Freedom of Information request (FOI 22/1107)
Published 17 January 2024
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FOI 22/1107
2nd December 2022
Dear
Thank you for your recent FOI requests in November 2022, where you asked for information on the following:
“Vaccine Analysis Print (VAP) for Vaxelis, Nimenrix, Revaxis, Rotarix , Priorix, Menitorix, MMRvaxPro, Prevenar 13, Infanrix Hexa, Gardasil and Bexsero.”
“I am requesting a package insert of Boostrix-IPV, diphtheria, tetanus, pertussis and polio vaccine (dTaP/IPV) manufactured by GlaxoSmithKline UK. More specifically, I would like to know about postmarketing experience. I’m not looking for patient information leaflet (PIL)”
Further to your request, please find attached Vaccine Analysis Prints (VAPs) for the products requested. Please note that these VAPs relate only to reports where the specific brand name has been provided by the reporter, brand names are not mandatory for Yellow Cards and are not always provided. These VAPs contain complete data for all UK spontaneous suspected adverse reactions, or side effects, including those which are associated with a fatal outcome. Please refer to the attached information sheet for guidelines on how to interpret these VAPs.
When considering the attached spontaneous ADR 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 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. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
• Additionally, 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.
With regards to your request for the package insert, I can confirm that the leaflet within the packet is known as the Patient Information Leaflet (PIL). However, this information is also provided in the Summary of Product Characteristics (SPC) which is used by healthcare professionals in the UK. The SPC in section 4.8 lists both undesirable effects and information on post marketing experience, these can be found on the MHRA website.
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