FDA Grants Emergency Authorization to Novavax COVID-19 Vaccine

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Novavax for its adjuvanted vaccine against COVID-19 in adults aged ≥18 years old.

The indication concludes 2 years of clinical research and US regulation pursuit for the biotechnology, making the two-dose NVX-CoV2373 the fourth vaccine authorized by the FDA for prevention of the pandemic virus.

The protein-based vaccine is comprised of genetic original SARS-CoV-2 strain sequencing, with antigen derived from the Spike protein and formulated with a proprietary Novavax adjuvant designed to improve immune response and increase neutralizing antibody levels.

Last month, the FDA's Vaccines and Related Biologics Advisory Committee (VRBPAC) panel voted 21-1 to support the Novavax EUA application, with experts highlighting the benefit of an alternative COVID-19 background to the widely available messenger RNA (mRNA) regimens from Pfizer-BioNTech and Moderna.

Its emergency authorization was based on findings from the phase 3 pivotal PREVENT-19 trial, in which investigators assessed NVX-CoV2373 in approximately 30,000 participants aged ≥18 years old in the US and Mexico. PREVENT-19 data showed a 90.4% vaccine efficacy (95% CI, 83.8 - 94.3; P <.001) versus placebo.

Common solicited adverse reactions among vaccinated participants aged 18 - 64 years old included local pain (82.2%), fatigue (62.0%), muscle pain (54.1%) headache (52.9%), joint pain (25.4%), and nausea or vomiting (15.6%).

Among adults ≥65 administered the vaccine regimen, each of the common solicited adverse events were observed at lesser rates.

The federal government secured an initial 3.2 million doses of the Novavax vaccine earlier this week, with plans to make them available for free to the public, as administered by health care professionals.

Donald Alcendor, PhD, assistant professor of cancer biology at Meharry Medical College and adjunct associate professor of pathology, microbiology and immunology at Vanderbilt University School of Medicine, explained the distinct benefit of NVX-CoV2373 among currently marketed vaccines in an interview with sister publication Contagion.

“When you look at the 5 major vaccines...what you see is that Novavax is unique among all of them," he said. "What makes Novavax new and different is it gets rid of trying to teach your body how to make that protein; Novavax gives you the actual protein."

In a statement accompanying the EUA announcement, PREVENT-19 co-lead Karen Kotloff, MD, professor of pediatrics at University of Maryland School of Medicine and associate director of clinical studies at the Center for Vaccine Development and Global Health, emphasized the significance of introducing a protein-based COVID-19 vaccine to the US population.

“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,” Kotloff said.

Novavax president and chief executive officer Stanley C. Erck echoed a similar sentiment, stating the EUA underscores “the critical need to offer another vaccine option for the US population while the pandemic continues."

Approximately 222 million (67.5%) of the US population has been reported as fully vaccinated against COVID-19 as of Monday, according to Our World in Data. The 7-day average for new COVID-19 cases surpassed 130,000 as of Tuesday.