ATLANTA — Federal vaccine advisers selected by Health Secretary Robert F. Kennedy Jr. are poised to vote Thursday on lifting a long-standing recommendation for all newborns to get the hepatitis B vaccine in what would be the most sweeping revision to the childhood vaccine schedule under Kennedy.
The panel is weighing a recommendation widely decried by medical and public health experts to give the vaccine at birth only for infants born to infected mothers and delay that first dose for others. While babies born to uninfected mothers are unlikely to contract hepatitis B, medical associations urge retaining the universal recommendation to ensure none lack protection from a highly infectious virus that can cause serious lifelong liver disease, cancer and death. Some babies have fallen through the cracks because their mothers were not tested, received false negatives or became infected after testing.
The Advisory Committee on Immunization Practices, a group of advisers outside government, recommend the immunization guidance for the director of the Centers for Disease Control and Prevention to provide Americans. But its decision on hepatitis B may have limited practical consequences for parents who want to vaccinate their newborns.
Doctors and hospitals can still offer the shots. Major private insurers have pledged to continue coverage for vaccines previously recommended by the panel through the end of 2026.
Critics say the bigger effect will be stoking parents’ fears about shots shown over decades to be safe and effective as Kennedy launches the Department of Health and Human Services into a wide-scale reconsideration of the early childhood vaccinations.
“The most dangerous part of this whole conversation is sowing doubt in the minds of parents,” said Michael Ninburg, former president of the World Hepatitis Alliance.
The vaccine panel first considered ending the hepatitis B birth dose recommendation during its September meeting, but delayed a vote after disagreement and requests for more data.
Robert Malone, a vaccine critic on the committee, said at the meeting that delaying the birth dose is justified to improve trust in public health, not because of new safety concerns. He said some parents were uncomfortable “with this medical procedure being performed at birth in a rather unilateral fashion without significant informed consent.”
Proponents for the change also said they wanted more data on risks and benefits, and that the dose is not needed as long as mothers are screened appropriately.
Regardless of how the panel votes, the American Academy of Pediatrics says it will continue promoting CDC guidance in place since 1991 for babies to get the first dose at birth, the second at one or two months, and the third between six and 15 months. Public health experts and researchers have credited the universal recommendation for dramatic declines in infections among children, teens and young adults.
The case for and against vaccination at birth
Some of the 11 ACIP members — who include vaccine skeptics selected by Kennedy after he purged the panel in June — have suggested that hepatitis B vaccine guidance should be based on risk, as some Western European countries do.
That’s a common refrain among some Kennedy supporters who say vaccinating babies born to hepatitis B-negative mothers in their first hours of life is unnecessary. Critics of broad vaccination recommendations argue they overlook individual risk factors — especially in the case of hepatitis B, which primarily spreads among adults through bodily fluids, such as during sex or sharing needles. But the virus can also spread through contact with caregivers or household members, even with microscopic amounts of blood.
Medical experts say the hepatitis B vaccine is so safe — and the consequences of getting the virus are so severe — that narrowing the recommendation would only result in missed shots for some infected babies. Ninety percent of newborns born to mothers with hepatitis B develop chronic infections, one-fourth of whom will die of chronic liver disease, according to the CDC.
Safety data presented at the September meeting showed administering the vaccine at birth did not increase risk for allergic reaction, deaths, seizures or neurological diseases.
“I have never seen a serious reaction to the hep B vaccine,” said Sean O’Leary, a pediatric infectious diseases specialist and chairman of AAP’s Committee on Infectious Diseases. “It is a very safe vaccine with very minimal risks.”
An agenda for the hepatitis B meeting posted late Wednesday night listed people connected to the anti-vaccine movement presenting to the vaccine advisers. Mark Blaxill, an anti-vaccine activist who was hired as a senior CDC adviser in the fall, is scheduled to give a presentation on hepatitis B vaccine safety. Blaxill has written books and articles promoting claims contradicted by medical associations and extensive vaccine safety research that childhood shots cause a broad range of health conditions. Cynthia Nevison, an autism and climate researcher with ties to anti-vaccine groups, is set to give a “burden of disease” presentation.
The panel’s new chairman, Kirk Milhoan, said Monday it’s not clear whether the discussion will focus on delaying the first dose until one month, two months or another interval — but stressed that the panel will discuss risks and benefits of delaying the birth dose.
“What is the risk of getting the disease if you delay the birth dose to where most vaccines start, which is at two months, and what is the potential benefit of delaying it two months?” Milhoan said in an interview.
Milhoan said some evidence suggests that delaying the last shot in the series to age 10, when adolescents are more likely to engage in risk-taking behavior, provides greater protection. President Donald Trump recently called for delaying the hepatitis B until adolescence.
James Campbell, vice chair of the AAP’s infectious diseases committee, said vaccination later in childhood can work. But the major advantage of vaccination during infancy is preventing infection early, when exposure risk might come from birth, caregiver contact or other nonsexual routes, he said.
“Delaying until age 10 leaves a long window of vulnerability,” he said.
Backlash to revising the recommendation
The Vaccine Integrity Project, an initiative at the University of Minnesota, on Tuesday released a review of more than 400 studies and reports which found the birth dose recommendation has cut infections in children by more than 95 percent. It said delaying the first dose would undermine decades of progress toward eliminating viral hepatitis as a public health threat.
“We did not discover safety or effectiveness data that support delaying the choice parents have to vaccinate their newborns against hepatitis B,” Michael Osterholm, the project director and an infectious diseases expert, said in a statement.
About 12 to 16 percent of pregnant women do not receive prenatal screening for hepatitis B, according to the CDC.
The vaccine advisers discussed increasing maternal screening at the September meeting as a way to safely delay an infant’s first hepatitis B vaccine dose. A recent CDC strategic initiative calls for increasing hepatitis B screening in pregnant women, according to a copy obtained by The Post.
Sen. Bill Cassidy (R-Louisiana), a physician who specializes in liver disease who has criticized Kennedy’s approach to vaccination, has warned repeatedly that federal health officials should not change the hepatitis B recommendation. His office didn’t respond to repeated requests for comment on the ACIP meeting.
Sen. John Hickenlooper (D-Colorado) and eight other Senate Democrats introduced a bill ahead of the ACIP meeting that would require the Department of Health and Human Services secretary to publish reasoning for rejecting any ACIP recommendations and would codify the committee’s process for reviewing new vaccines.
“This administration’s senseless attacks on science erodes Americans’ trust in public health and undermines families’ access to safe vaccines,” Hickenlooper said in a statement.
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