FOI release

Freedom of Information request on the regulatory approval of vaccinations (FOI 22/054)

Published 31 May 2022

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FOI 22/054

10th February 2022

Dear

Thank you for your email.

Regarding the following questions:

  1. Which person or persons within your department was responsible for authorizing each and all the injections, referred to as vaccines

  2. Which person or persons within your department was responsible for studying the results of each and all the vaccine manufactures clinical studies that resulted in the use of these injections being authorized

  3. Which person or persons within your department is responsible for the monitoring of each and all these injections, referred to as vaccines.

  4. Who in your department extracted samples and examined these injections

  5. Who is the supervisor responsible for overseeing the whole procedure of authorization of these injections

We do not give out names of MHRA employees, this information in exempt under Section 40 (2) (Personal information) of the FOI Act. Further Section 38 also applies (Health and Safety) in this instance, as the naming of MHRA employees may result in those persons receiving harassment and physical/mental harm.

  1. What has been the criteria in the past as to when a medical treatment was halted due to death and injury by that medical treatment

  2. What has your department set the number of deaths and adverse effects from these injections, referred to as vaccines, as the criteria for the halting of injecting

The Medicines and Healthcare products Regulatory Agency’s (MHRA’s) role is to continually monitor safety during widespread use of a vaccine. We have in place a proactive strategy to do this. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects.

Part of our monitoring role includes reviewing reports of suspected side effects. Any member of the public or health professional can submit suspected side effects through the Yellow Card scheme. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated (over 130 million COVID-19 vaccines have been given in the UK alone to date), including elderly people and people who have underlying illness. We regularly review safety information from the COVID-19 vaccine manufacturers and are in regular contact with other regulators across the world to exchange safety data on the COVID-19 vaccines. This is considered in our assessments alongside the UK data.

Information about our analysis of safety data regarding COVID-19 vaccines is published in our weekly summary of COVID-19 vaccine Yellow Card reports which is available at: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting.

Please be assured that the MHRA continues to closely monitor the safety of the COVID-19 vaccines used in the UK.

If you have any queries, please reply to this email.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Due to the ongoing pandemic, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

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