Today’s EUL pertains to vaccine to be marketed by Novavax as Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) in Europe and other markets. NVX-CoV2373 is also being manufactured and marketed in India and licensed territories by Serum Institute of India Pvt. Ltd. (SII), as Covovax™, which was granted EUL on December 17. Nuvaxovid and Covovax are based on the same Novavax recombinant protein technology and the EULs are based on a common pre-clinical, clinical and chemistry, manufacturing and controls (CMC) package.
Today’s EUL follows the receipt of conditional marketing authorization from the European Commission and prequalifies Nuvaxovid as meeting WHO standards for quality, safety and efficacy. EUL is a prerequisite for exports to numerous countries, including those participating in the COVAX Facility, which was established to enable equitable vaccine allocation and distribution. EUL also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. Novavax and SII have committed a cumulative 1.1 billion doses of the Novavax vaccine to COVAX.
The grant of EUL was based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 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 that evaluated the vaccine in more than 14,000 participants in the U.K., the results of which were also published in NEJM. In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring 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’ COVID-19 vaccine was recently granted emergency use authorization (EUA) in Indonesia and the Philippines, where it will be marketed as Covovax by SII. NVX-CoV2373 is also currently under review by multiple regulatory agencies worldwide. The company expects to submit its complete CMC data package to the U.S. 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.