Novavax's closely watched COVID-19 vaccine is on track for full approval ... about vaccine safety. With full FDA approval, Novavax would have permission to keep its shot on the market indefinitely.

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must do to seek approval of vaccines, a move that comes as the Trump administration has introduced uncertainty into the annual process for green-lighting updated coronavirus shots traditionally offered in the fall.

Shares rose 10% to $7.41 in premarket trading on Monday. The stock is down 21% on the year. The biotechnology company said the FDA approved the biologics license application for Nuvaxovid to prevent Covid-19 in adults ages 65 and up and individuals ages 12 through 64 who have at least one underlying condition that puts them at high risk for severe outcomes from the coronavirus.