ATLANTA, GA — The Centers for Disease Control and Prevention on Tuesday adopted a major change to its childhood immunization guidance, giving parents greater discretion over whether and when their newborns receive the hepatitis B vaccine when the mother tests negative for the virus.
The policy, approved December 16, allows what the CDC calls shared clinical decision-making for the hepatitis B birth dose, meaning parents and health care providers will weigh benefits, risks, and potential exposure before deciding to administer the vaccine at birth or begin the series later in infancy. For infants who do not receive the birth dose, the CDC suggests starting the series no earlier than two months of age.
The shift follows a vote by the CDC’s Advisory Committee on Immunization Practices and was approved by Acting CDC Director and Deputy Secretary of Health and Human Services Jim O’Neill. He said the decision reflects strong prenatal screening and the low risk of perinatal transmission when mothers test negative.
“This recommendation reflects ACIP’s rigorous review of the available evidence,” O’Neill said. “We are restoring the balance of informed consent to parents whose newborns face little risk of contracting hepatitis B.”
The change does not apply to infants born to mothers who test positive for hepatitis B or whose status is unknown. In those cases, the CDC said the current guidance remains unchanged: newborns should receive the hepatitis B vaccine and hepatitis B immune globulin within 12 hours of birth.
Federal health officials said prenatal screening for hepatitis B is highly reliable and already identifies nearly all infections during pregnancy, contributing to a very low rate of perinatal transmission in the United States. The updated recommendation is intended to preserve protections for higher-risk infants while allowing flexibility for families considered low risk.
Under the new guidance, parents and clinicians are encouraged to consider household risk factors, including whether a family member has hepatitis B or whether the infant will have frequent contact with people from regions where the virus is more common.
The CDC said the child and adolescent immunization schedule will be updated to reflect the change, and additional clinical guidance will be issued to help providers discuss vaccination timing with families. Coverage will remain consistent across all payment systems, including the Vaccines for Children Program, Medicaid, Medicare, the Children’s Health Insurance Program, and plans offered through the federal Health Insurance Marketplace.
The agency is also reviewing a secondary recommendation from ACIP suggesting that parents and clinicians consider antibody testing when deciding whether additional hepatitis B doses are needed later in childhood.
Health officials emphasized that the hepatitis B vaccine remains a safe and effective tool for preventing serious liver disease, particularly for infants at higher risk of exposure, even as the CDC moves to give families more choice in low-risk situations.
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