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Written Question
Yellow Card Scheme
Monday 24th July 2023

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, what the evidential basis is for the statement by the Medicines and Healthcare products Regulatory Agency that there is high public awareness of the Yellow Card scheme in relation to reporting suspected adverse reactions to Covid-19 vaccination.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Medicines and Healthcare products Regulatory Agency (MHRA) has worked with its partners across the health system to ensure that planned COVID-19 vaccination programme communications include information about the Yellow Card scheme. Information about the reporting of side effects via Yellow Card was included on both the information for vaccinees and the UK Health Security Agency materials to support the vaccination programme. These materials were made available as part of the initial call-recall process, as well as at vaccination centres.

Additionally, the MHRA optimised website search functionality for the dedicated Coronavirus Yellow Card reporting site and worked with media outlets to encourage them to carry messages about the reporting of side effects. The scheme was also promoted through targeted social media campaigns, the Drug Safety Update and a press release informing healthcare professionals and members of the public that reporting to the new site would enable the MHRA to rapidly identify new and emerging side effects. The general public were also encouraged to report any suspected side effects of the vaccine to the MHRA via a Yellow Card on televised press briefings.

The number of reports received through the scheme increased throughout the pandemic for non-COVID-19 medicines and vaccines from both patients and healthcare professionals, demonstrating increased public awareness of the important of reporting side effects. Patients are now the largest reporting group in the scheme, and in 2022 the highest number of reports from members of the public were received by the Yellow Card scheme to date.


Written Question
Coronavirus: Vaccination
Monday 24th July 2023

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, pursuant to the Answer of 27 June 2023 to Question 190812 on Coronavirus: Vaccination, what assessment he has made of (a) the robustness and (b) the implications for his policies of the study's findings in Table 2 on levels of Serious Adverse Events for people vaccinated with the Pfizer mRNA vaccine.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

All COVID-19 vaccines deployed in the United Kingdom have been authorised for use following a rigorous review by the independent regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA continuously monitors safety during the widespread use of a vaccine. It keeps all available evidence under review, including studies, published literature and data arising from usage in the UK and internationally, including the article referenced. The MHRA communicates safety advice based upon the totality of evidence rather than the strengths and limitations of individual data sources.


Written Question
Drugs: Side Effects
Friday 21st July 2023

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, what the rate is of hospital admissions from suspected adverse drug reactions.

Answered by Will Quince

The information requested is not held centrally.


Written Question
Mental Health Services: Veterans
Thursday 20th July 2023

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, what assessment he has made of the adequacy of the support for or veterans who show symptoms of PTSD (a) two, (b) five and (c) seven years after they left the Armed Forces.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

In April 2023, NHS England re-launched an integrated Op Courage service which brings together the current bespoke and separate strands into a single integrated veterans’ mental health service. This new service will make it easier for veterans to access the support they need and reduce the need for cross-referrals between services within Op Courage.

NHS England will continue to evaluate the service to ensure it meets the needs of service users as part of good and standard practice.


Written Question
Coronavirus: Vaccination
Tuesday 18th July 2023

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, in how many and what proportion of cases in which a fatal outcome was reported following covid-19 vaccination did a healthcare professional seek further information about the case; and how many and what proportion of such follow-up requests resulted in (a) further information and (b) no response being provided.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

The Medicines and Healthcare products Regulatory Agency (MHRA) acknowledge receipt of every Yellow Card report received and a team of safety experts follows up for further information as necessary, including all reports with a fatal outcome, based on the completeness, severity and clinical details provided in the report.

Responses to follow-up requests for adverse drug reaction (ADR) reports are recorded and stored with the original report on the MHRA’s ADR database. The information is then passed downstream for use in signal detection and the identification of safety concerns. The data is available for its core purpose of assessment and signal detection; however, the systems were not designed to quantify the follow-up metrics requested. As such, it is not possible to automatically generate metrics on the proportion of follow-up requests sent, or those which resulted in further information being received.


Written Question
Commission On Human Medicines
Thursday 29th June 2023

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, pursuant to the Answer of 13 June 2023 to Question 187628 on Commission on Human Medicines, and with reference to the Summary of the Commission on Human Medicines Meeting held between 1 March 2020 and 31 December 2020, when (a) a final decision on the issue under consideration at that meeting will be taken and (b) information withheld from the meeting summary under section 43 of the Freedom of Information Act 2000 will be released.

Answered by Will Quince

Multiple Commission on Human Medicines (CHM) meetings were held in the specified period, so further information is required for question A. The role of CHM is to provide the Licensing Authority with independent advice on the safety, efficacy and quality of medicinal products. It is the role of the Licensing Authority, on behalf of Secretary of State, to take a final decision to grant a marketing authorisation for a medicinal product. Following this decision a Public Assessment Report (PAR), containing the non-confidential parts of the MHRA’s assessment, is published on the MHRA website.

CHM discuss high number of products and applications at each of their meetings. Information withheld under Section 43 of the Freedom of Information (FOI) Act is withheld because the information is either (1) a trade secret; (2) would likely prejudice the commercial interests of any legal person. There is no time limit after which this information can be released, moreover, any consideration of its release would be made by consideration of whether the public interest in releasing outweighs any commercial harm that could be caused by its release. More information on Section 43 of the FOI Act is available from the Information Commissioner’s Office.


Written Question
World Health Organisation: Disease Control
Wednesday 28th June 2023

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, which (a) Government department and (b) Minister has responsibility for negotiations on (i) the World Health Organization Pandemic Preparedness Treaty and (ii) proposed amendments to the World Health Organization International Health Regulations (2005); and what recent assessment the Government has made of the potential effects of these measures.

Answered by Will Quince

The negotiations taking place at the World Health Organization (WHO) on the Pandemic Instrument are jointly led by the Department of Health and Social Care and the Foreign, Commonwealth, and Development Office. The negotiations taking place on the proposed amendments to the International Health Regulations 2005 (IHR) are being led by the Department of Health and Social Care. Myself and the Minister of State for Development and Africa, the Rt Hon Andrew Mitchell MP.

Both negotiations are Member State led and no text or amendments have been agreed yet for either instrument. The UK continues to negotiate the text of the Pandemic Instrument and the amendments to the IHR to ensure delivery of our priorities and provide the tools to achieve improvements globally in key areas of health emergency preparedness, prevention, and response. This could include promoting fast and open sharing of genetic sequencing data and pathogen samples; improving the implementation of the IHR; strengthening surveillance and detection of emerging diseases; strengthening health systems; increasing timeliness of emergency reporting; and promoting international collaboration on science and research.


Written Question
Coronavirus: Vaccination
Tuesday 27th June 2023

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, pursuant to the Answer of 13 June 2023 to Question 187960 on Coronavirus: Vaccination, if he will publish (a) the Medicines and Healthcare products Regulatory Agency's review of the study by Fraiman, J., et al., entitled Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults, published in the journal Vaccine on 22 September 2022 and (b) the latest information his Department holds on rates of serious adverse events associated with covid-19 vaccination.

Answered by Will Quince

No vaccine would be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) unless it meets our stringent standards of safety, quality and effectiveness.

The MHRA keep all available evidence under review including studies, published literature and data arising from the widespread use in the United Kingdom and globally including the article highlighted. The MHRA communicates safety advice based upon the totality of evidence rather than the strengths and limitations of individual data sources.

The MHRA position is that the benefits of these vaccines in preventing serious complications associated with COVID-19 continue to outweigh the known risks for the majority of individuals. A summary of the MHRA’s safety review is available at the following link:

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

The MHRA publishes a breakdown of reports received by seriousness on the Yellow Card website, however it is not possible to calculate seriousness rates from this data.


Written Question
Commission on Human Medicines
Tuesday 13th June 2023

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, when he plans to publish the minutes of the Commission on Human Medicines’ Expert Advisory Group meetings that took place between 1 March 2020 and 31 December 2020; and for what reason there has been a delay in publishing those minutes.

Answered by Will Quince

The summary minutes for the Commission on Human Medicines (CHM) and its Expert Advisory Group (EAG) for the period stated have been published and can be found at the following link:

https://app.box.com/s/jv487awvqzzsrdql0o34h9gg350ceyd4.

All published minutes for the CHM and its EAG are available at the following link:

https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership#summary-minutes.

The CHM also has an Expert Working Group (EWG). Minutes from meetings of EWGs are not published, but the Medicines and Healthcare products Regulatory Agency routinely publishes the minutes of the CHM where recommendations to the licensing authority are formally agreed.


Written Question
Coronavirus: Vaccination
Tuesday 13th June 2023

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, pursuant to the Answer of 23 May 2023 to Question 185548 on Coronavirus: Vaccination, whether he has made an assessment of the implications for his policies of that study’s finding on the Pfizer vaccine and the absolute risk increase of serious adverse events; and whether he has made a comparative assessment of (a) that study's and (b) the Medicines and Healthcare products Regulatory Agency's estimate of the number of serious adverse events associated with covid-19 vaccination.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

A vaccine will not be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) unless it meets stringent standards of safety, quality and effectiveness.

The MHRA continuously monitors safety during widespread use of a vaccine. As part of this monitoring role MHRA keeps all available evidence under review, including studies such as the one referenced, published literature and data on vaccine use in the United Kingdom and globally. The MHRA’s position is that the benefits of these vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known side effects in the majority of patients. A summary of side-effects reported to MHRA under their Yellow Card reporting system after vaccination with COVID vaccines is available at the following link:

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