FOI release

Freedom of Information request about EudraCT: 2020-002641-42 (FOI-21-479)

Published 28 June 2021

Thank you for your Freedom of Information (FOI) request (dated 4 May 2021), where you asked for information pertaining to the trial protocol for the following trial:

  • EudraCT: 2020-002641-42
  • Protocol title: “A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals”
  • Protocol  number: C4591001

As the above trial was not conducted in the UK, the MHRA did not assess its content and are therefore not in a position to answer specific questions relating to it.

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

10 South Colonnade, Canary Wharf, London E14 4PU