Vaccination advisory committee again postpones vote on hepatitis B vaccination for newborns

Accusations that moderators cherry-picked data and relied on scientific speculation derailed a vote by the federal vaccine advisory panel Thursday on whether to change a decades-old recommendation that all newborns be vaccinated against hepatitis B at birth.

The committee postponed the vote until Friday because some members wanted more time to resolve heated differences. The committee had already postponed the vote twice for similar reasons.

At one point in Thursday’s meeting, Dr. Jason Goldman, an American College of Physicians liaison to the committee, fumed at panelists for “promoting this anti-vaccination agenda without the data and evidence needed to make these informed decisions.”

“Do what is right,” Dr. told them. Goldman, adding that the people selected to present data to the committee did not have the “data-driven background for these presentations.”

The members of the panel, the Advisory Committee on Immunization Practices (ACIP), were hand-picked by Secretary of Health and Human Services Robert F. Kennedy Jr. after he fired all 17 original panel members.

The committee is tasked with shaping the country’s vaccination policy. Mr. Kennedy has frequently said that children are receiving too many vaccines, too many at the same time, and he has tasked the newly appointed committee with reviewing the safety and necessity of the vaccines included in the children’s immunization schedule, including the hepatitis B vaccine.

So far, however, the board’s meetings have been characterized by a level of turmoil, disunity and dysfunction unknown to the board’s staid, mostly routine meetings of the past.

Tempers have flared. Insults ensued: At the September meeting, a panelist was caught on a hot mic calling another committee member “an idiot.” And there is wide disagreement among committee members about the relative benefits and risks of the vaccines they are asked to discuss.

On Thursday, outside experts criticized the meeting’s disarray and what they said was an inappropriate focus on the theoretical harm of vaccines over the proven benefit.

“Today has made it clear that members of this committee are more interested in sowing fear than advancing vaccination policy,” said Dr. José Romero, member of the American Academy of Pediatrics Committee on Infectious Diseases.

“Parents deserve clarity, what they got was chaos,” he added.

Committee members were tasked with making a decision based on the effectiveness of the hepatitis B vaccine, its contribution to reducing infections and its safety. The first vaccination is given within 24 hours of birth to prevent infection with hepatitis B, a highly contagious virus that can cause serious liver damage.

But the format of the meeting broke with tradition in several ways. The speakers were not on the agenda until the morning of the meeting and the names of the Hepatitis B Working Group were not announced until pressed during the meeting.

And given the importance of their decisions, members were sharply criticized by outside experts for not using the established evidence-to-recommendations format, which typically includes detailed accounts of effectiveness, feasibility, cost-effectiveness and equity.

Instead of a speech by a Centers for Disease Control and Prevention scientist, Cynthia Nevison, a climate scientist at the University of Colorado, presented data on trends in disease prevalence. Dr. Nevison is a former board member of SafeMinds, an organization that supports the false theory that vaccines cause autism.

Mark Blaxill, a well-known anti-vaxxer and self-proclaimed “critic of the CDC” who is now an employee of the agency, presented data on the safety of the hepatitis B vaccine, relying on studies that included work by David Geier, a discredited researcher and outspoken vaccine critic.

The agenda for Friday, when the committee is scheduled to address broader questions about the childhood vaccination schedule, lists as a speaker Aaron Siri, a lawyer who has allied with Mr. Kennedy for years in court battles over vaccines.

But Senator Bill Cassidy, Republican of Louisiana and a gastroenterologist, noted in a social media post on Thursday that Mr. Siri was not an expert on childhood vaccines. “Aaron Siri is a litigator who makes a living suing vaccine manufacturers,” Mr. Cassidy wrote.

“The ACIP is completely discredited,” he added, referring to the vaccination committee. “They don’t protect children.”

Dr. Cassidy, chairman of the Senate Health Committee, cast the tie-breaking vote to confirm Mr. Kennedy after receiving assurances that as secretary he would not interfere in the work of the vaccine panel.

The committee’s decisions are not legally binding, but have significant implications for whether private insurance and government assistance programs are required to cover vaccinations.

Remarks before the meeting by committee members President Trump and Mr. Kennedy had indicated that the committee would likely vote to delay vaccines for babies whose mothers tested negative for hepatitis B.

Dr. Kirk Milhoan, the panel’s newly appointed chairman, also indicated earlier this week that members would most likely recommend against universal vaccination at birth and instead recommend delaying vaccination for most babies until they are older.

Health department officials asked members to explore whether such infants could be vaccinated instead when they were older, Dr. Milhoan, a pediatric cardiologist. “We were asked to do this,” he added.

However, the proposed wording for members to vote on was changed three times, prompting Dr. prompting Joseph Hibbeln, a panelist and neuroscientist who formerly worked at the National Institutes of Health, to say, “We really need to know what we’re voting on.”

The conversation became most heated after Mr. Blaxill presented data that he said suggested the vaccines were harmful.

Dr. Hibbeln demanded “firm and reproducible evidence of harm” from the vaccine. When Mr Blaxill replied that there was limited evidence of harm, Dr Hibblen: “So speculation and limited evidence? Got it.”

Many health experts are concerned about the hepatitis B vote because children are particularly vulnerable to the virus. More than 90 percent of infected infants develop chronic hepatitis B, which can lead to liver cirrhosis, liver failure and liver cancer, compared with fewer than 5 percent of people who become infected in adulthood.

Some high-income countries like Denmark – to which Dr. Nevison in her presentation and others have pointed out when comparing vaccination schedules – immunize babies at birth if the mother is known to be infected, and delay the first dose until 8 weeks of age for all others.

But these countries offer universal health care and are able to diagnose most women who may be infected, public health experts have stressed.

Each year in the United States, more than 17,000 infants are born to women who have hepatitis B. But nearly one in five pregnant women are not tested for the virus, and only about one in three women who test positive receive treatment, according to a report released Tuesday by the Vaccine Integrity Project, an initiative dedicated to protecting vaccine use in the United States.

A comparison is offered by congenital syphilis, another infectious disease for which pregnant women are examined. Denmark had no cases of congenital syphilis in 2023; There have been nearly 4,000 cases in the United States.

In her lecture, Dr. Nevison said it was not the birth dose of the hepatitis B vaccine that led to a decline in virus cases.

“It is the more targeted interventions that have had the greatest effect in reducing hepatitis B cases,” she said. “The targeted measures are working.”

She attributed the decline to better screening of blood products, safer sex practices and needle exchange programs.

But hepatitis B experts and pediatricians, including some members of the committee, questioned the source of the data and strongly disagreed with its interpretation.

“This disease has been declining in the United States thanks to the effectiveness of our current vaccination program,” said Dr. Cody Meissner, a professor of pediatrics at Dartmouth Geisel School of Medicine, who is widely considered the committee’s most qualified member.

As Dr. Robert Malone, the committee’s vice chairman who led the discussions, said Dr. Meissner “has an opinion,” replied Dr. Meissner: “Those are facts, Robert.”

Dr. Nevison said during her talk that the risk of transmitting the virus through methods other than maternal transmission is exaggerated. Only children living among Vietnamese immigrants and Hmong refugees are at significant risk of exposure to the virus and therefore require the birth dose of the vaccine, she said, adding: “There is little evidence that horizontal transmission ever posed a significant threat to the average American child, and the risk has likely been overstated.”

But while these communities are being screened for the disease, there is no comparable data for other populations, said Chari Cohen, president of the Hepatitis B Foundation.

“This is not just a problem among immigrants or communities of color,” she said. “It is a virus that can affect all Americans.”

Up to 70 percent of the approximately two million Americans with hepatitis B are unaware of their diagnosis, said Dr. Cohen.

Mr Kennedy has long questioned the safety of the hepatitis B vaccine, falsely claiming it had not been properly tested. He has also said without evidence that the vaccine causes autism, and he has criticized the CDC for recommending universal vaccination at birth.