Su Wang donated blood while attending medical school. That’s when she learned she was infected with hepatitis B, a virus that attacks the liver and can lead to cancer and death decades later.
“I was 18, healthy and in college,” she said. “And suddenly I developed a chronic disease that I didn’t even know about.”
Born in Florida in 1975, Wang grew up before the hepatitis B vaccine was routinely administered to newborns. For years she thought she had been infected by her mother, but later learned that both parents were negative. “My grandparents, who took care of me after I was born, probably passed it on to me,” she said. “This is how easily this virus spreads. It only spreads within families, not from exotic risk factors.”
Currently, Wang serves as Medical Director of the Viral Hepatitis Program 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 adopt a policy that would end the United States’ universal recommendation for newborn vaccination with hepatitis B vaccine and instead encourage individual-based decision-making.
Under the new approach, only infants born to mothers who test positive for hepatitis B will automatically receive the vaccine and hepatitis B antibodies immediately after birth. For everyone else, birth vaccination can be delayed until 2 months of age if parents choose to be vaccinated.
All committee members were appointed by Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccination activist. In an 8-3 vote, the panel decided that because most pregnant women are now tested for hepatitis B, vaccination at birth should only be reserved for infants whose mothers test positive. They structured shifts in ways that reduced interventions deemed unnecessary, matched immunizations to test results, and gave parents more control over timing. Supporters of the decision portrayed it as a move toward parental choice rather than a reflection of changes in epidemiology.
But for many clinicians and epidemiologists, these changes represent a dangerous step back that could undo three decades of progress toward eradicating a disease that still infects 2.4 million Americans and kills tens of thousands more each year. They see echoes of the 1980s, when risk-based vaccinations left an entire generation unprotected, and they worry the country will soon repeat those mistakes.
Moreover, the committee’s action on hepatitis B heralds further upheaval in the country’s childhood vaccine schedule, a cornerstone of public health, despite overwhelming data showing that the birth dose is effective and safe.
“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 the way vaccine policy is created.”
Emily Hilliard, a spokesperson for the Department of Health and Human Services, responded: “ACIP reviews all of the evidence presented and issues recommendations based on evidence and sound judgment to best protect America’s children.”
author of new independent review The Vaccine Integrity Project evaluated more than 400 studies and reports. public comment It was argued that delaying birth dosing “would reduce protection for infants and increase the risk of avoidable HBV infection, undermining decades of progress toward eliminating the hepatitis B virus.” The review was led by researchers at the University of Minnesota’s Center for Infectious Disease Research and Policy, which created the Vaccine Integrity Project in response to the Trump administration’s actions.Endangering the Federal Vaccine Environment,” and was reviewed by an external expert.
“We fought hard for a universal birth dose because targeted approaches were missing too many babies,” Wang said. “We know what happens if you wait.”
What is unfolding now is not just a technical policy update, but a fundamental test of the systems we have in place to protect the most vulnerable. This debate touches on several important questions, including whether tests are reliable enough to replace universal safety measures, how infectious hepatitis B really is, why past strategies have failed, and what the impact of the CDC’s internal overhaul will be on vaccine policy.
Limitations of Testing
Hepatitis B testing is at the center of the new ACIP recommendations, but even the CDC acknowledges that testing alone cannot guarantee protection. Pregnant women may test negative if the virus is acquired during the third trimester of pregnancy or during the “latent period” before hepatitis B surface antigen is detectable. False negatives occur. No matter how well designed a testing system is, it cannot catch every infection. This is why universal immunization was created in the first place.
If the mother’s condition is unknown at the time of delivery, hospitals should vaccinate the newborn with hepatitis B vaccine within 12 hours and add hepatitis B antibodies for premature infants or in case the mother later tests positive. However, in real clinical settings, these safeguards are routinely broken down. Results take time. Nurses miss or misread labs. Pharmacies are delaying deliveries. Your document will be lost.
“Every step you add increases the likelihood that something will fail,” Wang said. “Delaying vaccinations will only add another vaccine.”
ACIP’s vote shows how this logic is being challenged.
Some committee members suggested discontinuing the third hepatitis B vaccine if antibody levels appear high after the second hepatitis B vaccine.
But Brian McMahon, a liver disease expert who has been treating hepatitis B for decades, told panelists that the data did not support that idea. He said only “maybe 20 to 30 percent” of infants have adequate antibody levels after the first dose.
“Two doses are needed to actually reach a high level of protection,” he said. A third injection provides a stronger and longer-lasting response.
He said the overall message coming from the committee seemed designed to “suppress birth doses.”
“They’re making things more and more difficult,” McMahon said.
In a second vote, ACIP also recommended that parents and clinicians order post-vaccination serology testing (a blood test that measures levels of protective antibodies) 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 survive on toothbrushes, razors and household surfaces for up to a week. It is spread not only from mother to child, but also through everyday household contact, such as through shared items, open wounds, or exposure to small amounts of blood. In the 1980s, researchers discovered that about half of infections in American children came from family members other than their mothers.
That’s why state health departments continue to insist that all newborns be vaccinated within 24 hours of birth, regardless of maternal condition. “If you delay getting vaccinated, you miss a critical window of potential exposure.” new york advisory A warning was issued this year as well. It is stated that the vaccine is 80-100% effective if administered on time.
The Vaccine Integrity Project report highlights the stakes. Since the introduction of universal birth vaccination in 1991, pediatric hepatitis B infections in the United States have decreased by more than 99%. no way 2024 CDC analysis It is estimated that the current schedule has prevented more than 6 million hepatitis B infections and nearly 1 million hospitalizations.
The benefits last a lifetime. Infants vaccinated at birth are protected not only from hepatitis B, but also from liver failure and cancer, which can develop decades later. But because the disease progresses slowly, the consequences of policy changes may not surface for 20 to 30 years.
California doctor Trieu Pham doesn’t have to imagine such an outcome. Born in Vietnam in 1976, he was probably infected with the virus at birth. “If there had been a vaccine back then, I wouldn’t have gone through what I did,” he said. Diagnosed in his 20s, he developed liver cirrhosis at the age of 40. At the age of 47, his esophageal vein burst and he was vomiting blood. Ultimately, he needed a liver transplant to survive.
“You live with constant fatigue and fear,” he said. “And the saddest part is that it was preventable.”
All three of his children, who were vaccinated within hours of birth, were free of hepatitis B. “That’s the difference one day can make,” Pham said.
lessons already learned
In 1982, ACIP recommended the new hepatitis B vaccine only for high-risk adults (healthcare workers, injection drug users, and men who have sex with men). But by the late 1980s, it was clear that risk-based vaccination would not be able to curb transmission. Many newly infected adults did not fall into defined risk groups. Identifying high-risk groups has been shown to be imperfect, stigmatizing, and ultimately ineffective.
Meanwhile, infants infected during or shortly after birth showed symptoms such as: 90% chance Compared to chronic infections that occur less than 5% In adults. But public health officials repeated the same targeting strategy, this time targeting newborns. In 1988, the CDC recommended universal prenatal screening and linked infant immunizations to maternal test results to increase protection based on risk indicators rather than vaccinating all infants.
It failed as before. Many infected mothers have not been accurately identified. Some were not tested, some were tested too early, and for others the results were misread or not communicated. Too many infants are falling through the cracks, proof that another targeted approach cannot reliably protect infants.
In 1991, CDC issued landmark guidelines recommending that all infants, regardless of maternal infection status, be vaccinated against hepatitis B at birth and receive two additional doses during infancy. By 2005, this policy was fully incorporated into the routine immunization schedule and was reaffirmed in 2018. This development was based on data showing that universal, rather than targeted, strategies are most effective in preventing infection.
a matter of trust
CDC’s new hepatitis B policy is based on the premise that turning the decision over to parents will strengthen trust in the vaccine system. Supporters frame this as an empowerment transition, a way to give families more control.
In 1999, when it was last recommended to delay the first dose of hepatitis B vaccine for infants born to uninfected mothers, immunization rates were also fell Among infants born to infected people.
“Consent policies sound patient-centered, but they are actually inequitable. They leave behind the families most in need of protection – those most likely to miss out on prenatal care and testing, those most likely to fill gaps in hospital care, as well as infants with infections that go undetected or develop after testing, and who may be exposed and infected by other caregivers and family members,” Wang said.
These are often immigrant families, including Asian and Pacific Islander populations, where hepatitis B remains endemic. “We are already underdiagnosing and undertreating this population,” Wang said. “This change will further deepen that gap.”
Currently, the United States is the only country to abandon universal hepatitis B birth dose recommendations. Although it will take decades to collect outcome data, some researchers It is estimated that delaying the first dose of the hepatitis B vaccine until 2 months of age could result in more than 1,400 preventable infections and approximately 300 cases of liver cancer per year.
“We can’t choose what we inherit,” Wang said. “But we can choose what we communicate.”
