Written questions by McVey.

With reference to FOI2025/00320, for what reason the Adjuvanted Zoonotic Influenza Vaccine was authorised via UK Regulation 56.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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:https://assets.publishing.service.gov.uk/media/61c518a0e90e071971e2561e/Temporary_Authorisation_Patient_Information_BNT162_18_0_UK_Clean.pdfhttps://assets.publishing.service.gov.uk/media/61c51662d3bf7f1f7bc0ac8b/Temporary_Authorisation_HCP_Information_BNT162_19_0_UK_Clean.pdfThe 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:https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reportingRegarding 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:https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine

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.

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:https://assets.publishing.service.gov.uk/media/61c518a0e90e071971e2561e/Temporary_Authorisation_Patient_Information_BNT162_18_0_UK_Clean.pdfhttps://assets.publishing.service.gov.uk/media/61c51662d3bf7f1f7bc0ac8b/Temporary_Authorisation_HCP_Information_BNT162_19_0_UK_Clean.pdfThe 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:https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reportingRegarding 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:https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine

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.

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.

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.

Information related to the baseline and methodology for the additional appointments delivered is available at the following link:https://www.england.nhs.uk/statistics/statistical-work-areas/rtt-waiting-times/recovery-of-elective_activity-mi/

Pursuant to the Answer of 20 January 2025 to Question 23741 on Coronavirus: Vaccination, if he will publish (a) the questions posed to Pfizer/BioNTech and (b) the answers received that do not relate to commercially confidential issues.

The Medicines and Healthcare products Regulatory Agency (MHRA) does not intend to publish these questions, or any subsequent responses received from the manufacturers. It is routine practice for regulatory authorities to ask developers of new medicines and vaccines a series of technical questions based on their data submissions. These technical discussions can cover a range of issues, including commercially confidential issues such as manufacturing methods, and as such they are not published. However, the final outcome of the assessment, including a comprehensive summary of evidence for quality, safety, and efficacy, is published in the form of a Public Assessment Report, which has been published on the GOV.UK website, and which is available at the following link: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine We recognise that there is a public interest in the disclosure of commercial informationrelating to the authorisations of the COVID-19 vaccines following the COVID-19 pandemic.Due to the technical context of the 36 questions posed to Pfizer and BioNTech and any response that they may have issued, disclosure of such correspondence would risk compromising an existing competitive market environment, which would harm the reputation of the MHRA amongst pharmaceutical manufacturers and potentially disincentivise them from seeking an authorisation for the United Kingdom for highly beneficial new medicines or medical devices.

Pursuant to the Answer of 20 January 2025 to Question 23741 on Coronavirus: Vaccination, for what reason the MHRA has temporarily withdrawn the collection of minutes from the Commission on Human Medicines' Vaccine Benefit Risk Expert Working Group (meetings between 25 August 2020 and 5 May 2023).

To ensure the accuracy of redactions within the minutes in question the Medicines and Healthcare products Regulatory Agency (MHRA) has temporarily withdrawn the meeting minutes of the Vaccine Benefit Risk Expert Working Group to ensure accurate and transparent records.The MHRA anticipates republishing all minutes as soon as possible.For further transparency, when the minutes are republished, an alert will be sent to all subscribers who have registered for updates to the GOV.UK website for content of this type. I have also asked the rt hon member is alerted.

Pursuant to the Answer of 13 January 2025 to Question 22602 on Coronavirus: Vaccination, for what reason the Medicines and Healthcare products Regulatory Agency does not intend to publish this information.

It is routine practice for regulatory authorities to ask developers of new medicines and vaccines technical questions based on their data submissions. These technical questions can cover a range of issues, including commercially confidential issues such as manufacturing methods, and they are not published.The final outcome of the assessment, including the comprehensive summary of the evidence for quality, safety and efficacy, is published in the form of a Public Assessment Report, which is available at the following link:https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine

With reference to paragraph 3.6 of the minutes of the Covid-19 Vaccine Benefit Risk Expert Working Group held on 18 November 2020, if he will publish (a) the 36 questions posed by the Medicines and Healthcare products Regulatory Agency to Pfizer/BioNTech and (b) any response received from that company.

The Medicines and Healthcare products Regulatory Agency does not intend to publish these questions, or any subsequent responses received from the manufacturers.

What the average wait time is for hospital patients to be provided with medications at discharge.

The Department and NHS England recognise the need for patients who are ready to go home to be discharged as quick as possible, both for their benefit and to improve the efficiency of hospitals. Information on the average wait time for hospital patients to...

What steps he plans to take to make the hospital discharge process more efficient.

The Government will improve hospital discharge processes, to tackle delayed discharges, and to make sure people do not spend longer than necessary in hospital, freeing up hospital beds.We will do so by developing local partnerships, working between the Na...

What steps he is taking to increase the efficiency of supplying medication at hospital discharge to ensure faster discharge.

The Department and NHS England recognise the need for patients who are ready to go home to be discharged as quick as possible, both for their benefit and to improve the efficiency of hospitals. Information on the average wait time for hospital patients to...

Pursuant to the Answer of 18 November 2024 to Question 12696 on Primodos: Research, when the minutes and outcome of the November Commission on Human Medicines discussion will be published.

The Medicines and Healthcare products Regulatory Agency (MHRA), together with the wider Government, have committed to reviewing any new scientific evidence which comes to light.The new publication by Danielsson et al has been reviewed by the MHRA and advi...

Pursuant to the Answer of 21 November 2024 to Question 13772 on Cardiovascular Diseases: Emergency Calls, if he will provide this data for the period between March 2015 and March 2021; and what ass

Information on ambulance service demand is published by NHS England, including, as of April 2018, the monthly total number of cardiac arrests responded to by ambulance services. The following table shows the total number of cardiac arrests each month from...

What guidance his Department issues to hospitals on visiting times for friends and family.

Contact with family and friends is fundamental to the health and wellbeing of residents in care homes and people in hospital. We have worked with NHS England and the Care Quality Commission (CQC) to develop the policy options to strengthen the expectation...

Pursuant to the Answer of 18 November 2024 to Question 13773 on the Vaccine Damage Payment Scheme, how many claims have waited over a year for a decision; and what support his Department provides t

As of 1 December 2024, 1,107 claims have been waiting over a year for a resolution. All claims are managed on a case-by-case basis and there are several factors that may impact processing times. This includes time spent awaiting medical records from healt...