New Trump vaccine policy limits access to COVID shots
[May 21, 2025]
By MATTHEW PERRONE and LAURAN NEERGAARD
WASHINGTON (AP) — The Trump administration said Tuesday it will limit
approval for seasonal COVID-19 shots to seniors and others at high risk
pending more data on everyone else — raising questions about whether
some people who want a vaccine this fall will be able to get one.
Top officials for the Food and Drug Administration laid out new
standards for updated COVID shots, saying they'd continue to use a
streamlined approach to make them available to adults 65 and older as
well as children and younger adults with at least one high-risk health
problem.
But the FDA framework, published Tuesday in the New England Journal of
Medicine, urges companies to conduct large, lengthy studies before
tweaked vaccines can be approved for healthier people. It's a stark
break from the previous federal policy recommending an annual COVID shot
for all Americans six months and older. In the paper and a subsequent
online webcast, the FDA's top vaccine official said more than 100
million Americans still should qualify for what he termed a booster
under the new guidance.
Dr. Vinay Prasad described the new approach as a “reasonable compromise”
that will allow vaccinations in high-risk groups to continue while
generating new data about whether they still benefit healthier people.
"For many Americans we simply do not know the answer as to whether or
not they should be getting the seventh or eighth or ninth or tenth
COVID-19 booster,” said Prasad, who joined the FDA earlier this month.
He previously spent more than a decade in academia, frequently
criticizing the FDA's handling of drug and vaccine approvals.
It's unclear what the upcoming changes mean for people who may still
want a fall COVID-19 shot but don't clearly fit into one of the
categories.
“Is the pharmacist going to determine if you're in a high-risk group?”
asked Dr. Paul Offit, a vaccine expert at Children's Hospital of
Philadelphia. “The only thing that can come of this will make vaccines
less insurable and less available.”
The nation's leading pediatrics group said FDA's approach will limit
options for parents and their children.
“If the vaccine were no longer available or covered by insurance, it
will take the choice away from families who wish to protect their
children from COVID-19, especially among families already facing
barriers to care,” said Dr. Sean O'Leary of the American Academy of
Pediatrics.
Provisional data from the Centers for Disease Control and Prevention
shows more than 47,000 Americans died from COVID-related causes last
year. The virus was the underlying cause for two-thirds of those and it
was a contributing factor for the rest. Among them were 231 children
whose deaths were deemed COVID-related, 134 of them where the virus was
the direct cause -- numbers similar to yearly pediatric deaths from the
flu.
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 The new FDA approach is the
culmination of a series of recent steps under Health Secretary
Robert F. Kennedy Jr. scrutinizing the use of COVID shots and
raising questions about the broader availability of vaccines. It was
released two days ahead of the first meeting of FDA’s outside
vaccine experts under Trump.
Last week the FDA granted full approval of Novavax's COVID-19
vaccine but with major restrictions on who can get it — and
Tuesday's guidance mirrors those restrictions. The approval came
after Trump appointees overruled FDA scientists' earlier plans to
approve the shot without restrictions.
Pfizer and Moderna, makers of the most commonly used COVID shots,
each said they would continue to work with the agency.
For years, federal health officials have told most Americans to
expect annual updates to COVID-19 vaccines, similar to the annual
flu shot. Just like with flu vaccines, until now the FDA has
approved updated COVID shots so long as they show as much immune
protection as the previous year's version.
But FDA's new guidance appears to be the end of that approach,
according to Prasad and FDA Commissioner Marty Makary, who
co-authored the journal paper and joined the FDA webcast.
Prasad and Makary criticized the U.S.’s “one-size-fits-all,”
contrasting it with some European countries that recommend boosters
based on age, risk and other factors.
Prasad said the FDA will ask all manufacturers to do new clinical
trials in healthy people ages 50 to 64, randomly assigning them to
get a vaccine or a placebo and tracking outcomes with special
attention to severe disease, hospitalization or death. Companies
might need to repeat that requirement for future vaccine approvals
if there's a large virus mutation rather than the past year's
incremental evolution. Companies are also free to test their
vaccines for approval in younger adults and children, Prasad said,
adding “this is a free country.”
Since becoming the nation's top health official in February, Kennedy
has filled the FDA and other health agencies with outspoken critics
of the government’s handling of COVID shots, including Makary and
Prasad. Under federal procedures, the FDA releases new guidance in
draft form and allows the public to comment before finalizing its
plans. The publication of Tuesday's policy in a medical journal is
highly unusual and could run afoul of federal procedures, according
to FDA experts.
Health experts say there are legitimate questions about how much
everyone still benefits from yearly COVID vaccination or whether
they should be recommended only for people at increased risk.
In June, an influential panel of advisers to the CDC is set to
debate which vaccines should be recommended to which groups.
The FDA's announcement appears to usurp that advisory panel's job,
Offit said. He added that CDC studies have made clear that booster
doses do offer protection against mild to moderate illness for four
to six months after the shot even in healthy people.
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