RFK Jr. pledged not to upend US vaccine system, but big changes are
underway
[May 20, 2025]
By MATTHEW PERRONE and LAURAN NEERGAARD
WASHINGTON (AP) — Robert F. Kennedy Jr. clinched the political support
needed to become the nation’s top health official by pledging to work
within the decades-old federal system for approval and use of vaccines.
Yet his regulators are promising big changes that cloud the outlook for
what shots might even be available.
The Food and Drug Administration will soon “unleash a massive framework”
for how vaccines are tested and approved, according to Commissioner
Marty Makary. Details aren't yet public but the plan is being overseen
by the agency's new vaccine chief, Dr. Vinay Prasad, an outspoken critic
of the FDA's handling of COVID-19 boosters.
Makary and other Trump administration officials already have taken
unprecedented steps that raise uncertainty about next fall's COVID-19
vaccinations, including delaying FDA scientists' full approval of
Novavax's shot — and then restricting its use to people at higher risk
from the virus. They've also suggested seasonal tweaks to match the
latest circulating virus strains are new products requiring extra
testing.
The changes cross multiple health agencies.
The Centers for Disease Control and Prevention hasn't yet acted on an
influential advisory panel's recent recommendations on use of a new
meningitis shot or broader RSV vaccination. A meeting of Kennedy's “Make
America Healthy Again” allies was recently told to expect an end to
COVID-19 booster recommendations for children — something that vaccine
advisory panel was supposed to debate in June. And researchers around
the country lost National Institutes of Health funding to study vaccine
hesitancy.
“I think you have to assume that RFK Jr.’s intention is to make it
harder for vaccines to come to market,” said Dr. Amesh Adalja, a vaccine
expert at Johns Hopkins University. The changes are “looked at
suspiciously because this is someone with a proven track record of
evading the value of vaccines.”
Raising doubts about vaccines
In a Senate health committee hearing last week, Kennedy wrongly claimed
that the only vaccines tested against a placebo, or dummy shot, were for
COVID-19.
Sen. Bill Cassidy, a Louisiana Republican who chairs the committee,
briefly interrupted the hearing to say, “For the record, that’s not
true" — pointing to placebo-controlled studies of the rotavirus, measles
and HPV vaccines.
Concerned by rhetoric about how vaccines are tested, a group of doctors
recently compiled a list of more than 120 vaccine clinical trials
spanning decades, most of them placebo-controlled, including for shots
against polio, hepatitis B, mumps and tetanus.
“It directly debunks the claim that vaccines were never tested against
placebo,” said Dr. Jake Scott, a Stanford University infectious disease
physician who’s helping lead the project.
Antivaccine groups argue that some substances scientists call a placebo
may not really qualify, although the list shows simple saline shots are
common.
Sometimes a vaccine causes enough shot-site pain or swelling that it’s
evident who’s getting the vaccine and who’s in the control group — and
studies might use another option that slightly irritates the skin to
keep the test “blinded,” Scott explained.
And when there’s already a proven vaccine for the same disease, it’s
unethical to test a new version against a placebo, he said.
“We can’t always expect placebo-controlled trials,” Scott said. “It’s
imperative that be communicated clearly to the public, but it’s
challenging especially when there’s so much noise in social media and so
much misinformation.”
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Secretary of Health and Human Services Robert F. Kennedy Jr. appears
at a budget hearing before a House Appropriations, Subcommittee
hearing, Wednesday, May 14, 2025, in Washington. (AP Photo/Kevin
Wolf)
 Trump officials held up vaccine
decision
The administration's promise of a new vaccine framework comes ahead
of a Thursday meeting where FDA advisers will discuss updating
COVID-19 shots for this fall and winter.
The FDA’s credibility has long rested on the independence of its
scientific decisions. While the agency is led by a handful of
political appointees, approval decisions are almost always handled
by career scientists.
But that standard appears to be shifting. FDA staffers were poised
to approve Novavax’s vaccine early last month but the decision was
delayed by administration officials, including Makary, according to
two people with direct knowledge of the situation who spoke on
condition of anonymity to discuss agency matters. The shot was
approved late Friday with unusual restrictions.
Dr. Tracy Beth Hoeg — a political appointee serving as Makary's
special assistant — was involved in the unprecedented demand that
Novavax conduct a new clinical trial of its shot after approval,
according to the people. The requirement came shortly after the
agency's longtime vaccine chief, Dr. Peter Marks, was forced to
resign.
Hoeg — along with Makary and Prasad — spent much of the COVID-19
pandemic criticizing the FDA’s handling of booster shots,
particularly in children and young adults. All three were co-authors
of a 2022 paper stating that requiring booster shots in young people
would cause more harm than benefit.
Novavax isn’t the only vaccine manufacturer already affected by
changing attitudes at FDA. Earlier this month, Moderna pushed back
the target date for its new COVID-and-flu combination vaccine to
next year after the FDA requested additional effectiveness data.
COVID-19 booster critics are in control
As the FDA’s top official overseeing vaccines, Prasad is now in
position to reverse what he recently called “a number of missteps”
in how the FDA assessed the benefits and risks of COVID-19 boosters.
He questioned how much benefit yearly vaccinations continue to
offer. In a podcast shortly before assuming his FDA job, Prasad
suggested companies could study about 20,000 older adults in August
or September to show if an updated vaccine prevented COVID-related
hospitalizations.
There is “legitimate debate about who should be boosted, how
frequently they should be boosted and the value of boosting low-risk
individuals,” said Hopkins' Adalja. But he stressed that CDC's
Advisory Committee on Immunization Practices has the proper
expertise to be making those decisions.
And other experts say simply updating the strain that a COVID-19
vaccine targets doesn't make it a new product — and real-world data
shows each fall's update has offered benefit.
"The data are clear and compelling” that vaccination reduces
seniors' risk of hospitalization and serious illness for four to six
months, said Michael Osterholm, a University of Minnesota infectious
disease researcher.
Nor could that kind of study be accomplished quickly enough to get
millions of people vaccinated before the yearly winter surge, said
Dr. Jesse Goodman of Georgetown University, a former FDA vaccine
chief.
"You'd always be doing clinical trials and you'd never have a
vaccine that was up to date,” he said.
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