CDC Vaccine Advisory Committee Delays Vote on Hepatitis B Birth Dose Recommendation

A federal vaccine advisory committee on Thursday postponed a potentially landmark vote that could fundamentally alter hepatitis B (search)Search disease vaccination practices for newborns in the United States, delaying the decision until Friday after committee members voiced confusion about rapidly changing voting language.

The Advisory Committee on Immunization Practices (search)Search term (ACIP), meeting in Atlanta, had been scheduled to vote at 2:30 p.m. ET on whether to eliminate the universal recommendation that all newborns receive the hepatitis B vaccineView drug details within 24 hours of birth—a policy that has been in place since 1991.

Committee Confusion Over Voting Language

"This is the third version of the questions that most of the [ACIP] received in 72 hours," said Dr. Joseph Hibbeln, a committee member. "We're trying to evaluate a moving target."

Dr. Robert Malone, the ACIP vice chair running Thursday's meeting, called it an "audio/visual harmonization" problem as new voting language couldn't immediately be put up on slides. "We really need to know what we're voting on," a voice over the livestream said as the committee took a pause to sort things out.

The committee had previously been expected to vote on hepatitis B (search)Search disease vaccination changes at its September meeting, but that vote was postponed because the evidence fell short of what was needed to make a "confident evidence-based recommendation," according to Malone.

Proposed Policy Changes

The anticipated voting language posted online suggests shifting to "individual-based decision-making, in consultation with a health care provider" for a birth dose of the hepatitis B vaccineView drug details when parents have tested negative for the virus or whose status is unknown. For babies not receiving the birth dose, "it is suggested that the initial dose is administered no earlier than 2 months of age."

Committee member Vicky Pebsworth said a work group was tasked in September with evaluating whether a birth dose is necessary when mothers tested negative for hepatitis B (search)Search disease. "We need to address stakeholder and parent dissatisfaction" with the current recommendation, she said.

Kennedy's Reconstituted Committee

The committee is composed of members handpicked by Health Secretary Robert F. Kennedy Jr. after he fired all 17 previous sitting advisers in June. Kennedy, a leading anti-vaccine activist before becoming the nation's top health official, replaced them with a group that includes several anti-vaccine voices.

This marks the third meeting of the reconstituted committee, which has made several decisions that angered major medical groups. At a June meeting, it recommended removing thimerosalView drug details preservative from flu vaccines despite acknowledging no proof of harm. In September, it recommended new restrictions on combination vaccines and took the unprecedented step of not recommending COVID-19 (search)Search disease vaccinations even for high-risk populations.

Medical Community Pushback

Dr. Jason M. Goldman, president of the American College of Physicians (search)Search term, criticized the proceedings during the meeting, calling it "political theater" and adding that "you are basing this on concerns of individuals who don't want the vaccine."

Goldman told CNN that the presentations Thursday on hepatitis B (search)Search disease vaccination "are not following science," noting that studies casting doubt on vaccination necessity and safety were quoted out of context. He compared the nature of universal recommendations to other medical guidance: "I recommend a colonoscopy to a patient. They still have a choice to do it. The evidence shows colonoscopy reduces incidence of cancer. Same analogy. I recommend the hepatitis B vaccineView drug details. [The] patient can refuse. The evidence shows benefit of [the] vaccine in reducing disease."

U.S. Sen. Bill Cassidy, a Louisiana Republican who is a doctor, posted on social media Thursday: "The ACIP is totally discredited. They are not protecting children."

International Context and Concerns

Some committee members noted that the United States is among only a few wealthy nations with universal birth dose recommendations. "It's really important to keep in mind that the US is an outlier in recommending a universal birth dose of the hepatitis B vaccineView drug details compared to other high-income nations," said Dr. Tracy Beth Hoeg, recently appointed acting director of the FDA's Center for Drug Evaluation and Research.

According to a CDC analysis, among 37 wealthier nations, the US is one of eight to recommend hepatitis B vaccineView drug details to all infants at birth. However, according to the same analysis, no other country in the world that has had a universal birth dose has ever reverted from a universal to selective recommendation. The United States would be the first.

Dr. Michelle Goveia, executive director of global medical and scientific affairs at Merck (search)Search term and former CDC epidemic intelligence service officer, noted key differences: "Countries with at-risk recommendations typically have much smaller populations, often a fraction of the US population, and have health care systems that support constant screening, testing and care coordination. In contrast, US health systems face significant challenges in identifying people living with hepatitis B (search)Search disease."

Vaccination Success and Disease Impact

For decades, the government has advised that all babies be vaccinated against hepatitis B (search)Search disease right after birth. The shots are widely considered a public health success, with cases among children falling from about 18,000 per year to about 2,200 over approximately 30 years following the 1991 universal recommendation.

Hepatitis B (search)Search disease is a serious liver infection that can become chronic, especially in infants and children. As many as 90% of infants who contract hepatitis B go on to have chronic infections, meaning their immune systems don't completely clear the virus. Chronic hepatitis B is linked to increased risk of liver cancer (search)Search disease, organ failure and cirrhosis (search)Search disease, with affected individuals 70 to 85% more likely to die early.

Screening Limitations

At the committee's September meeting, CDC scientists reviewed studies showing that an estimated 12-16% of pregnant women are not screened for hepatitis B (search)Search disease during pregnancy, and fewer than half of infants born to mothers infected with hepatitis B are identified through prenatal screening. Women are typically tested during their first three months of pregnancy, but it's possible to miss maternal infections if a woman catches the virus after testing.

Dr. Cody Meissner, a professor of pediatrics at Dartmouth and the only current ACIP member with previous committee experience, defended the current program: "This disease has gone down in the United States thanks to the effectiveness of our current immunization program. The way I look at a neonatal birth dose is that it is a safety net."

Controversial Presentations

In a departure from past practices, the committee heard presentations from researchers with documented anti-vaccine positions. Dr. Cynthia Nevison, an atmospheric scientist at the University of Colorado at Boulder, presented research suggesting hepatitis B (search)Search disease infections had never been a real threat to infants, despite her lack of hepatitis B expertise.

Nevison's presentation included work co-authored with Dr. Mark Blaxill that was retracted by the Journal of Autism (search)Search disease and Developmental Disorders after concerns were raised about methodology and undisclosed ties to anti-vaccine groups.

The committee is expected to reconvene Friday morning for the delayed vote, with lawyer Aaron Siri, who worked with Kennedy on vaccine litigation, scheduled to present on the childhood immunization schedule.