On December 22, 2025, a storm of controversy erupted in the U.S. public health and scientific communities after the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to remove its longstanding universal recommendation that all newborns receive the hepatitis B vaccine at birth. The decision, made under the watch of Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., has drawn sharp criticism from lawmakers, scientists, and global health experts who warn that the move could undermine decades of progress in preventing hepatitis B infections among America’s youngest citizens.
Representative Robert Garcia, Ranking Member of the House Committee on Oversight and Government Reform, wasted no time in demanding answers. In a letter to Secretary Kennedy, Garcia called the ACIP’s decision a “radical takeover” and accused the agency of “uplifting conspiracy theorists and anti-vaxx propaganda” at the expense of public health. “I am deeply concerned by Secretary Kennedy’s radical takeover of the Department of Health and Human Services, especially the most recent decision to remove the recommendation that all babies receive the hepatitis B vaccine at birth. It is clear this agency no longer prioritizes the health of the American people, but instead prioritizes uplifting conspiracy theorists and anti-vaxx propaganda. Secretary Kennedy must prove why this decision was made by the ACIP before children across the country face the consequences,” Garcia said, according to official statements.
The ACIP’s new guidance now recommends the hepatitis B vaccine only for infants whose mothers test positive for the virus or whose maternal status is unknown. For mothers who test negative, the committee advises that parents consult their doctors and make an individual decision. This marks a dramatic shift from the previous universal approach, which experts credit with saving tens of thousands of children’s lives by preventing early-life hepatitis B infections—a disease that, if contracted in infancy, leads to chronic infection in 90% of cases and can result in liver failure or cancer, as noted by the Johns Hopkins Bloomberg School of Public Health.
Garcia’s letter demanded that HHS provide all data used to inform the ACIP’s vote, as well as documentation regarding potential conflicts of interest and the influence of anti-vaccine activists on the meeting. He also requested an assessment of the likely health impacts on American children. “Removing the universal recommendation for the hepatitis B vaccine fuels vaccine skepticism by implying that receiving the vaccine may be dangerous for infants, when the truth is that the universal dose of the hepatitis B vaccine has saved tens of thousands of children’s lives,” Garcia wrote, underscoring the urgency of the issue.
While the federal debate raged, state-level health officials scrambled to respond. The Arkansas Department of Health acknowledged it was reviewing its “updated immunization policy” in light of the new federal guidance, but stated it did not expect any immediate changes to school vaccination requirements. According to the Arkansas Democrat-Gazette, the department’s review was prompted by the CDC’s decision on hepatitis B vaccine administration timing for infants, but the state’s school immunization mandates would remain unchanged for now. This cautious approach reflects the uncertainty and confusion generated by the abrupt change at the federal level.
The controversy has not stopped at America’s borders. In a parallel development, the Trump administration announced a $1.6 million grant to fund a clinical trial on hepatitis B vaccination among newborns in Guinea-Bissau, West Africa—a region where nearly one in five people are infected with the virus. The study, led by Christine Stabell Benn and Peter Aaby from the University of Southern Denmark, will compare health outcomes in infants who receive the hepatitis B vaccine at birth with those who do not. But the trial has been lambasted by leading scientists as “highly unethical” and “extremely risky,” especially given the region’s high disease prevalence.
Martin McKee, professor of European public health at the London School of Hygiene and Tropical Medicine, minced no words: “This announcement has set alarm bells ringing in the global health community,” he told The Guardian. “It is not clear what the research question is. It seems to be about the safety of the vaccine rather than its effectiveness, but both are already well established, and to undertake such a study in a population where almost one in five of the adult population has a marker of infection seems extremely risky.”
Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, added his voice to the chorus of concern, saying, “[Kennedy] has a fixed, immutable belief that vaccines cause harm. He will do everything he can to try and prove that.” Offit also condemned the ethical implications of the trial: “It’s highly unethical to choose to give a vaccine to some children but not others.”
The Danish research team leading the African study is no stranger to controversy. For decades, Benn and Aaby have conducted randomized trials in Guinea-Bissau and Denmark, exploring so-called nonspecific vaccine effects—whether vaccines provide protection beyond their primary target disease. Yet a recent comprehensive review by Henrik Støvring of Aarhus University found their research wanting. “It is concerning that such a prominent research group has conducted so many randomized trials over such a long period without finding real results,” Støvring said, arguing that if randomized trials—the gold standard in medical research—fail to show an effect, it is misleading to present isolated findings as convincing evidence.
The new study in Guinea-Bissau, funded by the CDC award, does not focus on whether the hepatitis B vaccine is effective at birth (a question already settled in the scientific community) but rather on “overall health effects” of the vaccine when administered immediately after birth. Critics argue that this is a policy in search of evidence, and that the risks to vulnerable infants in a high-prevalence region are simply too great to justify withholding a proven intervention.
The timing of the CDC’s policy reversal and the launch of the African clinical trial has not gone unnoticed. Many experts see a disturbing alignment between the two, suggesting that the U.S. government’s shift away from universal infant hepatitis B vaccination is not only influencing domestic policy but also shaping research agendas abroad—sometimes with potentially dire consequences for the world’s most at-risk children.
As the debate intensifies, the stakes could hardly be higher. Hepatitis B remains a major global health threat, and the universal birth dose of the vaccine has long been regarded as a cornerstone of effective prevention. With the CDC’s new guidance, the future of this public health success story now hangs in the balance, as lawmakers, scientists, and advocates fight to ensure that the lessons of the past are not forgotten in the rush to embrace unproven ideas.
For now, the fate of the universal hepatitis B vaccine recommendation—and the children it was designed to protect—remains uncertain, caught in the crossfire between science, politics, and ideology.
