Help Register Login Login Hi, %{firstName}% Hi, %{firstName}% Games Car rental The U.S. Food and Drug Administration (FDA) has officially approved a COVID-19 vaccine from Novavax for adults 65 and older and for individuals ages 12 to 64 who have an underlying health condition that puts them at higher risk for serious illness from a coronavirus infection.

Novavax had expected full approval for broader use by April 1, after the FDA reviewed data from a 30,000-person clinical trial showing the vaccine was safe and effective. But instead of a broad approval, the FDA asked the company to conduct more research.

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.

After a six-week delay, the US Food and Drug Administration has approved Novavax’s Covid-19 vaccine, according to a letter from the agency, but only for people 65 and older and those 12 and up who have at least one underlying condition that puts them at higher risk of severe illness.

The U.S. Food and Drug Administration approved Novavax's COVIDd-19 vaccine with age restrictions after a six-week delay.

The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.

Regulators will soon “unleash a massive framework” for how vaccines are tested and approved, according to FDA Commissioner Marty Makary.

Novavax today announced that the US Food and Drug Administration (FDA) has approved full licensure for its COVID-19 vaccine, Nuvaxovid, which had been used since July 2022 under an emergency use authorization.

While the clearance is only for use in certain groups, Novavax’s long-awaited OK is still seen by analysts as a “win” for the company.

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.