Freedom of Information request (FOI 22/1177)
Published 17 January 2024
© Crown copyright 2024
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-12-december-2022/freedom-of-information-request-foi-221177
FOI 22/1177
14th December 2022
Dear
Thank you for your recent FOI request received 7th December 2022, where you asked for the following:
“As I originally stated I’m not looking for a patient information leaflet (PIL) but a manufacturer’s package insert that includes post-marketing experience. However if the package insert is not available, please provide Vaccine Analysis Print (VAP) for the Boostrix-IPV as these contain all of the post marketing experience.”
Boostrix-IPV is administered as a routine childhood immunisation to patients aged three years four months old or soon after and to pregnant women from 16 weeks gestation. The full routine immunisation schedule is available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1055877/UKHSA-12155-routine-complete-immunisation-schedule_Feb2022.pdf.
Further to your request ,please find attached Vaccine Analysis Print (VAP) for Boostrix- IPV. Please note that this VAP relates 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. This VAP contains 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 this VAP.
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 a manufacturer’s package insert that includes post-marketing experience I can confirm that this information is present in the UK Summary of Product Characteristics (SPC). The UK SPC for Boostrix-IPV is available at https://www.medicines.org.uk/emc/product/5302/smpc with post-marketing data present in Table 3. I have also attached a copy of the SPC for your ease of reference.
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