Freedom of Information request on the approval of the Valneva vaccine for ages 18-50 (FOI 22/641)
Published 27 March 2023
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FOI 22/641
11th May 2022
Dear
Thank you for your email.
Please find below answers to the questions you have raised below.
1.Why did Mhra not give the approval to over 50 year olds / Is there trial being awaited by Mhra for over 50 year old cohort and what is the time indication when Mhra might have it / Was up to 50 year olds Valneva original application / amended application or Mhra put this stipulation? Were clinical trial conducted in over 50 year olds?
What were the results in clinical trials from over 50 year olds?
As we plan to publish the public assessment report within the next 60 calendar days, we consider that your request is covered by Section 22 of the Freedom of Information Act (information intended for future publication) and the information you have asked for is therefore exempt from disclosure. Section 22 is a qualified exemption which means we have considered whether there is a greater public interest in releasing the information requested or withholding it. We recognise there is strong interest in seeing this data and accept it should not be withheld.
2.Can there be grounds for exceptional use in over 50 year olds / How is exceptional use to over 50 year olds permission seeked? Is there a template form / letter / does a letter from a medical professional acceptable?
MHRA cannot advise on use of the vaccine in over 50 year olds or use of the product off-label.
If you have a query about the information provided, please reply to this email.
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
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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:
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Yours sincerely
MHRA Customer Experience Centre