CDC Panel Revises Hepatitis B Vaccine Recommendations for Newborns

On December 5, 2025, the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted 8 to 3 to change the longstanding recommendation that all U.S. newborns receive the hepatitis B vaccine at birth. The new guidance advises that infants born to mothers who test negative for the hepatitis B virus should have the timing of their vaccination determined through consultation between parents and healthcare providers. If the birth dose is declined, the initial vaccine dose is recommended to be administered no earlier than two months of age.

This decision maintains the existing recommendation for infants born to mothers who test positive for hepatitis B or whose status is unknown, ensuring they receive the vaccine at birth. The ACIP's recommendation will become part of the CDC immunization schedule once adopted by the CDC director.

The change has elicited strong reactions from the medical and public health communities. Critics argue that the decision could increase the risk of hepatitis B infections among infants. The American Public Health Association expressed concern that the revised guidance "will leave children vulnerable to unnecessary exposure and preventable illness."

Vaccine manufacturers have also voiced apprehension. Merck, producer of Recombivax HB, and GSK, maker of Engerix-B, warned that the policy change could reverse progress made since 1991, which includes a 99% reduction in hepatitis B cases among children and young adults.

The ACIP's decision marks a significant shift in U.S. vaccination policy, moving from a universal to an individualized approach for hepatitis B vaccination in newborns. The CDC's acting director, Jim O'Neill, is expected to decide whether to adopt the committee's recommendation.