FOI release

Pfizer Covid Vaccine PASS Study C4591021

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00352

Received 28 March 2026

Published 5 June 2026

Request

My request relates to Pfizer's 'Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine' (ref C4591021). Interim Report 5 reported significantly higher incidence of some serious heart-related conditions among the vaccinated cohort. 1. In relation to Interim Report 5: a) when did MHRA decide to remove the Section 22 Exemption? b) when, by whom and where was Interim Report 5 published? c) please can I have a copy of MHRA's assessment of it 2. In relation to the Final Report: a) does MHRA hold a copy of the Final Report? b) if so, when did MHRA receive it? c) please can you send me a copy d) please can I have a copy of MHRA's assessment of it

Response

See attached

Documents

• FOI2026_00352 (redacted).pdf (657.5 KB)

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