FOI release

Freedom of Information request on a summary of Yellow Card reports for the Flublok Quadrivalent vaccine and COVID-19 vaccines (FOI 21-808)

Published 27 April 2022

5th August 2021 FOI 21/808

Dear

Thank you for your email dated 6th July 2021, where you asked for a summary of Yellow Card reports for the Flublok Quadrivalent vaccine and COVID-19 vaccines.

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.

For COVID-19 vaccinations we are proactively publishing details of adverse drug reactions received, including MHRA assessment of the data to provide context. This can be accessed using the link below: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

The MHRA intends to publish all suspected reactions reported in association with available COVID-19 vaccines in an interactive format as iDAPs, along with our ADR summary that is published each week. The use of iDAPs will enable users to view the data by categories of their choice such as age, sex and seriousness of reports. Users will also be able to download the data tables in CSV format. As we plan to publish the data, we consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is therefore exempt from disclosure.

Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and accept it should not be withheld however wish to publish this information alongside appropriate context and assessment.

We will send you a link to the iDAPs once they are published.

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