FOI release

Freedom of Information request on the 8-week immunisations in use in the UK, which include: DTaP/IPV/Hib/HepB (diphtheria, tetanus, pertussis, polio, haemophilus influenzae type b, and hepatitis B); Meningococcal group B (Men B); Rotavirus (FOI 22/484)

Published 1 June 2022

FOI 22/484

16th April 2022

Dear

Thank you for your email dated 22nd February 2022, where you requested data on the side effects that have been reported to the MHRA in association with the 8-week immunisations in use in the UK, which include:

• • • DTaP/IPV/Hib/HepB (diphtheria, tetanus, pertussis, polio, haemophilus influenzae type b, and hepatitis B)
• • • Meningococcal group B (Men B)
• • • Rotavirus

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.

As per your request, I would like to kindly direct you to the enclosed Vaccine Analysis Prints (VAPs) for DTaP/IPV/Hib/HepB, Men B and rotavirus vaccines. Please also find attached a VAP guidance sheet which provides you with further information on how to interpret the print. The prints contain information on all UK spontaneous suspected Adverse Drug Reaction (ADR) reports received through the Yellow Card scheme for the time period up to and including 02/03/2022. Please note that these data include reports received for all brands of each vaccine as well as reports in which the brand name was not provided by the reporter. For example, the data in the rotavirus VAP includes reports relating to all rotavirus vaccines including, Rotarix and reports in which a rotavirus vaccine was reported but a brand name was not provided.

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 these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://products.mhra.gov.uk/ for details on the possible side effects of each vaccine.

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.