FOI release

Freedom of Information request on whether Revaxis or Gardasil vaccines can cause Stevens-Johnson Syndrome (FOI 21/467)

Published 28 June 2021

24th May 2021 FOI 21/467 Dear

Thank you for your enquiry dated 23rd April 2021 where you asked for data on whether Revaxis or Gardasil vaccines can cause Stevens-Johnson Syndrome.

It may be helpful if I firstly describe the role of the Medicines and Healthcare products Regulatory Agency (MHRA) and the work that we do. The 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 is positive at the time of licensing and remains so thereafter.

As you may already be aware, information regarding each of these vaccines can be found in the Summary of Product Characteristics (SmPC) of each product, which can be found here: https://www.medicines.org.uk/emc/. Known possible side effects are listed in section 4.8 of the SmPC. Stevens-Johnson syndrome is not currently listed as a known possible side effect in the product information for either Gardasil, Gardasil 9 or Revaxis.

The Yellow Card scheme, which is run by the MHRA, is the UK program for collecting experiences of side effects from healthcare professionals and patients and is used to monitor the safety profile of all medicines, including those from prescriptions, over-the-counter or general retail sales. It is a voluntary scheme for healthcare professionals and members of the public; however, there is a legal requirement for pharmaceutical companies to report side effects that they have received to the scheme.

When considering spontaneous Yellow Card 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.

Up to 07/05/2021 the MHRA has not received any UK spontaneous suspected Adverse Drug Reaction (ADR) reports of Stevens-Johnson Syndrome with the Gardasil, Gardasil 9 or Revaxis vaccines.

Please be assured that the MHRA continuously monitors the safety of vaccines through a variety of pharmacovigilance processes, including the Yellow Card scheme. Should any important new safety issues be identified, appropriate regulatory action will be taken and communicated to healthcare professionals and patients alike.

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