By Kamal Choudhury
(Reuters) -Novavax shares jumped more than 15% on Monday after the company secured a long-awaited U.S. regulatory approval for its COVID-19 vaccine, albeit with new conditions, which helped allay some investor concerns over the future of the shot.
The U.S. Food and Drug Administration approved the vaccine, Nuvaxovid, but limited its use to individuals aged 65 and older and people over 12 years who have at least one underlying condition that puts them at high risk due to the illness.
The conditions on the label are medically unusual but consistent with the chatter to date, said BTIG analyst Thomas Shrader.
The vaccine’s future was called into question after the FDA missed its April 1 deadline to approve the shot — a more traditional protein-based vaccine unlike its messenger RNA-based rivals from Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE).
The approval will provide "a reassuring alternative" for those skeptical for mRNA shots, said William Schaffner, professor of infectious diseases at Vanderbilt University Medical Center.
It, however, was "a bit unusual" for the FDA to specify age groups and usage circumstances as it is usually done by the Centers for Disease Control and Prevention’s advisory committee, he said.
Novavax (NASDAQ:NVAX) now expects to be ready for commercial delivery of the vaccine in the U.S. this fall in partnership with France’s Sanofi (NASDAQ:SNY), with which it has a licensing deal, pending strain recommendation.
Novavax, along with its competitors, will need to seek additional approval to alter the strain of the virus its vaccine targets for the upcoming immunization season. The topic is set for discussion at a meeting of FDA vaccine advisers later this week.
The regulator has asked Novavax for post-marketing studies in individuals aged 50 through 64 without high-risk conditions for severe COVID-19.
The vaccine maker is working closely with Sanofi to assess funding and execution of this new trial, it said.
The full approval has triggered a $175 million milestone payment to Novavax from Sanofi.