Freedom of Information request on the number of adverse drug reaction (ADR) reports received for the BCG vaccine between the years 1997 - 2003 ( FOI 21/1248)
Published 31 May 2022
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FOI 21/1248
14th December 2021
Dear,
Thank you for your email dated 20th November, where you asked for the number of adverse drug reaction (ADR) reports received for the BCG vaccine between the years 1997 - 2003
Please find attached a Drug Analysis Print (DAP) for the BCG vaccine. The print contains information on all the UK spontaneous ADR reports received through the Yellow Card scheme from 01/01/1997 up to and including 31/12/2003. During this period, we received a total of 827 spontaneous UK Yellow Card reports associated with the BCG vaccine. Please note, as it is possible for one report to contain multiple ADRs, the number of ADRs is greater than the number of individual cases. Please find attached a DAP guidance sheet which provides you with further information on how to interpret the print.
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. Vaccines encompass a wide variety of products with different indications, different ingredients, and different mechanisms of action and as such safety for each vaccine is considered individually rather than as a group. If appropriate, regulatory action would be taken if any serious risks were confirmed.
As the data does 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