It took several attempts and much debate, but on Friday, the Centers for Disease Control and Prevention's (CDC’s) newly reworked Advisory Committee on Immunization Practices (ACIP) voted to upend the CDC's longstanding recommendation that a dose of the universal hepatitis B virus (HBV) vaccine be given to newborns.
The new recommendation from ACIP calls for “individual-based decision making” for parents deciding “when or if” to give the HBV vaccine to children born to women who test negative for the virus. The panel voted 8 to 2 in favor of the new language.
“Parents and health care providers should consider vaccine benefits, vaccine risks, and infection risks,” the recommendation states. “For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age.”
ACIP’s new stance represents a major change from the CDC's longstanding guidance that all babies receive a dose of the HBV vaccine within 24 hours of birth. Since the CDC made that initial recommendation in 1991, reported HBV infections among adolescents have dropped by 99%.
Several presentations given at this week's ACIP meeting preceded the committee's vote, including one from the committee’s childhood immunization schedule work group.
ACIP voting member Vicky Pebsworth, Ph.D., represented the work group with a briefing (PDF) supporting individual-based decision making, explaining that the U.S.’ universal birth dose policy is an “outlier” among other nations with a low prevalence of HBV and that some parent stakeholder groups would prefer “greater flexibility and the ability to decide what is best for their child.”
The wording of the new recommendation, which had been the source of much debate over the two-day ACIP meeting, may create additional barriers to care by potentially confusing physicians, Natasha Bagdasarian, M.D., chief medical executive for the state of Michigan, pointed out during the meeting.
The committee didn't reach a consensus on the specific wording of the recommendation by the time the vote happened. Cody Meissner, M.D., the only member of the committee to have previous experience serving on the ACIP, said he was “quite uncomfortable” with the language of the voting question.
Other voting members, such as Retsef Levi, Ph.D., contended that the revised recommendation will allow parents to “carefully think” about taking “the risk of giving another vaccine to their child,” he said.
Despite the outcome of the vote, Meissner, the former chief of the Tufts Medical Center division of pediatric infectious diseases, said he hopes pediatricians continue to administer the birth HBV vaccine dose within the 24-hour window.
“I think to follow any other course is not in the interest of the infant,” Meissner said before the vote. In his vote against the individual-decision framework, he added that “do no harm is a moral imperative. We are doing harm by changing this wording.”
The only other committee member to join Meissner in voting "no" was Joseph Hibbeln, M.D.
“I agree with Dr. Meissner that this has a great potential to cause harm, and I simply hope that the committee will accept its responsibility when this harm is caused,” Hibbeln said.
As well as changing the universal HBV birth dose guidance, the committee also voted 6-4 to recommend that parents consult with healthcare providers to decide whether a post-vaccination serology test should be offered when weighing the need for subsequent HBV vaccine doses. As it stands, the HBV vaccine schedule consists of a three-dose series given within the first six months of life.
Health insurance trade organization AHIP confirmed that health plans will “continue to cover all ACIP-recommended immunizations that were recommended as of September 1, 2025,” a spokesperson told Fierce over email.
Immediate backlash
The vote was quickly slammed by prominent healthcare organizations such as the American Medical Association (AMA).
“Today’s action is not 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,” AMA trustee Sandra Adamson Fryhofer, M.D., said in an emailed statement.
Congresswoman Diana DeGette, D-Co., a ranking member of the House Committee on Energy and Commerce's health subcommittee, pointed a finger at President Donald Trump and Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., who she says have “eroded Americans’ confidence in public health and diminished our capacity to protect the public."
Earlier this year, RFK Jr. overhauled the existing ACIP roster and repopulated it with his own appointments, a move that was widely panned by experts.
ACIP’s new vice chairman, Robert Malone, for his part, opened Friday’s meeting by “going off script” to explain that he is “not an anti-vaxxer” but is “absolutely opposed to vaccine mandates."
Sen. Bill Cassidy, M.D., La., who provided a key vote to advance RFK Jr.’s appointment before the HHS secretary was confirmed, took to X to emphasize that the birth dose of an HBV vaccine is “a recommendation, NOT a mandate.”
“As a liver doctor who has treated patients with hepatitis B for decades, this change to the vaccine schedule is a mistake,” Cassidy added.
The senator urged acting CDC Director Jim O’Neill, who took on the role in June after former Director Susan Monarez, Ph.D., was ousted, to maintain the current guidance on HBV vaccines. The CDC does not have to adopt the decisions of its vaccine advisory committee, although it typically does.
After the vote, the committee went on to discuss the evolution of the childhood immunization schedule and its comparison to those in other countries in a presentation given by Aaron Siri, a vaccine injury lawyer who has close ties to RFK Jr. In an X post Thursday, Cassidy called out Siri as a “trial attorney who makes his living suing vaccine manufacturers," adding that ACIP had become "totally discredited."