Freedom of Information request on interactive Drug Analysis Profile (iDAPs) for vaccinations (FOI 21-608)
Published 13 August 2021
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23rd June 2021 FOI 21/608
Dear
Thank you for your Freedom of Information (FOI) request where you requested information about interactive Drug Analysis Profile (iDAPs) for vaccinations.
Drug Analysis Prints (DAPs) are not currently provided on the website for vaccines but are available on request. Therefore, please find attached the DAP relating to the Hepatitis B vaccine, which list all reported, suspected reactions associated with Hepatitis B vaccines up to and including 20/06/2021. Please refer to the attached information sheet for guidelines on how to interpret the DAP. When considering the attached DAP, 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. The fact that symptoms occur after the administration 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 vaccines during the first one to two years on the market and then falls over time. Any emerging evidence relating to possible risks associated with vaccines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.
As the data provided in the print 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 recognised possible side effects.
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