Freedom of Information request on Yellow Card data for Infanrix Hexa (FOI 21/654)
Published 29 December 2021
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8th July 2021
FOI 21/654
Dear
Thank you for your email where you asked for Yellow Card data for infanrix hexa.
To clarify we collect Yellow Card reports based on the active substance of a medicine or a vaccine, however reports can also be submitted on a specific brand and these will be linked to the active substance in our drugs dictionary.
Further to your request please find attached the relevant Drug Analysis Print for DTPa IPV HiB HepB. This contains information on all the UK spontaneous Adverse Drug Reaction (ADR) reports received until 31/01/2021. 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 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.
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 individually assessed and cumulative information reviewed at regular intervals. If appropriate, regulatory action would be taken if any serious risks were confirmed.
As these data do 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 possible side effects of each 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.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division