FOI release

Freedom of Information request on the summary of suspected adverse events for all COVID-19 vaccinations (FOI 21-629)

Published 29 December 2021

2nd July 2021 FOI 21/629

Dear

Thank you for your email dated 5th June 2021, please accept our apologies that your initial correspondence was not received; Agency email addresses were updated to end @mhra.gov.uk in 2017, and after a period of parallel running the old suffixes are no longer active.

Further to your request I can confirm our summary of suspected adverse events for all vaccinations was postponed to October given the circumstances and need to focus on pandemic-related activities. We will be able to release the report in line with usual practise following this meeting.

As you will be aware, the MHRA continuously monitors the safety of all vaccines through a variety of pharmacovigilance processes including the Yellow Card Scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card Scheme are individually assessed and cumulative information reviewed at regular intervals. If appropriate, regulatory action would be taken if any serious risks were confirmed.

I hope the information provided is helpful, but 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 of this response; and can be addressed to this email address.

Yours sincerely, FOI Team, Vigilance and Risk Management of Medicines Division