Freedom of Information request on data pertaining to reported reactions and deaths for childhood immunisations based on ethnicity for the last 10 years (FOI 21/1186)
Published 26 May 2022
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FOI 21/1186
25th November 2021
Dear,
Thank you for your email dated 3rd November 2021, where you asked for information on the following:
o all available data pertaining to reported reactions and deaths for childhood immunisations.
o data set on reported reactions from childhood immunisations based on ethnicity for the last 10 years.
Please find attached a Drug Analysis Print (DAP) for each of the vaccines currently on the routine childhood vaccination schedule (as per January 2020), https://www.gov.uk/government/publications/the-complete-routine-immunisation-schedule. The prints contain information on all the UK spontaneous Adverse Drug Reaction (ADR) reports received through the Yellow Card scheme up to and including 09/11/2021. The attached DAP guidance sheet provides you with further information on how to interpret the print.
The tables attached show the total number of reports received for each vaccine over the last 10 years (09/11/2011 – 09/11/2021 inclusive), broken down by patient ethnicity. Please be aware that it is not mandatory to provide the patient ethnicity when submitting a Yellow Card report to the MHRA.
When considering the attached spontaneous 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 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 medicine, 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.
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