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CDC Ends Universal Hepatitis B Birth‑Dose, Limits Vaccine to At‑Risk Newborns

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CDC Announces End to Universal Birth‑Dose Guidance The Centers for Disease Control and Prevention announced on December 16, 2025 that the longstanding recommendation for all newborns to receive a hepatitis B vaccine within 24 hours is rescinded. The new policy restricts the birth‑dose to infants whose mothers test positive for hepatitis B or whose maternal status is unknown, while parents and physicians may decide on timing for all other babies. If the birth‑dose is deferred, the vaccination series should begin at two months of age [1][2].

Advisory Committee Vote and Jim O’Neill’s Acceptance The change follows an 8‑3 vote by the federal advisory committee on immunization practices, which advised delaying the birth‑dose for low‑risk infants. Acting CDC Director Jim O’Neill formally accepted the committee’s recommendation on the same day, making the policy shift official. Both outlets cite the vote and O’Neill’s role in implementing the new guidance [1][2].

Medical Leaders Warn of Increased Infant Illness Prominent public‑health and medical officials criticized the revision, arguing that removing the universal birth‑dose could lead to a rise in hepatitis B infections among infants. Because up to 90 percent of infants infected at birth develop chronic disease, experts fear the policy may reverse decades of progress in pediatric hepatitis B control. The articles note the concern that parental discretion may not ensure timely vaccination for all at‑risk children [1][2].

Birth‑Dose Policy Has Been Standard Since 1991 Since the Advisory Committee on Immunization Practices first recommended a birth‑dose in 1991 for medically stable infants weighing at least 4.4 pounds, the schedule has included follow‑up doses at approximately 1 and 6 months. Analyses have shown the birth‑dose to be safe and instrumental in reducing pediatric hepatitis B cases, underscoring the significance of the 2025 policy shift [1][2].

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Timeline

1991: ACIP issues guidance recommending a hepatitis B vaccine dose within 24 hours of birth for medically stable infants weighing at least 4.4 lb, followed by doses at about 1 and 6 months, establishing the universal birth‑dose standard that shapes U.S. practice for decades. [1]

2020s (approx.): A Vaccine Integrity Project analysis confirms the birth dose is safe and attributes it to a substantial decline in pediatric hepatitis B infections, reinforcing the public‑health rationale for universal newborn vaccination. [1]

Early 2025: The federal Advisory Committee on Immunization Practices votes 8‑3 to recommend delaying the universal birth dose, limiting it to infants whose mothers test positive for hepatitis B or whose mothers were not tested, signaling a shift in policy thinking. [1][2]

Dec 16, 2025: Acting CDC Director Jim O’Neill formally adopts the committee’s recommendation, ending the CDC’s universal birth‑dose guidance and restricting newborn vaccination to at‑risk cases, while allowing parents and physicians to decide on timing for other infants. [1][2]

Dec 16, 2025: Medical and public‑health leaders react sharply, warning “the new recommendation will lead to more illness” and arguing that the change could increase chronic hepatitis B among infants. [1][2]

Dec 16, 2025 onward: Families who postpone the birth dose are instructed to begin the hepatitis B vaccine series at age 2 months, shifting the immunization schedule for the majority of U.S. newborns. [1][2]

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