FOI release

Freedom of Information request on the deaths reported following the hepatitis B vaccination (FOI 21/405)

Published 31 May 2022

FOI 21/405

24th February 2022

Dear

Thank you for your email dated 26th January 2022, where you asked:

• The data for the death rate following hepatitis B vaccination broken down between the methods/different brands/types of vaccinations.

Firstly, it may be helpful if I describe the role of the Medicines and Healthcare products Regulatory Agency (MHRA) and the work that we do. The MHRA is a government agency within the United Kingdom that has responsibility for the regulation of medicines and medical devices and is responsible for ensuring that medicines, vaccines, healthcare products and medical equipment are safe for those who use them. You have asked for the death rate following administration of the hepatitis B vaccination. I can confirm that we do not hold complete information on the total number of fatalities which could be associated with the hepatitis B vaccines, nor the total number of patients exposed to each vaccine. We therefore suggest you contact the Office for National Statistics (ONS) who may be able to help with this.

The MHRA does hold information on reports of Adverse Drug Reactions (ADRs) which are voluntarily submitted from patients, carers and healthcare professionals within the UK. These reports aid our work in ensuring that medicines, vaccines, healthcare products and medical equipment are safe for those who use them. I can confirm that the MHRA has received 5091 spontaneous suspected ADR reports associated with the hepatitis B vaccination, up to the 20th February 2022. Of the 5091 reports, 6 reports are associated with a fatality and no safety concerns have been raised in association with the hepatitis B vaccination. Moreover, please find attached Vaccine Analysis Prints (VAPs) for all UK spontaneous ADR reports received by the MHRA in association with the hepatitis B vaccine, this includes individual VAPs for the brands; Recombivax-HB, H-B-VAX and H-B-VAX II, Fendrix, HBVAXPRO and Engerix B and a VAP for ADR reports where the specific brand of hepatitis B vaccine has not been reported. These prints contain information on all the UK spontaneous ADR reports received through the Yellow Card scheme up to and including the 20th February 2022. Please note, as it is possible for one report to contain multiple ADRs, the number of ADRs is greater than the number of individual cases. Please find attached a VAP guidance sheet which provides you with further information on how to interpret the print.

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.

• 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.

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 each vaccine.

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. If appropriate, regulatory action would be taken if any serious risks were confirmed.

As with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA. To ensure the comprehensive assessment of fatal reports, we follow-up all fatalities where permission has been provided to do so for further information including certified cause of death and post mortem information (if conducted).

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