ACIP Ends Universal Newborn Hepatitis B Shot, Shifts to Two‑Month Decision‑Making
Updated (3 articles)
ACIP votes 8‑3 to drop routine birth‑dose recommendation On December 5, 2025 the CDC Advisory Committee on Immunization Practices approved an 8‑3 vote ending the universal hepatitis B vaccine dose for newborns, limiting it to infants whose mothers test HBsAg‑positive or have unknown status [2][3]. The panel included eight members supporting the change and three dissenting, among them Drs. Meissner, Hibbeln and Pollak [2]. The committee was reconstituted earlier in the year by HHS Secretary Robert F. Kennedy Jr. after a wholesale replacement of its members [2].
New guidance delays first dose to at least two months The revised schedule directs that, when a birth dose is not given, the initial hepatitis B immunization should occur no earlier than the infant’s second month [2][3]. Parents of infants born to HBsAg‑negative mothers must engage in shared clinical decision‑making with health‑care providers to determine timing [2]. The policy retains the birth‑dose for infants of HBsAg‑positive or status‑unknown mothers [2][3].
Medical societies and experts condemn the shift The American Academy of Pediatrics, the Infectious Diseases Society of America, Dr. Paul Offit, and the Vaccine Integrity Project all argue the birth‑dose is essential for preventing severe disease and cite decades of safety data [1][3]. Lawmakers expressed concern that the change could increase hepatitis B incidence among children [1]. Critics on the panel described the evidence base for delaying the first dose as “unconscionable” and “making things up” [2].
CDC leadership and immunity‑testing policy await final decision Acting CDC Director Jim O’Neill will determine whether to adopt the ACIP recommendations, a step that historically follows advisory votes [1][2]. In a separate 6‑4 vote, the committee approved testing children for hepatitis B immunity before administering additional doses, aligning the program with broader vaccination strategies [1].
Modeling predicts thousands of extra infections if delay implemented medRxiv pre‑print estimates postponing the first dose to two months could cause at least 1,400 additional pediatric hepatitis B infections and 480 deaths, with higher numbers if delays extend further [3]. Historical data show the birth‑dose, introduced in 1991, reduced annual pediatric cases from roughly 18,000 to about 2,200 [3].
Sources
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1.
CNN: ACIP voted to end birth‑dose universalism: Details the 8‑3 vote, immunity‑testing approval, and reactions from medical groups and lawmakers, highlighting the upcoming CDC director decision .
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2.
CNN: CDC Advisory Committee Votes to End Universal Hepatitis B Newborn Vaccination: Focuses on the vote breakdown, shared decision‑making, panel composition under Robert F. Kennedy Jr., and expert criticism of the evidence base .
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3.
AP: ACIP Reverses Universal Newborn Hepatitis B Vaccine Recommendation: Emphasizes the shift to a two‑month first dose, warnings from Dr. Paul Offit, historical impact of the birth‑dose, and modeling predicting thousands of extra cases .
Timeline
1991 – The United States adopts a universal hepatitis B birth‑dose vaccine for all infants, establishing the schedule of doses at birth, 1–2 months, and 6–15 months [3].
1991‑2025 – Annual pediatric hepatitis B infections drop from roughly 18,000 to about 2,200, a decline credited to the early birth‑dose program [3].
Early 2025 – HHS Secretary Robert F. Kennedy Jr. reconstitutes the ACIP, dismissing the prior 17 members and appointing a new panel that later votes on the birth‑dose policy [2].
Mid‑2025 – The American Academy of Pediatrics declines to attend ACIP meetings this year, signaling strong institutional opposition to the upcoming schedule changes [2].
2025 (pre‑Dec) – A medRxiv modeling study projects that delaying the first hepatitis B dose to two months could generate at least 1,400 additional infections and 480 child deaths in the United States [3].
Dec 5, 2025 – The ACIP votes 8‑3 to end universal hepatitis B birth‑dose vaccination, recommending shared decision‑making and allowing the first dose to be given no earlier than two months for infants of HBsAg‑negative mothers [1][2][3].
Dec 5, 2025 – The committee also votes 6‑4 to require hepatitis B immunity testing before administering subsequent doses, aligning pediatric practice with broader vaccination programs [1].
Dec 5, 2025 – Dr. Paul Offit says the decision “has just condemned hundreds of children to a shorter life,” warning that the birth‑dose prevents severe disease [3].
Dec 5, 2025 – ACIP members Dr. Joseph Hibbeln and Dr. Cody Meissner call the recommendation “unconscionable” and accuse the panel of “making things up,” questioning the evidence base [2].
Dec 5, 2025 – A presentation compares U.S. vaccination policy to Denmark; FDA’s Dr. Tracy Beth Hoeg supports the change as consistent with peer nations, while CDC’s Dr. Adam Langer argues Denmark’s health context differs markedly [2].
Dec 5, 2025 – The American Academy of Pediatrics, the Infectious Diseases Society of America, and several lawmakers publicly criticize the shift, arguing it could increase hepatitis B illness among infants [1].
Dec 5, 2025 – Acting CDC Director Jim O’Neill is tasked with deciding whether to adopt the ACIP recommendations, a step that typically follows advisory votes [1].
2026 (expected) – The CDC is anticipated to issue final guidance on hepatitis B newborn vaccination after Jim O’Neill’s review, determining the practical rollout of the new shared‑decision model [1].
External resources (13 links)
- https://www.cdc.gov/acip/downloads/agendas/final-posted-2025-12-04-7pm-508.pdf (cited 2 times)
- https://www.cdc.gov/hepatitis-b/index.html (cited 1 times)
- https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-age.html#table-1 (cited 1 times)
- https://publications.aap.org/redbook/resources/15585/AAP-Immunization-Schedule?autologincheck=redirected (cited 1 times)
- https://www.aap.org/en/news-room/news-releases/aap/2025/hepatitis-b-immunization-is-critical-to-protect-all-newborns/ (cited 1 times)
- https://www.cidrap.umn.edu/vaccine-integrity-project/hepatitis-b (cited 1 times)
- https://x.com/AmerAcadPeds/status/1937858504225595782?s=20 (cited 2 times)
- https://truthsocial.com/@realDonaldTrump/posts/115669821715563033 (cited 1 times)
- https://x.com/SenBillCassidy/status/1996974038413971766?s=20 (cited 1 times)
- https://u7061146.ct.sendgrid.net/ls/click?upn=u001.gqh-2BaxUzlo7XKIuSly0rC1PygbyqXuZwfRaRn-2FsijaKb8T2E1r-2BS1QjsZ1BOiwi-2BtIWI160sfs3YqM8PsISDOk1hFRV17JHj-2FneOYGoT3o0EsNoud1uSYDpicyBivoA-2B5xYIBzhBMlW0GNGYt5vNwFoew9RzWIuiUUYuB-2FykLsA-3DXKLU_o6u21WJ7K0UM8DVeDhJcfjo32Bq4xjOG1x9ezGGucBin5GEAENhCOaddaPdB3nuRQxWbjlA5jSZUOKMK9s2FlA2AcemqaKHHIlEkn9l447BghGx6l34z9OZQ0uPuiZkdcPXcuieVdiRh1AoIiHyAsxFfjx64pWQZ4vhyZx1LQt1hiaSnfLnB-2Flmf65je7bsJXkHGrJAvXH01Xl4wNCKpJs8kbpJN2Q5e4AQ-2Fgrt7UzzrQJCMGfBBQO8syKcsXnETch8m6-2FPE6HvgMZjoruLaqeMJFRO03kBNn4RAGhvkvE3hBXjOojBwuQw33Pbvz1lc-2F8I20i-2F3i9I6lRocOq-2FX9dn3NjCK56FqJog-2FxVzcFkA-3D (cited 2 times)
- https://www.idsociety.org/~/link/32d1b62e77d74a7c9e19fd74f784e9e8.aspx (cited 2 times)
- https://u7061146.ct.sendgrid.net/ls/click?upn=u001.gqh-2BaxUzlo7XKIuSly0rC1PygbyqXuZwfRaRn-2FsijaKb8T2E1r-2BS1QjsZ1BOiwi-2BtIWI160sfs3YqM8PsISDOk1hFRV17JHj-2FneOYGoT3o0EsNoud1uSYDpicyBivoA-2B5xYIBzhBMlW0GNGYt5vNwFoew9RzWIuiUUYuB-2FykLsA-3D-IVw_qGZiFZTpoItOSqoZl-2BEdDdlKN8YG4TeBtQM04tj1tiEObpDwIdH9-2FKSaNl1fRKxXC1ghMXjwyUBSGIlBzhU6hLHavRgbskXbYD-2BSU-2FaPAhMGIxqZGygs6AU7HNVG-2Fd-2FNoaPRsjPwiW3hamki9rEcJTWZRYrVX-2FgfeNui1W5yVKFOHROaHcax2HEF5zVVtgq5MIwW0GsnL-2F-2F8mVCMnA1693Joct2fZXr046EMiLsO08fikH0v7bh054CfPXlWRLCMgchlrSVAEPLXTNhFc5wz4dHxsJRlfydb-2BBWRDWgS6MAIFJ9jNsME-2FWY7MYt1tmu9EIHXsxocpe5kVpRo6Hqdlg-3D-3D (cited 1 times)
- https://www.medrxiv.org/content/10.1101/2025.11.24.25340907v1 (cited 1 times)