FOI release

Freedom of Information request on the yellow card reports following the COVID-19 vaccine (FOI 21/1342)

Published 31 May 2022

FOI 21/1342

31st December 2021

Dear,

Thank you for your FOI request dated 21st December 2021.

The number of fatal reports is included in the Vaccine Analysis Prints published each week. Please note that a report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines. All reports are kept under continual review in order to identify possible new risks.

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

All Yellow Card reports we receive are promptly entered onto the MHRA’s Adverse Drug Reaction (ADR) database so that they are available for a process called signal detection. During signal detection, reports are evaluated, together with additional sources of evidence, by a team of safety experts to identify any new safety issues or side effects. We apply statistical techniques that can tell us if we are seeing more events than we would expect to see, based on what is known about background rates of illness in the absence of medication or vaccination. This aims to account for factors such as coincidental illness. We also look at the clinical characteristics to see if new patterns of illness are emerging that could indicate a new safety concern.

For the COVID-19 vaccines, we supplement this form of safety monitoring with other epidemiology studies, including data analysis on national vaccine usage, anonymised GP-based electronic healthcare records, and other healthcare data to proactively monitor safety. These combined safety data enable the MHRA to detect side effects or safety issues associated with COVID-19 vaccines. As well as confirming new risks, an equally important objective of monitoring will be to quickly rule out risks – in other words, to confirm that the vaccine is not responsible for a suspected side effect and to provide reassurance on its safety. We also take into account the international experience based on data from other countries using the same vaccines. For further information on how we use the data we collect, please view our COVID-19: vaccine surveillance strategy - GOV.UK (www.gov.uk).

As with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA to consider whether the medicine or vaccine may have caused the event or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. To ensure the comprehensive assessment of fatal reports, we follow-up all fatalities where necessary for further information.

As mentioned above, for all the fatal reports concerning COVID-19 vaccines, a follow-up letter is sent to the reporter to request further information, including a copy of the Post Mortem (PM) report and the certified Cause of Death. Once we receive this follow up information, it may change the classification of the case. In some instances, the reporter may not consider the death to be related to the COVID-19 vaccine. The classification of these cases would therefore be amended within our database and these updates reflected in the following weekly Coronavirus ADR publication.

Kind regards,

FOI Team