FOI release

Comirnaty Developmental Toxicity Data and Authorisation Procedures

Case reference FOI2026/00950

Received 25 August 2026

Published 13 October 2026

Request

Dear MHRA FOI Team, Thank you for your response to FOI2026/00830 and for your section 16 advice. I submit this as a new, refined request. It is limited to the three questions your response identified as likely capable of processing within the appropriate limit. Please provide the following recorded information: 1. The date on which MHRA received the final report of the developmental and reproductive toxicity study for Comirnaty, and the date of each interim DART dataset or report received before the final report. 2. For each of the following decisions, state the procedure under which the decision was made and the decision date: a. the Regulation 174 temporary authorisation of the Pfizer/BioNTech vaccine; b. the full marketing authorisation for Comirnaty; and c. the authorisation of Comirnaty for infants and children aged 6 months to 4 years. 3. Identify the role or post responsible for signing off an authorisation under the reliance route, and the criteria against which that decision is taken. I am not seeking a general email search, personal data, or all underlying documents at this stage. If any item is not held, please confirm that under section 1(1)(a).

Response

See attached

Documents

• FOI2026_00950 (redacted).pdf (1.2 MB)

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