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WASHINGTON — The Trump administration on Tuesday adopted its vaccine advisory committee’s recommendation to end the decades-old policy that every newborn be offered a hepatitis B shot, despite an outcry from health experts that the decision ignored key evidence around the shots.
Instead, parents should discuss with their doctors whether to vaccinate infants at birth against hepatitis B, the Centers for Disease Control and Prevention said. The change applies to babies born to mothers who test negative for hepatitis B.
Some doctors and hospital systems have shrugged off the new guidance from the CDC’s Advisory Committee on Immunization Practices, casting it aside for lacking evidence or saying it needs further scrutiny before being implemented in their practices. STAT spoke with seven doctors and four health systems across the country to understand how they’re incorporating it into their work. The divergence highlights how U.S. vaccine policy is becoming increasingly balkanized under the Trump administration.
“The practice should not be changing as we continue to follow evidence-based recommendations that have been around for decades,” said Vandana Madhavan, the clinical director of pediatric infectious disease at Massachusetts General Hospital. “This is uncharted waters, where the ACIP is making a recommendation that is not backed by the enormous body of evidence that the recommendations have had in the past.”
Some health systems and doctors have decided to continue following the decades-old guidance from the American Academy of Pediatrics, which advocates giving the hepatitis B shot at birth, or from their state health department, instead of the new federal guidance. In all cases, parents should still be able to choose whether or not to have their baby vaccinated for hepatitis B at birth and have the shot covered by insurance.
Separately, the CDC said it is still considering another recommendation from ACIP, that parents consider using a serology test after the first dose of hepatitis B vaccine to determine whether further shots in the series are needed. There is no evidence that antibody levels after the first dose indicate that babies will achieve long-term protection, and the question of serology testing is outside of ACIP’s purview.
The CDC did not change its policy for babies born to mothers who test positive for hepatitis B or whose status is unknown. They should receive a vaccine within 12 hours of birth as well as a dose of hepatitis B immune globulin.
Jim O’Neill, the CDC’s acting director, said the agency’s move to adopt the recommendation “reflects ACIP’s rigorous review of the available evidence.”
““We are restoring the balance of informed consent to parents whose newborns face little risk of contracting hepatitis B,” he continued.
Madhavan said she worries the new CDC recommendation will inject confusion into conversations with parents, but she said she plans to approach the conversations as she always has: sharing the best information about the safety and efficacy of the shots as parents make their decision.
Kaiser Permanente, a system that serves more than 12 million patients, posted a statement to its website on December 5 pledging to continue offering the shot to newborns. Children’s National in Washington, D.C., will likewise continue offering the shot per the AAP’s guidance, a spokesperson told STAT in an email. Colorado’s Denver Health said in a statement it would continue recommending the shot at birth.
Health care providers’ resistance to the government’s new recommendations raises a fresh challenge to officials looking to change vaccination practices nationwide.
It also highlights the hurdles administration leaders face in their efforts to restore trust in federal health agencies — even as doctors and hospital leaders reject the administration’s approach.
Some state health departments — including in Colorado, Illinois, New Jersey, and Washington — reaffirmed their support for the birth dose of the vaccine, as did two regional public health groups: the Northeast Public Health Collaborative and West Coast Health Alliance.
Several public health experts and pediatricians told STAT they didn’t expect the federal recommendations to convince doctors or hospital leaders to change their practices — though they did raise concerns about the guidance confusing patients and eroding trust in effective, safe interventions.
But some of the administration’s hand-picked vaccine advisers took issue with the health systems’ responses.
Robert Malone, ACIP’s vice chair, wrote on December 7 that the self-interests of the “academic-industrial-government vaccine complex” were the cause of the resistance to the vaccine birth dose, not the evidence being provided across public health groups.
Retsef Levi, an ACIP member who was supportive of the changes, said in an email that provider groups doubling down on “extreme vaccination policies” do so at their own peril.
“This approach is the primary reason why most Americans lost trust in these institutions,” he wrote. “Now, we are restoring that trust through evidence-based science.”
Still, Levi said that the government should not force changes in practice.
“I believe that the recent ACIP recommendations including the ones re Hep B bring back informed choice by patients, common sense based on scientific evidence and better alignment with policies in other developed countries,” Levi said in an email. “This approach is the only way to regain the public trust.”
As the committee begins its work to reexamine the childhood vaccine schedule as a whole, the early responses from providers on the hepatitis B vote suggests the panel’s advice may not have the sweeping effects on medical practices that some allies of health secretary Robert F. Kennedy Jr. had hoped.
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