The panel voted, in a 8-3 decision, to recommend individual decision-making in consultation with a health care provider to determine when or if to give the hepatitis B birth dose to a child whose mother tested negative for the virus.
Many medical experts and organizations including the American Academy of Pediatrics opposed such a change, saying it will leave young children at risk of an infection that can cause lifelong illness. They point to decades of research confirming the vaccine’s safety and effectiveness.
The decision came on the second day of the Advisory Committee on Immunization Practices’ December meeting, after confusion on Thursday led to the vote being delayed.
The panel — whose members were all appointed by Health and Human Services Secretary Robert F. Kennedy Jr. — began the day with a reading of the proposed voting language, followed by discussion from the panel members and other experts. Restef Levi, an ACIP member and mathematician who has no medical training, strongly argued against the universal birth dose, falsely claiming that experts had “never tested (the vaccines) appropriately.” Levi said he believed the committee should not recommend any timeline for the vaccine.
Dr. Cody Meissner, a pediatrics professor who previously served as a member of the Food and Drug Administration’s vaccines panel and an ACIP board member, and committee member Dr. Joseph Hibbeln continued to criticize the efforts to change the recommendations. Hibbeln said this was the fourth version of the language presented in 96 hours, and that “no rational science has been presented” to support changing the recommendations. Meisner emphasized that leaving the recommendation as-is would still allow parents to make their own choices about the vaccines their child receives.
“We’ve heard ‘do no harm’ as a moral imperative. We are doing harm by changing this wording,” Meissner said as he voted to oppose the change.
Hepatitis B is an incurable viral infection that can lead to liver disease, cancer and early death. The hepatitis B vaccine has been universally recommended for newborns in the U.S. since 1991. Over that time, research shows hepatitis B infections among infants and children have dropped 99%.
Recommendations from the advisory committee, known as ACIP, go to the CDC director for approval. Ultimately, decisions are left to the states, which tend to base their policies off the CDC’s guidelines but can choose to set their own. ACIP’s recommendations also carry weight with insurance companies: Most private insurers are required to cover the recommended vaccines. If the recommendation changes, what’s covered by insurance may also change.
The birth dose of hepatitis B vaccine has become a target of vaccine critics, including Kennedy, who falsely claimed on a podcast in June that it was a “likely culprit” in autism.
The birth dose of the vaccine has a long track record, and multiple studies show the shot is not associated with any increased risk of infant death, fever or sepsis, multiple sclerosis or autoimmune conditions. Severe reactions to the vaccine are rare. Research also shows there is no evidence of any safety benefit in waiting until a child is older.
The panel also voted Friday in a 6-4 decision, with one abstention, to recommend parents consult with their doctors about whether to have their children tested to see if the first vaccine dose gave them a certain level of protection against hepatitis B. Typically, the vaccine is given as part of a three-dose series. Some panelists criticized the lack of data showing one dose was as effective as three doses and called the language of the recommendation confusing.
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