FOI release

Freedom of Information request on the records of injuries and deaths by the Human Papilloma Virus (HPV) vaccines (all used brands in the UK) for the past 15 years (FOI 22/480)

Published 1 June 2022

FOI 22/480

18th March 2022

Dear

Thank you for your email dated 18th February 2022, where you asked for information on the following:

‘I wish to see the records of injuries and deaths by the Human Papilloma Virus (HPV) vaccines (all used brands in the UK) for the past 15 years’.

As you may be aware, the Medicines and Healthcare products Regulatory Agency (MHRA) is a government agency that has responsibility for the regulation of medicines and medical devices. The MHRA, together with independent expert advice from the Commission on Human Medicines (CHM), is responsible for ensuring that the overall balance of benefits in terms of effectiveness, and risks of medicines and vaccines is positive at the time of licensing and remains so thereafter.

One of the ways the MHRA monitors the safety of the HPV vaccine is via reports of suspected adverse drug reactions (ADR) to the Yellow Card Scheme. Further to your request, I can confirm that the MHRA has received 9909 UK spontaneous suspected ADR reports associated with the HPV vaccine, from the 18th February 2007 up to the 18th February 2022. This includes eight reports stating a fatal outcome. These reports have been reviewed in detail and based on the information provided, a link between the HPV vaccine and the patient’s death is not suspected. Please see the attached Vaccine Analysis Print (VAP) which list all UK spontaneously reported reactions for the HPV vaccine on the MHRA database. Please also find attached a guidance sheet which provides you with 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 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.

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 assessed and cumulative information reviewed at regular intervals. If appropriate, regulatory action would be taken if any new risks are identified. The safety evaluation of the HPV vaccine has been continuously monitored, the MHRA also published the UK safety experience of the first 4 years of the HPV vaccination programme.

As the data does not necessarily refer to proven side effects of the vaccine, the prints should not be interpreted as a list of known side effects. The product information, including the Summary of medicinal Products Characteristics (SmPC) and the Patient Information Leaflet (PIL) will contain details on the recognised possible side effects of each vaccine.

The product information for the HPV vaccines currently in use in the UK can be found via the following link, MHRA Products Substance

Please be reassured that the safety of all vaccines is of paramount importance and under constant review. We encourage everyone to report suspected adverse reactions to the scheme and patient safety is our highest priority.

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

The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information.

For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information

If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, 4-T, Medicines and Healthcare products Regulatory Agency, (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Copyright notice

The information supplied in response to your request is the copyright of MHRA and/or a third party or parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder