Freedom of Information request on COVID19 Vaccine Adverse Reaction Data (FOI 21/061)
Published 24 March 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-25-january-2021/freedom-of-information-request-on-covid19-vaccine-adverse-reaction-data-foi-21061
In response to your request for information about adverse reactions (ADR) to Covid-19 vaccines, I can confirm that the MHRA does hold this data.
We intend to publish details of all suspected reactions reported in association with available COVID-19 vaccines, along with our assessment of the data on a regular basis. This is to provide reassurance in the ongoing benefit and risk assessment of available vaccines.
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 believe that the public interest will be best served by accompanying the publication of the data with an analysis to aid its interpretation which is currently under preparation.
We will send you a link to the ADR data report once it has been published.
If you have a query about the information provided, please reply to this email.
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 you receive this response and addressed to: info@mhra.gov.uk
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000