By Grayson Logue
Monday, September 22, 2025
The Centers for Disease Control and Prevention’s Advisory
Committee on Immunization Practices (ACIP) met last week to review part of the
agency’s vaccine schedule. The independent panel considered proposed changes to
recommendations for the measles, mumps, rubella, and varicella (MMRV) vaccine;
hepatitis B vaccine; and COVID vaccine.
For years, hundreds of laws and regulations across
virtually every
state and several U.S. territories have incorporated the recommendations of
the panel. But Health and Human Services Secretary Robert F. Kennedy Jr. overhauled
the panel in June and stocked it with like-minded vaccine skeptics, prompting
medical associations and states to begin unwinding
their reliance ACIP guidance.
The Thursday-Friday meeting—the second since Kennedy took
the unprecedented step of firing all 17 previous ACIP members and the first
since he added five additional members just days earlier—further splintered the
previous consensus about who should get what vaccines, and when.
Lawmakers, medical associations, and former public health
officials had feared that the re-made committee would narrow or remove
recommendations for some vaccines at the meeting last week, not on the basis of
new scientific findings or data, but in furtherance of the secretary’s
anti-vaccine agenda. Indeed, the recently fired CDC Director Susan Monarez
testified before Congress last week that Kennedy had asked her to commit to
rubber-stamping whatever the committee decided regardless of the scientific evidence.
The results of the meeting were a mixed bag. ACIP tabled
a planned vote to recommend delaying the first dose of the hepatitis B vaccine
from birth to at least 1 month of age if the mother tests negative for the
disease. But the committee rescinded its recommendation for the combination
MMRV vaccine for children under age 4. The recommendation for a two-shot series
of a separate MMR vaccine and chickenpox (varicella) vaccine for young children
remained unchanged.
The panel also revoked the recommendation encouraging
routine COVID vaccination and replaced it with language recommending that
individuals 6 months and older consult with health care providers, a practice
known as shared clinical decision-making (SCDM),
about COVID immunization.
What’s the difference? As the CDC explains
on its site, a routine recommendation’s guidance is that “the default decision
should be to vaccinate the patient based on age group or other indication,
unless contraindicated. For shared clinical decision-making recommendations,
there is no default.” A member of ACIP’s COVID work group noted
during the meeting that under SCDM, “vaccination is often interpreted as
optional.”
The panel split 6-6 on a separate vote to require a
prescription to get a COVID vaccine; the committee’s chair, Martin Kulldorff,
broke the tie by voting no. Some members appeared
unaware of how a prescription requirement would impact vaccine access.
Kulldorff also said
during the meeting that the committee doesn’t have the authority to establish a
prescription requirement.
The shift in recommendations stops short of removing the
vaccine from the schedule entirely, and HHS has said in a
statement that insurers would continue to cover vaccination. But in the
immediate aftermath of the meeting, it is unclear
exactly how the new guidance will affect vaccine access. Multiple committee
members themselves voiced
confusion on what their votes actually meant for healthy people and for
vulnerable populations trying to get vaccinated. How the panel’s changes affect
access to vaccines will vary by location and how state laws integrate ACIP
recommendations.
A further complicating factor is that the Food and Drug
Administration’s approvals for the latest COVID vaccines, issued in August, are
narrower than the new ACIP guidance, limiting approved eligibility to people
over 65 or those with risky underlying conditions. The FDA’s limits have
already made it harder for many people to get a vaccine without an “off-label”
prescription from a doctor. The diverging and unclear guidance had already
resulted in widespread
confusion among state governments and pharmacies trying to preserve access
and led to even people within the eligible groups being unable to get the
vaccine.
Public health experts expressed
relief that infant access to the hepatitis B immunization was unchanged and
that the recommendation for the MMR and varicella vaccines was not rolled back
even if the option of the MMRV combo shot is now set to be removed from the
schedule.
“It’s kind of like low intensity, what they did in some
ways. … [O]nly 15 percent of kids took the combo,” Demetre Daskalakis, the
former director of the CDC’s National Center for Immunization and Respiratory
Diseases, said in an interview with the Atlantic Friday.
“It’s more the principle, that they—with no data, with no
reason to do it—have just removed a vaccine from the pediatric schedule.”
Indeed, the two-day meeting in Atlanta highlighted how
successful Kennedy has been in supplanting scientific decision-making and
evidence-based evaluation with rote vaccine skepticism. Many of the panel
members’ statements and presentations suggest ACIP will continue on a
trajectory away from consensus and data-driven vaccine analysis and toward a
vaccine-skeptical agenda marked by increased confusion and polarization.
Kulldorff, an epidemiologist who has served as a paid
expert witness in litigation against vaccine manufacturers, opened the meeting
by laying down a gauntlet to the committee’s critics. “When there are different
scientific views, only trust scientists who are willing to engage with and
publicly debate the scientists with other views,” he said. “With such debates,
you can weigh and determine the scientific reasoning by each side, but without
it, you cannot properly judge their arguments.” He cited an op-ed
authored by nine former CDC directors criticizing Kennedy and ACIP, challenging
them to a public debate: “If they want to be trusted, they should accept.”
Broad vaccine policy or public health goals are topics
appropriate for an open debate setting. But evaluating highly technical and
scientifically complex studies and safety data is not an exercise well-suited
to the debating stage, but rather, a structured, collaborative discussion where
different perspectives and questions can be explored on a foundation of
validated and accepted evidence—something the ACIP and its working groups were
previously known for and had formalized through its evidence-to-recommendation framework.
After Kennedy remade ACIP in June, the panel abandoned
that process, including much of the public transparency that came with it. The
details of the proposed changes the committee would be voting on, for example,
were not announced publicly before the meeting last week began—in fact, CDC
staff preparing materials for the meeting apparently didn’t
know the specifics of some proposals until the night before.
Several committee liaisons representing outside medical
groups during the meeting asked why ACIP is considering new recommendations for
these vaccines in the first place. Prior to Kennedy’s installment at HHS, ACIP
would schedule votes on changes to recommendations when new circumstances
(e.g., a public health emergency or a new vaccine) or new data and studies
arose that prompted reconsideration. The process for developing a potential new
recommendation or change to an existing one would often take the better part of
a year.
The absence of that process was clear throughout the
meeting but particularly when it came to the proposal to push the hepatitis B vaccine
birth dose for infants back to 1 month of age. Members seeming to favor the
change did not offer new safety evidence justifying the shift nor did they make
clear why 1 month was selected. “Why would we pick 1 month, why [not] 2
months?” asked Cody Meissner, a vaccine expert and pediatrician who’s also the
only current ACIP member who has served on the panel before. “There is no
evidence that it’s safer at a later time.”
“There’s no evidence of harm from administering the
neonatal vaccine that I’ve heard presented or that I’m aware of,” he added.
“Is there really a reason that the committee can provide
for making a change?” pressed
Flor Muñoz, a pediatrician and ACIP liaison representing the Infectious
Diseases Society of America.
Later in the meeting, committee member Robert Malone
addressed the query. “I think the question in my mind is a little
disingenuous,” he said. “The signal that is prompting this is not one of
safety, it’s one of trust. It’s one of parents being uncomfortable with this
medical procedure being performed at birth.”
Malone added that “hopefully, [parents] are comforted by
the data that have been provided, but I suspect that many concerns will
linger.” He also noted that he had received no communication from anyone at CDC
as to why ACIP was reviewing the hepatitis B recommendation now.
But the comments also highlighted what was on display
throughout the meeting: the elevation of vaccine skepticism for skepticism’s
sake, even in the face of contradictory evidence. While CDC staff presented a
systematic review of data on the hepatitis B vaccine, noting strong evidence
indicating its safety, Malone insisted, “The absence of data that statistically
proves lack of safety does not mean that the product is safe.” Retsef Levi, a
professor of operations management at MIT’s Sloan School of Management,
advanced a similar line.
Infectious disease experts and former public health
officials panned the members’ comments as removed from scientific reality. “You
can’t prove absolute safety—that’s proving a negative,” Jake Scott, an
infectious disease physician and clinical associate professor at Stanford
University, argued
on X in response to Malone’s comments. “We don’t have ‘absence of data.’ We
have mountains of evidence. You’re demanding logical impossibilities while
ignoring decades of proof.”
Tom Frieden, the CDC director during the Obama
administration, noted,
“There were statements that ‘concerns’ and ‘trust’ are more important than
data—including by members who themselves, or whose organizations, have been
primary disseminators of disinformation about vaccines.” Kennedy’s new picks
seemed to be doing exactly what he has long accused the public health
establishment of doing: substituting personal priors and ideology for sound
science.
The committee’s discussion of COVID vaccine information
also frustrated observers, as when Levi raised concerns about mRNA used in the
shots lingering in the body after vaccination. Drew Weissman, the director of
vaccine research at the University of Pennsylvania’s medical school and a
recipient of the 2023 Nobel Prize for work that helped lead to the development
of the COVID vaccines, said
the claims rely on cherry-picked research and bad information. “What these
people do, is that they search, they find one paper or two papers that make an
outlandish claim based on bad data that hundreds or thousands or tens of
thousands of other papers refute, they don’t mention everything that refutes
it,” he told Stat in an interview after the meeting.
Some panel members veered into anecdotes and speculation
about vaccine safety effects while committee liaisons and even other panel
members emphasized the lack of data to support their colleagues’ assertions.
“We’re going beyond data and turning into a discussion of speculation and a
discussion of possible clinical outcomes for which we have no data,” Joseph
Hibbeln, a neuroscientist who previously worked at the National Institutes of
Health, said
during the discussion of the hepatitis B vaccine.
And during both days, confusion among the committee
members was apparent, with some uncertain of what exactly they were voting on,
how the voting procedures worked, or even what effects their decisions would
have on vaccine policy.
On Thursday, the panel voted to preserve access to the
MMRV combo shot under the Vaccines for Children Program, which subsidizes
vaccines for uninsured or underinsured families, even though the move
conflicted with its previous vote to drop the recommendation for the combo
shot. Committee members opened the second day of the meeting explaining that
they were confused and had made the vote in error. As Kulldorff, the committee
chair, prepared to reverse the vote, he praised the “enormous depth and knowledge”
the panel possessed on vaccines and science but noted that nearly all of the
members “are rookies” on the panel.
“There are many technical issues that we might not grasp
as of yet,” he added.
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