FDA authorizes Novavax COVID-19 Vaccine, Adjuvanted for emergency use on severe adult cases

Bolstering the number of options for use against SARS-CoV-2, the United States Food and Drug Administration (FDA) issued an emergency use authorization (EUA) this week for the Novavax COVID-19 Vaccine, Adjuvanted.

This authorization greenlit the vaccine for use on those at least 18 years old and suffering severe cases of SARS-CoV-2. The two-dose series is based on the SARS-CoV-2 spike protein and the Matrix-M adjuvant. It was assessed through an ongoing, randomized, blinded, placebo-controlled study in the U.S. and Mexico that provided vaccines to approximately 17,200 people and placebos to another 8,300.

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” FDA Commissioner Robert Califf said. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19, and I encourage anyone who is eligible for but has not yet received a COVID-19 vaccine to consider doing so.”

From testing, the FDA determined the known and potential benefits of the vaccine outweigh its known and potential risks. The Novavax COVID-19 Vaccine, Adjuvanted, showcased an overall efficacy of 90.4 percent in preventing mild, moderate, and severe cases of COVID-19. Notably, this decreased to 78.6 percent efficacy among those 65 years old and older.

Additionally, all of this data was compiled before the delta and omicron variants emerged, so it is unknown how effective the vaccine is with those evolutions of SARS-CoV-2.