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

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CDC Withdraws Universal Birth‑Dose Guidance for All Infants The Centers for Disease Control and Prevention announced it will no longer advise a hepatitis B vaccine within 24 hours of birth for every newborn. The new policy restricts the birth dose to babies whose mothers test positive for hepatitis B or whose maternal status is unknown, following an 8‑3 vote by the federal advisory committee and acceptance by Acting CDC Director Jim O’Neill [1][2].

Decision Shifts to Parents and Physicians for Low‑Risk Babies For infants not meeting the at‑risk criteria, the choice to give a birth dose rests with parents and their doctors, and the standard vaccination series may begin at two months of age [1][2]. Previously, the schedule required a birth dose, followed by doses at about one and six months for medically stable infants weighing at least 4.4 pounds.

Medical Leaders Warn of Potential Rise in Infant Infections Numerous pediatric and public‑health experts criticized the change, arguing it could increase hepatitis B cases among newborns [1][2]. Infants who acquire the virus have a roughly 90 % chance of developing chronic infection, leading to long‑term liver disease.

Policy Reverses Decades‑Long Birth‑Dose Recommendation Since 1991, the Advisory Committee on Immunization Practices has endorsed a universal birth dose as a cornerstone of hepatitis B prevention [1][2]. The current revision marks the first major rollback of that guidance in over three decades.

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Timeline

1991 – The Advisory Committee on Immunization Practices (ACIP) first recommends a universal hepatitis B birth‑dose for medically stable infants weighing at least 4.4 lb, followed by doses at 1–2 months and 6–15 months, establishing the cornerstone of U.S. hepatitis B prevention policy[1].

Early 2025 – HHS Secretary Robert F. Kennedy Jr. dismisses the existing 17‑member ACIP and appoints a new panel, reshaping the advisory landscape that will later vote on the birth‑dose policy[2].

Dec 5, 2025 – The reconstituted ACIP votes 8‑3 to replace the universal newborn hepatitis B dose with a shared‑decision‑making model, allowing the first dose to be delayed until at least two months for infants of HBsAg‑negative mothers[2].

Dec 5, 2025 – Dissenting ACIP members Dr. Cody Meissner and Dr. Joseph Hibbeln denounce the proposal as “unconscionable” and claim the panel is “making things up,” arguing the evidence base for delaying vaccination is insufficient[2].

Dec 5, 2025 – The American Academy of Pediatrics publicly opposes the change, maintains that routine newborn hepatitis B vaccination remains the standard of care, and declines to attend ACIP meetings after the panel’s reconstitution[2].

Dec 5, 2025 – International comparison is raised: FDA’s Dr. Tracy Beth Hoeg cites Denmark’s schedule, which omits a routine birth dose, while CDC’s Dr. Adam Langer warns the Danish health context differs markedly from the United States[2].

Dec 16, 2025 – Acting CDC Director Jim O’Neill formally adopts the ACIP recommendation, ending the universal birth‑dose guidance and limiting it to infants whose mothers test positive for hepatitis B or whose status is unknown; families may now defer the series until age 2 months[3][4].

Dec 16, 2025 – Prominent medical and public‑health leaders condemn the new policy, warning it will “lead to more illness” and increase chronic hepatitis B infections that affect up to 90 % of infants who acquire the virus at birth[3].

Dec 16, 2025 – The CDC’s updated schedule retains the three‑dose series (birth, 1–2 months, 6–15 months) for at‑risk newborns but introduces immunity testing after subsequent doses to guide further vaccination, aligning the hepatitis B schedule with broader pediatric vaccine practices[1][1].

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