The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others over age 12 who have at least one medical condition that puts them at high risk from Covid.
Scientific advisers to the Centers for Disease Control and Prevention, who typically make decisions on who should get approved shots and when, have been debating whether to recommend Covid shots only to the most vulnerable Americans. The F.D.A.’s decision appeared to render at least part of their discussion moot.
The new restriction will sharply limit access to the Novavax vaccine for people under 65 who are in good health. It may leave Americans who do not have underlying conditions at risk if a more virulent version of the coronavirus were to emerge. It could also limit options for people who want the vaccine for a wide array of reasons, including to protect a vulnerable loved one.
The vaccine had previously been authorized under emergency use. Covid vaccines developed by Pfizer-BioNTech and Moderna, which are more widely used by Americans, were granted full approval in 2022. However, the companies are working on updated shots for the fall, and the new restrictions on the Novavax shot portend a more restrictive approach from the F.D.A.
The F.D.A.’s new restrictions also appeared to reflect the high degree of skepticism about vaccines from Robert F. Kennedy Jr., the health secretary, and the other leaders he has appointed at health agencies.
“This is incredibly disappointing,” said Dr. Camille Kotton, an infectious disease physician at Massachusetts General Hospital who cares for immunocompromised patients, and a former adviser to the C.D.C.
”I don’t know why they would make this restriction; I don’t know of any indication to make this change,” Dr. Kotton said, adding that many people are still hospitalized and dying as a result of Covid. “This is a dark day in American medicine.”
The approval of the shot, called Nuvaxovid, requires the company to complete studies on whether the vaccine is associated with several heart conditions. Some of the required research is possible to complete with available data.
But one new study would most likely require the company to follow thousands of healthy people who are 50 to 65 years old who take either the vaccine or a placebo. That study could cost tens of millions of dollars, at least, according to people familiar with such work.