Freedom of Information request about clinical trials for COVID-19 vaccines (FOI-21-227)
Published 7 May 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-8-march-2021/freedom-of-information-request-about-clinical-trials-for-covid-19-vaccines-foi-21-227
8th March 2021 FOI 21/227
Dear
Thank you for your email of the 08 February 2021, where you have asked for: • “Ct value of the PCR results for those who tested positive in the Phase 1 to 3 trials for such experimental genetic vaccine” • “serological studies to show asymptomatic individuals do not become infected or cannot infect others with Covid 19.”
The information you have requested would be exempt from release, under Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the Freedom of Information (FOI) Act.
Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.
Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in publishing information on the clinical trials performed, which can help competitors overcome regulatory hurdles in getting their own products to market.
Information concerning the authorisation of each vaccine, including MHRA’s assessment of the clinical studies that were performed, is available in the public domain. Links to this information have been provided to you in a previous response.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.
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