ACIP votes 8–3 to end universal Hep B birth dose; separate 6–4–1 vote backs post‑shot antibody testing
At a contentious Dec. 4–5 meeting, the HHS‑appointed ACIP voted 8–3 to end the longstanding universal hepatitis B birth‑dose recommendation — instead advising a birth dose for infants of HBV‑positive mothers while leaving administration for infants of HBV‑negative or unknown mothers to parent‑clinician decision or delayed dosing — and separately voted 6–4‑1 to recommend post‑vaccination antibody testing to determine whether fewer than three doses are needed. The recommendations, which must be approved by acting CDC director Jim O’Neill, have drawn sharp criticism from pediatric and infectious‑disease experts who warn that screening gaps and modeling estimates (roughly 1,400–2,700 excess infections annually) make rescinding the universal birth dose risky.
📌 Key Facts
- At the Dec. 5 ACIP meeting the committee voted 8–3 to end the recommendation of a universal hepatitis B vaccine given at birth, instead recommending a birth dose only for infants born to mothers who test positive for HBV; infants of mothers with negative or unknown status were advised to have the timing decided by parent and clinician.
- Separately, ACIP voted 6–4 with one abstention to support routine post‑shot antibody testing of infants after hepatitis B doses to determine whether fewer than three doses may be sufficient for some children.
- The ACIP changes are advisory and still require sign‑off by acting CDC director Jim O’Neill; state vaccine policies and insurer coverage could be affected if the CDC adopts the new guidance.
- The votes and process were highly contentious: HHS Secretary Robert F. Kennedy Jr. replaced the prior 17‑member ACIP earlier in the year, the panel’s chair was recently changed, meeting discussion featured rapidly shifting vote language, sharp exchanges among members, and criticism from major medical groups (including the AAP), scientists, and nonvoting liaisons.
- Public‑health experts warned of substantial risks from rescinding the universal birth dose: a birth dose within 24 hours is up to ~90% effective at preventing mother‑to‑child transmission and the full vaccine series confers about ~98–99% long‑lasting protection; infants infected at birth face ~90% risk of chronic infection and roughly 25% lifetime risk of dying from HBV‑related disease.
- Modeling and data cited by critics estimate harms if the birth dose is delayed — at least ~1,400 additional infant infections per year if delayed to two months (and larger increases if delayed to 12 months) — and operational concerns include gaps in maternal screening (about 16% not screened and some tests have false negatives) and many infected adults being unaware, creating a hidden exposure risk.
- Medical and public figures reacted strongly and split along political lines: major pediatric and infectious‑disease groups say they will continue to recommend the birth dose, Drs. Paul Offit and others warned reversing the policy endangers children, Senator Bill Cassidy and former FDA commissioner Scott Gottlieb publicly criticized the decision, while former President Trump and the White House signaled support and directed a review of the childhood vaccine schedule.
- Background context cited across reporting: the universal birth‑dose policy dramatically reduced childhood HBV in the U.S. (virtually eliminating pediatric cases seen before routine newborn vaccination), and supporters say the birth dose serves as a critical safety net when maternal testing is incomplete or results are unavailable.
📰 Sources (18)
- Former FDA commissioner Scott Gottlieb publicly criticizes the ACIP decision and refutes President Trump’s claim that Hep B is only sexually/needle transmitted, stressing high risk of perinatal transmission.
- Gottlieb cites a ~2% false‑negative rate for maternal hepatitis B tests and says this could translate to at least 1,000 newborn infections if the birth dose is delayed.
- He references a modeling estimate that about 1,400 infants could contract hepatitis B in the first year under the new guidance.
- Gottlieb reiterates risk statistics (e.g., ~90% of infected newborns develop chronic infection; ~25% die of sequelae) and says the birth‑dose plus series is ~99% effective at preventing chronic infection.
- Operational concern raised: many mothers are not tested, test results may not be checked, and relying solely on maternal screening is unsafe.
- CDC estimates about 640,000 U.S. adults have chronic hepatitis B, roughly half unaware of their infection, underscoring hidden exposure risk to infants.
- Hepatitis B virus can survive on surfaces for up to a week; small amounts of dried blood on shared household items (nail clippers, razors, toothbrushes) can transmit infection.
- Before universal newborn vaccination, only about half of HBV infections in children under 10 were perinatal; many were acquired via household/community exposure.
- Infants infected with HBV face ~90% risk of chronic infection and about 25% premature mortality from HBV-related disease (cirrhosis, liver cancer); no cure exists.
- Expert quotes: Dr. James Campbell said the U.S. once saw 18,000–20,000 HBV-positive births annually with a quarter progressing to liver cancer, now 'almost none' due to vaccination; ACIP member Dr. H. Cody Meissner stated, 'This disease has become a victim of the vaccine.'
- HHS Secretary Robert F. Kennedy Jr. previously fired all 17 ACIP members six months ago and installed replacements as part of a vaccine‑policy overhaul.
- CDC acting director Jim O’Neill must decide whether to accept the recommendation; the guidance language tells HBV‑negative pregnant women to consult providers and decide 'when or if' their newborns will receive the hepatitis B vaccine.
- The committee formed a working group to reconsider the entire childhood vaccine schedule and began with a presentation by Aaron Siri, who has pushed to revoke approval of the stand‑alone polio vaccine.
- The meeting became contentious, with sharp exchanges; Dr. Michael Osterholm called the vote a 'defining moment' and said federal health authorities can no longer be trusted on vaccines.
- President Trump said he signed a presidential memorandum directing HHS to 'fast track' a comprehensive evaluation of U.S. childhood vaccine schedules and consider alignment with other countries.
- Trump publicly praised ACIP’s vote to end the universal Hepatitis B birth‑dose recommendation and criticized the current vaccine schedule.
- The White House did not immediately provide additional comment to Fox News Digital.
- Sen. Bill Cassidy criticized the ACIP change, calling it a 'mistake.'
- CBS frames the reaction in a segment with analysis by Dr. Jon LaPook.
- PBS adds on-the-record reaction from Dr. Paul Offit, who says he was invited to testify before ACIP but declined.
- Offit provides historical epidemiology: in the early 1990s an estimated 30,000 U.S. children under 10 had hepatitis B, about half not from mother-to-child transmission, and describes household transmission routes (e.g., shared personal items).
- Offit argues the birth-dose recommendation virtually eliminated hepatitis B in children under 10 and says reversing it 'puts children in harm's way.'
- PBS characterizes the new guidance as shifting to parent–physician consultation rather than a universal birth-dose mandate.
- Sen. Bill Cassidy publicly urges the CDC’s acting director not to sign ACIP’s recommendation ending routine HBV newborn vaccination.
- Cassidy argues the birth-dose recommendation reduced newborn HBV infections from ~20,000 annually to fewer than 20 and warns cases could rise if the guidance changes.
- Cassidy labels ACIP 'totally discredited' and criticizes attorney Aaron Siri’s influence in vaccine debates.
- NPR reports the panel voted 8–3 to recommend a hepatitis B birth dose only for babies of HBV‑positive mothers; those with negative or unknown maternal status should consult physicians.
- ACIP separately voted 6–4 with one abstention to recommend testing infants’ antibody levels after each shot to determine whether fewer than three doses are needed.
- CDC official Dr. Adam Langer cautioned that stopping at one or two doses would depart from evidence tested in three‑dose vaccine trials.
- Quotations add on‑the‑record dissent and support: Dr. Cody Meissner warned infections will rise if the change is finalized; Retsef Levi called it a “fundamental change” and said parents may delay; PIDS liaison Dr. Grant Paulsen questioned the rationale for changing a policy that has worked.
- Confirms the recommendation still requires approval by the acting CDC director.
- Names acting CDC director Jim O’Neill as the official who will decide whether to adopt the recommendation.
- Adds on‑the‑record criticism from Dr. William Schaffner calling the panel 'the group that can’t shoot straight.'
- Quotes ACIP member Vicky Pebsworth saying there was 'pressure from stakeholder groups' to revisit the policy.
- Notes Dr. Peter Hotez declined to present, saying ACIP has shifted away from science-based decision-making.
- Specifies that in June HHS Secretary Robert F. Kennedy Jr. fired the entire 17‑member ACIP and replaced it, including with several anti‑vaccine voices.
- Frames the move as a return to a strategy abandoned more than three decades ago and emphasizes CDC currently has no permanent director.
- ACIP voted 8–2 to recommend delaying the hepatitis B vaccine birth dose until 2 months of age for infants born to mothers who test negative for hepatitis B.
- For infants of hepatitis B–negative mothers, the panel recommended individual decision‑making with a clinician on whether and when to administer a birth dose.
- Opposition noted from medical groups including the American Academy of Pediatrics, citing decades of data on safety and effectiveness and concern about increased risk.
- Panel composition noted: current ACIP members were appointed by HHS Secretary Robert F. Kennedy Jr.
- Named voices in the debate included Dr. Cody Meissner (opposed to the change) and Dr. Joseph Hibbeln; the meeting featured disputes over evidence and rapidly changing vote language.
- Recommendations now go to the CDC director for approval; state policies and insurer coverage could be affected if CDC adopts the change.
- No additional ACIP votes were scheduled in this meeting after the HepB decision.
- Article specifies that acting CDC director Jim O’Neill would make the final decision because the agency currently has no director.
- Names ACIP member Vicky Pebsworth, who said a work group was tasked in September with evaluating whether a birth dose is necessary when mothers test negative and cited the need to address stakeholder/parent dissatisfaction.
- Clarifies contemplated policy: a birth dose only for infants of hepatitis B–positive mothers, with other cases left to parent–physician decision-making.
- Notes meeting logistics: ACIP reconvenes Friday at 9 a.m. ET in Atlanta; PBS is streaming the session live.
- ACIP postponed planned votes on changes to the universal newborn hepatitis B recommendation and rescheduled them for Friday due to confusion and late changes in the vote language.
- Voting member Dr. Joseph Hibbeln criticized shifting question wording, calling it a 'moving target.'
- FDA representative Dr. Tracy Beth Høeg questioned the need for a universal birth dose in low‑risk infants; Dr. Cody Meissner defended the current policy’s effectiveness.
- Adviser Robert Malone challenged Meissner’s statements as opinion; Meissner replied, 'These are facts, Robert.'
- Nonvoting medical‑society liaisons condemned the process as deviating from ACIP norms.
- ACIP will explicitly vote on whether to continue universal newborn hepatitis B vaccination at birth or delay the first dose.
- CDC/AAP data points: 99% decline in infant/child hepatitis B infections since 1991; an estimated 2.4 million people in the U.S. have HBV and about half are unaware.
- Effectiveness figures: birth dose within 24 hours is up to 90% effective at preventing mother-to-child transmission; full three-dose series confers ~98% immunity.
- Screening gap: about 16% of pregnant women are not screened for HBV, making the birth dose a critical safety net.
- 2021 outcomes: 17,827 births to HBV-positive mothers but only 17 reported neonatal transmissions, with the AAP crediting the birth dose.
- Context notes: HHS Secretary Robert F. Kennedy Jr. appointed current ACIP members; CBS flags his prior false claim linking the birth dose to autism.
- A new (preprint) analysis estimates delaying the Hep B birth dose by two months could cause at least 1,400 additional preventable infections each year; delaying until age 12 could cause at least 2,700 per year.
- Expert quotes (Dr. Andrew Pavia/IDSA) warning that rescinding the universal birth dose would be “extremely dangerous.”
- Additional context on non-sexual transmission risks in children (e.g., day care, shared razors/toothbrushes, surface contamination lasting up to seven days).
- Reference to President Trump’s suggestion to delay vaccination until age 12, contrasted with transmission risks in early childhood.
- ACIP’s hepatitis B agenda item is set for a Dec. 4, 8 a.m. ET hearing with a live stream available.
- AP reports the HHS secretary’s advisory panel is expected to change the newborn hepatitis B recommendation, contradicting prior public-health guidance.
- The American Academy of Pediatrics (AAP), via Dr. Sean O’Leary, says it will continue to recommend the hepatitis B birth dose because it saves lives.
- ACIP will meet Dec. 4–5 to reconsider fundamental elements of the childhood vaccine schedule and is expected to make a controversial change to infant hepatitis B immunization.
- ACIP’s chair was replaced this week; the new chair is Dr. Kirk Milhoan, a pediatric cardiologist affiliated with the Independent Medical Alliance.
- ACIP’s September meeting devolved into confusion and a scheduled vote on hepatitis B was tabled.
- NPR reports the CDC changed its stance last month on whether vaccines may cause autism, further eroding confidence among mainstream medical groups.
- ACIP has reduced longstanding collaboration with groups like AAP and relies less on CDC staff; AAP, AAFP and the University of Minnesota’s Vaccine Integrity Project have begun issuing independent recommendations, with some states following them.
- A new ACIP working group will present its first report scrutinizing the childhood vaccine schedule.
- Quotes included from Mary Holland (Children’s Health Defense) and Dr. Sean O’Leary (AAP infectious diseases committee chair) reflecting sharply divergent views.
- Notes the ACIP panel considering the birth-dose recommendation is appointed by HHS Secretary Robert F. Kennedy Jr.
- Adds efficacy specifics: a hepatitis B birth dose given within 24 hours is up to 90% effective at preventing mother-to-child transmission; completing the 3-dose series confers ~98% immunity with protection lasting at least 30 years.
- Details Western Alaska outcomes: after targeted testing and vaccination campaigns, pediatric liver cancer has not been seen since 1995 and no infections are known in children under 30.
- Clarifies that maintaining the birth-dose recommendation preserves the broadest insurance coverage options; ACIP/CDC do not mandate vaccines and states control requirements.
- Documents RFK Jr.’s June podcast claims (autism link; hepatitis B not casually contagious) and counters with research that the virus can transmit via indirect contact and survive on surfaces for a week.