The FDA has authorized emergency use of Novavax’s updated Covid booster, just over a week after clearing updated versions of mRNA boosters from Pfizer and Moderna.
Novavax’s shot is the only protein-based Covid vaccine available in the US, and uses noninfectious copies of the Covid spike protein to prime the immune system. Unlike boosters from Moderna and Pfizer that target the variant KP.2, Novavax’s vaccine is aimed at a “parent strain” called JN.1.
KP.2 descends from Omicron variant JN.1, as does KP.3.1.1., the country’s current most prevalent strain. KP.3.1.1 now accounts for 42.2% of all cases in the US, according to CDC data, while JN.1 and KP.2 represent 0.2% and 3.1% of cases, respectively.
The FDA’s Vaccines and Related Biological Products Advisory Committee originally recommended that manufacturers target JN.1 for updated boosters, but regulators changed course a week later, recommending KP.2 “if feasible” based on circulation data.
Novavax said Friday that its updated vaccine provides “protection and cross-reactivity” across JN.1 and its related variants, including KP.2.3, KP.3, KP.3.1.1 and LB.1.
“Today’s authorization enables Novavax to launch our updated COVID-19 vaccine in the U.S. in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide,” Novavax CEO John Jacobs said in a news release.
The vaccine is authorized for people 12 years and older.