Written questions by McVey.

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

What information his Department holds on the number of public sector projects contracted by his Department that have had cost overruns due to mandatory net zero requirements since 5 July 2024.

This information is not held centrally and can only be obtained at disproportionate cost.

How many procurement contracts awarded by her Department since 5 July 2024 have been terminated due to non-performance.

No contracts awarded by HM Treasury since 5 July 2024 have been terminated for that reason.

How many procurement contracts awarded by her Department since 5 July 2024 have been awarded without competitive tendering.

No contracts covered by the Public Contracts Regulations have been awarded by HM Treasury since 5 July 2024 without competitive tendering.

How many and what proportion of public contracts awarded by his Department since 5 July 2024 have been awarded to (a) British SMEs and (b) companies based abroad.

The Department of Business and Trade has awarded and published 167 contracts over £10,000 ex VAT since 5 July 2024; 44 of which were to UK based SMEs, and 22 to companies based abroad.

How many public contracts awarded by her Department since 5 July 2024 have been awarded to companies with offshore tax arrangements.

The information requested is not readily available and to provide it would incur disproportionate cost. Where it makes business sense to do so, HM Treasury procures goods and services via Crown Commercial Service (CCS) framework agreements. Suppliers on those agreements must comply with the requirements of Procurement Policy Note 03/2014.

Whether she plans to increase the powers of the Child Maintenance Service to obtain accurate data on self-employed parents.

For self-employed paying parents, the gross income used in a maintenance calculation is provided by HM Revenue & Customs (HMRC). People who are self-employed are required to keep accurate records of their business income and expenses for tax purposes. HMRC can charge penalties for inaccurate reporting where it results in tax being unpaid.Cases involving complex income can be investigated by the Financial Investigation Unit (FIU). This is a specialist team which can request information from financial institutions to check the accuracy of information the CMS is given. The FIU uses its extensive investigative powers to ensure that families receive child maintenance appropriately and in accordance with the paying parent’s whole income.If necessary, criminal charges relating to information offences linked to the calculation, will be brought against those who persistently and deliberately evade their responsibility to provide financially for their children.The department is conducting a programme of work to review the child maintenance calculation to make sure it is fit for purpose and reflects today’s social trends. The review is wide-ranging and includes consideration of a range of issues including bringing the treatment of unearned income and assets within the calculation automatically. Proposed changes which emerge from the review will be subject to consultation.

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.

What assessment she has made of (a) how often family court proceedings are delayed on the day of the hearing and (b) the reason for those delays.

His Majesty’s Courts & Tribunals Service does not currently hold this data but a pilot of digital reforms in the family court is due to be rolled out later this year for private law proceedings and data on delays to court hearings will then be available.

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.

How many residential properties have been purchased in preparation for HS2 Phase 2b; and what proportion of these have been vacant for longer than six months in Tatton Constituency.

720 residential properties in total have been acquired on the former HS2 Phase 2b route. Of these, 59 are in the Tatton constituency, of which 19 have been vacant for more than six months.

Communities and Local Government, whether her Department provides guidance to chief executives of local authorities on attending meetings with Rt hon. and hon. Members.

The department does not issue such guidance. Councils are independent, democratic bodies accountable to the communities they serve.

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

Communities and Local Government, what steps her Department is taking to ensure biodiversity net gain is not used to override protections afforded to Local Wildlife Sites and other designated nature sites.

Development is restricted on sites which are designated for environmental or amenity value, and the National Planning Policy Framework requires local plans to identify, map and safeguard components of local wildlife-rich habitats and wider ecological networks, including the hierarchy of international, national and locally designated sites of importance for biodiversity.Biodiversity Net Gain is additional to these protections for nature and only required on new development that needs planning permission, therefore only applying on designated nature sites in the very limited circumstances where such development is permitted.