ACIP votes to update hepatitis B vaccine recommendation for infants

In the second meeting of the CDC's Advisory Committee on Immunization Practices (ACIP), the committee voted to update its recommendation for the hepatitis B virus (HBV) vaccine for infants born to women with hepatitis B surface antigen (HBsAg)–negative status.¹

ACIP votes on hepatitis B vaccine recommendation

On Friday, December 5, 2025, the committee voted on the following proposed recommendations.

The ACIP noted there is "no change to the vaccine recommendation for infants born to women who test HBsAg positive or have an unknown HBsAg status; existing recommendation remains the same."

VOTE 1

"For infants born to HBs-Ag-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. Parents and health care providers should consider vaccine benefits, vaccine risks, and infection risks. For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age. Y/N"

The committee voted as follows:

Yes - 8

No - 3

By this vote, this motion passed.

VOTE 2

"When evaluating the need for a subsequent HBV vaccine dose in children, parents should consult with health care providers to determine if a post-vaccination anti-HBs serology testing should be offered. Serology results should determine whether the established protective anti-HBs titer threshold of ≥10 mIU/mL has been achieved. The cost of this testing should be covered by insurance. Y/N"

The committee voted as follows:

Yes - 6

No - 4

Abstained - 1

By this vote, this motion passed.

VOTE 3

Approve the updated Vaccines for Children resolution for prevention of hepatitis B.

The committee voted as follows²:

Yes - 8

No - 0

Abstain - 3

By this vote, this motion passed.

Confusion, lack of data headline meeting, experts say

The December 5 votes came a day after they were delayed on the first day of the meeting, following initial confusion over the language of the votes and subsequent motions to update it.³ Several experts, medical societies, and agencies over the past week have called for a lack of relevant evidence from the ACIP workshop to support changing the universal recommendation for a vaccine dose within 24 hours of birth.

In a media briefing following the voting session on Friday, December 5, James Campbell, MD, MS, FAAP, vice chair of the American Academy of Pediatrics (AAP) Committee on Infectious Diseases, expressed frustration with the meeting, citing a lack of evidence and the fueling of doubt in public health.

"For the past 2 days, you've seen this brazen attempt to sow fear and distrust in vaccinations that have saved countless lives," said Campbell. "Rather than carefully assessing the totality of the evidence that we have on our vaccine policy, some members appeared more interested in using [the] meeting as a platform to advance predetermined views and interest on vaccines. We have overwhelming evidence suggesting that the birth dose helps to keep children safe from infection. But still, as I said, they voted to remove that recommendation for the birth dose for infants born to surface antigen–negative mothers, and I think we should all just make no mistake: As some of the members stated, this is a very dangerous decision."

In a statement issued via email communication after the votes, the AAP said it will continue to recommend the vaccine for all newborns: "All babies should receive a first dose of the hepatitis B vaccine within 24 hours of birth, a second dose at 1 to 2 months, and a third dose at 6 months. The pacing of these doses has been rigorously tested and proven to be safe and effective over several decades."

Further, AAP President Susan Kressly, MD, FAAP, said, "I want to reassure parents and clinicians that there is no new or concerning information about the hepatitis B vaccine that is prompting this change, nor has children’s risk of contracting hepatitis B changed. Instead, this is the result of a deliberate strategy to sow fear and distrust among families.”

References

1. Advisory Committee on Immunization Practices (ACIP) - December 5, 2025 - day 2 of 2. CDC. December 5, 2025. Accessed December 5, 2025. https://www.youtube.com/live/kUgXRUpKal4
2. Parkinson J. ACIP votes on hepatitis B vaccine marks more confusion, no supportive safety data, and uncertainty of public health policy. Contagion. December 5, 2025. Accessed December 5, 2025. https://www.contagionlive.com/view/acip-votes-on-hepatitis-b-vaccine-marks-more-confusion-no-supportive-safety-data-and-uncertainty-of-public-health-policy
3. Fitch J. ACIP delays vote on hepatitis B virus vaccine to December 5. Contemporary Pediatrics. December 4, 2025. Accessed December 5, 2025. https://www.contemporarypediatrics.com/view/acip-delays-vote-on-hepatitis-b-virus-vaccine-to-december-5