Novavax, Inc. was granted conditional marketing authorization (CMA) for Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted)  by the European Commission for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The authorization follows the EMA Committee for Medicinal Products for Human Use recommendation.
 
The EMA opinion and related EC decision is based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two Phase 3 clinical trials: PREVENT-19 which included 30,000 participants in the U.S. and Mexico; and a trial with 15,000 participants in the U.K. In both trials, NVX-CoV2373 demonstrated high efficacy and an acceptable safety and tolerability profile. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.
 
Novavax and the EC announced an advance purchase agreement for up to 200 million doses of Novavax’ COVID-19 vaccine in August 2021. Initial doses are expected to arrive in Europe in January.  Novavax is working with EMA and its partners to expedite local release testing.
 
This authorization leverages Novavax’ manufacturing partnership with Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, which will supply initial doses for the E.U. It will later be supplemented with data from additional manufacturing sites in Novavax’ global supply chain.
 
The vaccine is also currently under review by multiple regulatory agencies worldwide, and the company expects to submit its complete chemistry, manufacturing and controls (CMC) data package to the U.S. FDA by the end of the year.