Novavax on Friday filed final data with the Food and Drug Administration for its COVID-19 vaccine, clearing the way for a potential emergency approval next year.
The move was the last step for the Maryland-based biotechnology company to fulfill prerequisites for its protein-based vaccine, which is different than the other three vaccines approved in the U.S. from Pfizer, Moderna and Johnson & Johnson.
If all goes well, Novavax could seek emergency approval next month as the U.S. continues to prioritize booster shots amid a spike in confirmed coronavirus cases driven by the highly transmissible omicron variant.
"Novavax is committed to delivering our protein-based vaccine in the United States, where the COVID-19 pandemic continues to evolve with the emergence of new variants," Stanley Erck, the president and CEO of Novavax, said in a statement.