A key vaccine advisory panel for the Centers for Disease Control and Prevention voted Friday to drop a decades-old recommendation to vaccinate all newborns against hepatitis B, the committee’s most controversial decision since its overhaul by Health and Human Services Secretary Robert F. Kennedy Jr. in June.
The Advisory Committee on Immunization Practices voted 8 to 3 to adopt “individual-based decision making” for the newborn hep B vaccine dose for babies born to women who test negative, as are more than 99% of babies born in the U.S.
The move was met with condemnation by physicians and public health officials, including some on the committee. The CDC has recommended the shot since 1991, resulting in a 99% decline in rates of chronic hepatitis B infections in children and teens.
“‘Do no harm’ is a moral imperative. We are doing harm by changing this wording,” said Dr. Cody Meissner, an expert in pediatric infectious diseases at Dartmouth-Hitchcock Medical Center, who cast one of the few dissenting votes.
“This has a great potential to cause harm, and I simply hope the committee will accept this responsibility when that harm is caused,” said fellow no-vote Dr. Joseph Hibbeln, a psychiatrist formerly with the National Institutes of Health.
The committee spent the rest of Friday discussing the childhood and adolescent vaccination schedule. Comments from invited speakers and some committee members suggested that further revisions to the nation’s inoculation practices could be in store.
“Cumulative risk across the entire childhood vaccine schedule [is] a risk for which we do not have adequate data,” said committee vice chair Dr. Robert Malone, who contributed to early mRNA research but has since made a number of false and discredited assertions about flu and COVID-19 shots. “The potential cumulative risk” of childhood vaccines, he said, was “the elephant in the room.”
While CDC subject-matter experts were excluded from the meeting’s agenda, its second day began with a presentation from Aaron Siri, a leading antivaccine lawyer who has previously worked as Kennedy’s personal attorney.
Following a presentation in which Siri urged the committee to “end mandates” and “de-politicize vaccines,” Meissner called the attorney’s comments “a terrible, terrible distortion of all the facts.”
“You know how to present the facts that are favorable to you or to your client,” he added. “But for you to come here and make these absolutely outrageous statements about safety, I think it’s a big disappointment to me, and I don’t think you should have been invited.”
On X, Sen. Bill Cassidy (R-La.) criticized Siri’s presence, saying, “Siri is a trial attorney who makes his living suing vaccine manufacturers. He is presenting as if an expert on childhood vaccines. The ACIP is totally discredited. They are not protecting children.”
Changing the decades-old hep B recommendation has been a long-standing goal for vaccine opponents.
A planned vote on the issue at the committee’s meeting in September was tabled after fierce disagreement among members. When the discussion resumed Thursday, it repeatedly devolved into shouting.
“We’re trying to evaluate a moving target,” said Hibbeln, one of the move’s strongest opponents, during the meeting.
Although a change in the current recommendation would not bar newborns from receiving the vaccine, Medicaid and other public insurance programs would no longer be required to cover it, putting a birth dose out of reach for millions of poor families and complicating access for many others.
Unlike most vaccine-preventable diseases, such as whooping cough and chickenpox, hepatitis B is typically asymptomatic, often spreading silently until midlife, when 1 in 4 infected people develop liver cancer or cirrhosis.
“It’s one of the cancers with the highest mortality in the U.S.,” said Dr. Su Wang, medical director of Viral Hepatitis Programs and the Center for Asian Health at the Cooperman Barnabas Medical Center in New Jersey, who lives with the disease. “The life expectancy we give people is six months on average.”
Opponents of the current vaccine guidance — among them, Kennedy, surgeon general nominee Casey Means and President Trump — characterize the virus as the result of high-risk “adult” behavior, including sex and IV drug use.
“Hepatitis B is sexually transmitted,” Trump said at a White House news conference in September. “There’s no reason to give a baby that’s almost just born hepatitis B.”
But experts say that’s not how most people get the disease.
“It’s primarily transmitted mother to child,” said Dr. Chari Cohen, president of the Hepatitis B Foundation.
A majority of infected mothers are immigrants — particularly from the Philippines, China and Vietnam — making birth-dose vaccination an urgent priority for many California families.
Los Angeles County has recorded only a single case of perinatal Hep B transmission in the last five years, thanks in part to universal vaccination, the county health department said.
For some administration officials and panel members, the disease’s prevalence in immigrant communities is a talking point.
“The elephant in the room is immigration — we have had years of illegal immigration, undocumented people coming from higher-endemicity countries,” said Dr. Evelyn Griffin, one of the panel’s most vocal proponents of the change.
“We have problems adults need to solve with our resources there, rather than asking babies to solve this problem for us,” she said.
Griffin and other opponents of the current vaccine schedule say inoculating everyone places an unfair burden on healthy newborns from nonimmigrant families whose mothers have either screened negative or have few risk factors for the disease.
But experts say the proposed alternative of universal prenatal testing and aggressive risk assessment is unrealistic in the current American healthcare system. Today, less than 85% of mothers are screened — a number experts say will fall sharply if health subsidies disappear and Medicaid enrollment is cut in coming months.
“Our previous risk-based vaccination strategy failed,” said Katrin Werner Perez of the Alliance for Aging Research. “Prior to the 1991 change to universal vaccination, nearly 20,000 babies and children were infected annually in the U.S.”
For babies exposed to the blood-borne virus in utero or during delivery, every minute the shot is delayed heightens the risk of transmission. That reality prompted American public health officials to bump the first dose from early childhood, when it was given in the 1980s, to the first 24 hours of life, a recommendation the CDC has maintained since 1991.
“[The vaccine] saved thousands, if not millions of lives just in the U.S.,” Cohen said. “There’s more safety and efficacy data on the hepatitis B vaccine than just about anything else we put into our bodies.”
Those who catch hepatitis as infants are far more likely than those who get it as adults to develop chronic and ultimately fatal infections, data show.
Because the virus can live on surfaces for up to a week, doctors and public health experts stress that babies can contract it even from seemingly trivial exposures. Caregivers might not know they have the disease, and are unlikely to be tested, making the birth dose more urgent, they said.
“Mom is not the only person around the baby,” said Wang, who told the panel on Thursday she likely acquired the disease from her grandparents. “There’s grandparents, caregivers, other young children. You’re basically leaving that baby vulnerable.”
Even a small cut from shared nail clippers risks infection, data show.
Kennedy and his allies on the panel counter that the vaccine is unnecessary for most infants, and that delaying it would offer parents the opportunity to participate in “shared clinical decision-making” about whether and when to vaccinate.
Still, the panel has so far struggled to coalesce around an alternative recommendation. A planned vote Thursday was tabled in part because proposed language remained in flux even as the meeting was underway.
“This is the third version of the questions that most of the ACIP have received in 72 hours,” Hibbeln said.
Hibbeln and Meissner were vocal opponents of a change to the birth-dose recommendation when it was first debated in September.
“We will be creating new doubts in the mind of the public that are not justified,” Meissner said.
Others said the move would not go far enough.
“I don’t see even where is the argument to vaccinate younger children at all that live in a normal environment,” panelist Dr. Retsef Levi said in September.
In addition to limiting public coverage for the vaccine, a change to the recommendation could also force privately insured parents to navigate layers of complex authorizations in order to access a birth dose, experts warned.
Many feared the decision could further stigmatize the shot in a moment when many parents are refusing it simply because the recommendation is under review.
“States and hospitals are reporting declines in hepatitis B vaccination,” said Kayla Inthabandith of the Center for Advancing Health Equity in Rural and Underserved Communities. “Even some mothers living with hepatitis B are refusing the birth dose, putting their own infants at the highest risk of infection.”
Moving the recommendation from the first day of life to the second month could lead to 1,400 new infections a year, experts warned.
“Any child who gets a hepatitis B infection because we change policy is one too many,” said Dr. Judith Shlay. “I want us to make sure we never have any child get hepatitis B infection.”
