December 12, 2025 / 5:00 AM EST / KFF Health News
When Dr. Su Wang was in medical school, a blood donation revealed she had hepatitis B, a virus that can attack the liver and lead to cancer and death decades later. “I was 18, healthy, in college,” she said. “And suddenly I had a chronic illness I didn’t even know about.” Born in 1975 before the hepatitis B vaccine was routinely given to newborns, Wang later learned a grandparent likely passed the virus to her — “that’s how easy this virus spreads — not from some exotic risk factor, just family.”
Wang is now medical director for viral hepatitis programs at RWJBarnabas Health in New Jersey. Her story sits at the center of a major public-health turning point. On Dec. 5, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to end the universal U.S. recommendation for the newborn dose of the hepatitis B vaccine, adopting a policy urging individual-based decision-making.
Under the new approach, only infants born to mothers who test positive for hepatitis B will automatically receive a dose of vaccine and hepatitis B antibodies shortly after birth. For other infants, parents who choose to vaccinate can delay the birth dose until 2 months of age. All ACIP members were appointed by Health and Human Services Secretary Robert F. Kennedy Jr. In an 8-to-3 vote, the panel framed the shift as reducing unnecessary interventions, aligning vaccination with maternal test results, and giving parents more control over timing. Supporters described it as expanding parental choice rather than reflecting changing disease patterns.
Many clinicians and epidemiologists see the change as a dangerous rollback that could reverse decades of progress toward eliminating a disease that still infects up to 2.4 million Americans and causes tens of thousands of deaths annually. They draw parallels to the 1980s, when risk-based vaccination failed to protect whole cohorts, and warn the country may repeat that mistake. The move also signals possible broader upheaval to the childhood vaccine schedule, a cornerstone of public health.
“They’re not just trying to change one vaccine,” said Angela Rasmussen, a virologist and Vaccine editor. “They’re trying to dismantle how vaccine policy is made.” A Department of Health and Human Services spokesperson said ACIP reviews evidence and issues recommendations to best protect America’s children.
An independent review by the Vaccine Integrity Project, which evaluated more than 400 studies and reports, warned that delaying the birth dose “would reduce protection for infants and increase the risk of avoidable HBV infections, undermining decades of progress.” The review, led by researchers at the University of Minnesota’s Center for Infectious Disease Research and Policy, was vetted by outside experts.
“We fought hard for that universal birth dose because targeted approaches missed too many babies,” Wang said. “We know what happens when you wait.” The debate centers on whether testing can safely replace universal safeguards, how infectious hepatitis B is, why earlier strategies failed, and what CDC internal changes mean for vaccine policy.
The limits of testing are central to ACIP’s rationale and also to critiques of the change. Pregnant women may test negative if they acquire the virus late in pregnancy or during a window period before surface antigen becomes detectable. False negatives occur. No testing system can catch every infection, which is why universal vaccination was introduced.
If a mother’s status is unknown at delivery, hospitals are supposed to give the newborn a vaccine within 12 hours and add hepatitis B immune globulin for premature infants or if the mother later tests positive. But in real clinical settings, these safeguards often break down: results can be delayed, labs missed or misread, pharmacy deliveries stalled, and documentation lost. “Every step you add increases the chance that something falls through the cracks,” Wang said. “Delaying the vaccine just adds another.”
Some ACIP members suggested dropping the third hepatitis B shot if antibody levels look high after the second, and the committee also encouraged post-vaccine serology tests after the second or third dose, saying insurers should cover them. But liver disease specialist Dr. Brian McMahon warned the data don’t support dropping doses: “Only maybe 20% to 30%” of infants have adequate antibodies after the first shot, and “you need two doses to really reach a high level of protection,” with the third providing longer-lasting immunity. “They’re making it more and more difficult,” he said.
Hepatitis B is highly infectious compared with other bloodborne viruses: it can survive on toothbrushes, razors, and household surfaces for a week and spreads through ordinary family contact — shared items, open sores, small blood exposures — in addition to mother-to-child transmission. In the 1980s about half of infections in American children stemmed from household members rather than mothers, which is why many health departments insist every newborn be vaccinated within 24 hours of delivery regardless of maternal status. A New York advisory this year warned that delaying vaccination misses a crucial exposure window and noted the vaccine is 80% to 100% effective when given on time.
Since the universal birth dose was introduced in 1991, pediatric hepatitis B infections in the U.S. have dropped by more than 99%. A 2024 CDC analysis estimated the current schedule prevented over 6 million hepatitis B infections and nearly 1 million hospitalizations. The benefits are lifelong: infants vaccinated at birth are protected not only from early infection but from the liver failure and cancer hepatitis B can cause decades later. Because the disease progresses slowly, consequences of policy shifts may not appear for 20–30 years.
Dr. Trieu Pham, born in Vietnam in 1976, likely contracted hepatitis B at birth. Diagnosed in his 20s, he developed cirrhosis by 40 and later required a liver transplant. “If the vaccine had existed then, I wouldn’t have gone through what I did,” he said. His three children, vaccinated within hours of birth, are free of hepatitis B. “That’s the difference a day can make,” he said.
History underscores the risk of reverting to targeted strategies. In 1982, ACIP recommended hepatitis B vaccine only for high-risk adults. By the late 1980s it was clear risk-based vaccination couldn’t contain transmission because many infected people didn’t fit defined risk groups. In 1988, the CDC linked infant vaccination to maternal test results; the approach failed again as infected mothers went unidentified or results were not communicated correctly. In 1991 the CDC recommended a universal birth dose for all infants, followed by two additional doses in infancy; by 2005 this was standard and reaffirmed in 2018.
Proponents of the new policy argue moving the choice to parents will strengthen trust in vaccines, framing it as empowerment. But critics note opt-in policies often reduce coverage, especially among the families most at risk: those who miss prenatal care or testing, have undetected infections, or experience gaps in hospital care. These populations often include immigrant communities from regions where hepatitis B is endemic. “Opt-in policies sound patient-centered,” Wang said, “but in practice they’re inequitable. They leave behind the very families who need protection most.”
The United States will be the only country to abandon a universal hepatitis B birth dose recommendation. Some researchers predict delaying the first dose to 2 months could result in more than 1,400 preventable infections and about 300 liver cancer cases per year. “We don’t get to choose what we inherit,” Wang said. “But we do get to choose what we pass on.”
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