FOI release

Freedom of Information request on . How many deaths have been recorded as a result of the measles, mumps and rubella virus infections between 2010 and 2021, specifically Priorix and M-M-RVAXPRO (FOI 22/050)

Published 31 May 2022

FOI 22/050

31st January 2022

Dear,

MMR Yellow Card Data

Thank you for your FOI request dated 10th January 2022, where you requested the following information:

1. How many deaths have been recorded as a result of the measles, mumps and rubella virus infections between 2010 and 2021?

2. How many deaths have been recorded as a result of the MMR vaccines, specifically Priorix and M-M-RVAXPRO, between 2010 and 2021?

3. Are there any long-term observations/studies (5 years or more) keeping track of the effects of the MMR vaccines post inoculations?

When considering the spontaneous Adverse Drug Reaction (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://products.mhra.gov.uk/for details on the possible side effects of the vaccine.

Concerning your first and second questions, I can confirm that the MHRA does not hold this information as this falls outside of our remit. We suggest you contact the Office for National Statistics via the following email address: info@ons.gov.uk.

Part of the monitoring role of the MHRA includes reviewing reports of suspected side effects. I can confirm that the MHRA has received 5 spontaneous UK suspected ADR reports where a fatal outcome was reported concerning administration of the M-M-RVAXPRO Measles, Mumps and Rubella (MMR) vaccine and 5 spontaneous UK suspected ADR reports concerning administration of the Priorix MMR vaccine between 01/01/2010 and 31/12/2021 (data extracted on 26/01/2021). The M-M-RVAXPRO and Priorix vaccines were first authorised in the UK on 04/12/1997 and 05/05/2006, respectively. As stated above, please note that a reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have.

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 10 mentioned fatal cases and vaccination with the MMR vaccine. Millions of children have received MMR vaccines since they were authorised and they are considered very safe for the vast majority of individuals.

It is important to note that in the UK, the MMR vaccine is 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

In relation to your final question about long term studies, this information is available in the public domain via the Oxford Vaccine Knowledge Project. A summary on studies involving MMR studies can be found on their website: https://vk.ovg.ox.ac.uk/vk/mmr-vaccine.

I hope that you will find this information useful.

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