Update Dec 25' 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

These new disclosures related to the CTD of Comirnaty were officially released by the EMA to an individual requester, but not made publicly accessible by EMA despite its ‘exceptionally transparency measures’ comittment due to our pressure and ETI initiative. EMA tries to hide these documents from more than 2,100 EU citizens who requested them and whose rights are violated under EU transparency laws. We publish them here to ensure effective public access where transparency remains obstructed by EMA.

NEW UPDATES (integrated in the list below):

• 3.2.S.2.5-Process-Validation-and-or-Evaluation-Additional-Process-Evaluation-BNT-Mainz-and-Rentschler

• 3.2.S.2.5-Process-Validation-and-or-Evaluation-Filter-Qualification-and-Validation-BNT-Mainz-and-Rentschler

• 3.2.S.2.5-Process-Validation-and-or-Evaluation-Hold-Times

• 3.2.S.2.5-Process-Validation-and-or-Evaluation-Manufacturing-Process-BNT-Mainz-and-Rentschler

• 3.2.S.2.5-Process-Validation-and-or-Evaluation-Overview-BNT-Mainz-and-Rentschler

• 3.2.S.2.5-Process-Validation-and-or-Evaluation-Removal-of-Impurities-BNT-Mainz-and-Rentschler

Learn more about the background of the EMA Transparency Initiative (ETI) here

For your convenience, all re-releases and updates related to the CTD-Comirnaty are listed below (for CTD-Spikevax, see here).

The EMA promised to all ETI requesters to provide access to all CTD-releases on the Comirnaty website, but in practice, they are failing to do so. Thus, they only provide ZIP archives under the slogan “exceptional transparency” which are very difficult to access and nearly impossible to monitor for updates. In addition, the EMA secretly discloses relevant CTD files to individual requesters while violating the law of ETI requesters. Occasionally, requesters share these documents with me, allowing me to provide you and all ETI participants with access — as is the case with these current documents.

Please use the comment function!

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.

Photo by Claudio Schwarz on Unsplash

Entire List of EMA-Releases

• Comirnaty Residual DNA Characterization Report INX100594280 (PF-07302048)

• EMEA/H/C/005735/II/0202 Response to 19th January 2024 EMA Request for Supplementary Information

Common Technical Document (CTD)

Module 2.3 – Quality Overall Summary

2.3.P Drug Product

2.3.P.1 Description and Composition of Drug Product

2.3.S Drug Substance

2.3.S.1 General Information

Module 2.4 Non-Clinical Overview

• 2.4. Nonclinical Overview (update)

• 2.4 Non-Clinical Module 2.4 Appendix 1 (update Nov)

• 2.4 Non-Clinical Overview Comirnaty Omicron XBB.1.5 (update Nov)

• 2.4 Non-Clinical Overview Comirnaty Original/Omicron BA.4-5 Vaccine (update Nov)

• 2.4 Non-Clinical Addendum to the Nonclinical Overview – Tris-Sucrose (2021) (update Nov)

• 2.4 Non-Clinical Addendum to Nonclinical Overview - Tris-Sucrose/Paediatrics (update Nov)

• 2.4 Non-Clinical Addendum to the Nonclinical Overview – Tris-Sucrose (update Nov)

• 2.4 Non-Clinical Addendum to Nonclinical Overview - Tris-Sucrose/Paediatrics (update Nov)

Module 2.6 Non-Clinical Summary

• 2.6.4. pharmacokinetics written summary

• 2.6.5. pharmacokinetics tabulated summary

Module 3.2 Body of Quality Data

3.2 P Drug Product

3.2.P.2.3 Manufacturing Process Development

• 3.2.P.2.3 Manufacturing Process Development - Development History

• 3.2.P.2.3 Manufacturing Process Development - Process Development and Characterization

• 3.2.P.3.3. Description of Manufacturing Process and Process Controls LNP Production and Bulk Drug Product Formulation – Bivalent – [Puurs] (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

• 3.2.P.3.3. Description of Manufacturing Process and Process Controls LNP Production and Bulk Drug Product Formulation – Bivalent – [BNT Marburg] (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

• 3.2.P.3.3. Description of Manufacturing-Process and Process Controls Overview PFS (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

• 3.2.P.3.3. Description of Manufacturing Process and Process Controls Fill and Finish –PFS (Refrigerated, Glass) [Puurs] (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

• 3.2.P.3.3. Description of Manufacturing-Process and Process Controls Overview PFS Refrigerated-Glass (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

• 3.2.P.6. Reference Standards or Materials (Update Sept 25)

• 3.2.P.7 Container Closure System - Tris-Sucrose (Other Sites) (Update Sept 25)

• 3.2.P.8.1 Stability Summary and Conclusion Tris-Sucrose (Update Sept 25)

• 3.2.P.8.2 Stability Data - Post-Approval Stability Protocol and Stability Committment - Tris-Sucrose (Update Sept 25’)

• 3.2.P.8.3 Stability Data - Photostability - Tris-Sucrose (Update Sept 25’)

• 3.2.P.8.3 Stability Data - Thermal Stress and Cycling

• 3.2.P.8.3 Stability Data - Thermal Stress and Cycling - Tris-Sucrose (Update Sept 25’)

• 3.2.P.8.3 Stability Data - Additional Storage Conditions - Tris-Sucrose (Update Sept 25’)

3.2.S.2.2 Description of Manufacturing Process

• 3.2.S.2.2 Description of Manufacturing Process and Process Controls - Batch Scale and Definition [BNT Mainz and Rentschler]

• 3.2.S.2.2 Description of Manufacturing Process and Process Controls - Manufacturing Process [BNT Mainz and Rentschler]

• 3.2.S.2.2 Description of Manufacturing Process and Process Controls - Batch Scale and Definition [Andover]

• 3.2.S.2.2 Description of Manufacturing Process and Process Controls - Manufacturing Process [Andover]

3.2.S.2.3 Control of Materials

• 3.2.S.2.3. Control of Materials - Source, History and Generation of Plasmids [Pfizer Chesterfield] (EMA RELEASE UNDER 1049/01 - NOT AVAILABLE AT THE COMIRNATY PRODUCT WEBSITE, EXCLUSIVELY HERE)

• 3.2.S.2.3.1 Control of Materials - Generation of Plasmids (AGC) (2024)

• 3.2.S.2.3. Control of Materials - Materials Used in Manufacture [Andover] (2020)

• 3.2.S.2.3. Control of Materials - Materials Used in Manufacture [BNT Mainz & Rentschler] (2020)

• 3.2.S.2.3. Control of Materials - Source, History and Generation of Plasmids (2020)

3.2.S.2.4 Controls of Critical Steps and Intermediates

• 3.2.S.2.4 Control of Critical Steps and Intermediates - Hold Times [BNT Mainz and Rentschler]

• 3.2.S.2.4 Control of Critical Steps and Intermediates - In-Process Test Methods [BNT Mainz and Rentschler]

• 3.2.S.2.4 Control of Critical Steps and Intermediates - Hold Times [Andover]

• 3.2.S.2.4 Control of Critical Steps and Intermediates - In-Process Test Methods [Andover]

• 3.2.S.2.4 Control of Critical Steps and Intermediates- Manufacturing Process

3.2.S.2.5 Controls of Materials

• 3.2.S.2.5-Process-Validation-and-or-Evaluation-Additional-Process-Evaluation-BNT-Mainz-and-Rentschler (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

• 3.2.S.2.5-Process-Validation-and-or-Evaluation-Filter-Qualification-and-Validation-BNT-Mainz-and-Rentschler (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

• 3.2.S.2.5-Process-Validation-and-or-Evaluation-Hold-Times (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

• 3.2.S.2.5-Process-Validation-and-or-Evaluation-Manufacturing-Process-BNT-Mainz-and-Rentschler (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

• 3.2.S.2.5-Process-Validation-and-or-Evaluation-Overview-BNT-Mainz-and-Rentschler (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

• 3.2.S.2.5-Process-Validation-and-or-Evaluation-Removal-of-Impurities-BNT-Mainz-and-Rentschler (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

3.2.S.2.6 Manufacturing Process Development

• 3.2.S.2.6 Manufacturing Process Development - Control Strategy

• 3.2.S.2.6 Manufacturing Process Development - Development History and Comparability Assessment

• 3.2.S.2.6 Manufacturing Process Development - Analytical Method Evolution

3.2.S.4 Control of Drug Substance

3.2.S.4.1 Specification (name, manufacturer)

• 3.2.S.4.1 Specification - [Omicron] (Update Sept 25)

• 3.2.S.4.1 Specification - [Omicron (XBB.1.5) Variant] Update Sept 25)

3.2.S.4.2 Analytical Procedures (name, manufacturer)

• 3.2.S.4.2 Analytical Procedures – Overview [Omicron] (Update Sept 25)

• 3.2.S.4.2 Analytical Procedures – Overview Overview [Omicron (XBB.1.5) Variant] (Update Sept 25)

• 3.2.S.4.2 Analytical Procedures – Overview [Omicron (B.1.1.529) Variant] (Update Sept 25)

• 3.2.S.4.2 Analytical Procedures - Potentiometry (Update Sept 25)

• 3.2.S.4.2 Analytical Procedures - Ion-Pair Reversed Phase-High Performance Liquid Chromatography (IP-RP-HPLC) (Update September 25’) (Update Sept 25)

• 3.2.S.4.2 Analytical Procedures - Droplet Digital Polymerase Chain Reaction (ddPCR) - [Omicron] (Update Sept 25) (difference to document above??)

• 3.2.S.4.2 Analytical Procedures - Droplet Digital Polymerase Chain Reaction (ddPCR) -polyatail- [Omicron] (Update Sept 25)

• 3.2.S.4.2 Analytical Procedures - Droplet Digital Polymerase Chain Reaction (ddPCR) - [Omicron (XBB.1.5) Variant]

• 3.2.S.4.2 Analytical Procedures - Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) - (EMA RELEASE UNDER 1049/01 BUT NOT FOR PUBLIC AVAILABLE, EXCLUSIVELY HERE)

• 3.2.S.4.2 Analytical Procedures - Quantitative Polymerase Chain Reaction (qPCR) [Omicron] (EMA RELEASE UNDER 1049/01 BUT NOT FOR PUBLIC AVAILABLE, EXCLUSIVELY HERE)

• 3.2.S.4.2 Analytical Procedures - Ion Pair-Reversed Phase-High Performance Liquid Chromatography (IP-RP-HPLC) (Update Sept 25)

• 3.2.S.4.2 Analytical Procedures - Immunoblot (Update Sept 25)

• 3.2.S.4.2 Analytical Procedures - Endotoxin (Update Sept 25)

• 3.2.S.4.2 Analytical Procedures - Capillary Gel Electrophoresis (Update Sept 25)

• 3.2.S.4.2 Analytical Procedures - Bioburden (Update Sept 25)

• 3.2.S.4.2 Analytical Procedures - Appearance (Clarity and Coloration) (Update Sept 25)

3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer)

3.2.S.4.4 Batch Analyses (name, manufacturer)

3.2.S.4.5 Justification of Specification (name, manufacturer) .

Module 4.2 Study Reports

4.2.3.2 Repeat-Dose Toxicity

• Study 17-Day Intramuscular Toxicity Study of BNT162B2 (V9) and BNT162B3C in Wistar Han Rats with a 3-Week Recovery - Testing Facility Study Number: 20GR142

• Repeat Dose Toxicity Study of Three LNP Formulated RNA Platforms Endocing for Viral Proteins by Repeated Intramuscular Administration To Wistar Han Rat (Final Report 01 July 2020)

4.2.3.5.1 Fertility and Early Embryonic Development

• Combined Fertility and Developmental Study (Including Teratogenicity and Postnatal Investigations) of BNT162b1, BNT162b2 and BNT162b3 by Intramuscular Administration in the Wistar Rat