Five things to watch at this week’s meeting of CDC vaccine advisers
By Brenda Goodman, CNN
(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 recent review 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 we’re watching 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 pregnancy 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 revisit the risk of stroke 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 data 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 an updated look 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 reported at rates 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. In a June town hall 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 WHO’s member states.
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 to 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 that was read 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 recent interview 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 also said 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 mortality rate for children under age 5 is about double the global average, 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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