The Food and Drug Administration on Friday cleared Novavax’s coronavirus vaccine for emergency use in children 12 to 17 years old, giving adolescents a third option to prevent COVID-19 as they return to school.
The agency’s decision comes a month after the FDA authorized the shot for adults and more than a year after teenagers became eligible for the messenger RNA shots from Pfizer and, later, Moderna. The Centers for Disease Control and Prevention signed off on the FDA’s decision Monday.
The added option “will hopefully help increase vaccination rates … with the start of fall and the back-to-school season,” Novavax CEO Stanley Erck said in a statement.
Novavax believed its COVID-19 vaccine — the first that uses an older protein-based approach — could appeal to those hesitant to take shots that use the mRNA technology.
But its shot faces significant hurdles to gaining widespread use. Demand has weakened for COVID-19 vaccines and the shot’s late arrival has put it far behind Moderna’s and Pfizer’s dominant shots. About 608 million doses of all COVID-19 vaccines were administered in the U.S. through last week, according to CDC data. Only 11,990 of them were of Novavax’s shot.
Novavax’s shot is also limited to people who are unvaccinated. For children 12 to 17 years old, that means only 31%, or 7.7 million, of them are eligible to receive the Novavax shot. Uptake is slow with about 29,000 receiving their first dose last week, according to the American Academy of Pediatrics.
Novavax is also further behind on targeting the newer strains circulating in the population. Moderna and Pfizer are each advancing newer “bivalent” shots tailored to the omicron subvariants BA.4 and BA.5 that “will become available by early to mid September,” White House Covid-19 response coordinator Dr. Ashish Jha said last week. Pfizer and BioNTech filed for FDA authorization of an updated shot on Monday.
By comparison, Novavax expects to have clinical data for an omicron-targeting booster in September and for the vaccine to be available in the fourth quarter.
Novavax slashed its revenue forecast earlier this month, saying it does not expect any new U.S. sales in 2022 because of slowing demand. The U.S. government bought 3.2 million doses of the Novavax shot in July but is transitioning away from direct purchases to private market sales by 2023 as part of a longer-term approach to fighting the coronavirus pandemic.