Freedom of Information request about drug analysis profiles (FOI-21-076)
Published 28 May 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-19-april/freedom-of-information-request-about-drug-analysis-profiles-foi-21-076
Thank you for your email dated 19th March 2021, where you requested the following information for the COVID-19 vaccines:
“I request in spreadsheet or database format, e.g., comma-separated-values (CSV) (not PDF format), the full body of all anonymised raw data with the level of details as close as possible to that one available for Interactive Drug Analysis Profile (iDAP) and related CSV files, for all Covid-19 vaccines currently in use in the UK. Especially to include for EACH event, but not limited to:
SEX
AGE
DATE
REPORTER
REPORT SUBMISSION
ROUTE OF ADMINISTRATION
SERIOUSNESS
SYSTEM
ORGAN
CLASS”
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.
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. The current published data can be accessed here: 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