Freedom of Information request on the deaths reported following a COVID-19 vaccination (FOI 22/351)
Published 27 March 2023
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FOI 22/351
11th May 2022
Dear
Coronavirus Vaccine - Weekly Summary of Yellow Card Reporting
Thank you for your email dated 14th January, where you asked for the sex, age and ethnicity of those who have died post COVID-19 vaccine. Please accept my apologies for the delay in our response.
Regarding your request for a breakdown of the Yellow Card reports that have been submitted for the COVID-19 vaccines in association with a fatal outcome by patient age, sex and ethnicity this information is withheld under Section 41 of the Freedom of Information Act and is therefore exempt from disclosure. Section 41 relates to information provided to us in confidence, with the expectation that it will not be released.
Members of the public and healthcare professionals voluntarily submit reports of suspected side effects to the MHRA through the Yellow Card Scheme. As outlined in our Privacy Policy, the MHRA will not share the identity of anyone submitting a Yellow Card report with any person outside the MHRA without their explicit consent, unless we are required or permitted to do so by law. The Policy also states that we may receive requests for Yellow Card report data under the Freedom of Information Act. While we are legally obliged to provide some of the requested information, we only provide high-level summary information with all person-identifiable data excluded.
The MHRA has been working proactively to encourage members of the public or health professionals across the UK to immediately alert us to any concerns they have without a formal diagnosis using the Yellow Card scheme. The information and data provided to us by these third parties are shared in confidence and, as above, are personal data. Sharing the information and data received with the complainant would not reflect the commitments in MHRA’s confidentiality agreements, potential safety signals which would be of detriment both to the application of the Agency’s regulatory function and public health more widely.
As this is personal data in relation to an individuals’ health, this would be of detriment to them and may damage the engagement with the scheme.
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