FOI release

Freedom of Information request about pregnancy vaccination adverse reactions (FOI-21-177)

Published 7 May 2021

Our Ref: FOI 21/177 Dear, Thank you for your email dated 11th February2021, where you asked for information on the following: Any and all information you hold on the reported adverse effects of any of the routine pregnancy vaccinations-including seasonal influenza and whooping cough vaccines, including spontaneous abortion.

There are currently only two routine pregnancy vaccinations that are available, according to the current Routine Immunisation Schedule, which can be found here: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/899423/PHE_Complete_Immunisation_Schedule_Jun2020_05.pdf , both of which you referenced in your email. Please find attached Drug Analysis Prints(DAP)for the injectable influenza vaccine(seasonal influenza)and the dTaP/IPV vaccine (the pertussis-containing vaccine also known as the whooping cough vaccine, which also protects against polio, diphtheria and tetanus).The prints contain a list of all the UK spontaneous Adverse Drug Reaction (ADR) reports received in association with pregnancy and the influenza vaccine and the dTaP/IPV vaccine up to and including 22/02/2021.Please also find attached a guidance sheet which provides you with further information on how to interpret the prints.

When considering the attached 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. 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.

I can confirm that the MHRA have received 43UK spontaneous suspected ADR reports of the influenza vaccine in association with spontaneous abortion, 2 of foetal death and 9 of stillbirth. We have received1UK spontaneous suspected ADR report of the dTaP/IPV vaccine in association with spontaneous abortion, 4 of foetal death and 11 of still birth. This number of reports is well within the number expected to occur naturally given the number of women vaccinated over time. Millions of pregnant women have received these two vaccines, in the UK and globally and no associations with any adverse pregnancy or infant outcomes have been identified.

Following the introduction of the pertussis vaccination in pregnancy programme in 2012, 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.

As this data does not necessarily refer to proven side effects, reference to the product information, including the Summary of Product Characteristics (SmPC)for healthcare professionals and the Patient Information Leaflet(PIL), can be found here https://products.mhra.gov.uk/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, Vigilance and Risk Management of Medicines Division