In a landmark decision that’s sending shockwaves through the U.S. medical community, the Centers for Disease Control and Prevention (CDC) has officially ended its longstanding universal recommendation for administering the hepatitis B vaccine to all newborns within 24 hours of birth. Instead, the CDC now urges a case-by-case approach for infants born to mothers who test negative for the hepatitis B virus, embracing what it calls “shared clinical decision-making” between parents and healthcare providers. The move, announced on December 16, 2025, is the first major rollback of a universal childhood vaccine recommendation in the United States since the Advisory Committee on Immunization Practices (ACIP) was established nearly four decades ago.
The decision follows a contentious ACIP vote held over two days in early December. On December 4, committee members engaged in a full day of debate, with national vaccine experts and pediatricians weighing in both for and against the universal newborn dose. According to Medical Economics, the panel ultimately voted 8-3 on December 5 to withdraw the blanket recommendation for the first-day hepatitis B shot in infants whose mothers have tested negative for the virus. For these low-risk infants, the initial dose will now be optional and, if not given at birth, should be administered no earlier than two months of age.
This policy shift comes amid a broader transformation at the CDC and ACIP. As detailed by Peter A. McCullough, MD, MPH, in FOCAL POINTS, all 17 members of the ACIP were replaced in 2025 under the direction of Health Secretary Robert F. Kennedy Jr. The new committee, McCullough writes, has begun to emphasize parental consent and individualized risk assessment over the blanket mandates that characterized earlier decades. “Votes on COVID-19 boosters and RSV adult vaccines (2024–2025) emphasized case-by-case risk assessment—departing from prior blanket mandates,” McCullough noted, highlighting a new era of deliberation and transparency.
Supporters of the new policy argue that it restores parental autonomy and aligns with international practices. The CDC’s guidance now instructs parents and healthcare providers to consider specific risk factors—such as whether anyone in the household has hepatitis B or if there is frequent contact with individuals from regions where the disease is prevalent—before deciding on vaccination. The CDC’s announcement explained, “Individual-based decision-making, referred to on the CDC immunization schedule as shared clinical decision-making, means that parents and health care providers should consider vaccine benefits, vaccine risks, and infection risks, and that parents consult with their health care provider and decide when or if their child will begin the hepatitis B vaccine series.”
Yet, the decision has sparked fierce opposition from leading medical organizations. The American Medical Association (AMA) and the American Academy of Pediatrics (AAP) have both condemned the rollback, warning that it could reverse decades of progress in the fight against hepatitis B. In a statement, Sandra Adamson Fryhofer, MD, a trustee of the AMA, said, “Decades of scientific evidence shows that the birth dose of the hepatitis B vaccine is essential to protecting all newborns from a serious, chronic infection that can lead to liver disease, cirrhosis, liver cancer, and even death. Rolling back this recommendation creates confusion and doubt about vaccines, reverses hard-won progress in preventing hepatitis B, and will undoubtedly result in completely preventable illness and death.”
The AAP echoed these concerns, pointing to research from the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) that reviewed more than 400 studies and reports. The CIDRAP team concluded that delaying the birth dose would increase hepatitis B infections without improving vaccine safety or effectiveness. Since 1991, when the universal birth dose was introduced, pediatric hepatitis B incidence in the U.S. has dropped by 99%. The AAP’s president, Susan J. Kressly, MD, FAAP, wrote to ACIP, “Switching to a non-universal recommendation will result in many children contracting hepatitis B infection, with devastating results for their health.”
Donna Hallas, PhD, a clinical professor and pediatric nurse practitioner, also expressed strong opposition in Contemporary Pediatrics. She criticized the ACIP’s reliance on what she called “outdated data and opinions, not scientific evidence,” and argued that the birth dose is a powerful tool for primary prevention. “We cannot ignore the data that overwhelmingly support the positive outcomes from administering the hepatitis B vaccine dose to all newborns since 1991,” Hallas wrote. She further emphasized that 90% of infants infected at birth or during the first year of life develop chronic hepatitis B, a statistic that underscores the risks of foregoing early immunization.
Despite these warnings, the ACIP’s new approach reflects a shift toward individualized care. The committee’s deliberations included concerns about whether parents are truly informed when making vaccination decisions in the hectic hours after birth. Members also discussed the reliability of hepatitis B screening for pregnant women—a CDC fact sheet noted that screening has high reliability and is covered by all insurance programs, but data from CIDRAP indicate that 18% of pregnant women do not receive hepatitis B testing, and only 35% of those who test positive get all recommended follow-up care.
Notably, the ACIP did not change its recommendation for infants born to mothers who test positive for hepatitis B. For these high-risk newborns, the vaccine and hepatitis B immune globulin remain crucial, with studies showing they can reduce transmission by 83% to 97%. At least 17,000 infants are born each year to women with the disease, according to the CIDRAP review.
The broader context of this decision is a nearly 40-year trajectory in U.S. vaccine policy. After the 1986 National Childhood Vaccine Injury Act shielded manufacturers from liability, the ACIP rapidly expanded the childhood immunization schedule, often with minimal dissent. McCullough’s analysis suggests that, until recently, the committee’s votes were routinely unanimous and rarely revisited for long-term safety. Only in the past year, under new leadership, has the ACIP begun to reconsider its approach, introducing language that prioritizes parental consent and international benchmarking.
As the dust settles from this historic vote, the nation’s medical community finds itself at a crossroads. Advocates of the new policy hail it as a long-overdue recognition of parental rights and individualized care, while critics warn it could open the door to increased infections and erode public confidence in vaccines. One thing is certain: how the U.S. navigates this new era of vaccine policy will be watched closely by both supporters and skeptics across the globe.
The debate over the hepatitis B birth dose is far from over, but for now, the CDC’s policy change marks a dramatic departure from decades of universal vaccination—and sets the stage for a new chapter in American public health.
