Freedom of Information request on vaccine in phase 3 clinical trials (FOI 21/698)
Published 29 December 2021
© Crown copyright 2021
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-19-july-2021/freedom-of-information-request-on-vaccine-in-phase-3-clinical-trials-foi-21698
19th July 2021
FOI 21/698
Dear
Thank you for your information request, dated 23rd June, where you asked for “ Please provide details of all vaccines that have failed Phase 3 clinical trials in the last 10 years. This data should include reason for failure, length of trial and, if it is due to excess deaths, provide the number of subjects who passed away.”
I can confirm that the MHRA may hold some of the information that you have requested. However, we have also determined that the information is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further.
Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
In order to process your request, we would need to look at every Phase III clinical study report for every vaccine application received in the last 10 years to ascertain whether that study failed in its objectives and for what reasons. We consider that this would take longer than 24 working hours to complete.
We advise that you narrow your request, for example, by requesting information for a specific study.
Please note that summary results for clinical trials conducted are published and are available through the following registers:
https://www.isrctn.com
https://www.clinicaltrialsregister.eu/
https://clinicaltrials.gov/ct2/home
Please note that substantially similar requests made within 60 working days of an original request can be aggregated into one for the purposes of calculating a cost limit, meaning that section 12 could still apply.
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 would 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.
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000