PARLIAMENTARY WRITTEN QUESTION
Coronavirus: Vaccination (28 October 2024)

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 14 October 2024 to Question 6194 on Coronavirus: Vaccination, whether the Medicines and Healthcare products Regulatory Agency has made an assessment of the potential implications for future medical decisions 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; and when he plans to publish the full study.

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 and will review the final study report, when it’s made available by Pfizer, as part of safety monitoring procedures.

The MHRA does not publish study reports for company studies, and further publications of results are the responsibility of Pfizer-BioNTech. 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)
31 October 2024