Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, for what reason Primodos was not within the terms of reference of the Hughes Report: options for redress for those harmed by valproate and pelvic mesh, published on 7 February 2024.

Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)

The Government is hugely sympathetic to the families who believe that they or their children have suffered following the use of hormone pregnancy tests.

The previous administration did not ask the Patient Safety Commissioner, Dr Henrietta Hughes, to look at redress for hormone pregnancy tests as part of the Hughes Report, because a causal link between hormone pregnancy tests and adverse outcomes in pregnancy has not been demonstrated. An Expert Working Group of the independent Commission on Human Medicines reviewed the available scientific evidence in 2017 and concluded that it does not support a causal association. This position was reaffirmed in its most recent review in November 2024. However, we are committed to reviewing any new scientific evidence that comes to light.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how many and what proportion of claims have been submitted to the Vaccine Damage Payment Scheme for (a) fatalities and (b) illnesses for Covid 19 vaccines.

Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)

As of 31 March 2025, 19,895 claims had been submitted to the Vaccine Damage Payment Scheme relating to COVID-19 vaccination. 18,724, or 94% of these claims, were submitted for illnesses relating to COVID-19 vaccination and 1,171, or 6% of these claims, were submitted for fatalities relating to COVID-19 vaccination.

As of 31 March 2025, 958 claims had been submitted to the Vaccine Damage Payment Scheme relating to vaccinations other than COVID-19 vaccination. 903, or 94% of these claims, were submitted for illnesses relating to vaccinations other than COVID-19 vaccinations and 55, or 6% of these claims, were submitted for fatalities relating to vaccinations other than COVID-19 vaccination.

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.

Answered by Karin Smyth - Minister of State (Department of Health and Social Care)

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.