ACIP Votes to End Universal Hepatitis B Birth Dose Recommendation Amid Broader Review of U.S. Vaccine Schedule

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In a historic shift that aligns with President Trump’s recent to overhaul national vaccination policy, the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention (CDC) voted on December 5 to rescind the universal recommendation for the hepatitis B vaccine birth dose for infants born to mothers who test negative for the virus. The two-day , characterized by intense debate and sharp divisions among committee members, marked a significant departure from decades of established public health policy and clinical recommendations.

The meeting took place against the backdrop of President Trump’s December 5 directing both the CDC and the Department of Health and Human Services (HHS) writ large to review the U.S. childhood vaccine schedule. Specifically, it directs federal health agencies to assess the necessity of current vaccine frequency and to consider aligning U.S. recommendations with those in countries such as Denmark and Germany.

The primary focus of the meeting was the re-evaluation of the hepatitis B vaccine schedule. To date, the CDC has recommended a universal birth dose for all infants to prevent infection from mothers with unknown infection status or through domestic contacts. Following a contentious debate, the committee voted (8-3) to recommend “individual based decision making” (also referred to as “shared clinical decision making”) for infants born to hepatitis B surface antigen (HBsAg)-negative mothers. The new language suggests that for these low-risk infants, the first dose be administered “no earlier than two months of age.” The committee reaffirmed the birth dose for infants born to HBsAg-positive mothers and those with unknown status. Additionally, the committee voted (6-4-1) to recommend that parents consult with providers regarding post-vaccination serology testing to confirm immunity. The director of the CDC must adopt the recommendation before it will become part of the CDC’s immunization schedules. Under federal law, commercial health plans must cover the CDC’s recommended vaccines, but that includes vaccines recommended under shared clinical decision making, so parents and providers who choose to continue with the birth dose should continue to have health coverage for it. A birth dose should also continue to be available under the federal Vaccines for Children (VFC) program, which provides vaccines to Medicaid-covered children and uninsured or underinsured children.

The proceedings revealed deep fractures within the committee regarding the evidentiary basis for these changes. Dr. Cody Meissner and Dr. Joseph Hibbeln were particularly vocal in their opposition, expressing profound frustration with the process and the potential public health consequences.

Dr. Meissner argued that deviating from the three-dose series starting at birth ignores the reality of established safety and efficacy. He stated, “We are doing harm by changing this wording,” and further warned that the committee’s decision would result in increased cases of cirrhosis, liver cancer, and premature death. He characterized the push for change as “baseless skepticism” rather than thoughtful inquiry.

Dr. Hibbeln criticized the vote as “unconscionable,” pointing out that despite a three-month tabling of the issue to gather data between the September and December ACIP meetings, no evidence was presented to support the safety or efficacy of delaying the first dose to two months of age. He argued that the committee was voting based on “speculations and hypotheses” regarding infant physiology rather than substantive data.

Dissenters also raised concerns that the new “shared decision making” language would burden clinicians and confuse parents, with Dr. Meissner noting that the move essentially dismantles a safety net that protects children from lifelong incurable disease.

The approved changes to the hepatitis B schedule and the corresponding VFC resolution will now move to the CDC Director for final approval. (The Deputy Secretary of HHS, Jim O’Neill, is currently serving as acting CDC director, after the Senate-confirmed director was fired by President Trump in a dispute over vaccine policy.) If finalized, this marks a pivotal shift in U.S. vaccine policy, moving away from universal mandates toward a risk-based, individualized approach.

For additional topics discussed during the December ACIP meeting, Manatt on Health subscribers can see this Manatt on Health .

For more on the September ACIP meeting, Manatt on Health subscribers can see the September 22 of Insights This Week.

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