Universal Infant Vaccine Birth Dose Saves Thousands of Lives: A response from the Hepatitis B Foundation
June 25, 2025
The Hepatitis B Foundation is gravely concerned that efforts to revisit and review the longstanding ACIP recommendation that all infants in the U.S. receive the hepatitis B vaccine within 24 hours of birth will lead to its eventual elimination. This change to the “birth dose” recommendation marks a dangerous departure from evidence-based public health policy and places newborns at an unacceptable risk for chronic infection and liver cancer.
We are disturbed by the tone and implied bias in ACIP’s announcement to study universal hepatitis B birth dose. The question posed today, “Is it wise to administer the hepatitis B vaccine to newborns before they leave the hospital?,” is inherently biased against the vaccine, and is not an acceptable scientific research question.The stated question imposes doubt, is partial, and falsely implies that the hepatitis B birth dose is unsafe for babies while decades of research and implementation have shown that the birth dose is both safe and effective. To be clear, periodic reviews of vaccine data and disease trends can be useful for making public health recommendations. However, based on the discussion today, we are concerned that the planned review of data will be biased and non-objective, leading to a revised recommendation that will be detrimental to public health.
The universal hepatitis B birth dose recommendation, officially adopted by the U.S. in 1991, was implemented after targeted risk-based vaccination strategies failed to prevent perinatal and early childhood hepatitis B transmission. At the time, nearly 20,000 babies and children were infected annually in the U.S., and most infections went undiagnosed until later in life, frequently when liver cancer or significant liver damage had already developed.
Clinical and public health data have consistently shown that universal administration of the hepatitis B vaccine within the first 24 hours of life is the most effective strategy to prevent early childhood infections. Hepatitis B is highly infectious and is up to 100 times more transmissible than HIV. When acquired in infancy, the virus carries up to a 90% risk of progressing to a chronic infection. It is reckless to consider reversing decades of public health progress, and to needlessly change a recommendation for a safe, effective and cost-effective prevention strategy for a virus that has no cure.
In the U.S., the birth dose acts as a critical safety net for protecting newborns from unknown maternal infections, mitigating risks from incomplete or delayed prenatal screening, and preventing early childhood transmission of unknown infections in households and communities. The U.S. does not have a robust public health infrastructure that can properly capture every single person, or mother, living with hepatitis B. Universal vaccination is the only way to ensure that our communities are fully protected.
Furthermore, the hepatitis B vaccine is a marker of successful childhood vaccination for other diseases, such as polio and measles. Research has shown that children who receive the birth dose are three times more likely to receive other recommended vaccines within their recommended timeframe.
The potential reversal of this recommendation will lead to gaps in coverage, confusion among providers, and a likely increase in preventable hepatitis B infections. Such a reversal ignores decades of real-world success and undermines confidence in longstanding immunization policy. Allowing any newborn to become infected with a preventable virus that leads to liver cancer in 25% of people is egregious. We should have a zero-tolerance policy for perinatal hepatitis B transmission in the U.S. Every baby and child should be protected, and we should use every safe and effective tool we have.
The Hepatitis B Foundation strongly urges federal public health authorities to maintain the universal infant hepatitis B vaccine recommendation and to reaffirm their commitment to policies grounded in rigorous, peer-reviewed scientific evidence. Furthermore, we call on ACIP to maintain their fundamental core values of transparency, integrity, and evidence-based research.
For decades, the birth dose recommendation has prevented thousands of Americans from a devastating and life-threatening illness. It is a critical part of our nation’s strategy to eliminate hepatitis B and protect the health of future generations. We cannot allow a preventable, cancer-causing virus to destroy more lives. The health of our children and the integrity of our public health system deserve better.