FOI release

Freedom of Information request about adverse reaction data (FOI-21-170)

Published 7 May 2021

10th March 2021 Our Ref: FOI 21/170 Dear, Thank you for your email dated 9th February 2021, where you requested the following information for the COVID-19vaccines: 1. Adverse reaction data grouped by sex. 2. Adverse reaction data grouped by age group. 3. Adverse reaction grouped by ethnicity. We can confirm that the MHRA does hold this data. 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 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. Additionally, we intend to publish a full breakdown of all suspected reactions reported in association with available COVID-19 vaccines by ethnicity in our ADR summary that is published each week. 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. 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