Novavax files COVID-19 vaccine data with FDA

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.

Novavax submits final data packages to U.S. FDA as prerequisite to Emergency Use Authorization (EUA) application request for COVID-19 Vaccine Candidate. Learn more: https://t.co/y4cPQjQfgr pic.twitter.com/S5KUAIsW4f

— Novavax (@Novavax) December 31, 2021

Novavax is partnering with the Serum Institute of India, one of the largest vaccine manufacturers in the world, to deliver NVX-CoV2373.

The vaccine is derived from the spike protein pulled from the very first strain of the novel coronavirus, and is bolstered by an adjuvant, or an ingredient that enhances the immune system’s response.

A phase three trial in the U.S. and Mexico, with more than 25,000 participants, proved a vaccine efficacy of about 90 percent for the vaccine.