FOI release

Freedom of Information request on civil liability and immunity regarding the COVID-19 vaccines (FOI 21/914)

Published 20 January 2022

2nd September 2021

FOI 21/914

Dear

Regarding your questions about civil liability and immunity, information on this is available to view at the following link of our website page below:

https://www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu/consultation-document-changes-to-human-medicine-regulations-to-support-the-rollout-of-covid-19-vaccines#civil-liability-and-immunity

Any further enquiries concerning liability should be sent to the Department of Health and Social Care (DHSC).

All the Covid-19 vaccines approved for use in the UK now have conditional marketing authorisations (CMA) and supply of the vaccines has already or will transition from the Regulation 174 emergency use approval to the CMA moving forward.

Only 2 of the 4 approved vaccines (AZ & Pfizer) still have emergency use authorisations under Regulation 174 and the Conditions are specified and published on our website at the links below:

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

The conditions of Regulation 174 emergency use can be found at this link: https://www.legislation.gov.uk/uksi/2012/1916/regulation/174/made

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