FOI release

Freedom of Information request on the adverse reactions reported for Pneumococcal Polysaccharide Vaccine (FOI 22/404)

Published 31 May 2022

FOI 22/404

15th February 2022

Dear

Adverse reaction reports of Pneumococcal Polysaccharide Vaccine (PPV)

Thank you of your email dated 27th January 2022, where you requested information of adverse reactions to the pneumococcal polysaccharide vaccine in adults.

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 or events 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 for newly introduced medicines during the first one to two years on the market and then falls over time.

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 through the Yellow Card scheme are individually assessed and cumulative information reviewed at regular intervals.

Any emerging evidence relating to possible risks associated with vaccines and medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.

As this data does not provide information on the proven side effects, please refer to the product information which can be found here: https://products.mhra.gov.uk/ for details on the possible side effects of the pneumococcal polysaccharide vaccine.

I can confirm that the MHRA has received 2,746 UK spontaneous suspected ADR reports with administration of the pneumococcal polysaccharide vaccine (PPV), up to and including 02/02/2022. Please see the attached Vaccine Analysis Print (VAP) for a breakdown of the reported reactions and refer to the enclosed information sheet for guidelines on how to interpret the VAP.

It is important to note that in the UK, the PPV vaccine is offered to adults over 65 years as part of the routine immunisation schedule. Details of the current immunisation schedule can be found here: https://www.gov.uk/government/publications/the-complete-routine-immunisation-schedule.

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