FOI release

Freedom of Information request on adverse reactions to Priorix MMR and DTaP/IPV Repevax vaccines (FOI 21/636)

Published 29 December 2021

5th July 2021

FOI 21/636

Dear

Thank you for your FOI request dated 7th June 2021, where you requested the following information:

I am interested to learn more on suspected vaccine reactions to the following:- MMR (second dose) brand name Priorix and DTaP/IPV Repevax brand.

Further to your request, I can confirm that the MHRA has received 529 spontaneous UK suspected Adverse Drug Reaction (ADR) reports concerning administration of the Priorix Measles, Mumps and Rubella (MMR) vaccine and 1,007 spontaneous UK suspected ADR reports concerning administration of the dTaP/IPV Repevax vaccine up to and including 24/06/2021 (data extracted on 25/06/2021). Please see the drug analysis prints (DAPs) attached for a breakdown of the reported reactions. Please also refer to the enclosed information sheet for guidelines on how to interpret the DAPs.

When considering the 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 routine vaccines are given in the UK alone, and when any vaccine is administered to very large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms or events occur after use of a vaccine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the vaccine. 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. Therefore, Yellow Card data cannot be used to determine the incidence of a reaction or to compare the side effect profiles of different medicines or vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, 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.

Any emerging evidence relating to possible risks associated with vaccines and medicines, is carefully reviewed and, 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 the vaccine.

Please note that we do not request the reporter to inform us whether the suspect drug is the first dose or a booster dose of the vaccination, therefore it is not possible to provide the data for the first and second dose of the Priorix vaccine separately. The data provided relates to all reports of Priorix, irrespective of dose. Additionally, the data provided relates to all ADR reports received for the Priorix and Repevax vaccines.

It is also important to note that in the UK, the MMR vaccine and dTaP/IPV vaccines are given alongside other vaccines as part of the routine childhood immunisation schedule. Details of the current UK immunisation schedule can be found here: https://www.gov.uk/government/publications/the-complete-routine-immunisation-schedule.

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. Please note that there has been no causal association established between the fatal reports and vaccination with the MMR vaccine or dTaP/IPV vaccine.

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