Comirnaty - EMA disclosures relating to quality/impurities/contamination issues - updated 25th of January 2025

EMA recently released highly important but outdated CTD quality documents from 2020, despite important new information in these sections. New FOIA requests are therefore pending.

Common Technical Document

2.3.S: BNT162b Quality overall summary 2 2.3. Substance (26th of October 2020)

2.3.P: BNT162b Quality overall summary 2 2.3. Product (26th of October 2020)

3.2.S.2.4 Control of Critical Steps and Intermediates Hold Times [Andover] (24th October 2020)

3.2.S.2.4 Control of Critical Steps and Intermediates In-Process Test Methods [Andover] (24th October 2020)

3.2.S.2.4 Control of Critical Steps and Intermediates Hold Times [BNT Mainz and Rentschler] (28th Nov 2020)

3.2.S.2.4 Control of Critical Steps and Intermediates In-Process Test Methods [BNT Mainz and Rentschler] (28th Nov 2020)

3.2.S.2.4. Manufacturing Process - control critical steps manufacturing process (19th December 2020)

Variations

Committee for Medicinal Products for Human Use (CHMP), EMA/CHMP/21199/2024, Type II variation assessment report, Procedure No. EMEA/H/C/005735/II/0202 (29th February 2024) = on SV40 Variation!!! Important!!! discussed here (in German)

Pfizer gibt den SV40 Promotor in EMA Dokumenten zu

Committee for Medicinal Products for Human Use (CHMP), Assessment report of the post-authorization measure REC 027, Procedure Nr. EMEA/H/C/005735/PAM-ANX REC027 (20th May 2021) - already posted and discussed here

Committee for Medicinal Products for Human Use (CHMP), EMA/CHMP/429590/2021, Type IB variation report, Procedure Nr. EMEA/H/C/005735/IB/0055 (17th August 2021) - already posted and discussed here

Committee for Medicinal Products for Human Use (CHMP), EMA/CHMP/448917/2022, Type II group of variations assessment report, Procedure No. EMEA/H/C/005735/II/0056/G (17 February 2022)

Committee for Medicinal Products for Human Use (CHMP), EMA/CHMP/94082/2022, Type II group of variations assessment report, Procedure No. EMEA/H/C/005735/II/0109/G (10th March 2022)

Pharmacovigilance Risk Assessment Committee (PRAC), EMA/CHMP/PRAC/2296/2022, Type II variation assessment report, Procedure No. EMEA/H/C/005735/II/0087 (10th March 2022)

Committee for Medicinal Products for Human Use (CHMP), EMA/CHMP/50784/2022, Type IB variation report, Procedure Nr. EMEA/H/C/005735/IB/0106/G (31st March 2022) - already posted and discussed here

Committee for Medicinal Products for Human Use (CHMP), EMA/CHMP/822048/2022, Type II variation assessment report Procedure No. EMEA/H/C/005735/II/0148/G (8th December 2022) - already posted and discussed here

EMA Scientific Answers

EMA/277138/2024, Responses to your follow-up questions June 2024, including DNA contamination (4th July 2024)