Freedom of Information request on MHRA reports of fatal events in patients who have received a COVID-19 vaccine reports of fatal events in patients who have received a COVID-19 vaccine (FOI 21/1173)
Published 26 May 2022
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FOI 21/1173
3rd November 2021
Dear,
Thank you for your FOI request dated 30th October 2021.
The MHRA takes all reports of fatal events in patients who have received a COVID-19 vaccine very seriously and every report with a fatal outcome is fully evaluated and kept under continual review. We follow-up reports with a fatal outcome, where permission has been provided to do so, for further information, including post-mortem details if available. All details within a report are thoroughly assessed to consider whether the vaccine may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. The information is thoroughly analysed for patterns or evidence which might suggest a causal link between the vaccination and the death alongside data available from international sources. This is further considered by the Commission on Human Medicine and its Expert Advisory Groups.
In response to your second and third questions, it may be useful to know that it is not an obligatory requirement to submit a post-mortem when submitting a Yellow Card report with a fatal outcome. In order to identify how many Yellow Card reports associated with a COVID-19 vaccine and a fatal outcome had a post-mortem available, assessors at the MHRA would be required to manually review each case to determine if a post-mortem was performed and provided based on the supplied information. Therefore, this information is exempt from release under Section 12 of the FOI Act. Section 12 of the FOI Act specifies that a public authority may refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
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.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU