The Centers for Disease Control and Prevention on Tuesday changed its newborn hepatitis B guidance, no longer recommending vaccination for all newborns at birth and instead advising parents of low-risk infants to consult health care providers.
CDC Formalizes Shift From Universal Birth Dose
The change in newborn hepatitis B guidance follows a recommendation from the CDC’s Advisory Committee on Immunization Practices (ACIP), ending a policy in place since 1991. Acting CDC Director Jim O’Neill accepted the panel’s vote Tuesday, making the revised newborn hepatitis B guidance official.
Under the revised guidance, the CDC advises women who test negative during pregnancy to consult with a health care provider about whether their newborn should receive the first dose at birth. O’Neill said the change is intended to support shared decision-making between clinicians and parents.
The CDC continues to recommend immediate vaccination for infants born to mothers who test positive for hepatitis B or whose infection status is unknown.
Evidence and Concerns Cited by Experts
Hepatitis B is a viral infection that can lead to chronic liver disease, cirrhosis, and liver cancer. While supporters of the revised newborn hepatitis B guidance note strong prenatal screening programs, critics warn that screening gaps could leave some infants unprotected.
Federal data show pediatric cases of acute hepatitis B declined sharply after the CDC recommended a universal birth dose. According to the agency, reported cases among children fell by ninety-nine percent from 1990 to 2019. Studies have found that administering the vaccine shortly after birth reduces mother-to-child transmission by about seventy to ninety-seven percent and provides long-term protection.
ACIP members supporting the change said infants born to mothers who test negative face minimal risk and noted that some countries begin hepatitis B vaccination later in infancy. They also pointed to prenatal screening programs intended to identify mothers with hepatitis B before delivery.
Other health officials and clinicians emphasize that screening is not universal and that test results may be unavailable at the time of birth. They say a universal birth dose acts as a safety net, preventing missed cases and protecting infants from household or early-life exposure.
Sen. Bill Cassidy, R-La., a physician who has treated patients with hepatitis B, said in a social media post this month that delaying vaccination could increase infections over time. He was among several medical professionals who urged the CDC to retain the prior guidance.
Coverage, Access and Ongoing Recommendations
The CDC now suggests that infants who do not receive a birth dose begin the hepatitis B vaccine series at or after two months of age. The vaccine is typically given as a three-dose series over the first eighteen months of life.
The agency is also reviewing an additional ACIP recommendation that would encourage parents to consult clinicians about testing children for hepatitis B antibodies before later doses.
The Department of Health and Human Services said the revised guidance does not change insurance coverage. Hepatitis B vaccines remain covered by private insurers and are still provided at no cost to eligible families through the Vaccines for Children Program.
Professional medical organizations continue to issue their own recommendations. The American Academy of Pediatrics reaffirmed its guidance supporting a hepatitis B vaccine dose within twenty-four hours of birth, followed by additional doses at one to two months and six to eighteen months.
Globally, the World Health Organization recommends a birth dose of hepatitis B vaccine, and more than one hundred twenty countries have adopted that practice as part of their national immunization programs.
Health officials advise families to discuss the updated newborn hepatitis B guidance with their child’s health care provider to weigh risks, benefits, and timing. “The vaccine remains effective and widely available,” a pediatric infectious disease specialist said. “Parents should make decisions based on medical advice and individual circumstances.”
