The Centers for Disease Control and Prevention (CDC) made a major change to the childhood immunization schedule this week, ending a decades-old policy that supports giving all newborns a hepatitis B virus vaccine within 24 hours of birth.
Prominent healthcare organizations immediately denounced the CDC's policy change, saying the decision ignores key scientific evidence around the shots.
With the decision, announced Tuesday, the CDC adopted its vaccine advisory committee’s recommendation supporting an individual-based decision-making framework.
Dec. 5, the newly reworked Advisory Committee on Immunization Practices (ACIP) voted to upend the CDC's longstanding recommendation that a dose of the universal hepatitis B virus vaccine be given to newborns. The new recommendation from the ACIP calls for “individual-based decision making” for parents deciding “when or if” to give the HBV vaccine to children born to women who test negative for the virus. The panel voted 8 to 2 in favor of the new language.
The CDC had recommended the birth dose of the hepatitis B vaccine since 1991. Since that initial recommendation 34 years ago, the CDC has reported hepatitis B infections among adolescents have dropped by 99%.
Individual-based decision-making, referred to on the CDC immunization schedule as shared clinical decision-making, means that parents and healthcare providers should consider vaccine benefits, vaccine risks and infection risks, and that parents consult with their healthcare provider and decide when or whether their child will begin the hepatitis B vaccine series, CDC officials said in a press release.
Parents and healthcare providers should consider whether there are infection risks such as a household member who has hepatitis B or frequent contact with persons who have emigrated from areas where hepatitis B is common.
"This recommendation reflects ACIP’s rigorous review of the available evidence,” Jim O'Neill, acting director of the CDC and deputy secretary of health and human services, said in a statement. “We are restoring the balance of informed consent to parents whose newborns face little risk of contracting hepatitis B.”
Earlier this year, Department of Health and Human Services Secretary Robert F. Kennedy Jr. overhauled the existing ACIP roster and repopulated it with his own appointments, a move that was widely panned by experts.
Susan Kressly, president of the American Academy of Pediatrics (AAP), said the CDC's decision to no longer recommend the universal birth dose of the hepatitis B vaccine would lead to more hepatitis B infections in infants and children.
“Since the ACIP voted to downgrade the recommendation for a birth dose of hepatitis B vaccine, pediatricians are already reporting more parents declining to give their child this critical dose,” Kressly said in a statement after the CDC announced Tuesday it would adopt guidance from the ACIP. “As a pediatrician, this is heartbreaking when we have a vaccine that can prevent so many infections, and it is deeply disappointing to see the continued dismissal of expertise to inform recommendations that have broad implications on the health of America's children."
The AAP continues to recommend giving newborns a dose of hepatitis B vaccine within 24 hours of birth, with additional doses at 1-2 months and 6-18 months.
“Decades of scientific evidence shows that the birth dose of the hepatitis B vaccine is essential to protecting all newborns from a serious, chronic infection that can lead to liver disease, cirrhosis, liver cancer, and even death," Sandra Adamson Fryhofer, M.D., trustee of the American Medical Association, said in a statement.
"Rolling back this recommendation creates confusion and doubt about vaccines, reverses hard-won progress in preventing hepatitis B, and will undoubtedly result in completely preventable illness and death. Physicians continue to recommend the birth dose of the hepatitis B vaccine for all newborns, and we encourage parents with questions about vaccines to talk to their physician," Fryhofer said.
Following the ACIP recommendation announced Dec. 5, major health insurers committed to maintaining coverage for the hepatitis B vaccines for newborns.
Health insurance trade organization AHIP confirmed that health plans will “continue to cover all ACIP-recommended immunizations that were recommended as of Sept. 1, 2025,” a spokesperson told Fierce Healthcare over email earlier this month.
“While health plans continue to operate in an environment shaped by federal and state laws, as well as program and customer requirements, the evidence-based approach to coverage of immunizations will remain consistent," an AHIP spokesperson said.
A spokesperson for the Blue Cross and Blue Shield Association also said via email that BCBS companies are committed to ensuring access to vaccines that protect individuals and communities from serious illness.
"The decision to receive a vaccine is made between patients and their health care providers and we remain committed to maintaining rigorous, evidence-based processes to evaluate coverage policies. BCBS companies will continue covering all immunizations that were recommended by the Advisory Committee on Immunization Practices (ACIP) on Jan. 1, 2025, with no cost-sharing through 2026, while operating within federal and state laws and meeting program and customer requirements," the spokesperson said.
The hepatitis B vaccine will continue to be covered by Medicaid, Medicare, the Vaccines for Children Program, the Children’s Health Insurance Program and insurance plans available from the federal health insurance marketplace, the AAP said.