EMA Recommends Conditional Marketing Authorization For Novavax COVID-19 Vaccine For Adults

(RTTNews) - Biotechnology company Novavax, Inc. (NVAX) announced Monday that the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for Novavax' COVID-19 vaccine (NVX-CoV2373) to prevent COVID-19 in people from 18 years of age and older.

Upon authorization, NVX-CoV2373 will be marketed in the European Union (EU) as Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted).

An authorization from the Commission would deliver the first protein-based vaccine to the E.U. during a critical time when we believe having choice among vaccines will lead to increased immunization.

The EMA recommendation follows a positive CHMP opinion based on an expedited review of the totality of manufacturing, preclinical, and clinical trial data submitted by the company, with the conclusion that the vaccine meets the stringent criteria set by the E.U. for efficacy, safety and quality.

This included data from two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled almost 30,000 participants in the U.S. and Mexico, and achieved an overall efficacy of 90.4%, and a trial with more than 14,000 participants in the U.K. that achieved an overall efficacy of 89.7%. In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring safety and tolerability profile.

Novavax and the European Commission had announced an advance purchase agreement (APA) for up to 200 million doses of Novavax' COVID-19 vaccine in August 2021.