Regulatory NewsBREAK: ACIP Vote on Hepatitis Birth Dose Recommendation

On December 4 and 5, 2025, the Advisory Committee on Immunization Practices (ACIP) met to discuss and vote on the committee’s recommendations for the hepatitis B birth dose and the childhood and adolescent vaccination schedule.

Hepatitis B

• Presenters talked about the burden of the disease, vaccine safety, uncertainty about whether all three doses are needed to acquire protection, uncertainty about population-level benefits, and implementation considerations for the Vaccines for Children (VFC) program. 
• Discussion included concerns about removing a well-established, successful prevention strategy and the lack of evidence of risk being presented. 
• The committee also heard from representatives of vaccine manufacturers about numerous studies demonstrating the efficacy and safety of these vaccines.
• Dr. Jeanne Santoli (CDC) explained the resolution needed by the Vaccines for Children (VFC) program to align with ACIP’s proposed language.
• Andrew Johnson (CMS, ACIP ex officio) explained coverage requirements of ACIP-recommended vaccines and opined that there would be no coverage implications based on the language being voted on, as long as the decision is made in consultation with the health care provider.  
• ACIP voted to approve the following changes to their recommendations for HBV vaccines: 
  • VOTE 1: 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 [Footnote: Parents and health care providers should also consider whether there are risks, for example, such as a household member is HBsAg-positive or when there is frequent contact with persons who have emigrated from areas where Hepatitis B is common]. 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.
  • 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.
• There is no change to ACIP’s recommendation for infants born to women who test HBsAg-positive or have an unknown HBsAg status.
• VFC Resolution. The committee voted to approve a resolution aligning the VFC program with the updated ACIP recommendations. 

Childhood/Adolescent Vaccination Schedule

• The committee heard presentations on the evolution of the childhood/adolescent vaccination schedule, including claims of a relationship between vaccines and autism, and comparisons with other developed countries.
• The committee heard presentations on the evolution of the childhood/adolescent vaccination schedule, including claims of a relationship between vaccines and autism, comparisons with other developed countries, and aluminum adjuvants.

More on This Topic:

• ACIP Meeting Agenda  
• December 4, 2025 Meeting
• December 5, 2025 Meeting
• AMCP’s Comment Letter to ACIP

For questions, please reach out to Vicky Jucelin.