FOI release

Freedom of Information request on 61 Adverse Drug Reaction (ADR) reports with the meningococcal group B (MenB) vaccine

Published 28 May 2021

28th April 2021 FOI 21/406 Dear

Thank you for your follow-up email dated 31st March 2021, where you asked for information on the following: Could you please provide me with a breakdown of the 61 ADRs under the FOI act and confirm that you have not handled, procured or dispatched a men b vaccine with batch number lot 140121A.

As you may already know, 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. Vaccines encompass a wide variety of products with different indications, different ingredients and different mechanisms of action and as such safety for each vaccine is considered individually rather than as a group. If appropriate, regulatory action would be taken if any serious risks were confirmed.

Please find attached three tables which relate to your request for a breakdown of the 61 Adverse Drug Reaction (ADR) reports with the meningococcal group B (MenB) vaccine that include the batch number or a variation of “LOT 15D801A”. Table one refers to a case breakdown of all UK spontaneous suspected ADR reports associated with the meningococcal group B (MenB) vaccine that include the batch number or a variation of “LOT 15D801A”, received up to and including 29/03/2021. 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 the vaccine. 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.

Of the 61 ADR reports, the most frequently reported ADR related to vaccination site reactions and pyrexia. As this data does not necessarily refer to proven side effects, reference to the product information, including the Summary of Product Characteristics (SmPC) for healthcare professionals and patient information leaflet, can be found here https://products.mhra.gov.uk/ for details on the possible side effects of each vaccine. Injection site reactions and fever are both listed as very common and common side effects for the meningococcal group B (MenB) vaccine.

Tables two and three is an aggregation of the sex and age of patients for all UK spontaneous suspected ADR reports associated with the meningococcal group B (MenB) vaccine that include the batch number or a variation of “LOT 15D801A”, received up to and including 29/03/2021.

In reference to your question about confirmation of the handling, procurement or dispatchment of the meningococcal group B (MenB) vaccine with batch number lot 140121A, as per our last response the Bexsero batch 140121 was released by the Norwegian Medicines Authority (NoMA) for use in the EU. The National Institute for Biological Standards and Control (UK Medicines Control Laboratory) carried out some tests for NoMA. For this batch the NIBSC carried out some tests on the bulk materials used for the final vaccines, and also carried out a test on each of the final lots of the vaccine batches. Therefore, in order to carry out these tests, the NIBSC did handle this batch. In terms of information on the dispatchment in the UK of this particular batch of vaccine, Public Health England (https://www.gov.uk/government/organisations/public-health-england) or the Department of Health and Social Care (https://www.gov.uk/government/organisations/department-of-health-andsocial-care) would be best placed to answer this question based on their records, so please get in touch with them using the above links.

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