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.
“We’ve got to make sure the vaccine safety is crystal clear to engender public confidence,” said Dr. Ofer Levy, director of the precision vaccine program at Boston Children’s Hospital and an adviser to the F.D.A. on vaccines.
“On the other hand, where’s that line where you put in too much regulation, it starts to become so challenging that the economics of even making a vaccine are called into question?” Dr. Levy said. “I don’t pretend to know the answer.”
The F.D.A. said that a study of the Novavax shot in people younger than 12 is underway.
John C. Jacobs, the Novavax chief executive, said the approval was a “significant milestone” solidifying a pathway for the people who are most likely to seek out Covid vaccination to get the company’s shot.
The new restrictions on the shot could create a raft of problems for those who want the vaccine. For one, the approval document is unclear about what qualifies as an underlying condition. Prescribing the shots in healthy people under 65 would be considered off-label use, making it less likely that insurers would broadly cover the shots.
”I think we’re left confused about what this means for the consumer,” said Dr. Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia and an adviser to the F.D.A.
“I think the goal of Robert F. Kennedy Jr. is to make vaccines less available, more expensive and more feared,” Dr. Offit said. “His goal is to tear away at the vaccine infrastructure, because he believes that vaccines are not beneficial and are only harmful.”
Approval of the Novavax Covid shot also bucks norms that have been in place since the vaccines were first approved. This is the first time that the F.D.A. has included health criteria for Covid shots. Those decisions are typically made by the C.D.C.’s advisers.
Insurance carriers are required to cover vaccines recommended by the advisers, but the panel usually cannot expand the vaccine’s use beyond the bounds of the F.D.A. approval.
Novavax’s Covid shot was the last to become available during the pandemic because of unexpected manufacturing problems. It has been offered under emergency authorization since July 2022.
On Thursday, Dr. Marty Makary, who leads the F.D.A., said the agency would soon release a new framework for evaluating Covid shots. A meeting is scheduled for this coming Thursday to select the version of the virus that the fall Covid shots will cover.
Nuvaxovid is based on a more traditional vaccine platform, and is generally thought to have fewer side effects. It has served as an attractive alternative for those who are wary of the newer technology used in the mRNA vaccines made by Pfizer-BioNTech and Moderna.
“I have been recommending this vaccine for everyone who is mRNA-vaccine reluctant,” Dr. Kotton said. She said she and her two sons all opted for Novavax last fall, but none of them would qualify under the new criteria.
