Novavax COVID vaccine gets USFDA emergency use nod for 18 years and older

"The FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "This authorization reflects the strength of our COVID-19 vaccine's efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues."

"Patients and providers in the U.S. now have access to a protein-based COVID-19 vaccine backed by data that have demonstrated efficacy, safety, and tolerability," said Karen Kotloff, M.D., Professor of Pediatrics, University of Maryland School of Medicine, Associate Director of Clinical Studies at the Center for Vaccine Development and Global Health, COVID-19 Prevention Network co-lead for the PREVENT-19 trial. "Offering more vaccine technologies and options in our vaccination portfolio, including those built upon technologies that have been successfully used for years, will hopefully help to increase our country's vaccination rate."

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. 

The FDA EUA was based on data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and over in the U.S. and Mexico. In the trial, the Novavax COVID-19 Vaccine, Adjuvanted demonstrated 90.4% efficacy (95% confidence interval [CI], 83.8% to 94.3%; P<0.001) with a reassuring safety profile.

Doses of the Novavax COVID-19 Vaccine, Adjuvanted were shipped from the Serum Institute of India Pvt. Ltd. and are now in the U.S. The next step for the vaccine is a policy recommendation for use from the Centers for Disease Control and Prevention (CDC).

Earlier this week, the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, announced an agreement to secure an initial 3.2 million doses of the Novavax' COVID-19 Vaccine, Adjuvanted. These vaccine doses will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers.

In addition to the FDA EUA, the Novavax COVID-19 vaccine has received conditional authorization for use in individuals aged 18 and over from multiple regulatory agencies worldwide, including the European Commission (EC), and emergency use listing from the World Health Organization (WHO).

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