FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots

WASHINGTON – The Trump administration's effort to impose caller requirements connected Novavax's COVID-19 vaccine — the nation's lone traditional protein-based option for the coronavirus — is sowing uncertainty astir updates to different vaccines, too.

Novavax said Monday that the Food and Drug Administration was asking the institution to tally a caller objective proceedings of its vaccine aft the bureau grants afloat approval. The institution said it had responded and that it believed its changeable remains “approvable.”

But a play post connected societal media by FDA Commissioner Marty Makary suggested the imaginable of needing a caller proceedings earlier the shots' yearly strain update — thing improbable to beryllium imaginable earlier fall. That's raised questions astir whether other vaccines volition beryllium caught successful the turmoil.

“I don’t deliberation due to the fact that there’s a strain alteration that this is simply a caller product,” said Dr. Jesse Goodman of Georgetown University, a erstwhile FDA vaccine chief. If that’s the caller policy, “you’d ever beryllium doing objective trials and you’d ne'er person a vaccine that was up to date.”

The antithetic determination astatine FDA travel soon aft the agency's longtime vaccine chief was forced retired over disagreements with Makary's boss, Health Secretary Robert F. Kennedy Jr.

Kennedy won Senate confirmation to his job, successful part, by promising not to alteration 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 betwixt vaccines and autism, a nexus long-ago debunked.

The Novavax vaccine, which primitively showed effectiveness successful a astir 30,000-person objective trial, is inactive being sold nether exigency usage authorization successful the U.S. The nation's different 2 options, mRNA vaccines made by Pfizer and Moderna, person earned afloat FDA support for definite property groups.

Because the coronavirus continually mutates, manufacturers travel instructions from FDA to marque 1 alteration each twelvemonth to their look — which strain to people — conscionable similar flu vaccines.

The FDA was connected way to assistance Novavax afloat support by its April 1 people date, according to 2 radical with nonstop cognition of the concern who spoke connected information of anonymity to sermon confidential bureau matters. But Trump appointees directed FDA scientists to intermission their decision, according to 1 of the people. Since that highly antithetic move, Novavax and the bureau person been discussing further requirements for approval.

In his play tweet, FDA's Makary referred to the Novavax vaccine arsenic “a caller product,” presumably due to the fact that it had been updated to lucifer past year's communal coronavirus strain.

“New products necessitate caller objective studies,” Makary added.

An medication spokesperson didn't respond to circumstantial questions astir Pfizer and Moderna but suggested each COVID-19 vaccines could look stricter requirements.

“It’s present been years since COVID has presented the menace it erstwhile did, and the urgency to unreserved support of boosters without mean oversight nary longer exists,” said Andrew Nixon, a Health and Human Services spokesman, successful a statement.

The FDA had been treating the yearly COVID-19 strain updates precisely arsenic it's done for decades with flu vaccines — not arsenic caller products, but existing ones that are simply adjusted to support against the latest strains, said Dr. Paul Offit, a vaccine adept astatine Children's Hospital of Philadelphia.

Offit said the companies inactive indispensable execute tests successful tiny numbers of radical that amusement these updated vaccines nutrient levels of virus-fighting antibodies known to beryllium protective, and they're intimately monitored for safety.

Nixon, the HHS spokesman, suggested the argumentation mightiness not use to the flu shot, “which has been tried and tested for much than 80 years.”

Under national law, the FDA is required to travel established procedures erstwhile issuing requirements to drugmakers for approval. If the bureau skips definite steps oregon imposes further requirements for governmental reasons, experts say, it could beryllium sued by drugmakers — oregon adjacent patients, specified arsenic those who similar the Novavax vaccine implicit its competitors due to the fact that of an allergy oregon immoderate different reason.

In summation to ample objective trials conducted earlier each 3 COVID-19 vaccines were cleared for use, there's information connected real-world use, said erstwhile Health Secretary Xavier Becerra, who oversaw COVID-19 vaccine argumentation during the Biden administration.

“At the constituent wherever I had left, we had enactment immoderate 700 cardinal COVID vaccines into the arms of Americans,” helium said. "That’s a beauteous bully size objective trial."

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AP writer Amanda Seitz contributed to this story

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