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The vaccine panel chosen by Health and Human Services Secretary Robert Kennedy Jr. on Friday voted to scrap the long-standing global recommendation that all babies get the hepatitis B vaccine at birth, issuing weaker guidance for some infants.
The group, called the Advisory Committee on Immunization Practices, or ACIP, recommended that parents use individual decision-making in consultation with a health care provider to decide when or whether to give a birth dose of hepatitis B to a baby whose mother is negative for the virus. For babies who do not receive the birth dose, the committee recommended waiting to receive their first vaccine until they are at least 2 months old.
The acting director of the Centers for Disease Control and Prevention must still sign off on this new recommendation. The CDC currently recommends that every baby be vaccinated against hepatitis B within 24 hours of birth, regardless of their mother’s test status.
The move overturns the guidance, which has been credited with cutting infection rates in children by 99% since it was first introduced three decades ago and is widely considered a public health success story. Some committee members and public health experts warn that this change could have wide-ranging consequences, such as increased infections among children.
The vote affects only the timing of the first dose of the hepatitis B vaccine series. The second dose is given one or two months after birth, with a third dose between the ages of 6 and 18 months.
All pregnant women are supposed to be tested for hepatitis B during pregnancy. During previous meetings, some counselors questioned whether children should get a shot if their mothers test negative.
But test results can produce false negatives, some people become infected later in pregnancy after having the test, and children can become infected from other members of their family.
The closely watched two-day committee meeting in Atlanta comes after Kennedy dismissed the committee and appointed 12 new members, including some well-known vaccine critics. ACIP makes recommendations about who should receive certain shots and which vaccines should be covered by vaccine insurance companies at no cost.
Eight members voted yes, while three voted no. Some advisers strongly pushed back on the new guidance before the vote.
“This has great potential to cause harm, and I hope the committee will accept responsibility when that harm occurs,” said Dr. Joseph Hiblin, a psychiatrist and voting member.
Dr. Cody Misner, a voting member and professor of pediatrics at Dartmouth Geisel School of Medicine, said he hopes pediatricians will continue to administer the birth dose within the first 24 hours of birth and before discharge.
“Taking any other course is not in the best interest of the infants,” he said.
Meissner added that more children will and will become infected with hepatitis B. Hepatitis B, which can be passed from mother to child during birth, can lead to liver disease and premature death. Infants are more susceptible to chronic hepatitis C, for which there is no cure.
“We will see a resurgence of hepatitis B,” he said. “The vaccine is very effective. It does not make sense, in my opinion, to change the immunization schedule.”
The American Medical Association said in a statement on Friday that the vote “is reckless and undermines decades of public confidence in a vaccine proven to be effective in saving lives.” The group added that the decision was not based on scientific evidence and “creates confusion among parents about how best to protect their newborn children.”
Meanwhile, Ritzev Levy, a voting member and professor at MIT, falsely claimed during the meetings that experts had “never adequately tested” the hepatitis B vaccine.
Some panelists raised concerns about vaccination during the so-called neonatal period, a crucial window for brain and immune system development. But decades of evidence show that the hepatitis B vaccine has been safely given to newborns.
Other advisers said there was no evidence to support delaying the birth dose by two months.
“We have to make decisions with the data we have, and we only have to use reliable data to make decisions, not speculation and not hypotheses,” Hiblin said.
A 2024 study by the Centers for Disease Control and Prevention showed that the current vaccination schedule helped prevent more than 6 million hepatitis B infections and nearly 1 million hospitalizations due to hepatitis B.
Merck and GSK make hepatitis B vaccines used from birth. None of the doses represent a significant driver of revenue for the companies, so the new recommendations should not have a material impact on their business.
However, Merck said in a statement on Friday that it was “deeply concerned” by the vote, which it said risks “reversing this progress and putting infants at unnecessary risk of chronic infections, liver cancer and even death.” The company added that “there is no evidence that delay provides any benefit to children.”
“We await additional information and formal adoption of today’s recommendations by the Centers for Disease Control and Prevention to fully understand the potential impact,” GlaxoSmithKline said in a statement.
The committee’s vote will not affect insurance coverage of the shots, including Medicaid and the Children’s Health Insurance Program, Andrew Johnson, principal policy analyst for the Centers for Medicare and Medicaid, told members during the meeting.
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