disclosures of EMA's Embarrasing Redacted Re-Releases

Overriding public interest requires full transparency — EMA should clarify how independent validation is to be achieved with these redacted re-releases

Spikevax (Moderna) PSURs, including raw data sets - Update July 26'

released on an ongoing basis by the European Medicines Agency as requested since 2023 by the PSUR4doctors initiative comprising 130 European doctors

CTD-Spikevax: List of EMA's Embarrasing Redacted Re-Releases of the EMA Transparency Initiative - Update June 26' on Drug Substance, Nonclinical Overview and Written Summaries

Overriding public interest requires full transparency — EMA should clarify how independent validation is to be achieved with these redacted re-releases

Update May 26' CTD-Comirnaty: New Disclosures of EMA's Embarrasing Redacted Re-Releases

Overriding public interest requires full transparency — EMA should clarify how independent validation is to be achieved with these redacted re-releases

Update April 26' CTD-Comirnaty: New Disclosures of EMA's Embarrasing Redacted Re-Releases

Overriding public interest requires full transparency — EMA should clarify how independent validation is to be achieved with these redacted re-releases

New Update April 26' CTD-Comirnaty: New Disclosures of EMA's Embarrasing Redacted Re-Releases

Overriding public interest requires full transparency — EMA should clarify how independent validation is to be achieved with these redacted re-releases

Update March 26' Spikevax (Moderna) PSURs, including raw data sets

released on an ongoing basis by the European Medicines Agency as requested since 2023 by the PSUR4doctors initiative comprising 130 European doctors

New Update March 26' CTD-Comirnaty: New Disclosure of EMA's Embarrasing Redacted Re-Releases

Overriding public interest requires full transparency — EMA should clarify how independent validation is to be achieved with these redacted re-releases

Update March 26' CTD-Comirnaty: New Disclosures of EMA's Embarrasing Redacted Re-Releases

Overriding public interest requires full transparency — EMA should clarify how independent validation is to be achieved with these redacted re-releases

Update March 26': Jcovden / Janssen PSUR Disclosure Archive

New EMA Releases about Safety Signals of PSUR#1