CDC Changes Infant Hepatitis B Vaccine Recommendation

The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has voted 8 to 3 to recommend individual-based decision-making for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus.1

According to a December 5, 2025, release from the CDC, for infants not receiving the birth dose, ACIP suggests in its recommendation that the initial dose be administered no earlier than 2 months of age. ACIP additionally voted to recommend that when evaluating the need for a subsequent hepatitis B vaccine dose in children, parents should consult with health care providers to decide whether to test antibody levels to hepatitis surface antigen to evaluate adequacy of protection through serology results.1

Previously, CDC recommendations stated that all infants should receive a dose of hepatitis B vaccine at birth, regardless of the HBV infection status of the birth parent.2

"The American people have benefited from the committee's well-informed, rigorous discussion about the appropriateness of a vaccination in the first few hours of life," Deputy Secretary of Health and Human Services and CDC Acting Director Jim O'Neill said in a statement.1

The votes were preceded by December 4, 2025, presentations to ACIP on the hepatitis B disease burden, vaccine safety, and comparative nation immunization policies as well as briefings from representatives of the vaccine manufacturers. Specifically, a presentation from Cynthia Nevison, PhD, on the decline of the hepatitis B disease burden since 1985 concluded that the universal birth dose contribution to acute case decline is likely small, identifying sharp declines in post-transfusion hepatitis B transmission due to advanced blood screening, improved dialysis practices, and needle exchange programs.1

It also acknowledged a 2019 study that found 57.9% of estimated births to women who test positive for the hepatitis B surface antigen were attributable to non–US-born women, mainly from high-endemicity countries. The study reported that 0.5% of pregnancies in the US are to women who test positive for the hepatitis B surface antigen, which is the most significant risk to newborns for being infected with the virus.1

ACIP Childhood/Adolescent Schedule Workgroup Chair Vicky Pebsworth, PhD, RN, additionally presented the policy context and historical and international comparison of the immunization schedule for hepatitis B, determining the United States' universal recommendation of the hepatitis B vaccine birth dose is an outlier among developed countries with low hepatitis B prevalence.1

“The meeting lacked transparency, with many of the presentations showing one-sided data, and several points made by Committee members clearly showed that they have a very specific agenda,” the Hepatitis B Foundation wrote in a statement.3 “The hepatitis B vaccine birth dose has proven to be among our most effective tools for protecting infants from a preventable, cancer-causing disease. The committee members dismissed the extensive body of scientific data and real-life experience that prove the necessity, safety and value of the universal birth dose vaccine for hepatitis B.”

As described in the December 5, 2025, release from the CDC, a recommendation from ACIP becomes part of the CDC immunization schedule once it is adopted by the CDC director.1

References

1. CDC. ACIP Recommends Individual-Based Decision-Making for Hepatitis B Vaccine for Infants Born to Women Who Test Negative for the Virus. December 5, 2025. Accessed December 5, 2025. https://www.cdc.gov/media/releases/2025/2025-acip-recommends-individual-based-decision-making-for-hepatitis-b-vaccine-for-infants-born-to-women.html

2. CDC. Hepatitis B Perinatal Vaccine Information. August 27, 2025. Accessed December 5, 2025. https://www.cdc.gov/hepatitis-b/hcp/perinatal-provider-overview/vaccine-administration.html

3. Hepatitis B Foundation. Hepatitis B Foundation responds to ACIP discussion on Dec. 4, 2025. December 4, 2025. Accessed December 5, 2025. https://www.hepb.org/news-and-events/news-2/hepatitis-b-foundation-responds-to-acip-discussion-on-dec-4-2025/