ACIP votes to end universal birth-dose for hepatitis B vaccine with updated guidance for parents and doctors

This morning, during the CDC’s Advisory Committee on Immunization Practices (ACIP) day two meeting, the committee voted to end its long-standing recommendation that all newborns receive a hepatitis B (HepB) vaccine dose at birth.

The committee voted 8–3 to remove the universal birth-dose guidance for babies born to mothers who test negative for HepB. Under the new recommendation, parents are advised to delay the first dose until at least 2 months of age and to make the decision together with their child’s healthcare provider. Babies born to mothers who test positive for HepB will still receive the birth dose and HepB immunoglobulin.

During Friday’s meeting, ACIP also voted 6-4 to recommend that parents and healthcare providers consider a blood test to check antibody levels before giving additional HepB doses, with insurance covering the cost of the test.

This update comes during the second day of ACIP’s two-day December meeting. The vote follows months of discussion that began during the committee’s September 18 and 19 sessions, when ACIP reviewed birth-dose practices, safety updates and potential changes to guidance for HepB vaccines.

At that meeting, the committee voted 11–1 to postpone a decision on altering the universal birth-dose recommendation, citing "gaps" in the available data.

The December meeting continues under a reshaped ACIP. Earlier this year, HHS Secretary Robert F. Kennedy Jr. abruptly removed all 17 sitting committee members and later appointed new members, emphasizing transparency, evidence-based science and diverse expertise.

The committee is also under new leadership by Kirk Milhoan, M.D., Ph.D., a pediatric cardiologist and former Air Force flight surgeon, as chair, and Robert Malone, M.D., as vice chair. Martin Kulldorff, Ph.D., who chaired ACIP until earlier this year, was recently appointed chief science officer for HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE).

According to CNN, Malone explained at the start of the meeting why the HepB vote had been delayed in September.

"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."

A new working group, he added, was formed to review the evidence and provide a full spectrum of opinions on hepatitis B vaccination.

The vote to end the universal birth-dose recommendation has come with mixed feelings across medical groups and health professionals.

Supporters of the HepB vote argued that the previous universal recommendation was too broad and limited parental choice. According to The Washington Post, Retsef Levi, Ph.D., an ACIP panelist and professor of operations management at MIT Sloan School of Management, said this vote is “suggesting a fundamental change in their approach to this vaccine and maybe more broadly.

However, the American Medical Association (AMA) issued a public statement, with Trustee Sandra Adamson Fryhofer, M.D., saying today’s vote “to weaken the birth-dose recommendation for the Hepatitis B vaccine is reckless and undermines decades of public confidence in a proven, lifesaving vaccine.”

Fryhofer continued by sharing that this vote isn’t "based on scientific evidence, disregards data supporting the effectiveness of the Hepatitis B vaccine and creates confusion for parents about how best to protect their newborns."

She added that administering the birth dose is "crucial for protecting children from both perinatal and early postnatal transmission of the hepatitis B virus—and preventing a lifelong condition that can lead to chronic liver disease, cirrhosis, liver cancer, and death."

She concluded that the AMA urges the CDC to reject this recommendation and "uphold its commitment to science and public health. The consequences of failing to do so are too severe and the potential harm too great."

According to the CDC, part of this vote also includes guidance on post-vaccination testing. This means the ACIP recommends that parents and healthcare providers consider a blood test to confirm protective antibody levels before administering additional HepB doses.

The December 5 agenda continues into the afternoon with discussions on vaccine risk monitoring, childhood and adolescent immunization schedule considerations, adjuvants and contaminants. The meeting is livestreamed on the CDC’s YouTube channel.