A vaccine advisory group to the CDC voted to alter the childhood hepatitis B vaccine schedule, reversing a recommendation in place since 1991 and prompting concern from infectious disease experts who say the change lacks scientific justification and could lead to more chronic infections and long-term liver disease.
The Advisory Committee on Immunization Practices (ACIP) voted 8-3 to no longer recommend universal hepatitis B vaccination for newborns. The change was delayed and debated over multiple meetings, with some members saying they had not been given sufficient time to review revised language. Committee deliberations were described as confused during livestreamed sessions, and one member said the rapid sequence of votes was “incredibly problematic.”
The new ACIP recommendation advises individual-based decision making for infants born to HBsAg-negative women. It tells parents and health care providers to weigh vaccine benefits, risks, and infection risks when deciding whether to give the birth dose, and suggests that if the birth dose is not given the initial dose be delayed until no earlier than 2 months of age. The committee also voted, 6 yes to 4 no with one abstention, to recommend that parents consider blood tests to check infants’ immunity to hepatitis B before deciding on additional shots. The recommendations are not yet official; the CDC director must approve them.
Experts called the move unprecedented and dangerous. Jake Scott, MD, clinical associate professor of infectious diseases at Stanford Medicine, said the change “takes away the safety net, guaranteeing that more babies will become chronically infected, and years later, some will die of liver disease that could have been prevented.” John Schieffelin, MD, associate professor of pediatrics and section chief of pediatric infectious disease at Tulane University School of Medicine, said the decision “undermines the community’s trust in the scientific process” and misrepresents decades of safety and effectiveness data for the birth dose.
Perinatal transmission—from mother to infant at or around birth—is a major driver of hepatitis B in many settings. By some estimates, perinatal transmission accounts for as much as half of cases. About 90% of newborns infected perinatally develop chronic infection; roughly one in four of those chronically infected will die prematurely from liver disease such as cirrhosis or hepatocellular carcinoma. William Schaffner, MD, a professor of preventive medicine at Vanderbilt University, described universal birth-dose vaccination as “one of the great success stories of American public health,” saying it has essentially eliminated infant, childhood, and adolescent acute hepatitis B since its implementation.
Hepatitis B vaccination in the U.S. has been associated with a roughly 99% decline in cases since the universal birth-dose policy began in 1991. The vaccine series consists of three doses: the first at birth, the second at 1–2 months, and the third between 6 and 18 months of age.
Critics of the ACIP decision note that no new safety data were presented to support removing the universal birth recommendation. A comprehensive review by the Center for Infectious Disease Research and Policy (CIDRAP) as part of its Vaccine Integrity Project found the birth dose “consistently demonstrated to be safe” based on randomized trials, large cohort studies, and safety monitoring. Reported short-term reactions are limited to localized redness, swelling, and low-grade fever; no increase in serious adverse events was found among infants given the vaccine at birth versus those with delayed administration.
Concerns raised decades ago about thimerosal do not apply to current pediatric hepatitis B vaccines. Thimerosal-containing hepatitis B vaccines were recommended for removal from the market in 1999 after an FDA review found no evidence of harm beyond localized reactions; thimerosal was removed from routinely recommended childhood vaccines by 2001. Current hepatitis B vaccines may contain small amounts of aluminum as an adjuvant to boost immune response.
Proponents of the change argue that Hepatitis B is largely spread through sexual activity and injection drug use and that screening pregnant women could allow targeted vaccination of infants at high risk. Administration officials have pushed for expanded hepatitis B screening for pregnant women, advocating a selective approach that would vaccinate only infants of infected or high-risk mothers rather than all newborns.
Experts caution that screening alone is insufficient. “We tried that before 1991, and it did not work,” Schaffner said, noting screening reduced neonatal transmission only partially. Practical barriers—universal and timely testing of mothers, false negatives, infections acquired after initial testing, and breakdowns in communication or record transfer between testing sites and birth facilities—create gaps that a universal birth dose helps close. Jake Scott emphasized that selective approaches miss cases and that universal vaccination was adopted precisely because screening-based strategies proved inadequate.
Some ACIP members opposed the change. Dr. Cody Meissner, one of three who voted against dropping the universal birth recommendation, said, “We are doing harm by changing the wording.” Other public health and infectious-disease experts worry the shift will erode trust in childhood vaccination programs and create immunity gaps that could allow preventable diseases to reemerge.
Observers also linked the committee’s decision to broader shifts in the Department of Health and Human Services. In June, HHS Secretary Robert F. Kennedy Jr. dismissed all 17 previous ACIP members and appointed new members, several of whom have expressed skepticism about vaccines. Critics say the vote reflects that influence.
The ACIP’s move makes the United States the first country with an established birth dose to retreat from recommending universal newborn hepatitis B vaccination. Public health leaders warn that if finalized by the CDC director, the change could undo decades of progress in preventing hepatitis B transmission and its severe long-term consequences.