A CDC advisory panel voted to change the long-standing recommendation that all newborns receive a hepatitis B vaccine at birth, prompting sharp criticism from infectious disease experts who say the revision is not justified by new evidence and could increase chronic infections and future liver disease.
The Advisory Committee on Immunization Practices (ACIP) voted 8–3 to stop recommending a universal birth dose of hepatitis B vaccine. ACIP has advised a universal birth dose since 1991. The committee’s updated language shifts to individualized decision-making for infants born to mothers who test negative for hepatitis B surface antigen (HBsAg), asking parents and clinicians to weigh benefits, risks, and local infection risks when deciding on the birth dose. If the birth dose is not given, the draft guidance says the first vaccine should be delayed until no earlier than two months of age.
The committee also voted 6–4 with one abstention to recommend that parents consider blood testing to assess infants’ immunity before deciding on additional doses. Those recommendations are not yet final; the CDC director must approve them.
Experts called the change unprecedented and potentially harmful. Jake Scott, MD, clinical associate professor of infectious diseases at Stanford Medicine, said the move “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, pediatric infectious-disease specialist at Tulane University School of Medicine, said the decision “undermines the community’s trust in the scientific process” and runs counter to decades of safety and effectiveness data.
Perinatal transmission—from mother to infant at or around birth—remains a major driver of hepatitis B in many settings and is estimated in some analyses to account for as much as half of cases. About 90% of newborns infected perinatally develop chronic hepatitis B; roughly one in four of those chronically infected may die prematurely from liver conditions such as cirrhosis or hepatocellular carcinoma. William Schaffner, MD, professor of preventive medicine at Vanderbilt University, described the universal birth-dose policy as “one of the great success stories of American public health,” noting it has essentially eliminated acute hepatitis B in infants, children, and adolescents since its adoption.
Hepatitis B vaccination in the U.S. — a three-dose series given at birth, 1–2 months, and 6–18 months — has been associated with roughly a 99% decline in cases since the universal birth-dose policy began.
Critics note the ACIP decision was made without new safety data supporting the removal of the universal birth recommendation. A comprehensive review by the Center for Infectious Disease Research and Policy’s Vaccine Integrity Project found the birth dose to be consistently safe across randomized trials, large cohort studies, and safety monitoring. Short-term reactions are generally limited to localized redness, swelling, and low-grade fever, and studies have not shown an increase in serious adverse events when the vaccine is given at birth versus later.
Concerns from the 1990s about thimerosal do not apply to current pediatric hepatitis B vaccines; thimerosal-containing formulations were removed from routinely recommended childhood vaccines by 2001. Current vaccines may contain small amounts of aluminum as an adjuvant.
Proponents of the ACIP change argue hepatitis B transmission in the U.S. is now more commonly linked to sexual activity and injection drug use, and that expanded screening of pregnant women could permit targeted vaccination of infants at highest risk rather than vaccinating all newborns. Administration officials have advocated increased prenatal hepatitis B screening and a selective approach.
Public health experts counter that screening alone has proven insufficient. William Schaffner noted that screening-based strategies were tried before 1991 and did not eliminate neonatal transmission. Practical obstacles include incomplete or untimely maternal testing, false-negative results, infections acquired after initial testing, and communication failures between testing sites and birth facilities, creating gaps that a universal birth dose helps close.
Some ACIP members opposed the change. Dr. Cody Meissner, one of three who voted against dropping the universal birth recommendation, warned, “We are doing harm by changing the wording.” Observers also tied the committee’s vote to broader personnel changes at HHS: in June, Secretary Robert F. Kennedy Jr. dismissed the previous ACIP membership and appointed new members, several of whom have expressed skepticism about vaccines.
If the CDC director approves the recommendation, the United States would be the first country with an established birth-dose policy to step back from recommending a universal newborn hepatitis B vaccine. Public health leaders warn that finalizing the change could reverse decades of progress in preventing perinatal hepatitis B transmission and its severe long-term consequences.
