Anabelle Colaco
09 Dec 2025, 20:48 GMT+10
WASHINGTON, D.C.: U.S. vaccine advisers have voted to overturn more than three decades of standard practice by ending the recommendation that all newborns receive a hepatitis B shot at birth, a sweeping change that aligns with Health Secretary Robert F. Kennedy Jr.'s push to remake federal vaccine policy and has alarmed disease experts.
The panel said the shot should now be given at birth only to infants whose mothers test positive for hepatitis B or whose status is unknown. This replaces the universal recommendation introduced in 1991 to ensure all babies were protected from the virus, which can lead to chronic and potentially fatal liver disease.
For infants whose mothers test negative, the advisers said parents should work with healthcare providers to decide when to begin the three-dose series, with the first shot recommended no earlier than two months of age.
Public health specialists and significant medical associations criticised the reversal, saying it contradicts decades of data demonstrating the vaccine's safety and effectiveness. U.S. hepatitis B infections fell roughly 90 percent after universal vaccination began, dropping from 9.6 per 100,000 people to about one per 100,000 by 2018.
The CDC, now led by acting chief Jim O'Neill, who was appointed by Kennedy and is not a scientist, uses the advisers' votes to set national immunisation guidance. Health insurers said they would continue covering the vaccine.
"The vaccine is incredibly safe and has had a historic positive impact on public health since its inception. Rolling back the initiative to protect all children will almost certainly lead to an increase in hepatitis B cases nationwide," said Dr. Richard Rupp of the University of Texas Medical Branch.
The American Academy of Pediatrics said it still supports giving the birth dose.
Hepatitis B is spread through blood, semen, and certain other body fluids, and can be transmitted through close contact with people who may not know they are infected.
The advisers framed the shift as enhancing parental choice, echoing a long-standing theme of the anti-vaccine movement that Kennedy has championed. But experts said parents already have the right to refuse vaccines, and warned that the new framing could imply the vaccine is unsafe.
"This will signal to clinicians that there is something wrong with the vaccine; there is not," said Dr. Demetre Daskalakis, who resigned this year as director of the CDC's immunisation division.
Vaccine makers Merck, Sanofi, and GSK defended their products. Merck said it was "deeply concerned" by the vote.
The hepatitis B decision is the most sweeping of Kennedy's changes since taking office. He previously fired the committee's 17 independent experts and replaced them with members more aligned with his views. His leadership team has already withdrawn broad COVID-19 vaccine recommendations, reduced mRNA vaccine funding, and advised pregnant women to avoid Tylenol, citing unproven links to autism.
Committee members backing the change criticised long-established safety data. "People should be very, very suspicious when people tell them that something is safe, especially a vaccine," said panel member Retsef Levi of MIT.
Some advisers argued that the U.S. schedule is out of sync with countries like Denmark. However, CDC experts noted that Denmark's small population, universal healthcare, and extensive screening make comparisons misleading.
The panel also voted to advise antibody testing before later hepatitis B doses, though no new full schedule was provided.
Two members strongly opposed the overhaul, warning that weakening the recommendation will lead to rising infections.
"We will see more children and adolescents and adults infected with hepatitis B," said Joseph Hibbeln, a former NIH official on the panel.
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