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lite.cnn.com - on gopher - inofficial
ARTICLE VIEW:
Five things to watch at this week’s meeting of CDC vaccine advisers
By Brenda Goodman, CNN
Updated:
8:14 PM EDT, Wed September 17, 2025
Source: CNN
A group of advisers selected by US Health and Human Services Secretary
Robert F. Kennedy Jr. to make recommendations on the use of vaccines in
the United States will meet Thursday and Friday, and they are expected
to make changes to the US Centers for Disease Control and
Prevention’s childhood vaccine schedule.
In testimony before the Senate’s Health, Education, Labor, and
Pensions Committee on Wednesday, Dr. Susan Monarez, who was recently
ousted as CDC director, said that part of the reason for her removal
was her refusal to rubber-stamp recommendations made by the CDC’s
Advisory Committee on Immunization Practices, or ACIP.
Monarez said Kennedy wanted her to pledge to sign off on those
recommendations even before they were made.
“He said that the childhood vaccine schedule would be changing
starting in September, and I needed to be on board with it,” Monarez
said. “I refused to do it.”
On Wednesday, the White House rejected the notion that the big changes
were coming.
“No one, including Secretary Kennedy and President Trump, is calling
to throw out the entire childhood vaccine schedule or eliminate access
to lifesaving vaccines. Anyone suggesting that such actions are even on
the table does not know what they are talking about,” White House
spokesperson Kush Desai said in a statement.
Now, that committee is on the verge of making its recommendations. With
no permanent CDC director in place, its decisions might get final
sign-off from Kennedy, a longtime vaccine skeptic, or his deputy, Jim
O’Neill, who is currently acting CDC director. The recommendations
shape doctors’ guidance to patients, but also insurance coverage,
state vaccine policy and the federal Vaccines for Children program.
Typically, meetings of CDC’s vaccine advisers are expert-led,
science-heavy, deep dives on the safety and efficacy of shots doctors
recommend to patients to protect against infections. After months of
preparation, presentations and discussions are highly technical and
unfold over the course of several days, culminating in votes. Because
of the preparation, surprises are rare.
This week’s meeting isn’t expected to be typical, however.
In June, Kennedy abruptly removed all 17 sitting ACIP members, saying
the panel was “plagued with persistent conflicts of interest,”
although a found that conflicts of interest on ACIP had been at
historic lows for years.
Kennedy rapidly replaced them with eight of his own candidates,
although one withdrew during the vetting process because of financial
conflicts of interest. This week, he added five more.
The committee’s name remains the same, but members, processes and the
data presented have all changed – and that shapes the decisions
around vaccines people get.
“I think every one of them could be a potential circus act,” said
Dr. Michael Osterholm, who directs the Center for Infectious Disease
Research and Policy at the University of Minnesota, said of the
discussions on this meeting’s agenda. “We just don’t know yet for
sure what they’re going to try to do.”
Here are five things to watch over the next two days.
Will recommendations for Covid-19 vaccines change?
Making recommendations around this season’s updated Covid-19 vaccines
is ACIP’s main order of business. It’s already later than usual,
since the committee decided not to weigh in on them at its meeting in
June. The delay has created uncertainty around who can get vaccines and
left some providers in limbo.
First, ACIP could make recommendations that are in line with the US
Food and Drug Administration’s recent changes to the approval of the
vaccines.
The FDA has limited its approval to people 65 and older and anyone
older than 6 months who has at least one condition that puts them at
higher risk of a severe Covid-19 infection. But people in some states
that have laws connected to ACIP recommendations are having trouble
getting the vaccine without a doctor’s prescription, even if
they’re in one of these higher-risk groups.
Kennedy has already driven changes too, including for pregnant women
and children, although is a condition that puts a person at higher risk
for a severe Covid-19 infection and children under 2 are hospitalized
with Covid at the same rates as those over 65.
ACIP doesn’t have to stick with the FDA’s indications when
recommending the Covid vaccine, however, and there are there are signs
that the group could restrict access even further.
Briefing documents posted Wednesday suggest that the committee could be
planning to in people over the age of 65 who get the Covid-19 vaccine
— a safety signal that was identified in 2023 and subsequently ruled
out as being caused by the vaccine. Some experts worry that the
committee will use this to justify pushing the recommendation for
Covid-19 shots to age 75, instead of 65, which might limit some
people’s ability to get the vaccine.
People familiar with the committee’s plans say that health officials
have also been preparing presentations on the dangers of the vaccine to
pregnant women and on deaths after vaccination in children.
These risks have been studied before. Drugmaker Pfizer publicly posted
about its Covid-19 vaccine in pregnant women this week, noting that in
addition to other studies, it ran a placebo-controlled randomized trial
of its immunization in healthy pregnant women. It found congenital
anomalies in eight of 156 vaccinated participants and two of 159
unvaccinated participants, an incidence that was “within the range
observed in the general population, and events were not deemed to be
vaccine related.”
At the last ACIP meeting in June, CDC researchers presented at the
safety signals related to mRNA vaccines. Of eight post-vaccination
events that reached statistical significance — including heart
attacks, strokes, seizures and blood clots — only one, myocarditis,
remained after further investigation.
Although myocarditis is a recognized complication of the Covid-19
vaccines, safety studies have shown that the incidence has dropped
considerably since doctors began spacing out the doses of Covid-19
vaccines. Post-vaccination myocarditis in teens and younger adults is
now being that fall below those that would be expected in the general
population.
Federal officials have said that despite these new restrictions,
Covid-19 vaccines remain available to anyone who wants one.
“You can’t get it at every Starbucks, but there is no rule that
somebody cannot get it,” FDA Commissioner Dr. Marty Makary told
CNN’s Kate Bolduan.
If ACIP decides to further restrict the use of Covid-19 vaccines, it
will be a disservice, Osterholm said.
“I think this should be permissive, and anyone and everyone should
have access to it if they want it,” he said. “Remember, half the
kids last year who died from Covid had no underlying risk factors.
None.”
Dr. Fiona Havers, a medical epidemiologist and infectious disease
expert who recently left the CDC because of Kennedy’s changes to the
way the agency sets vaccine policy, said she believes that the
committee will downplay the impact of the infection.
“I think there may be attempts to minimize Covid-19 as a public
health problem,” she said.
Will newborns still get hepatitis B vaccines?
One of the votes scheduled for Thursday concerns the hepatitis B
vaccine, which is typically given to newborns because they’re at risk
of infection from birth.
Vaccine advocates are concerned that the committee could remove that
recommendation or recommend that children receive their first dose at
age 4, instead.
“I’m fairly certain they’re going to they’re planning just to
move forward with that, regardless of what the evidence says,” Havers
said. “And that is going to be a tragedy, honestly, that will lead to
preventable deaths in the future for children.”
Anti-vaccine activists have long questioned the need for the birth dose
of the vaccine, since hepatitis B is mainly transmitted through dirty
needles or sexual activity. hosted by NewsNation, Kennedy said
“it’s really a profit motive” to give it to newborns.
But the campaign to vaccinate babies against hepatitis B has been
wildly successful.
Before 1991, the year ACIP first recommended that every child be
vaccinated against hepatitis B at birth, an estimated 18,000 to 20,000
kids were diagnosed with the viral infection each year in the United
States.
About half of these children were infected during delivery or shortly
after birth by their mothers, who can carry the virus without any
apparent symptoms.
Now, however, the number of reported babies who caught the virus around
the time of birth has dropped into the double digits.
“Somewhere on the order of 20 or 30 per year total in the whole of
the United States,” said Dr. James Campbell, vice chair of the
American Association of Pediatrics’ Committee on Infectious Diseases.
The US has tried basing hepatitis B vaccination on risk, vaccinating
only health-care providers likely to be exposed to blood or infected
patients, men who have sex with men, users of injected drugs, and
people who live in the same households as those with long-term
infections. This strategy didn’t move the needle on chronic
infections, however. Only vaccinating children around the time of birth
has brought chronic hepatitis B infections down.
The campaign has been so successful that in 2009, the World Health
Organization recommended it for all countries. It’s now used in 117
of .
The universal vaccination of babies, along with prenatal testing of
mothers, has been a phenomenal success — and experts say that making
a change now will have consequences.
“We’re on the cusp, really, of eliminating perennial hepatitis B
from the United States if we continue with the program,” Campbell
said.
He said it’s unclear why the shot would be questioned at all.
“There’s no new safety data that would make you think, ‘oh, we
should never have done this, and there’s a safety problem,’ ”
Campbell said. “There’s no new efficacy data to show that somehow
the vaccine is no longer working, or there’s a problem with it, or we
should have a better vaccine.”
Changes for the measles, mumps, rubella and chickenpox vaccine?
Also on the agenda for Thursday are a pair of related votes on the
measles, mumps, rubella and varicella, or MMRV, vaccines.
At June’s ACIP meeting, Committee Chair Dr. Martin Kulldorff reviewed
the history of seizures that can happen after high fevers with the
combination shot.
That risk is the reason that in June 2009, ACIP recommended that
doctors give the measles-mumps-rubella, or MMR, vaccine and the
varicella vaccine separately for the first dose in kids ages 1 to 4.
“As far as we know, there are no new data to present, only to
re-discuss the data that have been known for decades about differences
in side effects on the first dose,” Campbell said.
Even if the committee votes to offer only separate MMR and varicella
vaccines to children, that would be less convenient, which will prevent
some children from being protected. It also denies parents the chance
to opt for a single shot instead of two.
Who’s weighing the evidence?
Historically, most of ACIP’s work assessing the safety and
effectiveness of vaccines has been done in 11 subcommittees, or work
groups. These groups meet more frequently than the full committee to
discuss evidence and frame recommendations for the full committee to
vote on.
In the past, the work groups have been made up mostly of experts from
ACIP’s liaison members, alongside representatives from federal
agencies such as the FDA and the CDC. Liaisons typically represented
groups such as the American Medical Association, the American Academy
of Pediatrics and the American Pharmacists Association. Members also
represent nurses and public health officials and other groups that play
a significant role in delivering vaccinations.
In July, however, HHS said in a letter to liaisons that they were too
conflicted to participate in the work groups.
This week’s discussions on the Covid-19 vaccines will be led by Dr.
Retsef Levi, a professor at MIT who has previously said without
evidence that the vaccines “cause serious harm, including death,”
among young people.
At the same time as Levi’s appointment to lead the Covid-19 work
group, HHS published an updated document for the group, giving him and
the subcommittee broader powers to investigate vaccine injuries and
study supposed side effects and precautions against vaccination.
The scope of the work group’s responsibilities were so broad, they
drew the attention of HHS lawyers who “expressed legal concerns”
about the widened scope and Levi’s outsized role in the group, and
proposed that government officials narrow its purview to topics “that
are within the scope of the CDC mission,” according to an August 25
email to federal health officials to Reuters.
The lawyers feared that Levi’s mandate would violate the Federal
Advisory Committee Act, which governs how advisory committees function,
Reuters reported. Under that law, the lawyers wrote, the CDC
“maintains responsibility to define agendas, scope of topics
addressed and membership,” not the work group chair – in this case,
Levi.
In a with journalist Maryanne Demasi, Levi said he “could not accept
that.”
“As it turns out, they were wrong, because it is within our scope,
and we now intend on examining these issues,” he said.
Levi he had recruited several experts in treating vaccine injuries and
long Covid to his work group and hoped to formulate recommendations for
how to diagnose and treat vaccine-injured people.
Who’s presenting the information?
Typically, when ACIP is considering a change, there’s new or updated
information, and a work group is convened to carefully evaluate the
evidence within a systematic framework. A leader from the work group or
a CDC scientist often presents the information in the ACIP meeting.
“It’s a very sort of formulaic, evidence-based process, but also
very transparent,” said Havers, the former CDC official.
For both the hepatitis B and MMRV votes this week, “they have
completely skipped the usual ACIP processes,” she said.
CDC reviews posted ahead of this week’s ACIP meeting showed that the
birth dose of hepatitis B vaccines in babies was very safe. It was not
associated with an increased risk of allergies, deaths from any cause,
seizures or sudden infant death syndrome.
The committee particularly asked CDC scientists to delve into one study
from Guinea-Bissau, published in 2004, looking at differences in
mortality rates in boys and girls who got three doses of a hepatitis B
vaccine starting at 7.5 months of age.
The study would seem to be an odd choice to inform vaccine policy in
the US. It involved a vaccine called Hepaccine, which is not licensed
in the US. It was conducted in an impoverished country in Africa where
the for children under age 5 is about , according to data collected by
UNICEF.
In that setting, it found, there was a higher rate of deaths in
children vaccinated against hepatitis B compared with those who were
not, and the effect was stronger in girls.
The study also has important limitations. It wasn’t originally
planned to look at death rates after hepatitis B vaccination, which
could skew the results. The study wasn’t randomized, so there could
be other important differences between children who were and were not
vaccinated that could account for the differences in death rates beyond
the vaccines. And a higher death rate in girls could reflect reductions
in death in boys, not greater harm to girls from the vaccine.
Dr. Debra Houry, the CDC’s former chief medical officer, was asked at
the Senate hearing Wednesday whether moving the hepatitis B birth dose
to age 4, as Kennedy has said he wants to do, would be supported by
science.
“If the vote is to change it to age 4, then that would not be based
on data,” she said.
Houry also said that some of the scientists who used to work under her
have stopped putting their names on papers and have refused to speak
about vaccines “because they feel they were personally targeted for
misinformation.”
Subject-matter experts won’t be presenting to ACIP anymore, she said.
“It’s taken up to a leadership level,” she said. “We did that
protect our staff and scientists so they would be disconnected and
their names not associated, so they won’t be targeted.”
CNN’s Tami Luhby, Meg Tirrell, Adam Cancryn and Jamie Gumbrecht
contributed to this report.
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