The Hepatitis B Vaccine Committee’s vote signals further disruption to immunization policy and public confidence

When Su Wang was in medical school, she donated blood. That’s when she learned she had hepatitis B, a virus that attacks the liver and can lead to cancer and death decades later.

“I was 18 years old, healthy, in college,” she said. “Suddenly, I had a chronic disease that I did not know existed.”

Born in Florida in 1975, Wang grew up before the hepatitis B vaccine was routinely given to newborns. For years, she assumed she had contracted the infection from her mother, only to later discover that her parents were seronegative. “It turns out that my grandparents, who took care of me after birth, may have passed this disease on to me,” she said. “That’s how easily this virus can spread — not from some exotic risk factor, just from family.”

Today, Wang is the medical director of viral hepatitis programs at RWJBarnabas Health in New Jersey. Her story is now at the center of a historic turning point in public health.

On December 5, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to end the U.S. global recommendation for newborn dose of hepatitis B vaccine, adopting instead a policy that encourages individualized decision-making.

Under the new approach, only infants born to mothers who test positive for hepatitis B will automatically receive a dose of the vaccine and hepatitis B antibodies shortly after birth. For everyone else, if the parents choose to vaccinate, the birth dose can be delayed until 2 months of age.

All members of the committee were appointed by Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist. In an 8-3 vote, the committee decided that since most pregnant women are now tested for hepatitis B, administration of the vaccine at birth should be limited to infants whose mothers test positive. They framed the shift as a way to reduce interventions deemed unnecessary, align vaccination with test results, and give parents more control over timing. Supporters of the decision called it a step toward parental choice rather than a reflection of changing epidemiology.

But for many doctors and epidemiologists, the change represents a dangerous setback that could reverse three decades of progress toward eliminating the disease that still infects up to 2.4 million Americans and kills tens of thousands each year. They see echoes of what happened in the 1980s, when risk-based vaccination left entire generations unprotected, and worry that the country is about to repeat that mistake.

Moreover, the committee’s move on hepatitis B — in the face of compelling data showing the birth dose is effective and safe — portends further disruption to the nation’s childhood vaccination schedule, a cornerstone of public health.

“They’re not just trying to change one vaccine,” said Angela Rasmussen, a virologist and editor of the scientific journal Vaccine. “They are trying to dismantle how vaccine policy is made.”

HHS spokeswoman Emily Hilliard responded: “ACIP reviews all evidence presented and issues recommendations based on the evidence and sound judgment to better protect America’s children.”

Authors A New independent review The Vaccine Safety Project, which evaluated more than 400 studies and reports, warned in A Public comment Delaying the birth dose “would reduce infant protection and increase the risk of avoidable hepatitis B virus infection, undermining decades of progress” toward eliminating hepatitis B virus. The review was led by researchers at the Center for Infectious Disease Research and Policy at the University of Minnesota, which created the Vaccine Safety Project in response to what it sees as the Trump administration’s actions that “Putting the federal vaccine landscape at risk“, and was examined by external experts.

“We fought hard for this universal birth dose because targeted approaches missed too many babies,” Wang said. “We know what happens when you wait.”

What is unfolding now is not just a technical policy update, but a fundamental test of systems meant to protect the most vulnerable. The debate revolves around some crucial questions — whether the test is reliable enough to replace universal safeguards, how contagious hepatitis B really is, why previous strategies have failed, and what the CDC’s internal changes mean for vaccine policy more generally.

Test limits

Hepatitis B testing is at the heart of the new ACIP recommendation, but even the CDC acknowledges that testing alone cannot guarantee protection. Pregnant women may test negative if the virus is acquired late in pregnancy or during the “window period,” before hepatitis B surface antigens become detectable. False negatives do occur. No testing system, no matter how well designed, can detect all infections. That’s why universal vaccination was created in the first place.

If the mother’s condition is unknown at birth, hospitals are supposed to give the newborn the hepatitis B vaccine within 12 hours, with hepatitis B antibodies added for premature babies or if the mother tests positive later. But in real clinical settings, these safeguards routinely break down. Results take time. Nurses miss or misread labs. Pharmacies are delaying deliveries. Documentation is lost.

“Every step you add increases the likelihood of something falling through the cracks,” Wang said. “The vaccine delay adds something else.”

The ACIP vote shows how this logic is being challenged.

Some panelists suggested dropping the third dose of hepatitis B vaccine if antibody levels appear high after the second dose.

But Brian McMahon, a hepatologist who has spent decades treating hepatitis B, told committee members that the data doesn’t support that idea. “Maybe only 20% to 30%” of infants have a sufficient level of antibodies after the first dose, he said.

“You need two doses to reach a high level of protection,” he said, while the third dose gives a stronger, longer-lasting response.

He said the overall message from the committee seemed designed to “discourage birth dose.”

“They make it more difficult,” McMahon said.

In the second vote, ACIP also encouraged parents and doctors to order post-vaccine serology tests — blood tests that measure protective antibody levels — after the second or third dose. ACIP said the tests should be covered by insurance.

More contagious than HIV or hepatitis C

Hepatitis B can live on toothbrushes, razors, and household surfaces for a week. It spreads not only from mother to child, but also through normal family contact: sharing objects, open sores, and small-scale blood exposure. In the 1980s, researchers found that about half of infections among American children came not from mothers, but from other family members.

That’s why state health departments continue to insist that every newborn be vaccinated within 24 hours of birth, regardless of the mother’s condition. “Delaying vaccination misses a critical period of potential exposure.” New York Consulting Be careful this year. She noted that the vaccine is 80% to 100% effective when given on time.

The Vaccine Safety Project report underscores the risks. Since universal birth dose was introduced in 1991, hepatitis B infection rates in children in the United States have decreased by more than 99%. A CDC 2024 analysis The current schedule is estimated to have prevented more than 6 million hepatitis B infections and nearly 1 million hospitalizations.

Benefits last a lifetime. Infants who are vaccinated at birth are protected not only from hepatitis B, but also from liver failure and the cancer it can cause decades later. However, because the disease unfolds slowly, the consequences of political transformations may not surface for twenty or thirty years.

Trieu Pham, a California doctor, doesn’t need to imagine those consequences. He was born in Vietnam in 1976, and was likely infected with the virus at birth. “If the vaccine had been around then, I wouldn’t have gone through what I did,” he said. He was diagnosed in his 20s and developed cirrhosis of the liver at age 40. At age 47, he was coughing up blood from ruptured esophageal veins. Ultimately, he needed a liver transplant to survive.

“You live with this constant fatigue and fear,” he said. “The saddest part is that it could have been prevented.”

Pham said his three children, all of whom were vaccinated within hours of their birth, are free of hepatitis B. “That’s the difference one day can make.”

A lesson I’ve already learned

In 1982, ACIP recommended the new hepatitis B vaccine only for adults at high risk: health care workers, injection drug users, and men who have sex with men. But by the late 1980s, it was clear that risk-based vaccination could not contain transmission. Many newly infected adults do not fit into any risk group. Identification of people at high risk has proven incomplete, stigmatizing, and ultimately ineffective.

Meanwhile, infants were infected during or shortly after birth 90% chance of chronic infection, compared with less than 5% In adults. However, public health officials repeated the same targeted strategy, this time with newborns. In 1988, the Centers for Disease Control and Prevention (CDC) recommended universal prenatal screening and linked infant vaccination to the mother’s test result, again basing protection on the risk sign rather than vaccinating all infants.

As before, he failed. Many affected mothers are not properly identified. Some were never tested, others were tested too early, and others had results that were misread or never reported. Too many children slipped through the cracks, evidence that other targeted approaches could not reliably protect them.

In 1991, the Centers for Disease Control and Prevention issued its landmark guidance recommending that all infants, regardless of their mothers’ infection status, receive the hepatitis B vaccine at birth, followed by two additional doses in infancy. By 2005, this policy had become an integral part of the routine immunization schedule, and was reaffirmed in 2018. This development was based on data showing that a global strategy, rather than a targeted strategy, is most effective in preventing infection.

A matter of trust

The Centers for Disease Control and Prevention’s new hepatitis B policy is based on the premise that conveying the decision to parents will enhance confidence in the vaccine system. Supporters portray it as an empowering shift, a way to give families more control.

In 1999, when it was last recommended to postpone the first dose of hepatitis B vaccine for infants born to uninfected mothers, vaccination rates soared. also decreased Among children born to those infected.

“Choice policies appear patient-centered, but they are actually inequitable,” Wang said. “They leave behind families who need protection most” – families most likely to miss prenatal care and testing, develop infections that go undetected or arise after testing, or slip through gaps in hospital care, as well as infants who could be exposed and transmitted by other caregivers and family members.

These households are often migrant, including from Asian and Pacific Island communities where hepatitis B remains endemic. “We already underdiagnose and undertreat this population,” Wang said. “This change would deepen this gap.”

The United States is now the only country to abandon the universal birth dose recommendation for hepatitis B. Although it will take decades to collect outcome data, Some researchers He predicted that delaying the first dose of hepatitis B vaccine to 2 months of age could result in more than 1,400 preventable infections and about 300 cases of liver cancer annually.

“We can’t choose what we inherit,” Wang said. “But we have to choose what we convey.”