The Trump administration’s decision to drop the long-standing recommendation that newborns receive a hepatitis B vaccine within 24 hours of birth will likely lead to hundreds of additional infections among children, along with more cases of liver cancer, deaths and millions in added health care costs, according to studies published Monday in JAMA Pediatrics.
Federal vaccine advisers to Health Secretary Robert F. Kennedy Jr. voted in December to replace the universal birth dose with a recommendation to delay the first shot until at least two months of age for infants born to mothers who test negative for the virus — a change later approved by the then–acting director of the Centers for Disease Control and Prevention.
Pediatricians and dozens of medical groups strongly opposed the move, saying it was not based on evidence, and warned it could harm children and their families. Although medications can control hepatitis B, there is no cure for chronic infection.
The JAMA studies are the first to model the policy’s potential impact. One estimated that delaying the first hepatitis B vaccine dose by two months for babies born in a single year to mothers who tested negative — about 80 percent of the 3.6 million U.S. births annually — would increase lifetime health-care costs by at least $16 million.
“These 2 studies were exceptionally well done and rigorous in their approach, assumptions, calculations, and conclusions,” wrote Arthur Reingold, emeritus professor of epidemiology at the University of California at Berkeley’s School of Public Health, in an email.
Reingold and other public health experts said the federal vaccine advisory committee should have considered this type of evidence before making its decision in December.
Instead, the panel departed from well-established standards, according to an accompanying editorial in JAMA Pediatrics. The committee failed to weigh key evidence, focusing on “theoretical risks of vaccines” while omitting data on the benefits of preventing chronic disease and death, the editorial said.
Eric Hall, an assistant professor of epidemiology at Oregon Health and Science University and a co-author of the cost study, said researchers shared a preliminary version of their findings in public comments ahead of the December meeting so committee members could review the data.
“We noticed that the committee did not have the evidence they needed to inform their decision,” Hall said. “But this group kind of blew past all that and didn’t make any effort to fill the evidence gaps that they might have had. They just went ahead anyway.”
The Department of Health and Human Services did not respond to a request for comment.
Hepatitis B is a virus that can cause lifelong infection, liver disease and cancer. Infants are at especially high risk: About 90 percent of babieswho become infected develop chronic disease, compared with about 5 percent of adults, according to the CDC.
Childbirth is a major risk factor for transmission because the virus is present in vaginal fluid and blood. Hepatitis B can also spread through tiny amounts of virus on toothbrushes or nail clippers, or contact with caregivers or household members. Screening practices are imperfect in the United States, and many people with chronic infections do not know it.
Since 1991, U.S. health officials have recommended that all infants receive the first dose of hepatitis B vaccine within 24 hours of birth, a strategy that public health experts have credited with close to a 99 percent declinein infections among children.
Members of the Advisory Committee on Immunization Practices appointed by Kennedy argued the universal recommendation was unnecessary for low-risk infants and that the risk of infection in the first months of life had been overstated.
The December vote came after Kennedy fired all 17 members of the advisory panel and installed new members, several of whom have been critical of vaccines. The decision to scale back the hepatitis B recommendation drew sharp criticism from nearly 70 medical and public health organizations, which said there was little evidence to justify abandoning a simple, highly effective intervention.
Instead of recommending that all babies receive a shot within 24 hours of birth, the committee’s guidance fell into two categories. For babies born to mothers who tested positive for the virus or who had not been tested, the recommendation stayed the same: those babies should continue to receive a dose at birth. But the panel encouraged parents of babies whose mothers tested negative for the virus defer the dose until two months of age, in consultation with a health care provider.
Pediatricians and infectious-disease experts say the policy ignores the logistical and real-world challenges that led the United States to adopt universal newborn vaccination in 1991 — longstanding gaps in prenatal screening and vaccination coverage.
The federal guidance is now out of step with major medical societies, which continue to recommend the universal birth dose.
Adding to the confusion, a federal judge has since put the vaccine advisory panel’s recommendations on a temporary hold. The judge said Kennedy had improperly replaced the entire panel, citing a lack of relevant expertise among members. That ruling means the CDC’s previous vaccine guidance — including the universal hepatitis B birth dose — remains in effect for now.
Public health and medical experts say the universal birth-dose policy acts as a safety net: Nearly 15 percent of pregnant women miss recommended hepatitis B screening, and more than half who test positive do not receive appropriate follow-up care—gaps that could leave newborn infections undetected.
Delaying the initial dose also decreases the likelihood that a child will complete the three-shot series needed for full protection, hepatitis experts have said.
Even under a universal birth-dose policy, babies can slip through the cracks, said Rachel Epstein, a pediatric and adult infectious diseases clinician at Boston Medical Center and an assistant professor of medicine and pediatrics at Boston University.
She and co-authors of a second study estimate that about 1,300 infants would still become infected with the virus each year under the policy that recommends the shot within 24 hours of birth. Their modeling also found infections would increase, with the size of the increase depending on how consistently pregnant women are screened and how widely the vaccine is given after birth.
Under the policy before Trump’s second term, nearly all babies received the shot at birth. But now, only babies of mothers who test positive or whose infection status is unknown are supposed to get a birth dose. “The question is, what percent will actually get vaccinated,” Epstein said.
The researchers modeled what would happen if only 10 percent of babies born to unscreened mothers received a birth dose. In that scenario, they estimated an additional 628 babies would get infected.
“One of the most concerning implications is how many more infected hep b babies will we see,” Epstein said. “A universal birth dose helps prevent a substantial number of infections in babies of a lifelong condition that we do not have a cure for.”
For clinicians, the shifting recommendations are adding to confusion for patients.
Brenna Hughes, 53, an ob-gyn in Durham, North Carolina, who has been delivering babies for decades, said she is noticing a slight uptick in people questioning “any interventions at birth.”
Some patients have seen news about the hepatitis B shot and “they don’t quite remember what it is.” As a result, they ask that nothing be given to their baby at the time of delivery, said Hughes, a member of the immunization committee for the American College of Obstetricians and Gynecologists.
Hughes says she reassures them that decades of evidence show clear benefits from the vaccine.
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