Freedom of Information request on inoculation ADRs (FOI 21-384)
Published 28 June 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-10-may-2021/freedom-of-information-request-on-inoculation-adrs-foi-21-384
Thank you for your email dated 9 th April 2021, where you asked:
“I hereby request the Data of Inoculations, including the months of December 2020 thru March 2021, categorized by ADR type and month. Data is to be gathered from the United Kingdom, unless the MHRA holds government-recorded Data from identical agencies in other countries.”
The MHRA is collecting data concerning any adverse reactions observed to vaccine treatment through our Yellow Card Scheme. We are regularly publishing Yellow Card data associated with COVID-19 vaccinations. Yellow Card data for drugs is routinely published on the Yellow Card website, with vaccine data available on request. However, for COVID-19 vaccinations we are proactively publishing details of adverse drug reactions received, including MHRA assessment of the data to provide context. Please note this data is updated weekly. https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions 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. 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