Freedom of Information request on the rolling review of the Novavax vaccine (FOI 21/977)
Published 20 January 2022
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3rd September 2021
FOI 21/977
Dear
Thank you for your email
Novavax has begun the rolling review process to obtain a licence with several regulatory agencies worldwide, including the MHRA, European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) and Health Canada. As part of the rolling review, the company will continue to submit additional information, including clinical and manufacturing data. The MHRA has been in active discussions with Novavax and we have procedures in place to ensure the assessment is conducted as efficiently as possible. Unfortunately, we cannot give you a timeline for when the company will be in a position to finalise their data submission or obtain approval.
However, the Deputy Chief Medical Officer, Professor Jonathan Van Tam sent an open letter to all UK residents who volunteered to take part in vaccine studies. This letter explains that the Department of Health and Social Care (DHSC) makes a firm commitment to all volunteers in formally approved COVID-19 vaccine trials in the UK that they will not be disadvantaged in terms of any future domestic vaccine certification, if introduced, compared to those who have had their vaccines under the standard NHS programme. The link to this letter is here: Letter from the Deputy Chief Medical Officer to UK vaccine study volunteers - GOV.UK (www.gov.uk). Note that all Chief Medical Officers agree this approach and will be looking to embed these arrangements across the four nations of the UK, where and when appropriate.
Further information on demonstrating COVID-19 vaccination status (including clinical trial participants) is available on the DHSC website at this link: Demonstrating your COVID-19 vaccination status - GOV.UK (www.gov.uk). If additional information is required, DHSC should be contacted Department of Health and Social Care - GOV.UK (www.gov.uk)
Kind regards,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU