FOI release

Freedom of Information request on side effects have been reported though the Yellow Card scheme, from taking the vaccine, (PNEUMOVAX) (FOI 21-807)

Published 27 April 2022

4th August 2021 FOI 21/807

Dear

Thank you of your email dated 5th July 2021, where you requested the following information: I’m trying to find out what side effects have been reported though the Yellow Card scheme, from taking the vaccine, (PNEUMOVAX) especially any serious side effects. Further to your request please find attached the relevant Drug Analysis Print (DAP). Please also find attached a DAP guidance sheet which provides you with further information on how to interpret the prints.

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.

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.

I can confirm that the MHRA has received 1,852 spontaneous UK suspected ADR reports following administration of the Pneumovax vaccine up to and including 08/07/2021. Please see the drug analysis prints (DAPs) attached for breakdown of the reported reactions. Please refer to the enclosed information sheet for guidelines on how to interpret the DAPs. 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. Please note that there has been no causal association established between the 34 fatal cases within the attached DAP and vaccination with the Pneumovax vaccine.

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 the vaccine as documented by the pharmaceutical company. The product information includes the Summary of medicinal Product Characteristics (SmPC) for healthcare professionals and the Patient Information Leaflet (PIL). The MHRA advises patients to familiarise themselves with the product information before taking any new medicine or vaccine. The PIL for the Pneumovax vaccine can be found here.

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