FOI release

Freedom of Information request on yellow card report data for COVID-19 vaccines (FOI 22/679)

Published 27 March 2023

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-6-june-2022/freedom-of-information-request-on-yellow-card-report-data-for-covid-19-vaccines-foi-22679

FOI 22/679

8th June 2022

Dear

Thank you for your email dated 9th May 2022 where you requested the following:

“”Information regarding suspected adverse reactions to vaccines is not currently available via the iDAPs but is available upon request”. Therefore, I would like to request this information for the following vaccinations…6 in one, MenB, MMR and Hib/MenB.”

The MHRA continuously monitors the safety of medicines and 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 and medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.

When considering the data provided within this response, 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. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. 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 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 medicines during the first one to two years on the market and then falls over time. For these reasons the enclosed data should not be used as a basis for determining incidence of side effects.

Further to your request, please find attached a Vaccine Analysis Print (VAP) for the following vaccines:

  1. Diphtheria, tetanus, pertussis, polio, haemophilus influenzae type b (Hib) and hepatitis B (6 in 1) vaccine

  2. Meningococcal group B (MenB) vaccine

  3. Measles, mumps, and rubella (MMR) vaccine

  4. Hib and Meningitis C (Hib/MenC) vaccine

Each VAP lists all suspected adverse reactions reported from UK spontaneous reports received through the Yellow Card scheme for that vaccine up to and including 31/05/2022. Please refer to the enclosed information sheet for guidelines on how to interpret the VAPs. Please note that the attached VAPs contain ADR reports for each brand of vaccine available as well as reports in which the brand of the vaccine was not provided.

Unfortunately, we are unable to provide the VAP for the requested Hib/MenB vaccine, as this combination vaccine is not available in the UK. Immunisation against Hib is available via the 6-in-1 and booster Hib/MenC (meningitis C) vaccines and immunisation against meningococcal group B is available via the single MenB vaccine. You can find more information on the routine vaccinations in the UK here. We have included the VAP for the Hib/MenC vaccines in case you intended to request for the Hib/MenC instead of Hib/MenB.

As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: MHRA Products - Home for details on the possible side effects of the vaccines.

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

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