Freedom of Information request on the safety signals detected and disproportionality analyses performed on the safety database for COVID-19 vaccines (FOI 21-439)
Published 28 June 2021
© Crown copyright 2021
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-3-may-2021/freedom-of-information-request-on-the-safety-signals-detected-and-disproportionality-analyses-performed-on-the-safety-database-for-covid-19-vaccines
5th May 2021 FOI 21/439 Dear
Thank you for you FOI request dated 23rd 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 safety signals detected and disproportionality analyses performed on the safety database for COVID-19 vaccines 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
Kind regards,
FOI Team Vigilance and Risk Management of Medicines Division Medicines and Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU