CDC Changes Hepatitis B Vaccine Birth Dose Recommendation for Newborns
- by Rishma Parpia
- Published
- Vaccines
The U.S. Centers for Disease Control and Prevention (CDC) has stopped recommending that all newborns receive the hepatitis B vaccine at birth, marking a significant shift in a policy that has been in place for decades. The change followed a vote by members at a Dec. 5, 2025 meeting of the Advisory Committee on Immunization Practices (ACIP), which reviews CDC vaccine recommendations and reflects updated assessments of risk, transmission, and public health priorities. Acting CDC Director Jim O’Neill formally approved the change, completing the process required to adopt it as agency policy. He said, “We are restoring the balance of informed consent to parents whose newborns face little risk of contracting hepatitis B.”1
Under the new guidance, the CDC will recommend hepatitis B vaccination at birth only for infants born to mothers who test positive for the virus or whose hepatitis B status is unknown at the time of delivery.2 Babies born to mothers who test negative will not receive the hepatitis B vaccine at birth and will instead receive it later in infancy if the parents consent to it, with the CDC recommending vaccination not before two months of age as part of the routine childhood vaccination schedule.3
CDC officials said improved prenatal screening and lower rates of hepatitis B in the United States played a role in the decision to revise the recommendation. According to the agency, nearly all pregnant women now receive hepatitis B testing during pregnancy, allowing clinicians to identify infants who face the highest risk at birth.4
ACIP’s Rationale Behind the CDC’s Hepatitis B Vaccine Update
The ACIP voted 8–3 to recommend hepatitis B vaccination at birth only for infants born to mothers who test positive for the virus or whose hepatitis B status is unknown. The committee said the recommendation reflects a shift toward a more targeted approach based on current screening practices and risk assessment. Under the guidance, mothers who test negative are advised to discuss vaccination timing with their health care providers.5
Committee members said the updated recommendation builds on decades of progress in reducing hepatitis B infections among children while accounting for widespread prenatal screening that now identifies nearly all cases of maternal infection. ACIP members emphasized that focusing the birth dose on higher-risk situations preserves protection while avoiding unnecessary interventions for infants at lower risk.6
During the meeting, some medical trade group representatives raised concerns about changing the long-standing universal birth dose policy; however, ACIP members maintained that the revised approach reflects current evidence and improved screening practices rather than a reduction in safety standards. The committee framed the change as an adjustment based on evolving public health conditions, not a reversal of prior success.7
The committee also voted on a separate recommendation related to the number of hepatitis B doses infants receive. Under the traditional schedule, children typically receive three doses, with the first dose at birth, a second dose one to three months later, and a third dose between six and 15 months of age. In a second vote, ACIP approved a recommendation, by a 6–4 margin with one abstention, to test infants’ antibody levels after each hepatitis B dose. Committee members said the approach allows clinicians to confirm immunity and tailor vaccination to individual needs. Under the recommendation, some children may require fewer than three doses if testing shows they have already developed adequate protection.8
The ACIP subgroup that reviewed the hepatitis B policy was led by voting member Vicky Pebsworth, RN, PhD, a nurse and board member of the National Vaccine Information Center (NVIC), an organization founded in 1982 that supports informed consent to medical risk taking and opposed the hepatitis B birth dose recommendation when it was instituted in 1991.9
Pebsworth said the United States’ universal hepatitis B birth dose policy stands apart from approaches used in other countries with low rates of hepatitis B and argued that a number of parent stakeholder groups favor greater flexibility. She said those groups want informed consent rights respected and more discretion in deciding vaccination timing based on the individual and family circumstances.10
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