FOI release

Freedom of Information request on breakdown by age for other types of ADR similarly to Thrombo-Embolic events (FOI 21-669)

Published 29 December 2021

14th July 2021 FOI 21/669

Dear

Thank you for your email dated 15th June 2021, where you requested the following: “I note that the only ADR you break down by age is for Thrombo-Embolic events. Can you release information similar to Table 5 on this page, to the same level of granularity for the other types of ADR please.”

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.

I hope the information provided and explanation regarding the exemption is helpful. If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

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