A dozen former FDA leaders lambaste claims by the agency's current
vaccine chief
[December 04, 2025]
By LAURAN NEERGAARD and LAURA UNGAR
WASHINGTON (AP) — A dozen prior leaders of the U.S. Food and Drug
Administration — appointed by Republicans and Democrats alike — issued a
scathing denunciation of new FDA assertions casting doubt on vaccine
safety.
The former officials say the agency's plans to revamp how life-saving
vaccines for flu, COVID-19 and other respiratory diseases are handled —
outlined in an internal FDA memo last week — would “disadvantage the
people the FDA exists to protect, including millions of Americans at
high risk from serious infections.”
“The proposed new directives are not small adjustments or coherent
policy updates. They represent a major shift in the FDA’s understanding
of its job,” the officials, former FDA commissioners and acting
commissioners, wrote Wednesday in The New England Journal of Medicine.
The internal memo by FDA vaccine chief Dr. Vinay Prasad hasn't been
publicly released. The document claimed — without providing evidence —
that COVID-19 vaccines caused 10 children’s deaths. It went on to
outline planned agency changes in handling those and certain other
vaccines, and said that FDA staff who disagreed should resign.
Among Prasad's plans were revising how yearly flu shot updates are
handled and focusing more on “the benefits and harms of giving multiple
vaccines at the same time." A common message of vaccine skeptics is that
too many shots may overwhelm kids' immune systems or that ingredients
may build up to cause harm — although scientists say repeated research
into those claims has turned up no concerns.
On Wednesday, the former FDA leaders wrote that Prasad’s claim about
child deaths related to COVID-19 vaccines had been reported to a
surveillance system that doesn’t contain medical records or other
information sufficient to prove a link — and that government scientists
had carefully combed through those reports in previous years, reaching
different conclusions. They also noted that “substantial evidence” shows
COVID-19 vaccines reduce children’s risk of severe disease and
hospitalization.
But the bigger picture, the former FDA leaders argued, is that the new
proposals would reject long-standing science about how to evaluate
vaccines being updated to better match virus strains, slow innovation to
replace older vaccines with newer, potentially better ones, and make the
process less transparent to the public.
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Health and Human Services Secretary Robert F. Kennedy Jr. speaks
during a news conference at the Hubert Humphrey Building Auditorium
in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, file)
 A spokesperson for the Department of
Health and Human Services said in a statement Wednesday night, “The
fact these criticisms are coming from former FDA officials who
opposed raising the bar for vaccine science confirms we are on the
right track."
Many doctors and public health experts also have expressed alarm
about the memo.
“Vaccines save lives, period,” Dr. Ronald Nahass, president of the
Infectious Diseases Society of America, said in a statement. “It is
a sad day when FDA creates confusion and mistrust without supplying
evidence, spreading propaganda that makes lifesaving vaccines harder
to access and that creates additional confusion and mistrust for the
public.”
The FDA's planned vaccine changes come at a time when Health
Secretary Robert F. Kennedy Jr. — who helped lead the anti-vaccine
movement for years — is seeking to broadly remake federal policies
on vaccines.
Kennedy already ousted a committee that advised the Centers for
Disease Control and Prevention on vaccine recommendation and
replaced it with handpicked members. And in August, he fired Susan
Monarez 29 days into her tenure as CDC chief over vaccine policy
disagreements. The CDC's vaccine advisory committee will meet
Thursday and Friday to discuss h epatitis B vaccinations in newborns
and other vaccine topics.
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Ungar reported from Louisville, Kentucky. Associated Press writer
Ali Swenson contributed to this report.
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