FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other
shots
[April 29, 2025]
By LAURAN NEERGAARD and MATTHEW PERRONE
WASHINGTON (AP) — 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 approval.
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 In his weekend tweet, FDA's Makary
referred to the Novavax vaccine as “a new product,” presumably
because it had been updated to match last year's common coronavirus
strain.
“New products require new clinical studies,” Makary added.
An administration spokesman didn't respond to specific questions
about Pfizer and Moderna but suggested all COVID-19 vaccines could
face stricter requirements.
“It’s now been years since COVID has presented the threat it once
did, and the urgency to rush approval of boosters without normal
oversight no longer exists,” said Andrew Nixon, a Health and Human
Services spokesman, in a statement.
The FDA had been treating the annual COVID-19 strain updates exactly
as it's done for decades with flu vaccines — not as new products,
but existing ones that are merely adjusted to protect against the
latest strains, said Dr. Paul Offit, a vaccine expert at Children's
Hospital of Philadelphia.
Offit said the companies still must perform tests in small numbers
of people that show these updated vaccines produce levels of
virus-fighting antibodies known to be protective, and they're
closely monitored for safety.
Nixon, the HHS spokesman, suggested the policy might not apply to
the flu shot, “which has been tried and tested for more than 80
years.”
Under federal law, the FDA is required to follow established
procedures when issuing requirements to drugmakers for approval. If
the agency skips certain steps or imposes additional requirements
for political reasons, experts say, it could be sued by drugmakers —
or even patients, such as those who prefer the Novavax vaccine over
its competitors because of an allergy or some other reason.
In addition to large clinical trials conducted before all three
COVID-19 vaccines were cleared for use, there's data on real-world
use, said former Health Secretary Xavier Becerra, who oversaw
COVID-19 vaccine policy during the Biden administration.
“At the point where I had left, we had put some 700 million COVID
vaccines into the arms of Americans,” he said. "That’s a pretty good
size clinical trial."
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AP writer Amanda Seitz contributed to this story
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