FOI 21/031 - Vaccine associated suspected adverse reactions reported via the yellow cars (NK)
Published 24 March 2021
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Thank you for your email dated 11th February 2021, where you requested:
“A link or the file to the paper/ report provided by the MHRA for JCVI on vaccinations and Immunisation’s June 2011 and report of 2012.”
Please find enclosed the JCVI reports of 2010 and 2011. These were the reports discussed in the 2011 and 2012 meetings. These reports detail the number of Adverse Drug Reaction (ADR) reports received for the vaccines which would have been on the routine schedule for that particular year https://www.gov.uk/government/publications/the-complete-routine-immunisation-schedule.
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.
When considering spontaneous suspected 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 drug, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a drug, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the drug. 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.
I hope the information provided is helpful; however, 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.
Please remember to quote the reference number above in any future communications. Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division