Some of these new disclosures related to the CTD of Comirnaty were officially released by the EMA to individual requesters, 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 DOCUMENTS
Module 2.3 – Quality Overall Summary
2.3.S Drug Substance
2.3.S.1 General Information
2.3.S.3 Characterisation
2.3.S.4 Control of Drug Substance
2.3.S.4 Control of Drug Substance [Omicron (BA.4/BA.5) Variant]
2.3.S.4 Control of Drug Substance [Omicron (LP.8.1) Variant]
2.3.S.7 Stability
2.3.R Regional Information
Module 2.6 Non-Clinical Summary
2.6.4 Pharmacokinetics Written Summary – version 23 May 2025
2.6.5 Pharmacokinetics Tabulated Summary – version 23 May 2025
Module 3.2 – Body of Quality Data
3.2.S Drug Substance
3.2.S.2.6 Manufacturing Process Development
3.2.S.3.1 Elucidation of Structure and Other Characteristics
3.2.S.4.3 Validation of Analytical Procedures
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 (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC YET, EXCLUSIVELY HERE)
Common Technical Document (CTD)
Module 2.3 – Quality Overall Summary
2.3.S Drug Substance
2.3.S.1 General Information
2.3.S.3 Characterisation
2.3.S.3 Characterisation – Overview – version 23 March 2024
2.3.S.3 Characterisation – Overview – version 23 October 2024
2.3.S.4 Control of Drug Substance
2.3.S.4 Control of Drug Substance [Omicron (B.1.1.529) Variant] (22 March 2024)
2.3.S.4 Control of Drug Substance [Omicron (BA.4/BA.5) Variant]
2.3.S.4 Control of Drug Substance [Omicron (XBB.1.5) Variant] (16 June 2023)
2.3.S.4 Control of Drug Substance [Omicron (JN.1) Variant] (9 May 2024)
2.3.S.4 Control of Drug Substance [Omicron (LP.8.1) Variant]
2.3.S.5 Reference Standards or Materials
2.3.S.6 Container Closure System
2.3.S.7 Stability
2.3.P Drug Product
2.3.R Regional Information
Module 2.4 Non-Clinical Overview
2.4 Non-Clinical Overview Comirnaty Original/Omicron BA.4-5 Vaccine
2.4 Non-Clinical Addendum to the Nonclinical Overview – Tris-Sucrose (2021)
2.4 Non-Clinical Addendum to Nonclinical Overview – Tris-Sucrose/Paediatrics
2.4 Non-Clinical Addendum to the Nonclinical Overview – Tris-Sucrose
2.4 Non-Clinical Addendum to Nonclinical Overview – Tris-Sucrose/Paediatrics
Module 2.6 Non-Clinical Summary
2.6.4 Pharmacokinetics Written Summary – version 23 May 2025
2.6.4 Pharmacokinetics Written Summary – version 29 September 2020
2.6.5 Pharmacokinetics Tabulated Summary – version 23 May 2025
2.6.5 Pharmacokinetics Tabulated Summary – version 29 September 2020
Module 3.2 – Body of Quality Data
3.2.S Drug Substance
3.2.S.2.2 Description of Manufacturing Process and Process Controls
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 – 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 Process Validation and/or Evaluation
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)
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)
3.2.S.2.5 Process Validation and/or Evaluation – Hold Times (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC)
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)
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)
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)
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.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)
3.2.S.2.6 Extended Comparability Assessment Report, INX100451011 (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC)
3.2.S.3 Characterisation
3.2.S.3.1 Elucidation of Structure and Other Characteristics
3.2.S.3.2 Impurities
3.2.S.4 Control of Drug Substance
3.2.S.4.1 Specification
3.2.S.4.2 Analytical Procedures
3.2.S.4.2 Analytical Procedures – Overview [Omicron (XBB.1.5) Variant]
3.2.S.4.2 Analytical Procedures – Overview [Omicron (B.1.1.529) Variant]
3.2.S.4.2 Analytical Procedures – Droplet Digital Polymerase Chain Reaction (ddPCR) – [Omicron]
3.2.S.4.2 Analytical Procedures – Poly(A) Tail ddPCR – [Omicron]
3.2.S.4.2 Analytical Procedures – Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC, EXCLUSIVELY HERE)
3.2.S.4.2 Analytical Procedures – Quantitative Polymerase Chain Reaction (qPCR) [Omicron] (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC, EXCLUSIVELY HERE)
3.2.S.4.2 Analytical Procedures – Capillary Gel Electrophoresis
3.2.S.4.2 Analytical Procedures – Appearance (Clarity and Coloration)
3.2.S.4.3 Validation of Analytical Procedures
3.2.S.4.3 Validation of Analytical Procedures – Quantitative Polymerase Chain Reaction (qPCR)
3.2.S.4.3 Validation of Analytical Procedures – Capillary Gel Electrophoresis
3.2.S.4.3 Validation of Analytical Procedures – Overview [Omicron (JN.1) Variant]
3.2.S.4.3 Validation of Analytical Procedures – Overview [Omicron (XBB.1.5) Variant]
3.2.S.4.3 Validation of Analytical Procedures – Overview [Omicron (B.1.1.529) Variant]
3.2.S.4.3 Validation of Analytical Procedures – UV Spectroscopy
3.2.S.4.3 Validation of Analytical Procedures – Overview [Omicron (KP.2) Variant]
3.2.S.4.4 Batch Analyses
3.2.S.4.5 Justification of Specification
3.2.S.5 Reference Standards or Materials
3.2.S.7 Stability
3.2.S.7.1 Stability Summary and Conclusions
3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment
3.2.S.7.3 Stability 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
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)
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)
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)
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)
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)
3.2.P.3.4 Controls of Critical Steps and Intermediates
3.2.P.3.4 Controls of Critical Steps and Intermediates – In-Process Monitoring and Control – Fill and Finish – PFS (Refrigerated, Glass) [Puurs] (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC)
3.2.P.3.4 Control of Critical Steps and Intermediates – Process Steps Hold Times – Fill and Finish – PFS [Puurs] (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC)
3.2.P.3.4 Control of Critical Steps and Intermediates – Drug Product Intermediate 0.5 mg/mL – Stability Data – Tris/Sucrose (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC)
3.2.P.3.4 Control of Critical Steps and Intermediates – Process Steps Hold Times – LNP Production and Drug Product Formulation – Tris-Sucrose [Puurs] (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC)
3.2.P.3.4 Controls of Critical Steps and Intermediates – In-Process Monitoring and Control – LNP Production and Bulk Drug Product Formulation – Tris-Sucrose [Puurs] (EMA RELEASE UNDER 1049/01 BUT NOT AVAILABLE FOR THE PUBLIC)
3.2.P.6 Reference Standards or Materials
3.2.P.7 Container Closure System
3.2.P.8 Stability
3.2.P.8.2 Post-Approval Stability Protocol and Stability Commitment – Tris-Sucrose
3.2.P.8.3 Stability Data – Thermal Stress and Cycling – Tris-Sucrose
3.2.P.8.3 Stability Data – Additional Storage Conditions – Tris-Sucrose
3.2.A Appendices
3.2.A.1 Facilities and Equipment
3.2.A.2 Adventitious Agents Safety Evaluation
3.2.A.2 Adventitious Agents – TSE/BSE Statement – ALC-0159 – Avanti
3.2.A.2 Adventitious Agents – TSE/BSE Statement – ALC-0315 – Croda
3.2.A.2 Adventitious Agents – TSE/BSE Statement – Cholesterol – Avanti
3.2.A.2 Adventitious Agents – TSE/BSE Statement – Cholesterol – Evonik
3.2.A.2 Adventitious Agents – TSE/BSE Statement – DSPC – Avanti
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