After contentious debates and three failed attempts at a vote, a federal vaccine committee decided on Friday to end the decades-long recommendation that all newborns be immunized at birth against hepatitis B, a highly infectious virus that leads to chronic liver disease in most infected children.
The panel, called the Advisory Committee on Immunization Practices, voted 8-3 that women who test negative for the virus should consult with their health care provider and “decide when or if their child will” be vaccinated against the virus at birth. The committee did not change the recommendation that newborns of mothers known to be infected or whose status is unknown be immunized. The change is not expected to affect insurance coverage of the shots.
The vote, which proceeded despite vehement protests from the dissenters, was a victory for Health Secretary Robert F. Kennedy Jr., who has sought for decades to overhaul the childhood vaccine schedule. More changes are likely follow in the next months, as the committee goes on to review all childhood immunizations. The meeting’s presenters and at least some of the panelists are known for their anti-vaccine views and are close associates of Mr. Kennedy.
For many public health experts, the vote also marked the end of trust in the Centers for Disease Control and Prevention and its vaccine advisers.
“The days of trusting A.C.I.P. and C.D.C. for vaccine recommendations are gone,” Dr. Richard Besser, a pediatrician and former acting director of the agency, said in a statement, referring to the vaccine committee.
“Policymakers, physicians, and families must turn to reputable medical and public health groups for guidance, and health insurers should do the same for informing what vaccines they will cover,” he said.
The votes on hepatitis B were originally scheduled for the September meeting but deferred twice because some members said there was insufficient data to make a decision. The committee attempted the vote again on Thursday, but postponed it after some panelists questioned whether a change was warranted.
Some panelists noted that the practice had helped to nearly eliminate cases among newborns in the United States, and that there was no evidence of harm from the shots at any age.
Dr. Cody Meissner, a professor of pediatrics at Dartmouth Geisel School of Medicine, said on Friday that if the vote passed, “we will see more children and adolescents and adults infected with hepatitis B,” he warned.
Mr. Kennedy and his associates have argued that hepatitis B is primarily a sexually transmitted disease and that babies do not need the protection unless their mothers are infected.
The risk of “infection throughout your early stage of life, and probably throughout most of your childhood, is extremely low,” Retsef Levi, a panelist and a professor of operations management at Massachusetts of Technology.
“To quantify how low it is, it’s probably one in several millions,” he said.
But supporters of the vaccine note that the virus can 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.
The C.D.C. has recommended since 1991 that doctors administer the first dose of the hepatitis B vaccine within 12 hours of birth to infants whose mother is known to be infected, and within 24 hours for all other newborns. The first dose is given on its own, but two later doses are often administered as combination products containing vaccines for other diseases, like diphtheria, tetanus and polio.
The panelists recommended that for infants born to mothers who test negative for the virus, parents decide whether and when to immunize their babies in consultation with their health care providers.
Parents and their providers should “consider vaccine benefits, vaccine risks, and infection risks” and administer the shot “no earlier than 2 months of age.”
The committee also voted to recommend that parents seek out antibody tests to evaluate the effectiveness of the vaccine, and that insurance should cover the cost of the test. “The vaccine panel does not typically make recommendations about testing.”
Dr. Joseph Hibbeln, a panelist and neuroscientist formerly at the National Institutes of Health, strongly objected to the language of the vote, which he noted was in the fourth iteration in 96 hours. The committee had not heard any data on why two months had been chosen or on the feasibility or need for an antibody test, he said, adding, “This is unconscionable.”
Dr. Meissner also raised objections, saying the recommendation for an antibody test is “kind of making things up, adding, “I mean, it’s like Never Never Land.”
Some outside experts were dismayed by the outcome, noting that unvaccinated infants would be at risk of being exposed to the virus at home or in other places they may share with infected people. As many as 70 percent of the roughly two million Americans with hepatitis B are unaware of their diagnosis.
“It is heartbreaking to see this science-driven agency turn into an ideological machine,” said Dr. Debra Houry, who served as the C.D.C.’s chief medical officer before resigning in protest in August.
Political appointees, many of them vaccine skeptics, have infused the agency, Dr. Houry said, adding, “I am very concerned about the future of C.D.C. at this point.”
The advisers did not “follow the scientific evidence, and risk undoing decades of progress in hepatitis B prevention, eroding vaccine confidence, and causing confusion among parents and health care providers,” said Dr. Noele Nelson, a hepatitis expert at Cornell Public Health and a senior author on the C.D.C.’s previous guidelines for the vaccine.
Mr. Kennedy fired all 17 previous members of the vaccine panel in June, replacing them with people who largely share his skepticism about vaccines. Meetings of the new members, most of whom have no experience in vaccine research or clinical practice, have been marred by disorganization and intense disagreements, sometimes devolving into shouting matches.
At the meeting on Thursday, Cynthia Nevison, a climate researcher at the University of Colorado, and Mark Blaxill, a well-known vaccine activist, presented data on disease rates and safety concerns about the vaccine.
Dr. Nevison and Mr. Blaxill were co-authors on a 2021 paper in the Journal of Autism and Developmental Disorders that purported to estimate the financial burden of rising autism cases. The journal later retracted the paper because of “misrepresentation of the incidence of autism,” problems with the way the study was conducted, and the authors’s undisclosed conflicts of interest.
The paper’s third author, Toby Rogers, delivered a public comment at the meeting on Thursday arguing that two widely used hepatitis B vaccines “should never should have been licensed” by the Food and Drug Administration. He did not disclose his close affiliation with Children’s Health Defense, the anti-vaccine organization that Mr. Kennedy founded.
Aaron Siri, a lawyer who for years joined with Mr. Kennedy in court battles over vaccines, is scheduled to present later on Friday about the childhood vaccination schedule.
Dr. Robert Malone, the panel’s vice chair, who ran the meeting, said that the committee had invited Dr. Paul Offit and Dr. Peter Hotez, two prominent vaccine experts, to present at the meeting, but that both had declined.
Dr. Offit, a pediatrician at the University of Pennsylvania, said the panel was offering misleading information to parents.
“This is a political group, not a scientific group,” he said in a message. “I don’t want any part of that.”
Dr. Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, echoed that sentiment. “I declined because A.C.I.P. seems to have shifted its mission away from science and evidence-based medicine,” he said in a message, referring to the vaccine committee. “I’m always happy to discuss the science of vaccines with individuals or groups who are committed to truth and genuine intellectual inquiry.”
A majority of the public may be inclined to agree. If the C.D.C. and the American Medical Association were to offer conflicting advice, according to a survey released on Monday by the Annenberg Public Policy Center of the University of Pennsylvania, more than twice as many Americans would trust the medical organization over the nation’s premier public health agency.
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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