Reading · Official Releases from the European Medicines Agency

New CTD files are now available for the following modules:

Module 2.3.S Drug Substance
Module 2.4 Nonclinical Overview
Module 2.6 Nonclinical Written and Tabulated Summaries

Learn more about the entire background of the EMA Transparency Initiative here.

EMA is posting a subset of re-releases at the Spikevax product website as so-called ‘exceptional transparency measures’ here.

For your convenience, all re-releases concerning Spikevax are provided in this list (for Comirnaty see latest update May 2026 here):

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Independent scientists are urged to examine these re-releases (some of them have already been posted at this substack) to demonstrate the regulators’ negligence, and set out clear scientific arguments why an overriding public interest exists to unredact these documents. Under Regulation (EC) No. 1049/2001, such overriding public interest overrides any claims of commercial confidentiality. Only by invoking this legal standard in front of EMA and the European Court, full disclosure be enforced and independent validation of EMA’s findings and regulatory actions can be made possible.

black and white no smoking sign — Photo by Bernd 📷 Dittrich on Unsplash

List of Spikevax CTD Modules

Module 2.3 quality overall summary

(not yet available)

Module 2.3.S Drug Substance

Module 2.4 Nonclinical Overview

Module 2.6 Nonclinical Written and Tabulated Summaries

Module 3.2 Body of Quality Data

3.2.P Drug Product

Module 4.2 Study Reports

4.2.2.3 Distribution

Spikevax-m4223-5002121-report Body

4.2.3.2 Repeat-Dose Toxicity (in order by species, by route, by duration; including supportive toxicokinetics evaluations)

4.2.3.3.1 In Vitro

4.2.3.3.2 In Vivo (including supportive toxicokinetics evaluations)

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

List of Spikevax CTD Modules

3.2.P Drug Product

Module 4.2 Study Reports

4.2.2.3 Distribution

4.2.3.2 Repeat-Dose Toxicity (in order by species, by route, by duration; including supportive toxicokinetics evaluations)

4.2.3.3.1 In Vitro

4.2.3.3.2 In Vivo (including supportive toxicokinetics evaluations)

4.2.3.7.2 Immunotoxicity

3.2.S.2.5 Process Validation and/or Evaluation

3.2.S.4.2 Analytical Procedures

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