Freedom of Information request on reactions reported in association with COVID-19 vaccines (FOI 21/1023)
Published 25 February 2022
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-6-september-2021/freedom-of-information-request-on-reactions-reported-in-association-with-covid-19-vaccines-foi-211023
9th September 2021
FOI 21/1023
Dear
Thank you for your email.
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 reference to points 5 and 6 this information is not held by MHRA and as such we would be unable to provide this and this would not be present in the iDAPs.
With regards to point 7, unfortunately, we are unable to provide details of past medical history for individual cases. Because of the way this information is captured within our database, this would require manual extraction of the information from each individual case. Therefore, this information is exempt from release under Section 12 of the FOI Act. 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. Please be reassured that any information provided regarding a patient’s past medical history or concurrent conditions is taken into account during the routine assessment of all cases that we receive.
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.
Kind regards,
MHRA Customer Service Centre