The CDC has ended its long-standing universal recommendation for a hepatitis B vaccine dose for all newborns and now advises parents of infants born to hepatitis B–negative mothers to consult their health care provider about administering the birth dose within 24 hours. Infants of mothers who are hepatitis B–positive or whose status is unknown should still receive the vaccine at birth. Experts warn the change could risk reversing substantial public-health gains—after universal birth-dose guidance, pediatric acute hepatitis B cases fell about 99% between 1990 and 2019. The AAP and many pediatricians continue to recommend a birth dose within 24 hours.
CDC Ends Universal Newborn Hepatitis B Recommendation; Advises Parental Consultation
Jim O'Neill at his Senate Health, Education, Labor, and Pensions Committee confirmation hearing to be deputy secretary of health and human services on May 8. (Stefani Reynolds / Bloomberg via Getty Images)
The Centers for Disease Control and Prevention (CDC) has rescinded its long-standing universal recommendation that all newborns receive a hepatitis B vaccine dose within 24 hours of birth. Under the new guidance, infants born to mothers who test negative for hepatitis B should prompt a discussion with their health care provider about whether to receive the birth dose. Newborns whose mothers are hepatitis B–positive or whose maternal infection status is unknown should still receive the vaccine within 24 hours.
What Changed
The CDC’s Advisory Committee on Immunization Practices (ACIP) — which was reconstituted earlier this year by Health Secretary Robert F. Kennedy Jr. — voted this month to alter the agency’s guidance. Acting CDC Director Jim O’Neill accepted the recommendation on Tuesday, making the change official.
“We are restoring the balance of informed consent to parents whose newborns face little risk of contracting hepatitis B,” O’Neill said in a statement announcing the policy change.
Details Of The New Guidance
Under the revised policy, infants who do not receive a birth dose are recommended to receive their first hepatitis B vaccine dose at two months of age or later. The panel also proposed a secondary recommendation that parents consider discussing antibody testing for hepatitis B in children before deciding whether to continue with subsequent vaccine doses. The hepatitis B vaccine is typically administered as a three-dose series.
Expert Reaction And Evidence
Many public health experts and medical organizations criticized the advisory committee’s deliberations, saying the meeting included misinformation and selective use of data. They warned that delaying the birth dose could allow infections to re-emerge. After the CDC began recommending a universal birth dose in 1991, pediatric cases of acute hepatitis B declined about 99% from 1990 to 2019.
Members of the Advisory Committee on Immunization Practices at CDC headquarters in Atlanta on Dec. 5. (Megan Varner / Bloomberg via Getty Images)
Critics also noted that hepatitis B can be transmitted from mother to child during delivery and that not all pregnant people are tested. Chronic hepatitis B infection has no cure, and delayed vaccination could raise the risk of future liver disease or cancer in some children.
Practical Impact
Pediatricians and major professional groups such as the American Academy of Pediatrics (AAP) continue to recommend administering the first hepatitis B dose within 24 hours of birth. The Department of Health and Human Services has said the new guidance will not change insurance coverage for the vaccine, and the shot remains available through the Vaccines for Children program for eligible infants.
Context
Observers place this decision within a broader set of recent CDC shifts that have drawn scrutiny. Earlier this year the agency’s vaccine advisory committee was overhauled, and leadership changes at CDC have attracted attention and debate from public health experts and policymakers.
This report summarizes developments and expert responses; parents with questions about hepatitis B vaccination for their newborns should consult their pediatrician or obstetric provider.
