On Jul. 13, 2022, Novavax announced that its COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) had received emergency use authorization from the Food and Drug Administration 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.

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, 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).