Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the Medicines and Healthcare products Regulatory Agency has received the final post-authorisation safety study report for the BNT162b2 covid-19 vaccine.

A post-authorisation safety study is a study that is carried out after a medicine has been authorised to obtain further information on a medicine's safety, or to measure the effectiveness of risk-management measures.

A total of 22 clinical studies are included, or were previously included, as additional pharmacovigilance activities in the Risk Management Plan (RMP) for the Pfizer/BioNTech (Comirnaty) vaccine. Of these studies, nine are reported as phase one, two, or three studies. Of the remaining studies, 10 are safety studies and three are vaccine effectiveness studies. Seven studies are ongoing, and 15 have been completed.

Milestones for these studies, including the due date of the submission of the final clinical study reports, are outlined in the RMP. The final study report for the clinical study Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine is due to be submitted to the Medicines and Healthcare products Regulatory Agency by 30 September 2025.