Wednesday , May 31 2023

a “possible” decision at the end of January, according to the European Medicines Agency


AstraZeneca could send a conditional marketing request for its vaccine next week, says EMA.

A decision on the EU authorization of the AstraZeneca / Oxford vaccine against Covid-19 could be taken at the end of January, the European Medicines Agency (EMA) said on Friday, under pressure from Member States.

«After receiving more data from the company, EMA expects AstraZeneca to submit a conditional marketing application for its vaccine next week, with a possible conclusion at the end of JanuaryThe Amsterdam agency announced at a public meeting.

«Of course, this will depend on the data we receive and the progress of the evaluation.EMA CEO Emer Cooke said during the video conference. “Once we receive the request, we will make a public announcement about it“She added.

The EMA has previously indicated that additional information on the safety and efficacy of the vaccine developed by the AstraZeneca group with the University of Oxford has been considered. “necessary».

The vaccine is currently subject to a “continuous examination“, Which allows the European regulatory authority to examine data on the safety and efficacy of vaccines as they are published, even before the manufacturer submits a formal application for authorization.

This procedure makes it possible to speed up the evaluation of an application for a marketing authorization once it has been made. The EMA authorized the Pfizer / BioNTech Covid-19 vaccine on 21 December and the Moderna vaccine on 6 January, for which the European Commission immediately gave the green light.

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