Comments for the September 2025 Meeting of the Advisory Committee on Immunization Practices (Docket No. CDC-2025-0454) / Recommendation of Hepatitis B Universal Birth Dose Vaccination
To the Advisory Committee on Immunization Practices (ACIP):
Treatment Action Group Appreciates the Opportunity to Submit Public Comments to the Advisory Committee on Immunization Practices (ACIP).
Treatment Action Group (TAG) strongly urges the Advisory Committee on Immunization Practices (ACIP) to maintain the recommendation of a universal hepatitis B virus (HBV) birth dose vaccine in the United States. As a global leader in childhood immunizations, America has a responsibility to uphold science-based policies that protect all infants, children, and adults from preventable diseases like hepatitis B. Universal birth dose vaccination is simple, safe, and highly effective, and it safeguards every baby, regardless of perceived risk or circumstance, and helps close gaps in a fragmented healthcare system.
Early administration of the hepatitis B vaccine is among the most critical components of this immunization, as age has a direct correlation with the likelihood of developing a chronic infection. Without HBV vaccination, approximately 90% of infants who are exposed to hepatitis B will develop a chronic infection, placing them at a significantly increased risk of cirrhosis and liver cancer later in life. In the U.S., before universal childhood vaccination was recommended, an estimated 18,000 children were infected with hepatitis B each year before age 10. Nearly half of these infections were transmitted from mother to child at birth. Many of the remaining 9,000 children had no known exposures to the virus. Now this number is down to almost zero. [Children’s Hospital of Philadelphia, “9,000 Reasons for Routine Childhood Hepatitis B Vaccination”, 10 July 2025, https://www.chop.edu/parents-pack/parents-pack-newsletter/9000-reasons-routine-childhood-hepatitis-b-vaccination]. As a nation, we cannot afford to go backwards.
It is well-documented that the hepatitis B vaccine is extremely safe for newborns. More than four decades of research and surveillance conducted by the Centers for Disease Control and Prevention (CDC) have shown that most side effects are mild and typical of vaccines, such as soreness at the injection site or a low-grade fever. Since its introduction in 1986, the vaccine has been administered over one billion times worldwide, providing millions of children with lifelong protection against this dangerous infection.
Most countries support the universal birth dose and follow the World Health Organization’s (WHO) and U.S. Centers for Disease Control and Prevention (CDC) recommendations to administer the hepatitis B vaccine to all infants within the first 24 hours of birth. Some have suggested that the U.S. should adopt a policy of vaccinating only babies born to infected mothers, as is done in other parts of the world. However, many of these countries have smaller populations and some have universal healthcare systems that make screening, testing, and linkage to care for hepatitis B much more feasible and reliable. Community organizations and health systems in the U.S. currently struggle to identify those living with the disease, which makes disease diagnosis and treatment tougher than disease prevention. The U.S. lacks the public health infrastructure to ensure that all at-risk babies receive the birth dose in a timely manner, making universal vaccination the safest and most effective approach.
Furthermore, history shows that universal hepatitis B vaccination is the best reliable way to prevent transmission of hepatitis B. Since implementing the birth dose, the U.S. has prevented over 500,000 childhood infections, reduced infant hepatitis B cases by 95%, and prevented an estimated 90,100 childhood deaths [Hepatitis B Foundation, “Hep B Birth Dose Media Kit,” https://www.hepb.org/resources-and-support/hep-b-birth-dose-media-toolkit/]. Up to 2.4 million people in the U.S. are currently living with hepatitis B, yet roughly 70% remain undiagnosed. This undetected population places babies and children at risk of accidental exposure to this cancer-causing virus.
We firmly believe that every parent has the right to make informed decisions for their children. However, those decisions must be guided by clear, objective, and scientifically rigorous recommendations. Eliminating the universal recommendation would create unnecessary barriers and confusion, limiting access to the vaccine and undermining parents’ ability to choose to protect their babies.
For your upcoming meeting, TAG urges ACIP and all relevant authorities to stand firmly behind science, prevention, and the continued protection of our youngest and most vulnerable citizens by maintaining the universal hepatitis B birth dose.
For further information please contact:
Joelle Dountio Ofimboudem
Acting Hepatitis Project Director
Treatment Action Group
jdountio@treatmentactiongroup.org
www.treatmentactiongroup.org