FOI release

Freedom of Information request (FOI 22/1091)

Published 17 January 2024

29th November 2022

FOI 22/1091

Dear,

Thank you for contacting the MHRA on 03/11/2022 to request a Vaccine Analysis Print for the DTaP IPV vaccine when given to pregnant women.

The MHRA undertook a large epidemiological study to proactively monitor the safety of pertussis vaccine in pregnancy which is published here:

https://www.bmj.com/content/349/bmj.g4219. Our analysis found no evidence of any risks to pregnancy. Rates of normal, healthy births, as well as any adverse outcomes, were similar to those seen in unvaccinated women.

Aside from our epidemiological study, we also continue to evaluate reports of suspected adverse reactions submitted Yellow Card scheme, as we do for all medicines and vaccines. We encourage such reporting to ensure we can continually appraise the safety of vaccines and medicines. In addition to the reassuring results from the epidemiological study mentioned above, we have not identified any safety concerns in relation to the administration of the pertussis vaccine in pregnancy from the Yellow Card reports received to date.

The following link will give you more information on pertussis vaccine use in Pregnancy. The link will direct you to the Public Health England website where you will find a factsheet and a leaflet: https://www.gov.uk/government/publications/resources-to-support-whooping-cough-vaccination

Please find attached a Vaccine Analysis Print containing a complete list of all UK spontaneous suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme up to 11/11/2022 for the DTaP IPV vaccine in which it is specified in the report that the recipient was a pregnant woman. This includes cases reporting suspected adverse events experienced by the woman who was vaccinated and those in which suspected adverse events occurred in the woman’s foetus or baby that was exposed to the vaccine while in utero. I have also provided an interpretation guide to help you to understand the data provided.

When considering 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 been. 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 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.

Yours sincerely,

FOI Team

Patient Safety Monitoring