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.

Question to the Department for Work and Pensions:

To ask the Secretary of State for Work and Pensions, whether she plans to increase the powers of the Child Maintenance Service to obtain accurate data on self-employed parents.

Answered by Andrew Western - Parliamentary Under-Secretary (Department for Work and Pensions)

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.

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.

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:

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

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:

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

Found: schedule (Standing Order No. 68) Chairs: Peter Dowd Clive Efford Sir Roger Gale Carolyn Harris Esther McVey

Found: schedule (Standing Order No. 68) Chairs: Peter Dowd Clive Efford Sir Roger Gale Carolyn Harris Esther McVey

Found: schedule (Standing Order No. 68) Chairs: Peter Dowd Clive Efford Sir Roger Gale Carolyn Harris Esther McVey

Found: schedule (Standing Order No. 68) Chairs: Peter Dowd Clive Efford Sir Roger Gale Carolyn Harris Esther McVey

Found: schedule (Standing Order No. 68) Chairs: Peter Dowd Clive Efford Sir Roger Gale Carolyn Harris Esther McVey

Found: schedule (Standing Order No. 68) Chairs: Peter Dowd Clive Efford Sir Roger Gale Carolyn Harris Esther McVey

Found: schedule (Standing Order No. 68) Chairs: Peter Dowd Clive Efford Sir Roger Gale Carolyn Harris Esther McVey

Found: schedule (Standing Order No. 68) Chairs: Peter Dowd Clive Efford Sir Roger Gale Carolyn Harris Esther McVey

Found: State for Housing at the RESI Convention (12 September 2019) 2.23 The former Housing Minister, Esther McVey