Freedom of Information request (FOI 22/1122)
Published 17 January 2024
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29th December 2022
FOI 22/1122
Dear
Thank you for your FOI request dated 14th November 2022, where you asked for information on the following:
“Please can I have the Yellow Card reports for the 2 different brands of MMR vaccine available in the UK. These are called Priorix and MMRVaxPro.”
Further to your request, please find attached Vaccine Analysis Prints (VAPs) for the products requested. Please note that these VAPs relate only to reports where the specific brand name has been provided by the reporter, brand names are not mandatory for Yellow Cards and are not always provided. These VAPs contain complete data for all UK spontaneous suspected adverse reactions, or side effects, including those which are associated with a fatal outcome. Please refer to the attached information sheet for guidelines on how to interpret these VAPs.
When considering the attached spontaneous ADR data, 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 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.
• Additionally, 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.
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 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.
As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://www.medicines.org.uk/emc/for details on the possible side effects of each vaccine.
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