Reading · Official Releases from the European Medicines Agency

Some of 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.

A NEW UPDATE (integrated in the list below):

3.2.S.2.6 – Manufacturing Process Development

BNT162b2, DS Comparability Assessment Report-INX100451011; BNT162b2 (PF-07302048) Comparability Report for Commercial Drug Substance; Manufacturing Process Transfer to BioNTech Marburg

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.

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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.

Comirnaty Residual DNA Characterization Report INX100594280 (PF-07302048)
EMEA/H/C/005735/II/0202 Response to 19th January 2024 EMA Request for Supplementary Information (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

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 (25 Oct 2020) (EMA update Jan 26)
2.3.S.1 General Information Omicron (XBB.5) Variant] (16 Jun 2023) (EMA update 30 Jan 26)
2.3.S.4. Control of Drug Substance [Omicron (XBB.1.5) Variant (16 June 2023) (EMA update Jan 26)
2.3.S.4. Control of Drug Substance [Omicron (JN.1) (9 May 2024) (EMA update Jan 26)
2.3.S.4. Control of Drug Substance [Omicron (B.1.1.529) Variant ] (22 March 2024) (EMA update Jan 26)
2.3.S.5. Reference Standards or Materials (3 June 2021) (EMA update 30 Jan 26)
2.3.S.6. Container Closure System (26 October 2020) (EMA update 30 Jan 26)
2.3.S.7. Stability [Omicron (B.1.1.529) Variant] (22 March 2024) (EMA update 30 Jan 26)

2.4. Nonclinical Overview (update)
2.4 Non-Clinical Module 2.4 Appendix 1 (EMA update Nov)
2.4 Non-Clinical Overview Comirnaty Omicron XBB.1.5 (EMA 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)

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.2.3 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.2.4 Controls of Critical Steps and Intermediates

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
DS Comparability Assessment Report-INX100451011; BNT162b2 (PF-07302048) Comparability Report for Commercial Drug Substance; Manufacturing Process Transfer to BioNTech Marburg (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)

3.2.S.4 Control of Drug Substance

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

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

3.2.A APPENDICES

3.2.A.1 Facilities and Equipment (name, manufacturer)

3.2.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)

3.2.A.3 Excipients

4.2.3.2 Repeat-Dose Toxicity

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

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