Fda Scrutiny Of Novavax Covid-19 Vaccine Sparks Uncertainty About Other Shots

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.