FOI release

Freedom of Information request on the number of UK spontaneous, suspected ADR reports and deaths for COVID vaccines for over 65s only (FOI 21/767)

Published 27 April 2022

9th August 2021 FOI 21/767

Dear Thank you for your email dated 08th July 2021, where you asked:

“Please provide the number of UK spontaneous, suspected ADR reports and deaths for COVID vaccines for over 65s only.”

The MHRA intends 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 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. Users will also be able to download the data tables in CSV format.

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 however wish to publish this information alongside appropriate context and assessment.

We will send you a link to the iDAPs once they are published. In relation to your request for number of deaths in those over the age of 65, we can confirm that unfortunately we do not hold information as we do not collect complete fatality data. We suggest you contact Office for National Statistics for death statistics.

Email: info@ons.gov.uk

The Yellow Card scheme 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 include some fatality reports and these can be viewed by following the link below: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions”

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.

Yours sincerely, FOI Team Vigilance and Risk Management of Medicines Division