ACIP: Statement on Changes to HBV Birth Dose Vaccine Recommendation

The American Association for the Study of Liver Diseases (AASLD) and its undersigned partner organizations – the American College of Gastroenterology (ACG), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), the Infectious Diseases Society of America (IDSA), and the North American Society for Pediatric Gastroenterology, Hepatology & Nutrition (NASPGHAN) – are alarmed by the 8-3 vote by the Advisory Committee on Immunization Practices (ACIP) to abandon the recommendation to initiate universal hepatitis B vaccination immediately after birth. Relying on the hepatitis B status of the infant’s mother to determine whether the birth dose is appropriate creates confusion and ambiguity for new parents, the community, and medical professionals when the evidence clearly supports the safety and effectiveness in providing lifetime protection of administering a universal birth dose after consultation between an infant’s parents and their health care provider. 

As the leading societies dedicated to prevention, treatment and cure of liver diseases, we continue to strongly recommend that the hepatitis B vaccine be administered at birth to all infants as part of the validated three dose schedule rather than delaying the first dose to two months for confirmed hepatitis B negative mothers and for the full vaccination series to be administered to all infants. We call on the Centers for Medicare & Medicaid Services to ensure that coverage for the birth dose without cost sharing remains in place and that states take steps to ensure access for all who choose the vaccine. 

Eliminating the universal birth dose recommendation will end a public health practice that has prevented 95% of new hepatitis B infections and an estimated 90,100 deaths in the United States. Relying on hepatitis B screening of pregnant women will not be as effective as universal vaccination. Despite a recommendation for universal screening of pregnant women for hepatitis B, up to 16% of pregnant women (more than 575,000 American newborns at risk each year) were not screened annually between 2015-2019. Should ACIP’s revised recommendation be implemented, this screening gap will result in preventable chronic hepatitis B infections which lead to the development of cirrhosis, liver failure, and liver cancer.  

Administering the hepatitis B vaccine within the first 24 hours of birth is the safest way to prevent perinatal transmission and protect infants and young children from horizontal transmission. According to the Centers for Disease Control and Prevention’s (CDC) data, approximately 90% of infants and 30% of children between ages 1-5 years exposed to hepatitis B will develop chronic hepatitis B compared to only 5% of adults. Research has shown that horizontal transmission, which can occur in daycare or through routine contact with caregivers or family members unaware of their status, carries around a 40% chance of infection. The birth dose closes critical gaps in maternal screening, documentation errors, missed opportunities for prevention, and the growing number of births occurring outside traditional hospital settings. While all infants should return for their well child visits, this does not always occur, and delaying the first dose for some infants will inevitably increase the number of infants who remain unvaccinated. 

The policy change will disproportionately affect communities already carrying the highest burden of hepatitis B, including Asian American, Pacific Islander, and African communities, as well as infants born in settings with inconsistent documentation or limited prenatal care. It also will undermine the commitment of the Department of Health and Human Services and the CDC – that we share – to eliminate viral hepatitis by 2030 as outlined in the Viral Hepatitis National Strategic Plan: A Roadmap to Elimination 2021-2025. We urge the CDC to reconsider this decision and reaffirm the universal birth dose as an essential component of comprehensive hepatitis B prevention. The evidence is unequivocal: universal birth dose vaccination saves lives, prevents chronic liver disease and liver cancer, and strengthens the nation’s public health infrastructure. 

Our organizations stand by the universal birth dose recommendation, which already provides for consultation between parents and health care providers, and will work with clinicians, community partners, families, and policymakers to ensure every infant in the United States continues to be protected from a lifelong, preventable liver disease.