Sanofi vaccine: the European Medicines Agency launches a rolling review of the product

Published by Laurent P. · Updated on 24 July 2021 at 15h12 · Published on 21 July 2021 at 10h49
Is the Sanofi vaccine soon to be marketed? This Tuesday July 20, 2021, the European Medicines Agency has announced they are to launch a rolling review of results from phase 3 of the ongoing clinical trial of the French laboratory candidate vaccine in order to allow or not marketing issuance as soon as possible.

Soon a Covid vaccine for Sanofi… This Tuesday July 20, the EMA – European Medicines Agency – said they are to launch a rolling review of French laboratory candidate vaccine created in partnership with UK group GSK. A review leading to marketing issuance if results of the ongoing phase 3 of the clinical trial are good and meeting safety criteria required by the European Union. “EMA’s human medicines committee has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur”, the regulator said in a release.

A decision to launch the review also based on the trial’s primary results, revealed by the laboratory several weeks ago which “suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease”, as the European regulator explains. The review also aims at enabling Sanofi to seek approval for issuance as soon as possible.

EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review”, the European Medicines Agency goes on. For the record, to date, four Covid vaccines have been approved for marketing in Europe: Pfizer/BioNTech, Moderna, Johnson & Johnson, and AstraZeneca. Sanofi vaccine could be the fifth. Marketing could occur from late 2021.

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