FOI release

Freedom of Information request on animal studies performed for COVID-19 vaccines

Published 28 May 2021

30th April 2021 FOI 21/396

Dear

Thank you for your email.

The MHRA’s assessment of the non-clinical data is available in the Public Assessment Reports (PARs), please review the following links to these for the authorised Covid-19 vaccines and please note that the details of the animal studies performed for each vaccine are available there.

https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19 https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna

Regarding the question concerning animal testing in general, by law new medicines are required to be tested on animals before they can advance to phase testing on human volunteers in clinical trials.

If you have a query about the information provided, please reply to this email.

If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: 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.

After that, if you remain dissatisfied, you may write to the Information Commissioner at; The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF. They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU