Advisers to Health Secretary Robert F. Kennedy Jr. appear poised to make consequential changes to the childhood vaccination schedule, delaying a shot that is routinely administered to newborns and discussing big changes to when or how other childhood immunizations are given.
Decisions by the group are not legally binding, but they have profound implications for whether private insurance and government assistance programs are required to cover the vaccines.
Depending on what the committee does, the changes could also further erode Americans’ confidence in immunizations. Although a majority of Americans still say they are confident about vaccines’ effectiveness, multiple surveys show the percentage has dropped sharply over the last few years.
Members of the group, called the Advisory Committee on Immunization Practices, were handpicked by Mr. Kennedy, who has long campaigned against many childhood vaccines. They are scheduled to meet on Thursday and Friday.
The specific proposals the members will vote on are still unknown. The agenda is thin on details, listing neither specific speakers nor times, merely mentioning “votes” on the first day of the two-day meeting. But public comments by some panelists, as well as by President Trump and Mr. Kennedy, hint at some possible outcomes.
The committee is likely to decide that a vaccine to prevent hepatitis B — a highly contagious disease that can severely damage the liver — should no longer be administered routinely at birth and perhaps should not be offered to children at all.
The committee members may also question the safety of ingredients like aluminum salts that are present in many childhood vaccines. And they are likely to discuss whether vaccines for different diseases should be offered as separate shots rather than in the combination products currently used.
The meeting comes on the heels of unsupported claims made by Dr. Vinay Prasad, the Food and Drug Administration’s top vaccine regulator, that Covid shots have killed “no fewer than 10” children. The internal memo did not provide any details or data. The memo went on to question the safety of administering multiple vaccines at the same time.
On Monday, the Department of Health and Human Services named Dr. Kirk Milhoan, a pediatric cardiologist and a current member of the committee, as its chair. During the coronavirus pandemic, Dr. Milhoan raised concerns about myocarditis caused by Covid vaccines and urged the Biden administration to withdraw the shots from the market. Martin Kulldorff, the outgoing chair of the committee, will take on a new role as a chief science officer at the Health Department. The changes may require the department to add new members to the committee.
Mr. Kennedy has frequently said that children are given too many vaccines and too many at the same time, which, he contends, overloads the immune system and leads to conditions like autism.
Dozens of studies have looked for a possible link between vaccines and autism and have not found one. And children now receive more shots because scientists have developed effective vaccines for more of the diseases that harmed and killed people decades ago, said Dr. Bruce Gellin, who led the U.S. National Vaccine Program Office from 2002 to 2017.
The slate of routine vaccinations has grown more complex, so “it makes sense to take a step back and say, ‘Are we doing this in the most efficient and effective way that’s based on evidence?’” Dr. Gellin said.
“The question is, are they going to do that?” he said of the panelists.
In a public comment submitted to the committee, a coalition of 15 Democratic governors urged the members to ground their decisions in “rigorous science” because the guidelines will affect “families, providers, insurers, state immunization systems, and overall public health.”
At a meeting in September that devolved into chaos and confusion, A.C.I.P. members voted to limit access to the Covid vaccine and to stop recommending a combination shot against measles, mumps, rubella and chickenpox for children under 4.
The panel shelved a vote on hepatitis B because some members wanted a more robust discussion first.
In October, the Centers for Disease Control and Prevention announced a new working group charged with reviewing the safety of childhood vaccines and their ingredients, as well as the times when the shots are administered and the other immunizations that are given to children at the same time.
The working group will “determine whether a change in the vaccine schedule may be warranted,” according to a document detailing the group’s goals.
Contrary to past practice, the names of the working group’s members have not been made public, and C.D.C. staff members are barred from participating in the meetings.
A similar working group for Covid, whose findings were presented at the September A.C.I.P. meeting, made sweeping statements about vaccine safety that were not backed by data, said Dr. Kathryn Edwards, who was a member of the vaccine committee in the 1990s.
“It just was really, really very disturbing,” she said.
Mr. Kennedy’s statements that vaccines have been added to the childhood schedule without adequate research is also inaccurate, Dr. Edwards said. She is a co-author of a textbook chapter on combination vaccines.
“Through the years, we’ve added one vaccine at a time, studying their impact on the other ones, and that’s how we’ve gotten to these schedules,” she said, adding, “I think that has to be acknowledged.”
But Dr. Prasad, who leads the F.D.A.’s vaccine division, said in the memo made public over the weekend that the agency’s current standards on giving multiple vaccines at the same time had created “a false sense of efficacy and safety.”
Dr. Prasad said that he was “open to vigorous discussions and debate” from F.D.A. employees but that anyone who did not agree with the new core principles should submit their resignations.
Other Trump administration officials, including Mr. Trump himself and the C.D.C.’s acting director, Jim O’Neill, have also suggested breaking up combination vaccines, including those for measles, mumps and rubella, into separate shots. They have argued that the combination vaccines produce too much of an immune jolt for young children.
But many immunologists say that represents a fundamental misunderstanding of the immune system. The vaccines manufactured today contain fewer antigens — the part of the vaccine that provokes an immune response — by orders of magnitude than those made decades ago. And children naturally encounter thousands of antigens in the course of a single day, the experts said.
Splitting the vaccines into separate shots would create formidable logistical hurdles for manufacturers, who may decide that it is too expensive and risky to continue making them, said Michael Osterholm, a public health expert at the University of Minnesota.
Companies would need to develop and test new, single-dose products, he said, and “we’re having a hard enough time keeping them producing the three-dose antigen vaccines.”
Administering vaccines as separate shots also would require multiple clinical visits, making it more difficult for parents to fully immunize their children and for doctors to keep their patients updated. It would also result in more needle jabs for children.
“On the one hand, this entire process started with a message of ‘Kids get too many shots,’” Ms. Cohen said. “And now we’re talking about taking away the combination vaccines, which of course is going to mean more doses for kids.”
“I’m not really sure what the end goal is here,” she added.
It is unclear how a new immunization schedule might affect the vaccines currently in use.
Since 1991, the C.D.C. has recommended that the hepatitis B vaccine be given as three doses, the first one administered right after birth. The hepatitis B shot is given on its own for the first dose, but the later two doses are often administered as combination products containing vaccines for other diseases, like diphtheria, tetanus and polio.
If A.C.I.P. votes to delay hepatitis B shots till age 4 or even age 12, as President Trump has suggested, doctors may no longer be able to administer the combination vaccines.
At the same time, parents who want the hepatitis B shot for their children may have trouble finding it or getting insurance companies to pay for it, said Chari Cohen, president of the Hepatitis B Foundation.
Public health experts credit the hepatitis B vaccine with nearly eliminating maternal transmission of the disease in the United States. Routine immunization has cut the number of babies infected at birth to fewer than 20 per year from about 20,000 babies per year.
Mr. Kennedy and his associates have argued that hepatitis B is primarily a sexually transmitted disease and babies do not need the protection unless their mothers are infected.
But supporters of the vaccine note that the virus can also be spread by household objects like toothbrushes, razors or combs that are used by an infected person. Only about half of cases before 1991 were a result of transmission from an infected mother. More than 90 percent of infants infected with the virus develop chronic hepatitis B.
Mr. Kennedy has pointed to other countries, like Denmark, that offer the vaccine only to babies of infected mothers. But the nationalized health care systems in such countries ensure that pregnant women are screened for diseases before delivery, some public health experts said.
In the United States, delaying the first dose to 2 months of age for babies of women with unknown hepatitis B status would result in about 1,400 additional infections per year, according to an estimate published on Monday by the Hepatitis B Foundation; delaying it to 12 years of age would lead to about 2,700 additional cases, the foundation estimated.
The Vaccine Integrity Project, an initiative dedicated to safeguarding vaccine use in the U.S., evaluated more than 400 studies over 40 years, and concluded that “the hepatitis B vaccine is safe regardless of vaccine timing.”
At their meeting, the panelists may also address the safety of vaccine ingredients like aluminum salts, or alum (not aluminum metal as it is sometimes incorrectly described.) Alum has been used as an adjuvant — a substance added to vaccines to boost the immune response — to vaccines for decades and is included now in dozens of vaccines.
By enhancing the immune response, alum allows for smaller doses of vaccines to be delivered in each dose. Taking it out of vaccines would be akin to leaving out eggs when making a cake, Dr. Gellin said: “You’re not going to get the protective immune response you need.”
Mr. Kennedy has said that aluminum can harm the brain. One study published by the C.D.C. in 2022 did find a small association with asthma that the researchers concluded warranted further investigation.
But this year, a large Danish study based on the country’s national registry found no association between cumulative alum exposure in the first two years of life and 50 medical conditions, including asthma, allergies and neurodevelopmental disorders.
Mr. Kennedy panned the study as a “deceitful propaganda stunt by the pharmaceutical industry.” But vaccine scientists said the analysis was carefully done.
“Just because he didn’t like the answer, it doesn’t mean that it wasn’t done perfectly,” Dr. Gellin said.
Apoorva Mandavilli reports on science and global health for The Times, with a focus on infectious diseases and pandemics and the public health agencies that try to manage them.
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