FOI release

Freedom of Information request on Yellow Card reports for the Flublok Quadrivalent vaccine (FOI 21/794)

Published 29 December 2021

22nd July 2021 FOI 21/794

Dear

Thank you for your email dated 2nd July 2021, where you asked for a summary of Yellow Card reports for the Flublok Quadrivalent vaccine.

Interactive Drug Analysis Profiles (iDAPs) are available on the Yellow Card website. Each iDAP contains complete data for all spontaneous suspected adverse drug reactions, or side effects, which have been reported on that drug substance to the MHRA, via the Yellow Card scheme from healthcare professionals and members of the public. They also include reports from pharmaceutical companies. iDAPs provided on this website are regularly updated. There is a time lag of around one month from receipt of a report to it appearing in the iDAP. Information regarding suspected adverse reactions to vaccines is not currently available via the iDAPs but is available upon request.

As per your request, please find attached a Product Analysis Print (PAP) for the Flublok Quadrivalent influenza vaccine. The print contains information on all the UK spontaneous Adverse Drug Reaction (ADR) reports received through the Yellow Card scheme up until the 09/07/2021. Please also find attached a PAP 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.

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 for details on the possible side effects of the Flublok 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