FOI release

Freedom of Information request on Adverse reaction data for flu vaccines and MMR vaccines from August 2020 to August 2021, as well as the number of vaccinations given (FOI 21/1266)

Published 31 May 2022

FOI 21/1266

22nd December 2021

Dear,

Thank you for your Freedom of Information (FOI) request dated 26th November 2021. Under the Freedom of Information (FOI) act, you have requested to be provided with the following:

  • • • Adverse reaction data for flu vaccines and MMR vaccines from August 2020 to August 2021, as well as the number of vaccinations given during the same time period.

The MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes including the Yellow Card Scheme. As part of our signal detection processes all adverse drug reaction (ADR) reports received by the Yellow Card Scheme are individually assessed and cumulative information reviewed at regular intervals. The Scheme relies on voluntary reporting of suspected ADRs by health professionals and patients and there is also a legal obligation for pharmaceutical companies to report ADRs for their products. Any emerging evidence relating to possible risks associated with vaccines and medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.

We have performed a search of any relevant cases we hold on our adverse reaction database. I can confirm that between 1 August 2020 and 31 July 2021 the MHRA have received 254 UK spontaneous suspected ADR reports associated with MMR vaccines, 212 UK spontaneous suspected ADR reports associated with live influenza vaccines and 1632 UK spontaneous suspected ADR reports associated with inactivated influenza vaccines and in total. Please find attached A Vaccine Analysis Print (VAP) for the MMR vaccines, live and inactivated influenza vaccines. Please refer to the information sheet for guidance on how to interpret the analysis prints.

To note, the inactivated influenza vaccine is the injectable influenza vaccine usually given to individuals aged 65 years of age or older, and the live influenza vaccine is the nasal vaccine given to eligible paediatric groups. Both are present on the routine immunisation schedule.

When considering the vaccine analysis prints, it is important to be aware of the following points:

  • • A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. Each year, millions of doses of routine vaccines are given in the UK alone, and when any vaccine is administered to very large numbers of people,