The US CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend delaying giving certain infants a dose of the hepatitis B vaccine at birth, claiming without evidence that there are gaps in safety and effectiveness data. Instead, committee members suggested a “shared decision-making” approach between parents and their physician, but the vaccine is currently still available to those who choose to vaccinate.

A majority — eight members — voted that women who have tested negative for hepatitis B should consult with clinicians on when they should give the vaccine and suggested that the initial dose “is administered no earlier than 2 months of age.”

In a second vote, six of 11 panelists approved language that when “evaluating the need for a subsequent HBV vaccine dose in children,” parents should consult with healthcare providers to determine whether post-vaccination serology testing for hepatitis B antibodies should be done to determine whether “the established protective anti-HBs titer threshold of ≥ 10 mIU/mL has been achieved.” 

Two panelists were vocal in their dissent. Cody Meissner, MD, professor of pediatrics at Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, said that no evidence had been presented on whether one dose of vaccine could confer protection. 

“We have no idea if less than three doses of the vaccine will be protective,” he said, adding that the language would discourage parents from vaccinating children at any point. “We’re not only worried about infection in the neonatal period. We’re worried about infection throughout life,” he said.

Meissner said he did not understand the need to change a “very well established” recommendation for infants to universally receive a dose at birth.

“We know it is safe, and we know it is very effective,” he said. With the new recommendation, “we are going to experience increased rates of hepatitis B, and it is not the right thing for us to do,” said Meissner.

ACIP colleague Joseph Hibbeln, MD, also voted no on both questions, stating multiple times that no evidence had been presented to support the recommendations. “This has a great potential to cause harm, and I simply hope that the committee will accept its responsibility when this harm is caused,” said Hibbeln, a psychiatrist.

Many medical professional organizations also expressed concern about the votes when ACIP Vice Chair Robert Malone, MD, allowed them time to comment.

“Your data is questionable. You do not present things in an honest, fair, equitable manner. You are not using evidence to recommend a framework, and you are creating confusion,” said Jason Goldman, MD, president of the American College of Physicians. “This vote is an unnecessary solution, looking to find a problem to solve,” said Goldman, who was previously a liaison to ACIP before the US Department of Health and Human Services (HHS) prohibited the liaison groups from official participation.

Jose Romero, MD, who was fired earlier this year by HHS Secretary Robert F. Kennedy, Jr from his position as ACIP chair, also issued a warning. “Let me be very clear about this, delaying the birth dose would leave newborns unprotected during a critical window in their lives,” he told reporters. “Children will die preventable deaths,” said Romero, now a member of the American Academy of Pediatrics’ (AAP) Committee on Infectious Diseases.

The AAP said it will continue to recommend a dose within 24 hours of birth, a second dose at 1-2 months, and a third dose at 6 months. “The pacing of these doses has been rigorously tested and proven to be safe and effective over several decades,” said the organization, in a statement.

In a statement issued after the meeting, American Medical Association (AMA) Trustee Sandra Adamson Fryhofer, MD, who was previously a liaison to ACIP, said, “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.”

Fryhofer, who also commented at the meeting, said in the statement that the AMA would “urge the CDC to reject this recommendation and uphold its commitment to science and public health.”

Safety and Effectiveness Challenged 

The current ACIP recommendation is for all infants to receive a dose at birth (which has been in place since 1991), followed by a second dose from 1 to 2 months of age and a third from 6 to 15 months of age.

A birth dose is crucial to prevent potential transmission, because vaccine efficacy for “post-exposure prophylaxis rapidly drops off by hours,” said Adam Langer, DVM, MPH, acting principal deputy director at CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention. Langer was not allowed to formally present to ACIP but gave remarks in response to panel questions. 

CDC data shows that, since 1991, pediatric hepatitis B infections have fallen by more than 95%. Infant infections have been almost eliminated, according to the Vaccine Integrity Project. 

A Vaccine Integrity Project review of some 400 studies over 40 years found that the birth-dose vaccine reduces perinatal transmission by roughly 70% when used alone, and that transmission is reduced by up to 97% when the vaccine is combined with administration of hepatitis B immune globulin.

The CDC has noted that the universal birth dose is important because many pregnant women may not get tested for hepatitis B. At the September ACIP meeting, Langer presented data showing that only about 87% of pregnant American women receive testing. 

In a just-released commentary in JAMA, three infectious disease specialists said that a vote to restrict “the birth dose only to infants born to HBsAg-positive mothers would raise perinatal HBV cases to 1101 — an additional 63%, or a 76% increase” from current levels.

The two individuals invited to speak to the ACIP panel presented data that they said showed that the birth dose had been ineffective and had numerous adverse events, with some leading to disability and death.

Cynthia Nevison, PhD, a climate scientist and longtime anti-vaccine activist who was hired by CDC the day before the ACIP meeting, presented data purporting to show that the only reason acute hepatitis B infections fell after the universal birth dose was recommended was due to better screening of the blood supply, implementation of safe sex practices, and needle exchange programs.

Mark Blaxill, a businessman and father of a daughter with autism who joined the CDC in September, presented several studies which he claimed showed that the vaccine had led to unexplained fevers and sudden infant death syndrome, among other issues.

“The safety evidence is quite limited,” claimed Blaxill.

He and Nevison were co-authors on a 2021 paper on autism prevalence that was later retracted by the publisher because of methodology concerns and inadequate disclosures of conflicts.

ACIP panelist Vicky Pebsworth, RN, who is on the board of the National Vaccine Information Center, an anti-vaccine organization, led the small work group that summarized safety and effectiveness data for the committee. The work group included ACIP members and two hand-picked participants; no medical societies, manufacturers, patient advocates, or subject matter experts participated.

Pebsworth claimed, without evidence, that “the threats of infection are very low” for infants and added that “vaccine safety risks are not well understood and were never assessed properly.” She said that parents should have the option to vaccinate children at “a point in time closer to the onset of risky behaviors sometimes encountered in adolescence.”

She also acknowledged that a main reason for the panel’s review was not due to new evidence, but because of “pressure coming from stakeholder groups wanting the policy to be revisited.”

The CDC director — who is still in an acting capacity — must approve the recommendation for it to be added to the child and adolescent immunization schedule. 

The JAMA commentary authors disclosed the following: Angela Ulrich reported that the Vaccine Integrity Project is supported by an unrestricted gift from Alumbra Innovations Foundation to the Center for Infectious Disease Research and Policy at the University of Minnesota. Rochelle Walensky reported receiving fees from Madryn Asset Management for serving as a senior policy advisor, Consonance Capital for serving as a senior advisory board member, and Doris Duke Foundation for serving as a trustee; consulting fees from Infectious Diseases Society of America; nonfinancial support from The Carter Center for serving on the board of directors; and serving as the Bayer Fellow in Health and Technology at the American Academy in Berlin (Bayer does not make vaccine products for infants available in the US), all outside the submitted work. 

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.