FOI release

Freedom of Information request on detailed report of the vaccine injuries and deaths of the Bexsero vaccine since it came out in 2016 (FOI 21-364)

Published 28 June 2021

5th May 2021 FOI 21/364

Thank you for your Freedom of Information request dated 7 th April 2021, where you asked for information on the following:

• Please could you send me a detailed report of the vaccine injuries and deaths of the men b (Bexsero) vaccine since it came out in 2016.

Bexsero was introduced to the routine schedule in September 2015 and is offered as part of the routine vaccinations at 2 months, 4 months with a booster at 12 months of age. Please note that vaccinations on the routine schedule may also be given outside the schedule as the vaccines are also available privately.

Further to your request please find attached a Drug Analysis Print (DAP) for MenB (Bexsero). The DAP provides all spontaneous suspected adverse reactions which have been reported for this vaccine to the MHRA, via the Yellow Card scheme up to and including 14th April 2021. Please refer to the attached guidance sheet for further instructions on how to interpret the DAP.

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. The nature and number of these reports submitted to MHRA to date is not unexpected and give no cause for concern. Bexsero vaccine is expected to have important benefits in protecting children from meningococcal group B infection.

When considering the spontaneous Adverse Drug Reaction (ADR) 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 vaccines are given in the UK alone, and when any vaccine is administered to very large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms occur after use of a vaccine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the vaccine. 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. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest

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 this vaccine.

As with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA, including an assessment of post-mortem details if available, to consider whether the vaccine (or medicine) may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. The MHRA hold weekly signal meetings in which vaccine/drug-reaction combinations which meet defined criteria are assessed by a group of scientists, physicians and pharmacists to determine if risk-minimisation measures need to be implemented. Any emerging evidence relating to possible risks associated with vaccines and medicines, would be carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.

I hope the information provided is helpful. The MHRA encourages the use of Yellow Card data however wishes to ensure that the data is studied and applied appropriately, and any conclusions/interpretations take into account the above information. For this reason, if you wish to use this information for a publication, we request that you engage with the MHRA during this process and provide a copy of the report.

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