The FDA has approved Novavax’s COVID-19 vaccine, Nuvavoxid, for use in adults 65 and older and in individuals ages 12-64 who have at least one underlying health condition.
The approval is based on phase 3 clinical trial data that showed that the protein-based vaccine is safe and effective in preventing COVID-19, according to a May 19 news release from Novavax.
However, the FDA is also requiring Novavax to conduct a phase 4 clinical trial in individuals ages 50-64 who do not have high-risk conditions.
Nuvavoxid has been available in the U.S. under emergency use authorization since July 2022, and unlike mRNA vaccines, Nuvavoxid uses a protein-based platform.
Novavax and Sanofi plan to distribute the updated formulation in the fall, pending final strain recommendations from the FDA’s vaccine advisory committee.
