World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the World Health Organization (WHO) has granted a second Emergency Use Listing (EUL) for NVX-CoV2373, Novavax’ recombinant protein nanoparticle COVID-19 vaccine with Matrix-M™ adjuvant, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. Today’s EUL pertains to a 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.
“Today’s Emergency Use Listing underscores the ongoing need and potential for Novavax to help significantly increase COVID-19 vaccine access across the globe through a protein-based option built on a well-understood platform,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the World Health Organization for its thorough assessment and look forward to helping address major obstacles to controlling the pandemic, including practical barriers to access and vaccine hesitancy.”
“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.”
“It is very welcome news that the world now has an additional weapon from Novavax in its arsenal of tools to fight COVID-19,” said Dr Richard Hatchett, Chief Executive Officer, Coalition for Epidemic Preparedness Innovations (CEPI). “CEPI’s investments to accelerate the clinical development and manufacturing of Novavax’ vaccine have been critical to progressing this vaccine and enabling equitable access through 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 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.