FDA authorizes Novavax’s updated Covid vaccine, paving way for fall rollout

The Food and Drug Administration authorized Novavax's updated protein-based Covid vaccine for emergency use in people ages 12 and up on Friday, paving the way for the shot to compete with Pfizer and Moderna's jabs this fall and winter. 

Novavax's vaccine targets the highly contagious omicron subvariant JN.1, which began circulating widely in the U.S. earlier this year. JN.1 only accounted for 0.2% of cases circulating nationwide as of this week, according to the latest Centers for Disease Control and Prevention data. 

Novavax manufactures protein-based vaccines, which cannot be quickly updated to target another strain of the virus.

Despite that, the biotech company has noted that its shot provides protection against descendants of JN.1 that are currently dominant in the U.S., including KP.2.3, KP.3, KP.3.1.1 and LB.1.

"Our updated vaccine targets JN.1, the 'parent strain' of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses," Novavax CEO John Jacobs said in a statement.

Novavax said it expects its shot to be "broadly available" in thousands of locations across the U.S., including retail and independent pharmacies and regional grocers.

Shares of Novavax rose more than 8% on Friday following the announcement. 

The FDA's decision comes only a week after it approved a new round of messenger RNA shots from Pfizer and Moderna, which both target another offshoot of JN.1 called KP.2. Last year, the agency authorized Novavax's shot nearly a month after clearing vaccines from its rivals, putting the company at a disadvantage. 

Public health officials see Novavax's vaccine as a valuable alternative for people who don't want to take mRNA shots from Pfizer and Moderna, which use a newer