The European Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
The authorization follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation to authorize the vaccine (also known as NVX-CoV2373) and is applicable in all 27 European Union (E.U.) member states.
“We welcome today’s European Commission decision reflecting the first authorization of a protein-based COVID-19 vaccine for the people of the E.U.,” says Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the European Medicines Agency, the Committee for Medicinal Products for Human Use reviewers and the European Commission for their thorough assessment as we look forward to playing a critical role in helping to address the continued threat of COVID-19. We also thank the thousands of clinical trial participants, our partners and Novavax employees worldwide who have contributed to this historic milestone.”
Two Phase III trials
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, the results of which were published in The New England Journal of Medicine (NEJM); and a trial with 15,000 participants in the U.K., the results of which were also published in NEJM. 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.
An advance purchase agreement
Novavax and the EC announced an advance purchase agreement (APA) 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), 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. Novavax and SII recently received emergency use authorization (EUA) in Indonesia and the Philippines, where it will be commercialized by SII under the trade name Covovax™. The companies also received emergency use listing for Covovax from the World Health Organization. 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. Food and Drug Administration (FDA) by the end of the year.
Photo of Novavax laboratory scientist: Patrick Seibert