Updated December 5, 2025 at 12:12 PM CST
In a historic vote, the Centers for Disease Control and Prevention's vaccine advisers recommended narrowing the agency's hepatitis B immunization guidance for newborns.
The result, if approved by the CDC's acting director, will be a rollback of a universal recommendation to start hepatitis B immunization at birth, a standard practice in the U.S. for more than 30 years that has been credited with dramatically lowering liver diseases caused by the virus.
The Advisory Committee on Immunization Practices, or ACIP, voted 8-3 to recommend hepatitis B at birth only for infants born to women who test positive for the virus that attacks the liver. Women whose hepatitis B status is negative or unknown should talk with their doctors about vaccination, the recommendation says.
The changes were made over the strong objections of liaisons from the medical community, who say the decades-long universal birth dose policy has dramatically reduced cases of hepatitis B in U.S. children.
"Our question is why? Why is there pressure today to change something that has been working, due to safety concerns that may be more theoretical than real?" asked Dr. Grant Paulsen during Thursday's meeting. He was representing the Pediatric Infectious Diseases Society.
There was a second vote regarding the number of shots babies get. Full immunization of infants involves three shots: usually one given at birth, a second shot one to three months later and a third at six to 15 months of age.
The panel voted 6-4, with one member abstaining, to recommend testing children's antibody levels after each hepatitis B shot to determine whether additional shots are needed. The result may be that some children get one or two shots instead of the standard three shots.
Dr. Adam Langer, a CDC official in charge of the agency's center that includes hepatitis prevention, said during the panel's discussion that clinical studies of approved hepatitis B vaccines tested a three-shot regimen. Stopping at one or two shots based on antibody testing would be making an assumption about efficacy that isn't supported by existing data, he said.
Sharply diverging views among members
The split vote on removing the recommendation for the universal vaccine reflects disagreement among the members. Several members who served on a subgroup that has been reviewing the topic led the votes in favor of the change.
The committee voting this week was hand selected by Health Secretary Robert F. Kennedy Jr., who has long questioned many vaccines. Several of the voting members themselves have a history of questioning the safety of long-used vaccines.
Retsef Levi, a voting member and professor at the MIT Sloan School of Management, heralded the move as "a fundamental change in the approach to this vaccine," which would encourage parents to "carefully think about whether they want to take the risk of giving another vaccine to their child." Levi said parents may want to delay the vaccine for years. "That's going to be up to them and their physicians," he said.
A handful of members raised concerns over the lack of evidence supporting the change and concerns it will put children at risk.
"We know vaccines are safe," said Dr. Cody Meissner, a professor of pediatrics at Dartmouth's Geisel School of Medicine and the only current member who has served on the committee in previous years. "The hepatitis B vaccine recommendation is very well established. We know it is safe, and we know it is very effective, and to make the changes that are being proposed, we will see more children and adolescents and adults infected with hepatitis B."
Meissner added that he saw clear evidence of the benefits of the universal hepatitis B birth dose, but not the harms. When he registered his "no" vote, he stated, "Do no harm is a moral imperative. We are doing harm by changing this wording."
The previous recommendation to vaccinate all healthy newborns against hepatitis B was designed to make sure no at-risk infant falls through the cracks. Hepatitis B can be transmitted from mothers to infants during childbirth, but can also be spread through contact with an infected person's body fluids including saliva and blood.
Immunization in infancy confers lifelong protection against the hepatitis B virus, which can cause serious, potentially fatal health problems including liver cancer and cirrhosis. It is the cornerstone of a decades-long strategy to eliminate hepatitis B in the U.S.
Questioning vaccines
Friday's votes came after a previous attempt to change the universal vaccination recommendation failed at an ACIP meeting in September. That meeting descended into chaos, forcing the committee to postpone until this week's meeting.
During this week's discussion, Malone framed the debate as a "diversity of opinion regarding the existence of evidence of harm," and said questions about harms were "largely unresolved" due to a lack of data.
Representatives from medical groups attending the meeting strongly disputed this characterization. "How can this committee justify removing a well established, successful and safe prevention strategy that is going to protect the most vulnerable Infants, when the proper measures to identify those infants who are at risk are not in place?" asked Dr. Flor Munoz, a liaison from the Infectious Diseases Society of America.
The hepatitis B decision marks the most significant change in federal vaccine policy since Health Secretary Kennedy, a long-time vaccine critic, launched an effort to overhaul how Americans are vaccinated against infectious diseases. Kennedy's health agencies have already narrowed access to the COVID-19 vaccines, recommended young babies get vaccinated against chicken pox separately and changed the CDC's stance on a link between vaccines and autism.
The CDC is now scrutinizing the entire childhood vaccine schedule, which for decades has protected children against dangerous diseases, including measles, mumps, tetanus and polio.
Dr. Rochelle Walensky, former CDC director, said that over the past few months, she has observed a systematic undermining of the nation's vaccine program.
"This meeting was another one of those chisels in the infrastructure that we rely on to keep our children, ourselves and our communities safe," Walensky said at a press briefing Thursday.
Those arguing for the changed recommendation question the safety of giving the hepatitis B vaccine to newborns, and have suggested that it could be linked with health problems and autoimmune diseases later on — a claim that is not supported by the cumulative evidence.
The ACIP subgroup which reviewed the hepatitis B policy was led by voting member Vicky Pebsworth, a nurse and board member of the National Vaccine Information Center, an advocacy group that questions vaccine safety.
"There was pressure coming from stakeholder groups wanting the policy to be revisited," she said.
A debate about preventing transmission
Some ACIP members argued that universal vaccination at birth is unnecessary because babies could be protected by increased screening of pregnant women and only inoculating babies of mothers who test positive.
Doctors and researchers who work on hepatitis B say these assertions do not reflect the realities they see, based on data and experience caring for patients.
"Risk-based recommendations do not work," says Dr. Su Wang, an internist and researcher at the Cooperman Barnabas Medical Center in New Jersey, and a global health adviser at the Hepatitis B Foundation. Hepatitis B doesn't only spread through sexual contact or drug use, she said, adding infants can get infected "through microscopic blood that can be transmitted through everyday exposures."
Wang also said screening alone could not fill the gaps: "Newborns can't control who cares for them or whether the adults around them even know their hepatitis B status."
Even if the vaccine remains freely available, weakening the recommendation could lead to fewer babies getting the vaccine, doctors said.
"Adding excessive or ambiguous language around shared decision-making muddies the waters, creates a false sense of scientific uncertainty, and places barriers to care," said Dr. Natasha Bagdasarian, an infectious diseases physician representing the Association of State and Territorial Health Officials at this week's meeting. "Many health care providers interpret it as a sign a vaccine is controversial, or that they may be exposed to additional liabilities."
The immediate impacts of the policy change are not clear. Andrew Johnson, a policy analyst with the Centers for Medicare and Medicaid Services, said the vaccine would still be covered by all types of insurance including Medicaid and the Children's Health Insurance Program: "We see no coverage gaps in the newly proposed language and don't believe it would restrict access."
Public health experts urge individuals to look to their medical providers, and to independent recommendations made by professional medical groups, such as the American Academy of Pediatric and the American Medical Association, for science-based advice on preventing disease and staying healthy.
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