ACIP to vote on major hepatitis B vaccine update that could reshape the childhood vaccine schedule

The CDC’s Advisory Committee on Immunization Practices (ACIP) began its December 4 and 5, 2025, meeting today, launching two full days of presentations, public comment and planned votes that could reshape how infants and children receive hepatitis B (HepB) vaccines and other routine immunizations.

ACIP meets three times each year to review new scientific evidence and vote on recommendations that ultimately guide vaccine availability, insurance coverage and public health programs such as Vaccines for Children (VFC).

Today’s meeting is a follow up on issues raised during ACIP’s previous session on September 18 and 19, when discussions were focused on COVID-19 vaccines and routine immunizations for measles, mumps, rubella and varicella (MMRV). The HepB vaccine was also a significant topic during the span of the two-day September meeting, where ACIP reviewed birth-dose practices, safety updates and possible changes to existing guidance.

On September 19, the committee voted 11–1 to postpone a vote on whether to change its longstanding recommendation that all infants receive the HepB vaccine at birth. The only dissenting vote came from then-chair Martin Kulldorff, Ph.D.

The December meeting is also taking place under a reshaped ACIP. Following the HHS and CDC announcement in early September of the appointment of five new committee members, the announcement described the changes as part of an effort to emphasize transparency, evidence-based science and diverse expertise.

“ACIP safeguards the health of Americans by issuing objective, evidence-based vaccine recommendations,” HHS Secretary Robert F. Kennedy Jr. said in the September 15 announcement. “Its new members bring diverse expertise that strengthens the committee and ensures it fulfills its mission with transparency, independence and gold-standard science.”

Earlier this year, however, Kennedy abruptly fired all 17 sitting ACIP members before appointing new individuals. This move drew widespread attention due to his long history as an anti-vaccine activist.

Just days before this week’s meeting, ACIP leadership shifted again. On December 1, HHS announced that Kulldorff had been appointed chief science officer for the Office of the Assistant Secretary for Planning and Evaluation (ASPE). Kirk Milhoan, M.D., Ph.D., a pediatric cardiologist and former U.S. Air Force flight surgeon, now serves as ACIP chair, with Robert Malone, M.D., as vice chair.

According to CNN, Malone opened today’s meeting by explaining why the committee delayed the hepatitis B vote in September. He said the evidence presented previously had “gaps” and did not meet the standards needed for a “confident evidence-based recommendation.”

“That decision was not about hesitation or reluctance. It was about standards,” he said. “I want to emphasize this is exactly how the scientific process is supposed to function.”

He added that ACIP convened a new working group since the last meeting and that he was “not able to disclose the nuance of that work group, but it is quite diverse in membership and represents a full spectrum of opinion regarding hepatitis B vaccination.”

Much of today’s agenda focused on HepB. The meeting, held at CDC headquarters in Atlanta, began at 8:00 a.m. with agency updates, followed by several presentations and discussions on the vaccine. The VFC and CMS teams are planned to give updates later in the day, leading into additional discussion, public comments and planned votes before the meeting adjourned at 5:00 p.m.

Two key hepatitis B votes are expected:

Vote 1:
ACIP recommends giving the HepB birth dose and HepB immunoglobulin to babies born to mothers who test HBsAg-positive. For babies whose mothers test HBsAg-negative or whose status is unknown, ACIP said parents should decide with their doctor. They should consider the benefits and risks of the vaccine and the risk of infection. If the birth dose is skipped, the first shot should be given at 2 months of age or later.

Vote 2:
ACIP says parents and doctors may want to do a blood test before giving more hepatitis B doses. This test checks if the child has reached the protective antibody level of 10 mIU/mL or higher. Insurance should cover the cost of this test.

Tomorrow’s agenda begins at 9 a.m. with roll call and updates from ACIP workgroups. The day will also include sessions on CDC vaccine risk monitoring, the history of the vaccine schedule, childhood and adolescent schedule considerations and discussions on adjuvants and contaminants before adjourning at 5:30 p.m.

The meeting continues to be livestreamed for the public on the CDC’s YouTube channel.