FOI release

Freedom of Information request the reported side effects of the Human Papilloma virus (HPV) vaccine since it was introduced in the UK in 2008 to the latest available date ( FOI 21/1254)

Published 31 May 2022

FOI 21/1254

16th December 2021

Dear,

Thank you for your recent correspondence dated the 17th November and the 23rd November 2021. These have both been combined to create the above reference number. You requested the following information under the Freedom of Information (FOI) act:

• • Information on the reported side effects of the Human Papilloma virus (HPV) vaccine since it was introduced in the UK in 2008 to the latest available date.
• • The side effects table for Gardasil 9
• • To understand the classification of these reported side effects by type into serious ones and not.
• • The information on http://timeforaction.org.uk/ has a graph stating the source as MHRA. Is the information correct and was this put together by MHRA or someone from this organisation who has used MHRA data.

To provide some background, the Medicines and Healthcare products Regulatory Agency (MHRA) is a government agency that has responsibility for the regulation of medicines and medical devices and approves the content of information that is available on the safe use of the product. 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.

On the advice of the Joint Committee on Vaccination and Immunisation (JCVI), a HPV national vaccination programme was introduced in 2008 to protect secondary school Year 8 girls (aged 12 to 13 years old) against cervical cancer. At that time, a catch-up programme also took place to vaccinate girls aged 13 to 18 years old. Since September 2008 the human papillomavirus (HPV) vaccine Cervarix was being used extensively in the UK routine HPV immunisation programme, however, Gardasil has been the HPV vaccine used in the NHS vaccination programme since 2012. Sometime during the 2021 to 2022 academic year, the HPV vaccine used in the NHS programme will switch to Gardasil 9, where previously Gardasil and Gardasil 9 had only been available privately. More information on this can be found on the NHS website, https://www.nhs.uk/conditions/vaccinations/hpv-vaccine-cervarix-gardasil-safety/.

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, please find attached a Vaccine Analysis Print (VAP) for each of the HPV vaccines- Gardasil 9, Gardasil, Cervarix and one where the brand of HPV vaccine was not reported. The prints list all UK spontaneously reported ADRs for each HPV vaccine on the MHRA database up to and including 9/12/2021. Overall, the MHRA have received 191 reports for the Gardasil 9 Vaccine, 2462 reports for the Gardasil Vaccine, 6340 reports for the Cervarix vaccine, and 901 reports for where the brand of the HPV vaccine was not reported. Please also find attached a guidance sheet which provides you with further information on how to interpret the prints.

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 this 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 Product Characteristics (SmPC) for healthcare professionals and Patient Information Leaflet (PIL) which is provided with every medicine and vaccine, can be found here https://products.mhra.gov.uk/. Within the product information, you will find information about the vaccine including the known possible side effects. However, it is important to note that it does not necessarily mean all patients will suffer from the potential side effects listed. Like with all vaccines, unfortunately it is not possible to predict who will experience a side effect to a vaccination prior to use.

Regarding your third question, the seriousness of a report in our database is determined according to two criteria. Firstly, whether the reporter considered the report to be serious via the seriousness criterion available on the Yellow Card form for both healthcare professionals and patients. These categories can be selected by the reporter at the time of reporting. Secondly, seriousness can be determined by the reported reaction terms and how it is defined in our medical dictionary. Therefore, an ADR report can be serious because the reporter considers the reaction to be serious or because the reaction term itself is considered serious in our medical dictionary.

With regards to your fourth question about the graph on the website link you kindly provided, I can confirm that this graph was not produced by the MHRA. The graph has been generated from an interpretation of data pertaining to suspected ADR reports for HPV and all other vaccinations which was provided in a previous FOI request. The graph does not contain all the information provided in the original FOI response and combines data where it may not be appropriate to do so. It is not possible to draw conclusions from the comparison of the HPV vaccine with other vaccination programmes. There are a number of factors that can lead to variable reporting from one vaccine to another as mentioned earlier in this response. For these reasons the MHRA would not consider the graph to be an accurate reflection of the data held on the MHRA database.

Please be assured that the safety of all vaccines is of paramount importance and under constant review.

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 this response’s date and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division