CDC Advisers Vote 8-3 To Reclassify Newborn Hepatitis B Shot, Sparking Widespread Concern

Summary: The Centers for Disease Control and Prevention’s vaccine advisory committee voted 8-3 to remove the long-standing recommendation that all U.S. newborns receive the hepatitis B vaccine at birth, reclassifying most birth doses as a “shared clinical decision-making” option. Experts warn the change could create confusion, reduce access for vulnerable families and lead to more infections and deaths.

What the Committee Decided

On Friday morning, the Advisory Committee on Immunization Practices (ACIP) voted 8-3 to change guidance so that most newborn hepatitis B doses are considered a “shared clinical decision-making” recommendation rather than a routine birth dose. The committee left intact the recommendation that infants born to mothers who test positive for hepatitis B should receive the vaccine at birth.

Who’s Behind the Change

The committee’s members were appointed by Health Secretary Robert F. Kennedy Jr. Former President Donald Trump publicly supported removing the long-standing recommendation and signed a memo calling for U.S. child immunization guidance to be reviewed and aligned with practices in “peer, developed countries.”

Why Experts Are Alarmed

Public health specialists, pediatricians and advocacy groups warned the shift will cause confusion about routine newborn immunizations and could create access barriers—particularly for low-income families. Because advisory guidance often shapes official policy and insurance coverage, the ACIP vote could have immediate practical consequences.

“This is going to lead to an increase in preventable infections among children,” said Michaela Jackson, program director of prevention policy at the Hepatitis B Foundation.

Cody Meissner, a pediatrics professor at Dartmouth’s Geisel School of Medicine and one of the committee’s most experienced members, argued the change does harm by weakening clear, evidence-based guidance: “We’re giving it to protect the infant against a potentially fatal disease. We know it’s safe and we know it’s very effective.”

Other advisers warned that the shared clinical decision-making label is vague and typically reserved for non-routine vaccines. Natasha Bagdasarian, an infectious disease physician and liaison for the Association of State and Territorial Health Officials, said many providers interpret that language as a signal the vaccine is controversial or requires extra administrative steps, creating practical barriers to care.

Policy and Practical Consequences

The ACIP recommendations will now go to Jim O’Neill, acting director of the CDC, who will decide whether to change official federal guidance. Independent medical organizations such as the American Academy of Pediatrics continue to strongly recommend that all infants receive the hepatitis B vaccine within 24 hours of birth.

Advisers also proposed routine blood testing after the first shot to determine whether more doses are needed. That testing approach is unproven in this context, and it is unclear whether such tests would accurately reflect protection from the complete three-dose series. Recommending universal post-vaccination testing — and requiring insurers to cover it — would extend beyond ACIP’s usual role and could complicate implementation.

Projected Health Impact

A recent model cited during the discussion estimated that delaying the birth dose until two months would lead to at least 1,400 additional infections, about 300 more cases of liver cancer, and roughly 480 extra deaths every year in the United States. Liver cancer carries a low five-year survival rate (about 18% in the U.S.).

Experts also note that more than half of people with hepatitis B do not know where they contracted the virus. Transmission can occur in households, daycare settings, through shared personal items, or in other everyday settings because the virus can remain infectious on surfaces for up to a week.

Access Concerns for Low-Income Families

The Vaccines for Children (VFC) program, which covers vaccinations for roughly 52% of U.S. children, must follow ACIP guidance. Changing the guidance could therefore make it harder for families who rely on VFC to obtain the birth dose, public health officials warned.

Meeting Tensions and Next Steps

The second day of the ACIP meeting opened early and became heated. Members postponed the vote three times to request more data and revised wording. Some advisers, including Joseph Hibbeln (a former NIH neurologist), said there was insufficient evidence to support the change.

Following the vote, the recommendations will be reviewed by the acting CDC director. Any final policy change would likely affect clinical practice, insurance coverage, and how hospitals and birth facilities administer newborn vaccines.

Bottom line: The ACIP’s reclassification of the hepatitis B birth dose represents a significant shift in U.S. vaccine guidance that experts fear will reduce early protection for infants and disproportionately affect vulnerable populations.