WASHINGTON — The Trump administration’s effort to impose new requirements on Novavax’s COVID-19 vaccine — the nation’s only traditional protein-based option for the coronavirus — is sowing uncertainty about updates to other vaccines, too.
Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine after the agency grants full approval. The company said it had responded and that it believed its shot remains “approvable.”
But a weekend post on social media by FDA Commissioner Marty Makary suggested the prospect of needing a new trial before the shots’ yearly strain update — something unlikely to be possible before fall. That’s raised questions about whether other vaccines will be caught in the turmoil.
“I don’t think because there’s a strain change that this is a new product,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. If that’s the new policy, “you’d always be doing clinical trials and you’d never have a vaccine that was up to date.”
The unusual move at FDA come shortly after the agency’s longtime vaccine chief was forced out over disagreements with Makary’s boss, Health Secretary Robert F. Kennedy Jr.
Kennedy won Senate confirmation to his job, in part, by promising not to change the nation’s vaccine schedule. Since taking office, he’s promised to “investigate” children’s shots, canceled meetings of expert vaccine advisers and directed officials to look again for connections between vaccines and autism, a link long-ago debunked.
The Novavax vaccine, which originally showed effectiveness in a nearly 30,000-person clinical trial, is still being sold under emergency use authorization in the U.S. The nation’s other two options, mRNA vaccines made by Pfizer and Moderna, have earned full FDA approval for certain age groups.
Because the coronavirus continually mutates, manufacturers follow instructions from FDA to make one change each year to their recipe — which strain to target — just like flu vaccines.
The FDA was on track to grant Novavax full approval by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss confidential agency matters. But Trump appointees directed FDA scientists to pause their decision, according to one of the people. Since that highly unusual move, Novavax and the agency have been discussing additional requirements for