FOI release

Freedom of Information request about COVID-19 vaccine adverse reactions (FOI-21-230)

Published 7 May 2021

FOI 21/230 Dear,

Thank you for your email dated 12th February 2021 where you requested details of all deaths within 28 days of receiving a COVID-19 vaccination, broken down by different categories, alongside additional questions regarding how deaths are investigated.

Please see below further details on your request for all deaths within 28days of receiving a COVID-19 vaccination.

Age group/vaccine manufacturer

We intend to publish all suspected reactions reported in association with available COVID-19 vaccines in an interactive format as interactive drug analysis profiles (iDAPs), along with our adverse drug reaction (ADR)summary that is published each week. The use of iDAPs will enable users to view the data by categories of their choice such as age, sex and seriousness of reports, and will be available for each of the COVID-19 vaccine in use in the UK.

As we plan to publish the data, we consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is therefore exempt from disclosure. Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and accept it should not be withheld. We will send you a link to the iDAPs once they are published.

Underlying conditions/any medications the recipient was taking

Yellow Card data requests fall into two categories: I (a/b) and II. Category I a/b data are releasable under the provisions of the Freedom of Information Act (FOIA) 2000. Category Ia comprises anonymised aggregated data e.g. iDAPs.Category Ib data comprises a pre-defined basic set of case details.

If further case details are required, such as underlying conditions and any concomitant medication(s),this would then fall under Category II. Category II data requests are considered by the Pharmacovigilance Expert Advisory Group (PEAG). The remit of PEAG is to consider the method of study, its appropriateness, the implications of the Freedom of Information Act and Data Protection Act on data release and how use of other data would interact with Yellow Card data. PEAG also advises on the relevance of seeking ethics review of a proposal from the NHS Research Ethics Committee. Please follow this link to our website where you can find out more, including the application form which needs to be completed. https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership#pharmacovigilance-eag

If your application is approved, then there will be an additional cost to cover the time to anonymise the data which we would only be able to advise on once we understand exactly what type of data you are interested in. The completed application form must be sent via email to type2yellowcarddata@mhra.gov.uk; we can then advise on any specific questions you may have.

How many deaths are currently under investigation?

Every report, especially those with a fatal outcome are fully evaluated by the MHRA and kept under continual review. We follow-up all fatalities where permission has been provided to do so for further information including post-mortem details if available. It is the role of the pathologist to determine cause of death via post-mortem and this falls outside of the MHRA remit. 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.

Part of our continuous analysis includes an evaluation of natural death rates over time, to determine if any specific trends or patterns are occurring that might indicate a vaccine safety concern. Based on age-stratified all-cause mortality in England and Wales taken from the Office for National Statistics death registrations, several thousand deaths are expected to have occurred, naturally, within 7 days of the many millions of doses of vaccines administered so far, mostly in the elderly. Our review of individual reports and patterns of reporting does not suggest the vaccine played a role in the deaths reported.

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.

Please note that your request for an internal review of FOI 21/135 has been logged and will be responded to separately from this correspondence. Yours Sincerely, FOI Team, Vigilance and Risk Management of Medicines Division