Asked by: Esther McVey (Conservative - Tatton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to UKHSA FOI Request Ref: 617 H5 Influenza Vaccine, whether one tender response was received; and what steps he has taken to encourage more responses.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
One tender response was received. The requirement for this vaccine specified that the product must be licensed for use in the United Kingdom. At the time the tender was published, only one supplier was able to meet this criterion. This was despite prior engagement with the market ahead of the release of the tender documentation.
The UK Health Security Agency (UKHSA) routinely undertakes proactive market and horizon scanning to identify emerging technologies and new suppliers across a range of industries. We remain committed to fostering a competitive environment that encourages innovation, while meeting the scope of the UKHSA to respond to public health outcomes.
Asked by: Esther McVey (Conservative - Tatton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to FOI2025/00320, for what reason the Adjuvanted Zoonotic Influenza Vaccine was authorised via UK Regulation 56.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in a pre‐filled syringe (PLGB 47991/0013) was authorised by the Medicines and Healthcare products Regulatory Agency via UK Regulation 56 of The Human Medicines Regulations 2012 on 6 October 2023. This created a duplicate unbranded licence that was identical to Aflunov suspension for injection in a pre-filled syringe (PLGB 47991/0004), which was authorised in the United Kingdom on 29 November 2010 by a European Commission decision, following a centralised procedure by the European Medicines Agency (EMA; EMEA/H/C/002094). Subsequent to the granting of this duplicate unbranded licence, further lifecycle management actions were authorised for this licence.
Asked by: Esther McVey (Conservative - Tatton)
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.
Asked by: Esther McVey (Conservative - Tatton)
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.
Asked by: Esther McVey (Conservative - Tatton)
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.
Asked by: Esther McVey (Conservative - Tatton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the Prescription Medicines Code of Practice Authority case rulings with reference (a) AUTH/3815/8/23 and (b) 3886/3/24 on Moderna’s NextCOVE trial in children, if he will make an assessment of the potential impact of those rulings on the nature of his Department's future work with that company on mRNA (i) research and (ii) development.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority, and the Research Ethics Committee (REC) review and approve clinical trials on the basis of the benefits and risks, in line with the UK Clinical Trials regulatory (UK CTR) framework.
The safety of those participating in clinical trials is the MHRA’s first priority, and our oversight of trial conduct is informed by the trial’s sponsor efficiently notifying us of safety issues during the conduct of their trial.
Sponsors and investigators involved in the conduct of clinical trials are expected to have robust processes to ensure compliance with The Medicines for Human Use (Clinical Trials) Regulations, which includes compliance with the provision and use of documentation that has been approved for use by a REC.
Where doubts about the safety, conduct, or scientific validity of a clinical trial are identified, the MHRA may take action, in line with the UK CTR, which could include requiring changes to be made to the trial protocol, or suspension or termination of a trial.
Asked by: Esther McVey (Conservative - Tatton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to paragraph 3.7 of the minutes of the Covid-19 Vaccine Benefit Risk Expert Working Group held on 18 November 2020, if he will publish the risk-based evaluation for the Pfizer/BioNTech mRNA vaccine.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
The reactogenicity of vaccines refers to their capacity to produce common or “expected” adverse reactions following vaccination such as fever, tiredness, and a sore arm at the vaccination site. These reactions, and the frequency with which they occur, are listed in section four of the vaccine package leaflet, which states what possible side effects people may experience. Regarding the reference to reactogenicity in paragraph 3.19 of the minutes of the COVID-19 Vaccine Benefit Risk Expert Working Group held on 18 November 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published information for the recipients of the Pfizer/BioNTech mRNA vaccine, as well as for healthcare professionals. These documents detail the reactogenic nature of the vaccines, and are available, respectively, at the following two links:
The MHRA also regularly published coronavirus vaccine summaries of Yellow Card reporting throughout the pandemic. Amongst many other matters regarding the safety of the COVID-19 vaccines, the reactogenic nature of the vaccines was regularly discussed in these communications, which are available at the following link:
Regarding paragraph 3.7 of these same minutes, the MHRA published product information for the COVID-19 vaccines on the GOV.UK website when regulatory approval was given, starting from 2 December 2020 when the Pfizer/BioNTech (Comirnaty) vaccine was the first COVID-19 vaccine in the world to be approved. On this day, the risk-based evaluation for the Pfizer/BioNTech mRNA vaccine referenced in this paragraph of the minutes was published as part of a summary of the public assessment report for the COVID-19 vaccine Pfizer/BioNTech, which is available at the following link:
Asked by: Esther McVey (Conservative - Tatton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to paragraph 3.19 of the minutes of the Covid-19 Vaccine Benefit Risk Expert Working Group held on 18 November 2020, if he will publish the communications undertaken to inform recipients of the Pfizer/BioNTech mRNA vaccine about its highly reactogenic nature.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
The reactogenicity of vaccines refers to their capacity to produce common or “expected” adverse reactions following vaccination such as fever, tiredness, and a sore arm at the vaccination site. These reactions, and the frequency with which they occur, are listed in section four of the vaccine package leaflet, which states what possible side effects people may experience. Regarding the reference to reactogenicity in paragraph 3.19 of the minutes of the COVID-19 Vaccine Benefit Risk Expert Working Group held on 18 November 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published information for the recipients of the Pfizer/BioNTech mRNA vaccine, as well as for healthcare professionals. These documents detail the reactogenic nature of the vaccines, and are available, respectively, at the following two links:
The MHRA also regularly published coronavirus vaccine summaries of Yellow Card reporting throughout the pandemic. Amongst many other matters regarding the safety of the COVID-19 vaccines, the reactogenic nature of the vaccines was regularly discussed in these communications, which are available at the following link:
Regarding paragraph 3.7 of these same minutes, the MHRA published product information for the COVID-19 vaccines on the GOV.UK website when regulatory approval was given, starting from 2 December 2020 when the Pfizer/BioNTech (Comirnaty) vaccine was the first COVID-19 vaccine in the world to be approved. On this day, the risk-based evaluation for the Pfizer/BioNTech mRNA vaccine referenced in this paragraph of the minutes was published as part of a summary of the public assessment report for the COVID-19 vaccine Pfizer/BioNTech, which is available at the following link:
Asked by: Esther McVey (Conservative - Tatton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the information on the Vaccine Damage Payment Scheme (VDPS) claim process, published by the NHS Business Services Authority, if he will publish the past tribunal decisions and case law used to assess applications to the Vaccine Damage Payment Scheme.
Answered by Ashley Dalton - Parliamentary Under-Secretary (Department of Health and Social Care)
Vaccine Damage Payment Scheme (VDPS) appeals are heard by the First-tier Social Security and Child Support Tribunal. The tribunal does not publish these decisions as they are non-binding and contain personal information.
First-tier tribunal decisions do not set a precedent for other cases. All claims to the VDPS are assessed on a case-by-case basis, using the latest available medical evidence. Medical assessors will consider: the claim form; medical records from the vaccinated person’s healthcare providers; clinical research; epidemiological evidence; and the current consensus of expert medical opinion.
Asked by: Esther McVey (Conservative - Tatton)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the Prime Minister's Office press release entitled Over two million extra NHS appointments delivered early as trusts handed £40 million to go further and faster, published on 16 February 2025, if he will publish the evidence base for the announcement.
Answered by Karin Smyth - Minister of State (Department of Health and Social Care)
Information related to the baseline and methodology for the additional appointments delivered is available at the following link: