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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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