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US Hepatitis B Birth-Dose Policy Upended by New Vaccine Advisory Panel

US Hepatitis B Birth-Dose Policy Upended by New Vaccine Advisory Panel

An RFK Jr.–installed committee moves to end a 34-year universal newborn hepatitis B shot recommendation, triggering a broader battle over the US childhood vaccine schedule.

Overview

In December 2025, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted 8–3 to end the longstanding recommendation that all US newborns receive a hepatitis B vaccine dose within 24 hours of birth. Instead, for infants whose mothers test negative for hepatitis B, ACIP now recommends “individual-based” or shared clinical decision-making, with any initial dose suggested no earlier than two months of age. Newborns of mothers who test positive or whose status is unknown would still be advised to receive a birth dose.

The move, engineered by a reconstituted ACIP appointed by Health and Human Services Secretary Robert F. Kennedy Jr., has drawn fierce opposition from major medical and public-health groups, which credit the universal birth dose—adopted in 1991—with driving a roughly 99% decline in chronic hepatitis B among US children and adolescents. Critics warn the shift could lead to missed vaccinations, more infant infections, and a precedent for politically driven rollbacks across the childhood vaccine schedule, especially as President Donald Trump has ordered a broader review of US immunization recommendations in light of the hepatitis B decision.

Key Indicators

8–3
ACIP vote margin
The reconstituted ACIP voted 8–3 on December 5, 2025, to replace universal birth‑dose hepatitis B vaccination with individual-based decision-making for infants of hepatitis B–negative mothers.
99%
Drop in pediatric chronic hepatitis B
Medical societies estimate chronic hepatitis B in US children and adolescents has fallen by about 99% since adoption of universal newborn vaccination in 1991.
90–1,400
Projected extra infections per year
Independent modeling cited by critics suggests the new policy could cause between roughly 90 and 1,400 additional hepatitis B infections annually, leading to hundreds of preventable deaths over time.
16%
Pregnancies without HBV screening
Between 2015 and 2019, up to 16% of pregnant women—about 575,000 births a year—were not screened for hepatitis B, undermining any strategy that relies solely on maternal testing instead of a universal birth dose.
≈120
Countries recommending birth-dose
Before the ACIP reversal, the US was one of nearly 120 countries recommending a hepatitis B birth-dose vaccine; under the new guidance it becomes an outlier among nations that use universal newborn dosing.

People Involved

Robert F. Kennedy Jr.
Robert F. Kennedy Jr.
US Secretary of Health and Human Services (Architect of ACIP overhaul and leading advocate of weakening the birth-dose recommendation)
Donald Trump
Donald Trump
President of the United States (Backing ACIP’s shift and ordering a broader review of childhood vaccines)
Jim O’Neill
Jim O’Neill
Deputy HHS Secretary and Acting CDC Director (Holds final authority to adopt or reject ACIP’s hepatitis B recommendation)
Vicky Pebsworth
Vicky Pebsworth
Chair, ACIP Childhood/Adolescent Schedule Workgroup (Key internal proponent of revising the birth-dose recommendation)
Michaela Jackson
Michaela Jackson
Program Director of Prevention Policy, Hepatitis B Foundation (Leading public-health critic of the ACIP change)
Bill Cassidy
Bill Cassidy
US Senator (R-Louisiana), Chair of Senate HELP Committee and hepatologist (Pressuring CDC not to adopt the new guidance)
Ulrich von Andrian
Ulrich von Andrian
President, American Association of Immunologists (Representing immunology community opposition to the policy shift)

Organizations Involved

Advisory Committee on Immunization Practices (ACIP)
Advisory Committee on Immunization Practices (ACIP)
Federal Advisory Committee
Status: Reconstituted under RFK Jr.; driving changes to the childhood vaccine schedule starting with hepatitis B at birth

ACIP is the CDC’s external advisory committee that develops recommendations on the use of vaccines in the US civilian population. Its recommendations, once adopted by the CDC director, shape the official immunization schedule and influence insurance coverage and state policies.

Centers for Disease Control and Prevention (CDC)
Centers for Disease Control and Prevention (CDC)
Government Agency
Status: Holds final authority to adopt ACIP’s new recommendation into the national schedule

The CDC is the lead US public-health agency, responsible for disease surveillance, outbreak response, and issuing national health guidance, including immunization schedules. Its director must sign off on ACIP recommendations for them to become official policy.

American Public Health Association (APHA)
American Public Health Association (APHA)
Professional Association
Status: Organized expert pushback urging CDC to keep universal newborn hepatitis B vaccination

APHA is a large umbrella organization for public-health professionals, often weighing in on federal health policy through scientific statements and public comments.

American Academy of Pediatrics (AAP)
American Academy of Pediatrics (AAP)
Professional Association
Status: Maintains recommendation that all newborns get hepatitis B vaccine within 24 hours

The American Academy of Pediatrics represents tens of thousands of pediatricians and issues influential clinical guidelines on child health, including immunization policy.

Timeline

  1. Debate widens over future of entire US childhood immunization schedule

    Analysis

    As of December 7, 2025, acting CDC Director Jim O’Neill has not yet formally adopted ACIP’s hepatitis B recommendation. Analysts note that the vote has become a test case for whether the Trump–Kennedy team can systematically recast the US childhood vaccine schedule, amid warnings from experts that undermining hepatitis B policy could cascade into broader declines in vaccination and new outbreaks of preventable diseases.

  2. States and lawmakers move to shore up newborn hepatitis B protections

    Political Response

    Connecticut’s health department publicly reaffirms its support for universal newborn hepatitis B vaccination within 24 hours of birth, while New York legislators denounce ACIP’s 'indefensible' move and cite it as a reason to advance state-level vaccine integrity legislation.

  3. Trump signs memo ordering review of US childhood vaccine schedule

    Executive Action

    The White House announces a presidential memorandum instructing HHS and CDC to reassess the US childhood vaccine schedule and consider aligning it with selected 'peer' countries, explicitly citing ACIP’s hepatitis B decision as a catalyst.

  4. President Trump praises the vote and hints at wider vaccine schedule changes

    Public Statement

    President Trump calls ACIP’s move a 'very good decision' and reiterates his view that the US childhood vaccine schedule is excessive compared with other wealthy countries, foreshadowing a broader push to change immunization policy.

  5. Medical and scientific organizations denounce the ACIP vote

    Public Statement

    The American Association of Immunologists, infectious disease and liver societies, and the AAP issue statements urging CDC to reject ACIP’s change, warning that even modest delays in vaccination could significantly increase chronic infections, liver cancers, and deaths and undermine confidence in vaccination.

  6. ACIP votes 8–3 to end universal newborn hepatitis B birth-dose recommendation

    Policy Decision

    ACIP votes 8–3 to recommend 'individual-based decision-making' for hepatitis B vaccination, including the birth dose, for infants whose mothers test negative for the virus, suggesting that if the birth dose is declined, the first shot be given no earlier than two months of age. The universal recommendation remains for infants of HBsAg-positive or unknown-status mothers.

  7. Contentious ACIP meeting airs anti-vaccine rhetoric; hepatitis B vote delayed

    Hearing

    During the first day of ACIP’s December meeting in Atlanta, presenters include researchers and activists linked to retracted autism-vaccine studies and anti-vaccine litigation. Confusion over voting language and concerns from some members lead the panel to postpone a decision on the hepatitis B birth dose.

  8. APHA and 73 public-health scholars urge CDC to keep universal newborn vaccination

    Public Statement

    In a public comment filed ahead of ACIP’s December meeting, APHA and dozens of deans and scholars warn that eliminating the birth dose risks undoing a policy that has prevented over 500,000 childhood infections and about 90,100 deaths, with no new evidence of safety concerns.

  9. ACIP mandates universal prenatal hepatitis B screening and previews possible birth-dose changes

    Policy

    At its September meeting, ACIP votes to recommend that all pregnant women be tested for hepatitis B, a step HHS notes will be covered across insurance programs. The panel also discusses revising the infant birth-dose recommendation but delays a vote.

  10. RFK Jr. fires all ACIP members and installs a new panel

    Governance

    Soon after taking office as HHS secretary, Robert F. Kennedy Jr. dismisses all 17 ACIP members and appoints a new slate that includes vaccine-mandate critics and individuals linked to anti-vaccine groups such as Children’s Health Defense. Meeting agendas shift away from CDC scientists toward outside skeptics.

  11. Birth dose tightened: AAP and ACIP call for hepatitis B shot within 24 hours

    Policy

    To further reduce perinatal transmission, ACIP and AAP specify that the first hepatitis B dose for medically stable, 2,000 g–plus infants born to HBsAg-negative mothers should be given within 24 hours of birth, not merely before hospital discharge.

  12. ACIP explicitly recommends a birth dose for all infants

    Policy

    ACIP updates its hepatitis B guidance to recommend a birth dose for all infants, though with permissive language that allows some practitioners to delay the shot. Later analysis shows birth-dose receipt is associated with better on-time completion of the vaccine series.

  13. US briefly suspends routine newborn hepatitis B vaccination over thimerosal concerns

    Policy

    After a joint AAP/USPHS statement raising theoretical concerns about the mercury-containing preservative thimerosal, many US hospitals suspend the hepatitis B birth dose for low-risk infants. Subsequent studies describe confusion, incomplete resumption of birth-dose policies, and a widely reported case of an infant death from hepatitis B after a birth-dose program was halted.

  14. ACIP endorses universal childhood hepatitis B vaccination starting at birth

    Policy

    The CDC’s ACIP recommends a comprehensive strategy to eliminate hepatitis B transmission in the United States through universal childhood vaccination, including initiation of the series in infancy. This policy replaces a high-risk approach that missed many infected mothers and infants.

Scenarios

1

CDC adopts ACIP recommendation; universal birth-dose quietly erodes

Discussed by: Time, MarketWatch, and multiple public-health commentators

In this scenario, acting CDC Director Jim O’Neill signs off on ACIP’s recommendation with minimal modification. The official immunization schedule drops the blanket call for a hepatitis B birth dose in infants of hepatitis B–negative mothers, substituting shared clinical decision-making and suggesting initiation at or after two months of age. Hospitals in many regions respond by changing standing orders and default electronic health-record prompts. While large health systems and some states continue to strongly promote birth-dose vaccination, uptake declines in communities where clinicians are vaccine-hesitant or fear legal exposure when recommending a now non-routine vaccine. Modeling projections of 90–1,400 additional infections per year begin to materialize over several birth cohorts, with cases concentrated among families facing gaps in prenatal care, undocumented maternal status, or higher community prevalence. The administration touts this as proof that 'choice' and 'international alignment' can be pursued without eliminating access, even as specialist societies document rising preventable hepatitis B morbidity.

2

CDC slows or modifies adoption under backlash, preserving de facto universal birth-dose

Discussed by: Statements from AAI, IDSA, APHA, AAP and reporting in the Washington Post and C&EN

Under sustained pressure from medical organizations, governors, and key legislators such as Senator Bill Cassidy, CDC could delay final adoption or send ACIP’s recommendation back for reconsideration. O’Neill might opt for a compromise that retains explicit language strongly encouraging birth-dose vaccination for all infants while adding clarifications about shared decision-making—effectively blunting the impact of ACIP’s vote. Federal communications could emphasize continuity of practice, and CMS could explicitly incentivize hospitals to keep standing birth-dose orders. This would maintain high coverage while signaling political openness to 'parental choice.' Public-health observers see this as a partial containment of the damage, though they worry about the precedent that a politically remade ACIP can overturn long-established vaccine policies.

3

Patchwork emerges: states and major systems mandate or strongly require hospital birth-dose

Discussed by: Regional news (e.g., Connecticut, New York), policy advocates, and APHA commentators

If CDC adopts ACIP’s recommendation, or even if it hesitates, states may assert their own authority. Some, like Connecticut and New York, have already moved to reaffirm universal birth-dose policy or to propose statutes that effectively require hospitals to offer or administer the vaccine for all newborns. Large hospital systems and pediatric networks could adopt internal policies preserving universal birth-dose regardless of the federal schedule. Over time, this leads to a patchwork: children in certain states and health systems enjoy near-1990s-level protection, while others—particularly in politically conservative states that embrace RFK Jr.’s views—see lower coverage and higher rates of perinatal and early-childhood hepatitis B. The disparity reinforces broader red–blue divides in vaccine-preventable diseases and complicates national efforts at elimination.

4

Hepatitis B reversal becomes template for broader rollback of childhood vaccines

Discussed by: Guardian and Washington Post analyses, plus vaccine-policy experts

Public-health experts warn that the hepatitis B decision is not an endpoint but a starting point. Under this scenario, Kennedy’s ACIP uses the same tactics—cherry-picked international comparisons, heightened focus on unproven safety concerns, and 'shared clinical decision-making' language—to weaken recommendations for other childhood vaccines, such as MMR, varicella, HPV, and COVID-19 doses. President Trump’s order to review the entire schedule provides political cover for this process. Over several years, the US shifts from a predominantly routine, schedule-driven model toward a fragmented, choice-centric approach. Infections that were previously rare—measles, congenital rubella, severe pertussis in infants—recur in localized outbreaks, as seen in previous episodes of declining vaccination in the US and Europe.

5

Legal and electoral backlash reverses the hepatitis B decision and curbs political control of ACIP

Discussed by: Speculative commentary by legal scholars and health-policy analysts

If outbreaks or high-profile infant deaths are traced to missed birth-dose vaccinations, the hepatitis B policy could become politically toxic. State attorneys general, medical organizations, or affected families might challenge the ACIP process in court, arguing that the wholesale firing and replacement of its members violated administrative norms or that deliberate exclusion of CDC scientists rendered the process arbitrary and capricious. A future administration could restore traditional ACIP membership criteria and explicitly reassert universal newborn hepatitis B vaccination, similar to how previous US and foreign governments have walked back vaccine-related policy missteps. This scenario depends heavily on political turnover and the salience of vaccine-preventable tragedies in upcoming election cycles.

Historical Context

1999 US Suspension of Hepatitis B Birth-Dose Over Thimerosal Concerns

1999–2000

What Happened

In 1999, following a joint statement by the American Academy of Pediatrics and US Public Health Service about the mercury-containing preservative thimerosal, many hospitals suspended routine newborn hepatitis B vaccination for infants not considered high risk. Subsequent research in Cook County, Illinois, found that nearly half of nurseries that had offered routine birth-dose vaccination stopped after July 1999, and a substantial fraction never resumed even after thimerosal-free vaccines were available. At least one widely reported case involved an infant born to a mother mistakenly believed to be hepatitis B–negative who did not receive a birth dose and died of acute hepatic failure at three months of age.

Outcome

Short term: Suspension of the birth dose led to confusion, missed prophylaxis even for some infants of infected mothers, and measurable drops in newborn vaccination rates.

Long term: Public-health authorities later emphasized the importance of the birth dose as a safety net against testing and documentation errors, helping drive the 2005 and 2016 policy tightening that ACIP is now attempting to reverse.

Why It's Relevant

This episode shows how even temporary weakening of birth-dose policy can produce durable implementation gaps and tragic outcomes—and how much harder it is to rebuild universal practice once it has been relaxed, a dynamic directly relevant to today's ACIP decision.

MMR Vaccine–Autism Scare and Measles Resurgence in the UK

1998–2010

What Happened

In 1998, Andrew Wakefield and co-authors published a now-retracted Lancet paper falsely suggesting a link between the MMR vaccine and autism. Extensive investigations later exposed serious fraud, conflicts of interest, and ethical violations, and Wakefield lost his medical license. Nonetheless, UK MMR coverage fell from the low 90% range in the mid-1990s to around 80–85% nationally—and as low as ~60% in parts of London—well below herd immunity thresholds. Measles cases surged, including a 2006 death and multiple localized epidemics.

Outcome

Short term: Declining vaccination led to large outbreaks and avoidable deaths, eroding trust in both public-health messaging and the media outlets that amplified Wakefield’s claims.

Long term: After years of effort, the UK eventually restored higher coverage and, for a time, measles was declared eliminated. But the MMR scare remains a touchstone for anti-vaccine narratives and continues to fuel hesitancy, leading to new waves of measles cases in subsequent years.

Why It's Relevant

The MMR episode illustrates how scientifically unfounded vaccine fears, once institutionalized or validated by authorities, can quickly reverse disease-control gains and prove difficult to unwind—a warning echoed by experts worried that ACIP’s hepatitis B reversal will legitimize broader anti-vaccine narratives.

Nigeria’s 2003–2004 Polio Vaccine Boycott and Resurgent Polio in Africa

2003–2005

What Happened

In 2003, political and religious leaders in several northern Nigerian states suspended polio vaccination campaigns, citing rumors that the oral polio vaccine was contaminated to cause sterility or HIV infection. The boycott led to a sharp resurgence of polio within Nigeria and reintroduction of wild poliovirus into numerous previously polio-free countries across West and Central Africa, threatening global eradication efforts.

Outcome

Short term: Polio cases doubled in Nigeria and spread to many neighboring countries, paralyzing thousands of children and forcing massive emergency vaccination campaigns to regain control.

Long term: The crisis delayed global polio eradication by years and underscored how local political decisions and misinformation can have wide-reaching international consequences for vaccine-preventable diseases.

Why It's Relevant

While the US hepatitis B debate is unfolding in a very different context, Nigeria’s experience shows how quickly doubts about vaccine safety—when amplified by political or religious authorities—can undermine public-health programs and export risk beyond their original setting. It underscores the stakes if US institutions normalize anti-vaccine rhetoric in official policy forums such as ACIP.