U.S. FDA Grants Emergency Use Authorization for Gaithersburg’s Novavax COVID-19 Vaccine

Novavax, a Gaithersburg-based, biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases,  announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and over.

Per the press release: “Today’s 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.”

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. Among participants 18 through 64 years of age, solicited adverse reactions (AR) following administration of any dose of the Novavax COVID-19 Vaccine, Adjuvanted were injection site pain/tenderness (82.2%), fatigue/malaise (62.0%), muscle pain (54.1%), headache (52.9%), joint pain (25.4%), nausea/vomiting (15.6%), injection site redness (7.0%), injection site swelling (6.3%), and fever (6.0%). In participants 65 years of age or over, solicited ARs following administration of any dose of the Novavax COVID-19 Vaccine, Adjuvanted were injection site pain/tenderness (63.4%), fatigue/malaise (39.2%), muscle pain (30.2%), headache (29.2%), joint pain (15.4%), nausea/vomiting (7.3%), injection site swelling (5.3%), injection site redness (4.8%), and fever (2.0%).

Doses of the Novavax COVID-19 Vaccine, Adjuvanted were shipped from the Serum Institute of India Pvt. Ltd., the world’s largest vaccine manufacturer by volume, 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).

This project has been supported in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedicdal Advanced Research and Development Authority (BARDA), through the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under contract #MCDC2011-001.

Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.
The Novavax COVID-19 Vaccine, Adjuvanted has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to provide a two-dose primary series to individuals 18 years of age and older to prevent Coronavirus Disease 2019 (COVID-19).

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Authorized Use
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.