The Advisory Committee on Immunization Practices ("ACIP") of the Centers for Disease Control and Prevention ("CDC") met on December 4 and 5, 2025 to discuss and vote on recommendations regarding the Hepatitis B vaccine. In particular, ACIP assessed the use of a universal birth dose of Hepatitis B vaccine in children whose mothers are HBsAg-negative. For the past 30 years, the CDC has recommended all infants receive a dose of the hepatitis B vaccine within 24 hours of birth, regardless of the mother’s virus status.
On December 5, 2025, ACIP voted to recommend individual-based decision-making for parents, in consultation with a healthcare provider, to determine whether to give the hepatitis B birth dose to a child whose mother tested negative for the virus. If the birth dose is not given, ACIP recommends delaying the hepatitis B vaccine until a child is at least two months old for children born to mothers who test negative for the virus. ACIP also voted to recommend that when evaluating the need for a subsequent hepatitis B vaccine dose in children, parents should consult with health care providers to decide whether to test antibody levels for hepatitis surface antigen to evaluate the adequacy of protection through serology results.
This change in the recommendation is important because the Affordable Care Act requires plans and issuers to cover without cost-sharing immunizations for routine use in children, adolescents, and adults that have, in effect, a recommendation from ACIP. A recommendation from ACIP is considered in effect after it has been adopted by the Director of the CDC, and a recommendation is considered to be for routine use if it is listed on the Immunization Schedules of the CDC.
Now that ACIP has voted to modify the recommendations for the Hepatitis B vaccine at birth, the CDC Director will consider adopting the new recommendations and updating its child immunization schedule. However, even if the recommendations are adopted by the CDC, there will not be a change to what plans and issuers are required to cover without cost sharing for the hepatitis B birth dose to a child whose mother tested negative for the virus because of individual decision-making. If adopted by the CDC Director, the tests to measure antibody levels would also likely need to be covered without cost sharing.
We are monitoring developments related to ACIP recommendations and CDC’s immunization schedules. Please reach out to your Groom attorney if you have any questions.
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