Esther McVey

The UK possesses tremendous tidal resource and could play a role in balancing the intermittency of wind and solar generation as we transition towards clean power.

The UK remains the world leader in tidal stream generation technologies, with around half of the world's operational deployment of this situated in UK waters. On 3^rd September 2024, the Government announced that six tidal stream contracts were secured with a joint capacity of 28MW in Contracts for Difference Allocation Round 6. The UK is on track to have over 130 MW of tidal stream capacity deployed by 2029.

The Government is also open to considering well-developed proposals for harnessing the tidal range energy in the bays and estuaries around our coastlines, including barrage schemes and other alternatives.

The UK possesses tremendous tidal resource and could play a role in balancing the intermittency of wind and solar generation as we transition towards a carbon-neutral power sector.

The UK remains the world leader in tidal stream generation technologies, with around half of the world's operational deployment of this situated in UK waters. On 3^rd September 2024, the Government announced that six tidal stream contracts were secured with a joint capacity of 28MW in Contracts for Difference Allocation Round 6. The UK is on track to have over 130 MW of tidal stream capacity deployed by 2029.

The Government is also open to considering well-developed proposals for harnessing the tidal range energy in the bays and estuaries around our coastlines, including barrage schemes and other alternatives.

Great British Energy will create thousands of jobs and build supply chains across the UK, including at its future head office in Scotland. Its investments will support companies across the energy industry, providing opportunities for high quality, well-paid work. We already see the diversity of projects across the UK – from wind turbine construction in Teesside and Merseyside, to nuclear power in Suffolk, tidal projects in Scotland, hydropower in Wales, solar farms in Wiltshire and offshore wind in Belfast. Every part of the UK has a role to play in delivering energy security and transition to clean power by 2030.

The Government believes that the only way to guarantee our energy security and protect billpayers permanently is to speed up the transition away from fossil fuels and towards homegrown clean energy. The creation of Great British Energy will help us to harness clean energy and have less reliance on foreign, volatile energy markets, and help in our commitment to produce all of the UK's energy from clean power sources by 2030.

In the short-term, we will continue to deliver the Warm Home Discount which provides a £150 annual rebate on energy bills for eligible low-income households. We will also invest an extra £6.6 billion in energy efficiency funding over this Parliament to upgrade 5 million homes and cut bills for families.

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.

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.

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.

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.

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.

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.

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.pdf

https://assets.publishing.service.gov.uk/media/61c51662d3bf7f1f7bc0ac8b/Temporary_Authorisation_HCP_Information_BNT162_19_0_UK_Clean.pdf

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:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

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:

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-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.pdf

https://assets.publishing.service.gov.uk/media/61c51662d3bf7f1f7bc0ac8b/Temporary_Authorisation_HCP_Information_BNT162_19_0_UK_Clean.pdf

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:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

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:

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine

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.

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/

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 information

relating 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.

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.

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

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

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 be provided with medication at the point of discharge is not held centrally by NHS England, and it is the responsibility of individual trusts to monitor discharge and medication efficiency. To support hospitals on improving processes, guidance has been published, which is available at the following link:

https://www.england.nhs.uk/urgent-emergency-care/improving-hospital-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 be provided with medication at the point of discharge is not held centrally by NHS England, and it is the responsibility of individual trusts to monitor discharge and medication efficiency. To support hospitals on improving processes, guidance has been published, which is available at the following link:

https://www.england.nhs.uk/urgent-emergency-care/improving-hospital-discharge/

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 National Health Service and social care, making sure people get the right support from health and social care services to return home as soon as possible. Currently, every acute hospital has access to a care transfer hub, which brings together professionals from the NHS and local authorities to manage discharges for people with more complex needs, and collaboration between integrated care boards and local authorities will continue to be supported by the Better Care Fund framework through 2025/26.

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 advice has been sought from the Government’s independent advisory body, the Commission on Human Medicines (CHM), who have provided their independent expert advice on our assessment of whether the findings of the latest publication justify a further review. The MHRA will consider the recommendations given by the CHM before deciding whether any further action is warranted.

The minutes of the November CHM meeting will be made publicly available through the GOV.UK website at the earliest opportunity.

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 for care providers and hospitals in England to allow visiting. This included introducing secondary legislation to amend CQC regulations. Further information on CQC regulations, specifically Regulation 9A: Visiting and accompanying in care homes, hospitals and hospices, is available at the following link:

https://www.cqc.org.uk/guidance-providers/regulations/regulation-9a-visiting-and-accompanying

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 April 2018 to June 2024:

Source: the data is published by NHS England, and is available at the following link: https://www.england.nhs.uk/statistics/statistical-work-areas/ambulance-quality-indicators/

The increasing aging population and complexity that comes with more patients with multiple comorbidities may be reflected in the trend of rising in category 1 incidents.

In the financial year (FY) 2022/23, 1,298 applications were assessed, and 72 applications were successful. In the FY 2023/24, 3,806 applications were assessed, and 99 applications were successful. In the FY 2024/25, 4,664 applications have been assessed, and 27 applications have been successful.

We are unable to disclose the specific number of applications that were successful in the 2021/22 FY, as that number is fewer than or equal to five, and could lead to individuals being identified. For the FYs 2022/23 to 2024/25, the mean average number of successful applications is 66, the median average is 72, and the range is 72. The mean average, median average, and range do not include numbers for the 2021/22 FY, as including this information could lead to individuals being identified. The payment amount for successful claims is fixed at £120,000.

Between 1 November 2021 and 1 December 2024, the total spent by the NHS Business Services Authority on behalf of the Department on legal fees to defend against appeals within the Vaccine Damage Payment Scheme was £50,608.

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 healthcare providers, or appropriate legal identification documentation, or awaiting consent from claimants for access to their medical records

The Vaccine Damage Payment Scheme transferred from the Department for Work and Pensions to the NHS Business Services Authority (NHSBSA) in November 2021. We cannot provide any costings for the scheme during the period in which it was operated by the Department for Work and Pensions. Since the NHSBSA took over operation of the scheme, the following costs have been incurred for the medical assessments of the claims:

• in the financial year 2021/22, no costs were incurred, as the claims assessment did not begin until May 2022;
• in the financial year 2022/23, the total cost of the medical assessments was £5,018,638.73;
• in the financial year 2023/24, the total cost of the medical assessments was £10,500,029.88; and
• in the current financial year, up to 1 November 2024, the total cost of the medical assessments is £9,616,394.02.

These are annual totals since we do not separate the budgets for initial assessments and mandatory reversals, the review of claims already assessed.

The rise in category 1 incidents reflects an increase in the proportion of patients’ ambulance services that have been determined to require an immediate face-to-face response. This may reflect a long-term trend of rising pressures on the health services from an increasing aging population, and complexity that comes with more patients with multiple comorbidities. Information on increases in ambulance service demand is published by NHS England. The total number of cardiac arrests that ambulance services responded to is published by month, however this information does not include other cardiac incidents, for example heart attack or angina, and the information is not disaggregated by incident category. The following table shows the total number of cardiac arrests each month from March 2021 to June 2024:

Source: The data is published by NHS England, and is available at the following link: https://www.england.nhs.uk/statistics/statistical-work-areas/ambulance-quality-indicators/