Novavax asked the Food and Drug Administration on Monday to authorize its protein-based COVID-19 vaccine for adults.
The vaccine is already available for use in at least 170 countries, but if cleared for emergency use in the United States, it would provide an alternative to the popular mRNA-based shots from Pfizer-BioNTech and Moderna.
For certain groups of people — particularly young men — the mRNA vaccines carry a slightly elevated risk of a heart condition called myocarditis. Novavax's vaccine has not been linked to myocarditis.
The decision will now go to the FDA, which is expected to take several weeks to review the application. Novavax CEO Stanley Erck has said the vaccine could be authorized by U.S. regulators as early as February.