PARLIAMENTARY WRITTEN QUESTION
Coronavirus: Vaccination (6 November 2024)

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 31 October 2024 to Question 11248 on Coronavirus: Vaccination, what discussions the MHRA has had with industry safety regulators on the potential implications of the Pfizer study abstract entitled Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine dated 12 March 2024 on an assessment of individuals’ medical fitness to operate safety critical systems.

Asked by:
Esther McVey (Conservative)

The study abstract has been reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA), as part of its continuous post approval safety monitoring procedures for the Pfizer-BioNTech COVID-19 Vaccine (Comirnaty). The abstract is available at the following link:

https://catalogues.ema.europa.eu/system/files/2024-06/C4591021%20Interim%205%20Study%20Report%20Abstract%20_0.pdf

The MHRA does not consider that any regulatory action is warranted at this time, therefore has not discussed this study abstract with industry safety regulators. The MHRA will review the final study report, when it is made available by Pfizer, as part of safety monitoring procedures.

The MHRA continues to closely monitor the safety of all COVID-19 vaccines and will take any regulatory action necessary should any new safety concerns be identified.

Answered by:
Andrew Gwynne (Independent)
11 November 2024