Freedom of Information request about adverse drug reactions (ADR) to Covid-19 vaccines (FOI -21-436)
Published 28 June 2021
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Thank you for your Freedom of Information (FOI) request dated 22nd April 2021.
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. Unfortunately, in this instance your request falls under Section 12 of the FOI Act as the information you have requested relating to the statistical analysis produced for each vaccine would require longer than 24 working hours to complete.
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
Additionally, patient information is exempt from release under Section 40 of the FOI Act which protects personal data, the disclosure of which would breach one or more of the data protection principles therefore we cannot provide individual case safety reports.
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