The Food and Drug Administration has approved the Novavax COVID-19 vaccine—with strict conditions.
Coming after four years of clinical trials, the vaccine will only be available for older adults and people over the age of 12 who have at least one medical condition that means they’re at high risk from COVID, according to The New York Times.
Advisers at the Centers for Disease Control and Prevention have been debating whether to recommend COVID vaccines for only the most vulnerable. The decision to restrict who can access the Novavax vaccine would appear to resolve the question, at least in part.
The restrictions mean that healthy adults under the age of 65 who may want the vaccine for reasons other than their own health—to protect an immunocompromised relative or friend, for example—will not be able to get the Novavax vaccine. It also leaves those same people vulnerable if a more virulent strain of COVID comes along.
Critics have expressed concern that the restrictions reflect Health Secretary Robert F. Kennedy Jr‘s vaccine skepticism, with one ousted FDA vaccine chief describing Kennedy’s tenure thus far as “very scary.”
The vaccine was previously only authorized for emergency use, whereas vaccines developed by Pfizer-BioNTech and Moderna were granted full approval by the FDA in 2022. Both of those companies are currently developing updated versions of their vaccines for the fall.
The New York Times spoke to Dr. Camille Kotton, an infectious disease physician and former CDC adviser, who said that the decision to restrict access was “incredibly disappointing.” She continued, “I don’t know why they would make this restriction; I don’t know of any indication to make this change.“
Kotton, who cares for immunocompromised patients at Massachusetts General Hospital, added, “This is a dark day in American medicine.”
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