FOI release

Freedom of Information request on adverse reactions following the BCG vaccine and the COVID-19 vaccines (FOI 22/668)

Published 22 March 2023

FOI 22/668

25 May 2022

Dear

Thank you for your Freedom of Information (FOI) request dated 3rd May 2022 where you requested adverse reaction data on the BCG vaccine and also COVID-19 vaccines of all brands. In response to your query, please find attached a Vaccine Analysis Profile (VAP) for the BCG vaccine and directions to where the same information regarding COVID-19 vaccines can be found, as this is already published online.

When considering the attached analysis print, 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 vaccinations are given in the UK alone, and when any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or to compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced vaccines during the first one to two years on the market and then falls over time.

The MHRA continually 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. Any emerging evidence relating to possible risks associated with vaccines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.

Please find attached a VAP relating to the BCG vaccine. The VAP lists all UK spontaneously reported, suspected adverse reactions with the BCG vaccine up to and including 17/05/2022. The DAP will include all brands of the respective BCG vaccine in the data. Please refer to the attached information sheet for guidelines on how to interpret the VAP

Moreover, in relation to the data on the COVID-19 vaccines, a VAP for each brand of COVID-19 vaccine can be found within our coronavirus vaccine - weekly summary of Yellow Card reporting. Information can also be found here on our analysis of these Yellow Card reports.

As the data provided in the print does not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://products.mhra.gov.uk/for details on the recognised possible side effects of each vaccine.

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