Freedom of Information request on deaths following COVID-19 vaccination (FOI 21/838)
Published 20 January 2022
© Crown copyright 2022
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-16-august-2021/freedom-of-information-request-on-deaths-following-covid-19-vaccination-foi-21838
19th August 2021
FOI 21/838
Dear
Thank you for your FOI request dated 21st July 2021.
Death statistics are not held by the MHRA and as such we would advise you to contact the Office for National Statistics
Contact us - Office for National Statistics (ons.gov.uk)
The Yellow Card scheme is run by the MHRA and is the UK system for collecting and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines and medical devices. Reports received through our Yellow Card scheme associated with the COVID-19 vaccines including reports associated with a fatal outcome can be viewed by following the link below:
https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions
When viewing the data at the link above you should remember that:
- Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the medicine or vaccine may have caused the adverse reaction. The existence of an adverse reaction report in the profile does not necessarily mean that the vaccine has caused the suspected reaction.
- It may be difficult to tell the difference between something that has occurred naturally and a suspected adverse reaction. Sometimes these events can be part of the condition being treated rather than being caused by the vaccine.
- Many factors have to be considered when assessing whether the vaccine has caused a reported adverse reaction. When monitoring the safety of vaccines and medicines, MHRA staff carry out careful analysis of these factors.
Regarding your request for adverse reaction data for all vaccines over the last 10 years, we can confirm that the MHRA collects reports of suspected adverse reactions to medicines and vaccines via the Yellow Card scheme and these reports are entered onto our database. 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. We consider that extracting the information that you have requested will take longer than 24 working hours to complete.
As your request has been refused under Section 12 of the FOI Act, we cannot answer any part of it however we will be happy to provide a response to any refined request you send in the future. For example, you could refine your request by specifying which vaccines you are interested in. I have included a link to the current routine immunisation schedule:
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