Freedom of information request about yellow card reports for meningitis acwy and diphtheria, tetanus and polio vaccinations (foi-21-168)

* Medicines & Healthcare products Regulatory Agency FOI release FREEDOM OF INFORMATION REQUEST ABOUT YELLOW CARD REPORTS FOR MENINGITIS ACWY AND DIPHTHERIA, TETANUS AND POLIO

VACCINATIONS (FOI-21-168) Published 7 May 2021 © Crown copyright 2021 This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view

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https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-8-march-2021/freedom-of-information-request-about-yellow-card-reports-for-meningitis-acwy-and-diphtheria-tetanus-and-polio-vaccinations-foi-21-168

9th March 2021 Dear , FOI 21/168 Thank you for your FOI request dated 8th February 2021, where you requested the following information: “Data on Yellow Card reports for meningitis ACWY and

diphtheria, tetanus and polio vaccinations. Please include details of the side effects and fatalities” When considering the spontaneous Adverse Drug Reaction (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 routine vaccines are given in the UK alone, and when any vaccine is administered to very large numbers of people, some recipients will inevitably experience illness following

vaccination. The fact that symptoms or events occur after use of a vaccine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by

the vaccine. 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. 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. 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 the vaccine. I can confirm that the MHRA has received

1841 spontaneous UK suspected adverse drug reaction (ADR) reports concerning administration of the meningococcal A,C,W135,Y vaccine, and 2195 spontaneous UK suspected ADR reports of the

tetanus, diphtheria and polio (Td/IPV) vaccine up to and including 4th March 2021. A full list of reported adverse reactions and associated fatal outcomes is provided in the attached Drug

Analysis Prints (DAPs) for each of the vaccines. Please refer to the enclosed information sheet for guidelines on how to interpret the DAPs. 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. 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. 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 Back to top