Freedom of Information request on adverse reactions to Seqirus and Pneumovax (FOI 21/740)
Published 29 December 2021
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26th July 2021
FOI 21/740
Dear
Thank you of your email dated 23rd June 2021, where you requested the following information:
Can you kindly advise me how to ascertain any side effects/contra indications supplied by the pharmaceutical companies and also details of any other adverse reports in relation to these particular vaccinations – Seqirus and Pneumovax?
When considering the spontaneous Adverse Drug Reaction (ADR) data, it is important to be aware of the following points:
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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.
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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 and 52 reports following administration of the Seqirus influenza 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 DAPs and vaccination with the Pneumovax vaccine and between the 1 fatal case and the Seqirus 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 and the PIL for the Seqirus vaccine can be found here. In your FOI request you also mention that you are interested in the contraindications associated with each of the vaccines. This information can also be found in the respective SmPCs (section 4.3) and PILs (section 2).
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