Policy

CDC advisers vote 8-3 to end the universal hepatitis B birth dose

ACIP replaced a recommendation in place since 1991 with individual decision-making for babies born to mothers who test negative. The CDC has not yet adopted it.

The Advisory Committee on Immunization Practices voted 8-3 today to end the recommendation that every newborn in the United States receive a dose of hepatitis B vaccine at birth — a policy that has been standard since 1991 [s1].

Under the new recommendation, the birth dose is recommended for infants whose mothers test positive for hepatitis B surface antigen or whose status is unknown [s1]. For infants born to mothers who test negative, the decision moves to what the committee calls individual-based decision-making: parents and clinicians weigh the vaccine's benefits and risks together, and the default of vaccinating before hospital discharge disappears [s3]. For infants who do not receive a birth dose, the committee indicated the first dose should not be given before two months of age [s4].

The vote does not by itself change anything. ACIP recommendations must be formally adopted by the director of the CDC before they enter the immunization schedule [s3]. The recommendation now goes to Acting CDC Director Jim O'Neill [s1].

What the birth dose was for

The birth dose exists because of a timing problem. Hepatitis B transmitted from mother to infant at or around delivery is far more likely to become chronic than infection acquired later in life. If an unvaccinated newborn contracts hepatitis B in the first year of life, up to 90% develop chronic infection [s1]. Among people with chronic infection, up to 25% die of related complications [s1] — a figure the American Association of Immunologists puts at roughly one in four facing premature death from liver disease or cancer [s2].

When a pregnant woman has hepatitis B and no preventive measures are taken, 70% to 90% of her unvaccinated infants become infected [s1].

Since universal infant vaccination began in 1991, hepatitis B infection rates have fallen by 99% [s1]; the AAI describes the same decline specifically in chronic hepatitis B among children and adolescents [s2].

The clinical logic of a universal birth dose was never that every newborn is at high risk. It was that maternal screening is imperfect — tests can be missed, mistimed, mislabelled, or the result unavailable at delivery — and that a dose given to every infant catches the ones the screening system loses. Removing the universal dose shifts the burden onto the reliability of maternal screening and record transfer.

The dissent inside the room

Two of the committee's own members argued against the change on the record. Cody Meissner of Dartmouth said there is "plenty of evidence of efficacy and no evidence regarding lack of safety" [s1]. Wilbur Chen said: "We have had multiple decades to look for a safety signal, and we haven't found it" [s1].

Former CDC Director Tom Frieden said the recommendation to end the universal birth dose "puts millions at greater risk" of liver damage, cancer and early death [s1].

The American Association of Immunologists said it was "extremely disappointed" and urged the CDC to reject the recommendation, stating that "the science behind the hepatitis B vaccine is robust and well-established" [s2]. The statement was issued under the name of AAI President Ulrich von Andrian [s2]. The AAI also pointed to independent analysis warning that even modest delays could produce a "substantial increase in preventable chronic infections, liver cancers, and deaths" [s2].

What is not in dispute

Notably, the arguments made against the change were not about new safety data. The AAI's position is that the evidence base is well-established [s2]; Meissner's framing was the absence of evidence of harm [s1]. No party in the coverage of the vote pointed to a newly identified safety signal for hepatitis B vaccine as the reason for the change.

That is the crux of the disagreement. A shift from a universal recommendation to individual decision-making can be justified either by new evidence of harm or by a re-weighting of known risks and benefits. The record of this meeting, as reported, reflects the second.

What happens next

Three questions are open as of tonight.

Whether the CDC adopts it. The recommendation is not policy until the agency's director signs off [s3].

What downstream systems do. ACIP recommendations are load-bearing for more than clinical practice: they anchor the Vaccines for Children programme and insurance coverage requirements. A change from "routine" to "individual-based decision-making" is a different coverage category, and hospitals, insurers and state programmes will need to interpret it.

What states do. Several states and professional bodies had already signalled they would maintain their own guidance regardless of the federal recommendation.

This article is informational. It does not constitute medical advice, and decisions about infant vaccination are for parents and their clinicians.

Sources

Sources

  1. A New CDC Recommendation Could Mean a Big Change for Childhood VaccinesTIME , December 5, 2025
  2. AAI Statement Following ACIP Vote to End the Recommendation of Hepatitis B Vaccination For All Infants at BirthAmerican Association of Immunologists , December 5, 2025
  3. ACIP updates recommendation for hepatitis B vaccine at birthAmerican Hospital Association , December 5, 2025
  4. ACIP Votes Against Universal Birth-Dose of Hep B VaccineAmerican College of Osteopathic Internists , December 5, 2025

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