FDA nod for Novavax Covid vax, with stricter new conditions

The Food and Drug Administration on Friday approved the Novavax Covid-19 vaccine, but only for older adults and for others older than 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 FDA’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 younger than 65 who are in good health.

The vaccine had previously been authorised under emergency use. Covid vaccines developed by Pfizer and Moderna, which are more widely used by Americans, were granted full approval in 2022. For companies working on updated shots for the fall, the new riders portend a more restrictive approach from the FDA.

The FDA’s new restrictions appear 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.