FOI release

Freedom of Information request on deaths following HPV vaccination (FOI 21/656)

Published 29 December 2021

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-5-july-2021/freedom-of-information-request-on-deaths-following-hpv-vaccination-foi-21656

6th July 2021

FOI 21/656

Dear

Thank you for your recent correspondence dated on 11th June 2021, where you asked for information on the following:

  1. The number of deaths, in England, whereby the HPV vaccine was recorded as the cause of death for the periods 2018/19, 2019/20 and 2020/21
  2. The number of adverse reactions (combined) recorded as being as a result of the HPV vaccine for the periods 2018/19, 2019/2020 and 2020/21
  3. The combined total cost (£s), of HPV vaccine damage payments made within the periods 2018/19, 2019/20 and 2020/21

In regards to point 1, unfortunately the MHRA does not hold information on certified cause of death and we therefore cannot provide information on the number of times any medicine or vaccine has been recorded as such. The Yellow Card scheme accepts all reports of suspected adverse reactions to medicines and vaccines, including where a patient may have died, even if this suspicion is not recorded on the death certificate.

In response to point 2 of your request, please find attached the Drug Analysis Prints (DAPs) for the HPV vaccines over the requested time periods. These reports contain information on all the UK spontaneous ADR reports received including those with a fatal outcome. Please also find attached a DAP 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.

  • 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://www.medicines.org.uk/emc/ for details on the possible side effects of each vaccine.

Further to point 3 of your request, the MHRA also has no involvement in the vaccine compensation scheme and holds no information on any compensation paid to claimants or whether claimants have reported their suspected adverse reactions to the Yellow Card scheme. The vaccine compensation scheme is run by the Department for Work and Pensions, information on how make a Freedom on Information request can be found on their website

https://www.gov.uk/government/organisations/department-for-work-pensions%20

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.

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

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