Freedom of Information request on Drug Analysis Print (DAP) for the quadrivalent influenza vaccine (QIV) and trivalent influenza vaccine (TIV) (FOI 21/864)
Published 20 January 2022
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19th August 2021
FOI 21/864
Dear
Thank you for your email dated 21st July 2021, where you requested a Drug Analysis Print (DAP) for the quadrivalent influenza vaccine (QIV) and trivalent influenza vaccine (TIV), specifically for adverse skin reactions.
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 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.
As per your request, I would like to kindly direct you to the enclosed DAPs for both live and inactivated versions of QIV and TIV vaccines. The prints contain information on all UK spontaneous suspected Adverse Drug Reaction (ADR) reports received through the Yellow Card scheme for the time period up to and including 09/08/2021. Please also find attached a DAP guidance sheet which provides you with further information on how to interpret the print.
The data is divided into two groups; ADR reports following the administration of the live attenuated influenza vaccines (LAIVs) and ADR reports following the inactivated flu vaccines. These are the main two flu vaccine groups; the LAIVs are mostly given to children, and the inactivated flu vaccines are typically administered to adults, especially the elderly. Further to your request, regarding the number of adverse skin reactions, you can find this within the DAPs under the Reaction Name “Skin disorders”. Please find below the summary in Table 1, for the total number of reports of skin disorder reactions in association with requested vaccines, in both live and inactivated versions.
Table 1 – Total number of skin disorder reports for live and inactivated versions of the QIV and TIV vaccines
| Version of Vaccine | Quadrivalent influenza vaccine | Trivalent influenza vaccine |
|---|---|---|
| Live | 906 | n/a |
| Inactivated | 1142 | 444 |
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 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: https://products.mhra.gov.uk/ for details on the possible side effects of each influenza 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