Novavax asks FDA to authorize its Covid shot

Novavax has asked the Food and Drug Administration to authorize its Covid-19 shot for emergency use, opening the door for it to become the fourth vaccine available for adults living in the U.S.

“We believe our vaccine offers a differentiated option … that can be an alternative to the portfolio of available vaccines to help fight the Covid-19 pandemic,” Stanley Erck, the company’s president and chief executive officer, said in a statement. 

Background: The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time. But the company has lagged behind other manufacturers in readying its Covid shot for regulatory scrutiny. While federal officials have hoped that Novavax could serve as a safe and effective backup option, the company has struggled with domestic manufacturing. If authorized, the Serum Institute of India would be responsible for making the vaccine until other sites are ready.

How it stacks up: Late-stage trials in the U.S., Mexico and the U.K. showed that the shot was roughly 90 percent effective in preventing symptomatic disease — although these trials were conducted before the Delta and Omicron variants began circulating widely.