by The Coalition for Global Hepatitis Elimination and Karen Ernst
On December 4th, the federal Advisory Committee on Immunization Practices (ACIP) will consider rescinding the recommendation for the first shot newborns usually receive: the hepatitis B vaccine. Given within 24 hours of birth, this proven vaccine protects babies during a critical window of exposure to a virus that can cause liver failure and cancer. Reversing this long-established practice would break with more than three decades of evidence supporting hepatitis B vaccination for all newborns.
The hepatitis B “birth dose” vaccine is a triumph in public health. Routinely administered in the U.S. since 1991, it has reduced new infections by 99% among children and adolescents. Entire generations have been spared lifelong infections that can lead to cirrhosis, liver failure, and liver cancer. The policy is so effective that eliminating hepatitis B in the United States is now within reach.
However, some people, notably the Secretary of Health and Human Services, cite unsubstantiated safety concerns about continuing the recommended hepatitis B vaccination schedule. Raising fears based on speculation while ignoring extensive scientific evidence undermines public trust. Americans deserve clear answers to common questions about newborn hepatitis B vaccination, grounded in well-established science. As experts in hepatitis B vaccination with decades of experience in the U.S. and globally, we would like to address these concerns.
Yes. The hepatitis B vaccine has been extensively studied. Since 1982, billions of doses have been administered worldwide, including in multiple countries with strong systems for monitoring vaccine safety. Other than extremely rare allergic reactions, no serious long-term safety issues are linked to this vaccine. This includes finding no association between vaccination and autism. We agree public health monitoring and rigorously conducted studies should continue to assure the safety of vaccines. The current safety data from large-scale cohort and case-control studies support the statement from the World Health Organization: “vaccines do not cause autism”.
Universal newborn hepatitis B vaccination is a safety net that ensures all babies receive protection, not just those with perfect paperwork. Infants born to mothers diagnosed with hepatitis B are at the highest risk for infection, so screening is recommended for all pregnant women. However, about 15% are missed, leaving their hepatitis B status unknown, and test results are not always available at delivery. Infants can also be exposed to the virus during health care and in households. Programs to improve maternal screening will benefit mothers and help ensure infant vaccination, but until those efforts show major improvements, stopping universal newborn hepatitis B vaccination is premature.
Timing matters. Transmission of this virus occurs during delivery. When hepatitis B virus is transmitted at birth, 80–90% of infected infants develop lifelong chronic infection. Of babies infected at birth, one in four will die from liver cancer or cirrhosis. Once the baby is exposed to the virus, the immune response to the vaccine must begin immediately to get ahead of viral replication and prevent lifelong infection. Delaying hepatitis B vaccination even by a day increases the risk of transmission to the newborn. Administering the vaccine as soon as possible after delivery provides the strongest protection.
As of 2024, 115 of 194 WHO member states recommend a universal hepatitis B birth dose. Five European countries (Bulgaria, Lithuania, Poland, Portugal, and Romania) vaccinate all newborns. Others rely on maternal screening to identify infants who need vaccination. U.S. vaccination policy reflects our own burden of disease, health care access, and demographic factors. The United States has more people living with chronic hepatitis B and a more diverse population with varying risk levels. We also lack a unified national health system and consistent medical record tracking, increasing the risk of gaps in care.
Hepatitis B virus can spread through sexual contact, which is why hepatitis B vaccination is also recommended for adolescents and adults. However, children exposed to the virus at birth are also at high risk of infection. Hepatitis B-exposed children have an 80%-90% risk of chronic infection compared to only 5% for adults. A timely dose of hepatitis B vaccine protects people at a time when they are most vulnerable to chronic infection, progressive liver damage, and liver cancer in later life. Indeed, hepatitis B vaccine is the first vaccine proven to prevent cancer.
People want confidence that recommendations are rooted in proven, transparent evidence. Those of us who work to vaccinate children to eliminate hepatitis B share the same goal as parents: preventing an incurable chronic infection and avoiding disease with hepatitis B vaccines that are proven, safe, and effective. The hepatitis B birth dose meets that standard. Rescinding this recommendation now, after 30 years of success, reintroduces health risks for newborns and undermines progress against a virus that still claims thousands of American lives. An ACIP decision to no longer recommend hepatitis B vaccination of newborns is a step toward spread, not elimination, of this health threat.
With hepatitis B vaccination, our nation has the real opportunity to eliminate hepatitis B for future generations. Today, that progress depends on keeping in place a policy that is working as intended. We urge the Secretary of Health and Human Services and ACIP members to rely on the strong scientific evidence and decades of program experience that shaped previous recommendations. Continue to recommend hepatitis B vaccination for all newborns. By doing so, ACIP will move the United States toward a future in which hepatitis B is no longer a threat to American children, and toward the ultimate goal of eliminating hepatitis B for all.
Karen Ernst is the director of Voices for Vaccines.
The Coalition for Global Hepatitis Elimination is a nonprofit founded in 2019 as a program of The Task Force for Global Health. The Coalition pursues worldwide elimination of viral hepatitis and is a partner of Voices for Vaccines.
