Freedom of Information request on the Drug Analysis Print (DAP) for the Fluenz Tetra vaccine (FOI 21/1272)
Published 31 May 2022
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FOI 21/1272
6th December 2021
Dear,
Thank you for your email dated 30th November 2021, where you asked for Drug Analysis Print (DAP) for the Fluenz Tetra vaccine.
As per your request, please find attached a DAP for the vaccine requested above. This print contains information on all of the UK spontaneous suspected Adverse Drug Reaction (ADR) reports received through the Yellow Card scheme up to and including 30/09/2021. Please note that this data includes reports received for all brands of the vaccine as well as reports in which the brand name was not provided by the reporter. Please also 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:
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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.
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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 vaccine and may be stimulated by promotion and publicity about a particular vaccine. Reporting tends to be highest for newly introduced medicines or vaccines 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: MHRA Products - Home
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.
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