Freedom of Information request on the rolling review of the Valneva COVID-19 vaccine (FOI 22/691)
Published 27 March 2023
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FOI 22/691
19th May 2022
Dear
Thank you for your email.
Please find below answers to the questions you have raised below;
1.Is Mhra still participating in rolling review or unrolling review of Valneva Covid 19 vaccine?
A.The Valneva vaccine was approved in April 2022, this marked the end of the rolling review, however, data to fulfil certain conditions will continue to be reviewed. Valneva COVID-19 vaccine approved by MHRA - GOV.UK (www.gov.uk). These conditions will be listed in the public assessment report which should be available shortly.
2.Is Mhra still participating in rolling review or unrolling review of pending clinical trial updates and results of Valneva Covid 19 vaccine?
A.The company can elect to submit variations to their conditional Marketing Authorisation, for example, if data are available to support use in older age groups, the company may submit these data for assessment.
3.Was / Is Mhra aware of pending clinical trial of over 50 year olds - to be precise its in over 56 year olds in New Zealand as listed here and is Mhra doing a rolling or unrolling review or no review.
A.we are aware of the NZ study (Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years - Full Text View - ClinicalTrials.gov), however, this trial is active and results are not yet available. Furthermore, it would be the applicant’s decision to submit a variation to extend the use to >50s. The summary of product characteristics also includes some information on the limited data available in over 50 year olds.
[https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1069169/COVID-19Vaccine_Valneva_SmPC-final.pdf](https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1069169/COVID-19_Vaccine_Valneva_SmPC-_final.pdf)
4.As this clinical trial is for those over 56 years old that means 51-55 year old are not accounted for in Valneva EUA or in New Zealand trial, so does this unaccounted 51-55 year old cohort mean that there is a misprint / typo in the upper range limit proposed in the EUA by Mhra that it should have been 18 to 55 year olds rather than 18 to 50 year olds?
A.This is not a typographical error, MHRA assessors considered that data in age >50 were too limited, for more information please refer to the SPC provided in our response to Q.3. above. And please note that the MHRA approval is not an Emergency Use Approval but a Conditional Marketing Authorisation.
5.Did Mhra intervene in the initial UK run clinical trial design of 4000 persons where only 1 pc were over 50 year olds to tell Valneva to increase the 1 pc?
A.it is the decision of the applicant / company to design their trial. MHRA can provide guidance and assistance when requested/required.
6.If Mhra is doing rolling review of over 56 year olds clinical trials has it asked Valneva when the results are going to be given to Mhra? If Mhra has not asked Valneva and if Valneva has results in September 2022 approximately how much time shall Mhra take to increase upper age limit of EUA if results show use in over 56 year olds?
A.Please see our response to Q.2, we would not like to speculate on an estimated time-frame; the company may choose to not submit a variation, and if they do choose to any estimations would only be informative if the variation was granted by MHRA.
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Yours sincerely
MHRA Customer Experience Centre