CDC advisers delay crucial vote on hepatitis B vaccination in tense meeting

By Brenda Goodman, Meg Tirrell, Deidre McPhillips, Jamie Gumbrecht, Katherine Dillinger, CNN

(CNN) — In a meeting punctuated by conflict and confusion, the independent vaccine advisers to the US Centers for Disease Control and Prevention on Thursday again delayed a vote that could dramatically change hepatitis B vaccination practice in the United States.

The members of the Advisory Committee on Immunization Practices, or ACIP, had been scheduled to weigh in on whether to change recommendations regarding hepatitis B vaccination for newborns in the US. The vote, now set to take place at Friday’s session, had already been pushed back at the advisers’ September meeting. But during Thursday’s meeting, advisers stumbled over repetitive language and lack of clarity about what they were voting on.

A change to the hepatitis B recommendations would be the most significant change to the childhood vaccine schedule yet under US Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist who abruptly fired the 17 sitting members of the advisory committee this summer and replaced them with his own picks.

The consequences of the committee’s votes and plans can have major implications for vaccination in the United States. Its recommendations shape doctors’ guidance to patients as well as state vaccine policy, insurance coverage and the Vaccines for Children program.

‘Trying to evaluate a moving target’

As the meeting got underway, the advisers heard about the burden of hepatitis B from Dr. Cynthia Nevison, a research associate at the University of Colorado at Boulder, where she is an atmospheric scientist — an atypical specialty to present before a public health agency’s vaccine committee.

One of her research studies, called “Autism Tsunami,” was written with the next ACIP presenter — Dr. Mark Blaxill, who introduced himself as a critic of the CDC who is now working at the agency — and was retracted by the journal that published it.

The editors of the journal said the authors misrepresented and selectively cited, or cherrypicked, data and that there were no valid justifications for the mechanisms the authors proposed for prevention.

In her presentation, Nevison, who introduced herself as a contractor for the CDC, suggested that hepatitis B infections had never been a real threat to infants.

Nevison’s presentation sought to cast doubt on the importance of the hepatitis B vaccine and on recent modeling evidence that indicated doing away with the birth dose would increase the number of preventable hepatitis B cases and deaths in kids.

“There’s very little evidence that horizontal transmission has ever been a significant threat to the average American child, and the risk probably has been overstated,” Nevison said.

After another presentation on vaccine safety, members began to dissect the voting questions that could make a seismic change to hepatitis B vaccination strategies. The questions were changed repeatedly before the advisers were scheduled to vote Thursday, an echo of some of the confusion that also pervaded previous meetings.

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

When new voting language couldn’t immediately be put up on slides, Vice Chair Dr. Robert Malone cited an “audio/visual harmonization” problem before calling for a short break.

“We really need to know what we’re voting on,” a voice over the livestream said as the committee, some of whom had joined remotely, took a pause.

After the break, Malone noted that committee Chair Dr. Kirk Milhoan — a cardiologist who took the reins after HHS announced this week that Dr. Martin Kulldorff had left for another role in the agency – “is about to jump on a plane to go to Asia and would not be available, I believe, for voting tomorrow.”

The committee then voted 6-3 in favor of a delay “to provide adequate time for members to review the vote language.”

Why change the recommendation?

One question hanging over the vaccine advisory committee meeting is why it decided to take a new look at the recommendation that babies get a dose of the hepatitis B vaccine at birth.

The viral infection can hide in the body for years, until it leads to liver failure, cirrhosis or cancer. No new studies have revealed safety concerns about the hepatitis B vaccine, and there has been a dramatic decline in cases among infants since 1991, when the CDC recommended universal vaccination for babies. Reported hepatitis B infections in infants plummeted from an estimated 18,000 cases every year to about 20 per year.

“Why is there pressure today to change something that has been working?” asked Dr. Grant Paulsen, who participated in the meeting as a representative of the Pediatric Infectious Diseases Society.

Some committee members seemed to echo skepticism about a change. Hibbeln, a psychiatrist, pointed out that the near-elimination of hepatitis B infections in kids was considered one of the 10 greatest accomplishments in science and medicine in the United States, “so we have a high burden of proof to change this system or change our recommendations.”

“If there are any documents or documentation of rates of risks and rates of harm, I have not heard any,” Hibbeln said.

Committee member Dr. Vicky Pebsworth, who led the working group that studied hepatitis B vaccination, said ACIP has a responsibility to periodically review its policies.

“Plus, we were aware that there was pressure coming from stakeholder groups wanting the policy to be revisited,” added Pebsworth, a registered nurse who has been on the board of the National Vaccine Information Center, a group that casts doubt on the safety of vaccines while downplaying their benefits.

In her presentation, Pebsworth cited two surveys of parents: one of Oregon parents in 2014, and a 2025 survey conducted by the Kaiser Family Foundation and The Washington Post. In both surveys, a minority of parents reported delaying or refusing the hepatitis B vaccine. Among those who did, many said they were concerned about vaccine safety or they felt the baby was too young to receive the shot.

Committee member Dr. Evelyn Griffin, an obstetrician-gynecologist, said immigration was the “elephant in the room.”

“We have had years of illegal immigration, undocumented people,” coming from countries where hepatitis B infections are more common than the United States, she said.

Griffin said she and her family went through the legal immigration process when they moved from Canada.

“The legal immigration process … is very voluntary in terms of documenting your hepatitis B status, in terms of being tested for it, in terms of even if you want to document it. No one’s asking if you are hepatitis B positive or negative,” Griffin said. “I hope those programs are better now.”

Criticism from public health experts

Dr. Jason Goldman, the liaison from the American College of Physicians, told CNN that Thursday’s presentations on hepatitis B vaccination were “not following science.”

Studies casting doubt on the need for hepatitis B vaccination and its safety were quoted out of context, and the proposed voting language on vaccine recommendations “is inappropriate,” Goldman added.

He compared the nature of the recommendation that all babies receive a dose at birth with one he might make as a physician for other health decisions, such as whether patients should get a colonoscopy to screen for colorectal cancer.

“I recommend a colonoscopy to a patient. They still have a choice to do it. The evidence shows colonoscopy reduces incidence of cancer,” Goldman said. “Same analogy. I recommend the hepatitis B vaccine. [The] patient can refuse. The evidence shows benefit of [the] vaccine in reducing disease.”

In his comments to the advisers, Goldman said the meeting should be ended without a vote.

“You are wasting taxpayer dollars by not having scientific rigorous discussion on issues that truly matter,” he said. “The best thing you can do is adjourn the meeting and discuss vaccine issues that actually need to be taken up.”

Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told CNN on Thursday that the ACIP meeting is a historic moment in public health.

“Remember right now that all of the information we have from over 400 studies and over the past 40 years show that these doses delivered to an infant at birth are absolutely critical in stopping this transmission from a mother to a baby. And all the science supports that. The only group right now that is saying to the contrary is this administration,” he said. “We now have lost CDC and the Advisory Committee on Immunization Practices as credible, reliable sources of information.”

Thursday’s session closed with a heated debate about evidence and how it’s evaluated.

“There’s been a lot of data and some misinformation presented today,” said Dr. Amy Middleman, a pediatrician from Oklahoma who attended the meeting as a representative of the Society of Adolescent Health and Medicine.

She urged the committee members to return to a process of systematic review that doesn’t focus on specific studies or data points but takes into account all the scientific evidence that’s available on a policy question.

“These decisions really affect a lot of people’s lives, and we really are obligated to our countrymen to make sure that we do this in an organized process,” she said. “We can’t just dump a pile of unfolded laundry on the floor and then try to determine from that whether or not we need more T-shirts or more pants.”

ACIP member Dr. Retsef Levi, a professor of management at the Massachusetts Institute of Technology who has suggested that Covid-19 vaccines are deadly and should be pulled from the market, said the committee had not considered the totality of the evidence because they deemed much of it to be low-quality.

“I appreciate beliefs and feelings, but the data presented to us by the CDC, not misinformation, is telling a different story than what you believe in,” Levi said.

Middleman responded, “This is not beliefs and feelings. This is looking at the data.”

On the agenda Friday

The most recent version of the voting language says the CDC advisers will consider three issues on Friday morning:

• Whether to recommend a birth dose of hepatitis B vaccine and immunoglobulin for infants born to women who test positive for the virus, and individual decision-making in consultation with a health care provider for women who test negative. The vaccine would be suggested no earlier than 2 months of age for infants who don’t get a dose at birth.
• Whether to reaffirm the current standard recommending a birth dose of vaccine and immunoglobulin for children of women whose hepatitis B status is unknown.
• Whether to recommend that parents consult with health care providers when deciding whether children need hepatitis B tests before subsequent vaccine doses.

Friday’s meeting is also set to feature discussion on the vaccine schedule for children and teens. Aaron Siri, a managing partner at the law firm Siri & Glimstad LLP, is scheduled to give a presentation about the schedule.

Siri, who’s worked closely with Kennedy and served as his personal lawyer during Kennedy’s presidential campaign, has handled a number of vaccine-related cases, particularly challenging vaccine requirements. In 2022, he filed a petition on behalf of the Informed Consent Action Network, or ICAN, a nonprofit that challenges the safety of vaccines and vaccine mandates, for the US Food and Drug Administration to revoke approval of the polio vaccine used in the US.

Siri’s presence on Friday’s agenda drew criticism from Sen. Bill Cassidy, the Republican doctor who chairs the Senate Health, Education, Labor and Pensions Committee. Cassidy struggled openly with his pivotal vote to confirm Kennedy as HHS secretary and has himself been the subject of increased attention as Kennedy takes steps to undermine vaccine confidence in the US.

“Aaron Siri is a trial attorney who makes his living suing vaccine manufacturers,” Cassidy said Thursday in a post on X. “He is presenting as if an expert on childhood vaccines. The ACIP is totally discredited. They are not protecting children.”

Asked in September whether parents could trust ACIP if the advisers vote to change the childhood vaccine schedule, Cassidy said, “No.”

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