The European Medicines Agency (EMA) announced on Wednesday 17 November that it had received a conditional marketing authorisation application for the Covid-19 vaccine Nuvaxovid (NVX-CoV2373) developed by the US laboratory Novavax.
The Agency has already examined a large amount of data on this vaccine, the rolling review of which started in February 2021.
As a result, the review of the application for authorisation “will proceed under an accelerated timeline, and an opinion on the marketing authorisation could be issued within weeks if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine”, the EMA said in a statement on Wednesday.
Once authorised, and subject to approval by the European Commission, Nuvaxovid would become the fifth vaccine authorised in the EU.
Last August, the Commission signed an advance purchase agreement with Novavax (see EUROPE 12774/7). The latter will allow the EU to procure up to 200 million doses of the US vaccine by 2023. (Original version in French by Agathe Cherki)