Health and Human Services Secretary Robert F. Kennedy Jr.’s Select Vaccine Committee is scheduled to vote Thursday on whether to change the long-standing recommendation that all infants receive the hepatitis B vaccine within 24 hours of birth.
It is unclear whether the committee, known as the Advisory Committee on Immunization Practices (ACIP), could significantly slow or eliminate so-called birth-dose vaccinations for infants whose mothers have tested negative for the virus. The group voted on vaccines in September after some members called for a more robust discussion first.
But any change could have far-reaching implications, and some public health experts say there is a risk of more chronic infections in children if fewer newborns are vaccinated against the virus.
Hepatitis B can be passed from mother to baby during birth and can lead to liver disease and early death. There is no cure.
“We have vaccines that are very effective in preventing rare diseases, and we should make the most of them,” Neil Mania, a professor of public health at Northeastern University, told CNBC.
Birth dose recommendations were introduced in 1991 and are credited with reducing infections in children by 99% since then. Mr Mania said this was a “remarkable success story, but there is a risk that it could be reversed if the committee changes its recommendations”.
The commission’s decision is not legally binding, as it is up to states to make vaccinations mandatory. However, ACIP’s recommendations have a significant impact on whether private insurance plans and government assistance programs will cover vaccines at no cost to eligible children.
The commission’s two-day meeting scheduled for Atlanta comes after President Kennedy disbanded the commission earlier this year and appointed 12 new members, including prominent vaccine critics. At the September meeting, some advisers questioned whether the shot’s benefits outweighed the potential safety risks.
But the jab is “an incredibly safe vaccine with minimal risk,” Dr Sean O’Leary, chair of the American Academy of Pediatrics’ infectious diseases committee, said at a press conference on Tuesday.
“I’ve actually never seen fever associated with the hepatitis B vaccine,” said O’Leary, who worked as a general pediatrician for eight years and worked in a neonatal unit.
He added that the AAP, which publishes its own vaccine schedule, still recommends hepatitis B vaccine given at all births because it “saves lives.”
A new review published Tuesday of more than 400 studies over 40 years also found no evidence that delaying the birth dose of hepatitis B vaccine improves safety or effectiveness. The review also found that the birth dose did not cause short- or long-term serious adverse events or death.
A 2024 CDC study showed that current vaccination schedules helped prevent more than 6 million hepatitis B infections and nearly 1 million hepatitis B-related hospitalizations.
Merck and GSK produce the hepatitis B vaccine, which is used from birth. Neither shot is a significant revenue driver for the company.
But John Grabenstein, a former Merck & Co. vaccine executive and military pharmacist, said the change in recommendations could disrupt vaccine supplies to companies.
“They’re building up reserves and doing careful calculations to maintain the status quo,” Gravenstein, who has no remaining financial ties to Merck, told CNBC. “Disrupting the status quo without warning can easily lead to spot shortages, with too much of one thing and not enough of another.”
Still, he said the primary concern from a public health perspective is that fewer children will be vaccinated on time, making them more susceptible to infection.
Merck & Co. also advocated changes to the recommendations at the committee’s September meeting.
“Reconsidering the established schedule for neonatal hepatitis B vaccination poses a significant risk to the health of children and the public and could lead to a resurgence of preventable infections,” Dr. Richard Haupt, head of global medicine and science for vaccines and infectious diseases at Merck & Co., said at the time.
