ACIP Votes to Modify Decades-Long Hepatitis B Birth Dose Recommendation

The CDC's Advisory Committee on Immunization Practices (ACIP) voted on Friday to modify a decades-long recommendation that all newborns receive the hepatitis B (HBV) vaccine at birth.¹ The panel voted 8–3 in favor of narrowing the universal birth-dose guidance, instead recommending that parents of infants born to mothers who test negative for hepatitis B make vaccination decisions in consultation with their clinician.^2-4

The vote marks the first major revision to the newborn hepatitis B vaccination recommendation in more than 30 years. Under the previous guidance, the birth dose served as a universal safeguard to prevent perinatal transmission and to avoid missed opportunities to vaccinate infants at risk. Hepatitis B infection in infancy can lead to chronic infection and later-life complications, including cirrhosis and liver cancer.⁵

The Voting Language

The voting language approved by the committee states: “For infants born to HBsAg-negative women: ACIP recommends individual-based decision-making, in consultation with a health care provider, for parents deciding when or if to give the HBV vaccine, including the birth dose. … For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age.”¹

The recommendation does not change current guidance for infants born to mothers who test positive for hepatitis B or whose status is unknown. These infants should still receive the birth dose, consistent with existing CDC practice.¹

A footnote in the voting document notes that parents and health care providers should also consider household or community risk factors, such as exposure to individuals who are hepatitis B–positive or who have emigrated from regions with high prevalence.^1,3

Split Views and Sharp Disagreement

The vote followed months of debate and a failed attempt to revise the recommendation at the ACIP’s September meeting, which was postponed amid procedural difficulties.⁴ As reflected in current media reports, committee members expressed sharply diverging views on the evidence and potential impact of the shift.

Some members argued the change provides needed flexibility. ACIP member Hillary Blackburn said, “The language offers flexibility, access, coverage at any time. I vote yes.”²

Others strongly opposed the change. ACIP member Joe Hibbeln stated, “This has a great potential to cause harm and I simply hope that the committee will accept its responsibility when this harm is caused and I vote no.”²

Several liaisons from professional societies voiced similar concerns. Dr. Grant Paulsen of the Pediatric Infectious Diseases Society asked, “Our question is why? Why is there pressure today to change something that has been working, due to safety concerns that may be more theoretical than real?”⁴

Dr. Cody Meissner, the only current voting member with previous years of ACIP service, warned that a policy change could reverse decades of progress: “We know vaccines are safe … and to make the changes that are being proposed, we will see more children and adolescents and adults infected with hepatitis B.” He added during his vote, “Do no harm is a moral imperative. We are doing harm by changing this wording.”⁴

Several panel members who supported the modification framed the change as a shift toward parental choice. Voting member Retsef Levi described it as “a fundamental change in the approach to this vaccine” that would allow parents to “carefully think about whether they want to take the risk of giving another vaccine to their child.”⁴

Considerations About Evidence

The universal hepatitis B birth dose recommendation was introduced in the early 1990s and is credited with significant reductions in hepatitis B infection among US infants and children. This historical context was highlighted repeatedly by medical society liaisons at the meeting, who argued that delaying or individualizing the birth dose could increase the risk of undetected maternal infection or missed vaccination opportunities.^2-4

Some committee members who favored the change cited concerns about newborn vaccine exposures or questions they described as unresolved. Dr. Vicky Pebsworth, who led the subgroup that developed the proposal, said “there was pressure coming from stakeholder groups wanting the policy to be revisited.”⁴

Other health experts emphasized that suggested links between the birth dose and later autoimmune or health problems are not supported by cumulative research evidence⁴.

Additional Vote: Antibody Testing & Dose Number

ACIP also voted on a related proposal concerning the number of hepatitis B doses infants might need. Full vaccination typically involves a 3 -dose series, the first at birth, the second between 1 and 3 months of age and the third between 6 and 15 months.⁵ In the 6–4 vote with one abstention, the committee recommended that parents of older infants and children discuss hepatitis B antibody testing with their clinician to determine whether additional doses are needed.^3,4

The result could be that some children receive 1 or 2 doses rather than the standard 3 doses. However, CDC official Dr. Adam Langer cautioned during the meeting that existing vaccines were studied using a 3-dose schedule, and “stopping at one or two shots based on antibody testing would be making an assumption about efficacy that isn’t supported by existing data.”⁴

Next Steps

The change will take effect only if signed by the CDC’s acting director, Health and Human Services Deputy Secretary Jim O’Neill.³ Once approved, the revised recommendation will be incorporated into CDC vaccination guidance documents and schedules.

The discussion surrounding the hepatitis B birth dose will likely continue as clinicians, public health organizations, and families interpret the new guidance and consider how individual decision-making may affect hepatitis B prevention efforts.

This is a developing story. Please check back for regular updates.

References

1. ACIP recommneds individual-based decision-making for hepatitis B vaccine for infants born to womrn who test negative for the virus. News release. US Department of Health and Human Services. December 5, 2025. Accessed December 5, 2025. https://www.hhs.gov/press-room/acip-recommends-individual-based-decision-making-hepatitis-b-vaccine-birth-dose-infants-born-women-test-negative-virus.html

2. Choi J. CDC panel passes recommendation to change hepatitis B vaccine guidance. The Hill. December 5, 2025. Accessed December 5, 2025. https://thehill.com/policy/healthcare/5635408-cdc-vaccine-hepatitis-b-newborns/

3. Benadjaoud Y, Kekatos M. CDC vaccine advisory committee votes to remove universal recommendation for hepatitis B shot at birth. ABC News. December 5, 2025. Accessed December 5, 2025. https://abcnews.go.com/Health/cdc-vaccine-advisory-committee-votes-remove-universal-recommendation/story

4. Huang P, Stein R, Wroth C. CDC advisers vote to overturn decades-long policy on hepatitis B vaccine for infants. Shots Health News. NPR. December 5, 2025. Accessed December 5, 2025. https://www.npr.org/sections/shots-health-news/2025/12/05/nx-s1-5634004/cdc-hepatitis-b-vaccine-acip-meeting

5. Hepatitis B. World Health Organization. Updated July 23, 2025. Accessed December 5, 2025. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b