FOI release

Freedom of Information request on all new approved vaccines in the UK and the adverse reactions reported (FOI 21/1063)

Published 27 April 2022

8th October 2021

FOI 21/1063

Dear

Thank you for your latest email dated 13th September 2021, where you requested a list of all new vaccines approved for use in the UK, the number of vaccine deaths, per vaccine, per month for each year from 2000 to 2010 and 2021.

As per your request, please find attached the list of marketing authorisations granted by the MHRA for new vaccines from 2000 to 2010 and 2021. Table 1 shows a total of 23 new vaccines and Table 2 a total of 3 vaccines that were granted authorisation, along with the authorisation holder company name, the date of granting and authorisation number, of each vaccine. Further to your request, regarding the number of vaccine deaths, per vaccine, per month for each year from 2000 to 2010, I would like to kindly direct you to the enclosed Drug Analysis Prints (DAPs) for the vaccines listed in Table 1. The DAPs include details of all UK spontaneous suspected adverse reactions reported to the MHRA up until the data lock point of 30/09/2021. Please refer to the information sheet for guidance on how to interpret the DAPs. Please note that we do not have any Adverse Drug Reaction (ADR) reports regarding BCG VACCINE SSI. Data regarding the vaccines approved within 2021 (listed in Table 2) is available publicly via the MHRA website: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting#annex-1-vaccine-analysis-print

Details of FOI 21/590 have also been attached as per your request, providing data regarding the number of vaccine deaths, per vaccine, per month for each year from 2010 to 2020. In line with GDPR, the enquirer’s details have been redacted.

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.

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 each vaccine. In addition, you can also find the product information for the COVID-19 vaccines, which includes information relating to the composition of the individual vaccines and associated listed side-effects available on the Yellow Card Coronavirus website.

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. Vaccines encompass a wide variety of products with different indications, different ingredients, and different mechanisms of action and as such safety for each vaccine is considered individually rather than as a group.

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