Covid: Europe begins to study Sanofi vaccine dossier



Posted on Jul 20, 2021 7:15 PMUpdated on Jul 20, 2021, 7:30 PM

Things are progressing … While France is anguished at the prospect of a fourth epidemic wave and the controversies over vaccines endlessly, the European Medicines Agency announced on Tuesday the launch of the continuous review procedure of Sanofi vaccine against Covid. A step for the French laboratory, which was unable to offer effective doses at the same time as the actors of RNA vaccines – Pfizer / BioNTech and Moderna.

The decision of the European health authorities to begin the procedure paving the way for a possible marketing authorization is based on preliminary preclinical and clinical results, results “which suggest that the vaccine triggers the production of antibodies and could help protect of the disease ”according to the agency. The latter will continue the procedure until it has sufficient information for the laboratory to submit a formal request for Marketing Authorization.

Essential Phase III results

This type of authorization, from which several vaccines against Covid have already benefited, (J & J, Sinovac…) Saves time on the examination of the registration file, even if the results of Phase III remain essential . Sanofi arrives very late in the fight against the pandemic, having had to redo Phase II following a dosage error, with a vaccine hoped for at the end of the year. He is thus trying to save time by all means, in the hope that his vaccine can be used as a third booster dose against the variants.

Health authorities seem to consider that the third dose may be different from the first two, the goal being to stimulate the immune system regardless of the means. Until now, it does not appear that there is any incompatibility between vaccines based on different technologies (RNA, adenovirus, etc.).

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