Novavax Monday said that the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for its COVID-19 vaccine.
The vaccine is also known as NVX-CoV2373, and it is expected to prevent COVID-19 in people from 18 years of age and older. Upon authorization, NVX-CoV2373 will be marketed in the European Union (E.U.) as Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted).
Subsequently, the European Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine.
Also, Nuvaxovid COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) has been listed for emergency use by the WHO.
“We welcome the news that Nuvaxovid has also received WHO Emergency Use Listing, providing the world – and COVAX participants – with another promising class of vaccine as well as yet another tool in the battle against COVID-19,” said Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance. “With data on safety and efficacy against several variants, strong potential in booster regimens, and standard storage temperatures, Nuvaxovid will provide countries with another critical option in the quest to help protect their populations.”
“Novavax appreciates the CHMP’s positive opinion concerning our vaccine, and we look forward to a decision from the European Commission,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “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, Novavax said. 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%, the results of which were published in the New England Journal of Medicine (NEJM)); and a trial with more than 14,000 participants in the U.K. that achieved an overall efficacy of 89.7%, the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring safety and tolerability profile.
200 million doses in August
Novavax and the European Commission announced an advance purchase agreement (APA) for up to 200 million doses of Novavax’ COVID-19 vaccine in August 2021. This filing 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.
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.
The brand name Nuvaxovid™ has not yet been authorized for use in the U.S. by the FDA.