WASHINGTON — Moderna Inc.’s vaccine for COVID-19 received full approval from the U.S. Food and Drug Administration for people 18 and older, an important milestone that bolsters the shot’s use as a major weapon against the virus.
The vaccine, which goes by the brand name Spikevax, had previously been available to adults in the U.S. under an emergency use authorization from the FDA. But the full clearance lets Moderna market the vaccine to adults with the full imprimatur of the FDA.
Moderna shares climbed 2.8% to $163.93. The company began its rolling submission for the approval last June. Pfizer Inc. has the only other fully authorized vaccine in the U.S., cleared by the FDA in August.
Meanwhile, Novavax Inc. said it had filed with U.S. regulators requesting emergency authorization for its COVID-19 vaccine in the U.S. for adults 18 and over.
Authorization of the vaccine could bring a third type of COVID-19 vaccine to the market in the United States, in addition to the messenger RNA and adenovirus vaccines that have been the mainstay of the vaccine rollout so far. By contrast, Novavax uses more tried-and-true technology to create a vaccine made up of genetically engineered spike proteins.
The vaccine uses protein technology that doesn’t require it to be frozen, making it particularly useful for far-flung locations without the cold-chain infrastructure needed for messenger RNA vaccines. The company is also testing a third booster shot.
