Novavax’s COVID vaccine finally wins FDA authorization for use in unvaccinated

Enlarge / Empty vials of the Novavax Inc. Nuvaxovid COVID-19 vaccine arranged at the Tegel Vaccine Center in Berlin, Germany, on Monday, March 7, 2022. (credit: Getty | Bloomberg )

The US Food and Drug Administration on Wednesday issued a long-awaited authorization for Novavax's COVID-19 vaccine. It is the fourth COVID-19 vaccine to gain authorization in the US, but it's the first to use a more conventional protein-subunit design.

For now, the two-dose vaccine is mainly aimed at the roughly 72 million Americans who have yet to receive one dose of a COVID-19 vaccine. The FDA's emergency use authorization only allows for its use as a primary series, not a booster for those already vaccinated. Though Novavax is expected to seek booster authorization later, the company and the FDA hope that the vaccine's traditional formulation will entice vaccination holdouts now, particularly as BA.5 sweeps the country.

Some consider the vaccine's protein-subunit design as a more tried-and-true design relative to the newer mRNA-based platform used in the leading COVID-19 vaccines made by Pfizer-BioNTech and Moderna. While mRNA-based vaccines made their public debut during the pandemic, protein-subunit-based vaccines were already in use against various diseases, including hepatitis B, flu, pertussis (whooping cough), and meningococcal infections.