Freedom of Information request on adverse reactions following the MMR vaccinations (FOI 21/1030) - GOV.UK

30th September 2021

FOI 21/1030

Dear

Thank you for your Freedom of Information (FOI) request dated 7th September 2021.

Under the Freedom of Information (FOI) act, you have requested to be provided with the following:

• Information on Yellow Card reports if any from the last year (2019-2020) from both brands of the MMR. How many vaccines versus reports of reactions and what type/symptoms of reaction.

When considering the Vaccine Analysis Print, 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 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 and therefore cannot be used to determine the incidence of a reaction. 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. For these reasons the enclosed data should not be used as a basis for determining incidence of side effects.

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 drug reaction (ADR) reports received by the Yellow Card Scheme are individually assessed and cumulative information reviewed at regular intervals. The Scheme relies on voluntary reporting of suspected ADRs by health professionals and patients and there is also a legal obligation for pharmaceutical companies to report ADRs for their products. 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.

We have performed a search of any relevant cases we hold on our adverse reaction database. I can confirm the MHRA have received 71 UK spontaneous suspected ADR reports associated with M-M-RVAXPRO and 46 UK spontaneous suspected ADR reports associated with Priorix in total. Please find attached both a Product Analysis Print (PAP) for M-M-RVAXPRO and a PAP for Priorix vaccine. The print includes details of all UK spontaneous suspected adverse reactions reported to the MHRA between 01/01/2019 and 31/12/2020. Please refer to the information sheet for guidance on how to interpret the PAP.

The PAPs should not be used to compare the safety profile of the two vaccines. As mentioned above, reporting rates of ADRs are influenced by many factors and the data should not be used as a basis for determining incidence of side effects. Furthermore, this data does not 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 each vaccine.

In regards to your question on the total number of vaccines administered, I can confirm the MHRA do not hold this data. This information can be requested from Public Health England (PHE).

I hope this information is useful to you and thank you again for getting in touch with us.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division