An influential panel of US vaccine advisers voted to revoke a longstanding recommendation that all babies receive hepatitis B shots within 24 hours of birth, a move expected to reverse the country’s progress toward eliminating the disease.
The decision is the most consequential action taken by the Advisory Committee on Immunization Practices since the group was
The vote allows parents to delay the shot for at least two months, or skip it altogether, if the mother tests negative for the virus. The panel also said parents and health-care providers can use blood tests to guide whether future shots are needed, though there is no evidence showing they prove immunity. It confirmed the changes would apply to the Vaccines for Children federal program, which offers free immunization to the poor and uninsured.
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A spokesperson for Merck said the company was deeply concerned by the committee’s vote, which “disregards decades of safety and effectiveness data that unequivocally support the hepatitis B birth dose.” The change risks putting infants at unnecessary risk of chronic infection, liver cancer and even death, they said.
“We await additional information and an official adoption of today’s recommendations by CDC to fully understand the potential impact,” a GSK spokesperson said in a statement.
Three Doses
Children need three doses of the hepatitis B vaccine, usually given throughout the first 18 months of life, to be considered fully vaccinated.
Friday’s 8-to-3 vote in favor of the change prompted strong objections from some panel members.
“We have heard ‘do no harm’ is a moral imperative,” said Cody Meissner, a professor of pediatrics at Dartmouth Geisel School of Medicine and the former chief of pediatric infectious diseases at Tufts Medical Center. “We are doing harm by changing this wording,” he said, pointing out that infection rates will rise as a result of the decision.
“This has a great potential to cause harm and I simply hope that the committee will accept its responsibility when this harm is caused,” said Joseph Hibbeln, a psychiatrist and neuroscientist who worked at National Institutes of Health.
ACIP members were split over the implications of the vote. Some said it would have no impact, as doctors and parents can still use the vaccinations however they want, and they will continue to be fully covered by health insurance programs at no additional cost. Others said the change signals that something was wrong with the original, universal recommendation, and should lead to a rethinking of how the shots are used.
“We’ve given doctors and patients the freedom, and we’ve made sure it was paid for,” said Kirk Milhoan, a pediatric cardiologist and the panel chair. “I have the freedom in this vote to either do it at birth or do it whenever I’d like with shared decision making,” he said.
But Retsef Levi, an operations professor at the Massachusetts Institute of Technology, said the shift suggests the old recommendation to vaccinate all newborns was not appropriate. “Parents should carefully think about whether they want to take the risk of giving another vaccine to their child,” he said.
‘Reckless’
The American Medical Association called the committee’s decision “reckless” and said it “undermines decades of public confidence in a proven, lifesaving vaccine.”
“We urge the CDC to reject this recommendation and uphold its commitment to science and public health,” AMA trustee Sandra Adamson Fryhofer said in a statement. “The consequences of failing to do so are too severe and the potential harm too great.”
ACIP is highly influential because its recommendations help determine which shots insurers are required to cover.
Trump and Kennedy, a vocal vaccine critic, have questioned medical consensus on whether babies should get hepatitis B shots, raising unrelated concerns that the virus can be contracted sexually. Infected newborns typically get it from their mothers during birth. Kennedy has also promoted
The panel’s Thursday session included presentations from speakers who hold views far out of sync with mainstream scientists and who sought to cast doubt on the safety of vaccines and their role in preventing disease.
Heated Exchanges
Some of the ACIP members appeared disturbed by the statements and exchanges at times grew testy.
Public health experts have criticized the arguments Kennedy has deployed against hepatitis B vaccines. Hepatitis B is a dangerous viral infection of the liver. A preliminary paper showed that delaying the shot by two months would potentially result in more than 1,400 more new hepatitis B cases, 304 new instances of liver cancer and more than $222 million in additional health-care costs in the first year. The study, led by Oregon Health & Science University, hasn’t yet been formally published.
Several representatives from major medical groups also used a comment period to excoriate the panel. “This committee shows no understanding of the gravity of the moment of the recommendations that you make,” said Jason Goldman, president of the American College of Physicians.
Robert Malone, an ACIP member, announced Thursday that the panel would be adding a new so-called work group that would analyze vaccinations in pregnancy.
Revamped Panel
In June, Kennedy fired every member of ACIP and many of the replacements hold views similar to his. In a last-minute change this week, HHS
The outside experts that were given presentation slots were also aligned with the anti-vaccine movement. Some were associated with the Children’s Health Defense, the anti-vaccine organization Kennedy once chaired.
The decision to delay the shots means many newborns could still contract an infection and have to live with chronic hepatitis B later in life. Additionally, blood tests aren’t currently used to determine if a child needs to complete their three-shot hepatitis B course because they don’t show that someone is fully protected against illness.
Adam Langer, the CDC’s acting principal deputy director at the center for HIV, viral hepatitis, STD and TB prevention, said “we have no data at all” to show whether blood tests determine if someone should complete a vaccine series. Suggesting someone needs an extra test also opens the door for people to skip out on later doses needed to become fully immunized.
ACIP was originally scheduled to vote on hepatitis B shots in September, but delayed the move after a two-day meeting marked by technical glitches and confusion. During that session, ACIP declined to back a combined shot for measles, mumps, rubella and chickenpox that some families prefer.
It also voted to require people consult a health-care provider before receiving a Covid shot, a decision that left many people
(Updates with Trump comment, in fourth paragraph.)
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