FOI release

Freedom of Information request on the MHRA's authorisation for the use of eight experimental vaccines in the "Cov Boost Study" in the UK (FOI 21-614)

Published 13 August 2021

3rd June 2021 FOI 21/614

Dear

Thank you for your enquiry dated 21st May 2021 which has been considered under the Freedom of Information (FOI) Act.

Regarding ‘Subject: C J 139: “Cov-Boost Study” to evaluate Covid 19 vaccine boosters’ you asked for the following:

• Details of the authorisation provided by MHRA [as medical regulator] for the use of the 8 experimental vaccines in the “Cov Boost Study” in the UK.

The following clinical trial application was approved by the MHRA on the 17th May 2021; ‘A randomised, phase II UK multi-centre study to determine reactogenicity and immunogenicity of booster vaccination against ancestral and novel variants of SARS-CoV-2 (COV-BOOST).’

The formal letter of authorisation is appended to this letter as requested.

We now consider this request closed.

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 .

Please remember to quote the reference number above in any future communications. Please note, 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.

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