FDA Approves Emergency Use of Novavax COVID-19 Vaccine

Vaccine is given in two shots, three weeks apart

covid vaccine
Adobe Stock

THURSDAY, July 14, 2022 (HealthDay News) -- Unvaccinated Americans should soon have a fourth COVID-19 vaccine option.

On Wednesday, the Novavax offering was the latest to receive emergency use authorization from the U.S. Food and Drug Administration. Advisers to the U.S. Centers for Disease Control and Prevention will meet next week to decide who should be eligible for the shot.

"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, M.D., said in a statement. "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."

Right now, the Novavax shot is only authorized as an initial immunization series, so those who have gotten one of the three other COVID-19 vaccines cannot use it as a booster shot, The New York Times reported. The company plans to apply for booster authorization soon.

"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," Novavax President and CEO Stanley Erck said in a company statement. "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."

Novavax's vaccine is given in two shots, three weeks apart. The Biden administration plans to buy 3.2 million doses, enough for 1.6 million people.

The New York Times Article

Products