FOI release

Freedom of Information request about COVID-19 vaccine adverse reactions (FOI-21-183)

Published 7 May 2021

8th March 2021 FOI 21/183

Dear

Thank you for your email.

More than 114,000 people across the UK have died within 28 days of a positive test for coronavirus (COVID-19). Rates of COVID-19 infection and hospitalisation remain high. Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19. A national immunisation campaign has been underway since early December 2020.

Two COVID-19 vaccines, Pfizer/BioNTech and Oxford University/AstraZeneca vaccines, are currently being used in the UK. Both have been authorised for supply by the Medicines and Healthcare products Regulatory Agency (MHRA) following a thorough review of safety, quality and efficacy information from clinical trials. In clinical trials, both vaccines showed very high levels of protection against symptomatic infections with COVID-19. We expect data to be available soon on the impact of the vaccination campaign in reducing infections and illness in the UK.

Please note that we have published ADR data and this is available to view at the following links of our website page below, please note this information will be published weekly moving forward: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting Since the start of the vaccine campaigns we have been working in close collaboration across the healthcare system to ensure healthcare professionals and patients are aware of the Yellow Card scheme and how they can report to us. Information on Yellow Card reporting has been included in NHS training materials, as well as the materials available to individuals both before and after vaccination. Both vaccinees and healthcare professionals are strongly encouraged to report any suspicion of a side effect to the MHRA. As with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA. We follow-up all fatalities where permission has been provided to do so for further information including post-mortem details if available. All details within a report are thoroughly assessed to consider whether the vaccine (or medicine) may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. Our review of individual reports and patterns of reporting does not suggest the vaccine played a role in the deaths reported. The MHRA is a regulatory body and receives money to licence marketing authorisations. It has not received any funding from organisations in relation to the production of the vaccine.

If you have a query about the information provided, 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: [email protected].

Due to the ongoing Covid-19 situation, 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 Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000