Universal hepatitis B vaccination at birth saves lives

Key takeaways:

• The hepatitis B vaccine is safe and effective for preventing HBV infection in newborns.
• Universal HBV vaccination is the best way to prevent chronic HBV infection, cirrhosis and liver cancer.

Universal administration of a hepatitis B vaccine within 24 hours of birth is a safe, highly effective, evidence-based practice that has saved thousands of lives by preventing chronic hepatitis B infection in newborns.

The HBV vaccine became the first anticancer vaccine to be approved by the FDA in 1981, and there is over 4 decades of research and surveillance by the CDC showing that it has a highly favorable safety profile and can be safely administered in newborns.

Newborns are particularly vulnerable to developing chronic HBV infection, which is a leading cause of liver cancer. According to the American Academy of Pediatrics, 90% of newborns infected with HBV at birth will develop chronic HBV infection, and up to 25% of those who develop chronic HBV infection will die from complications of this disease, including from liver failure, cirrhosis and liver cancer.

Preventing HBV infection and liver cancer through vaccination is important because HBV infection can progress directly to liver cancer without the development of cirrhosis, and liver cancer mortality rates remain high in the United States, with a 5-year survival of just 22%.

The current, longstanding CDC recommendation for universal birth dose HBV vaccine administration is the most effective strategy to prevent chronic hepatitis B infection in infants and reduce the incidence of liver cancer.

Up to 2.4 million people live with chronic HBV infection in the U.S. According to the CDC, over 17,500 infants in the U.S. were born to people with HBV infection in 2021. Of note, approximately 70% of people with chronic HBV infection are not aware of their infection, placing unvaccinated infants and children at risk of accidental exposure to HBV.

In 1991, before the CDC recommended universal childhood HBV vaccination, approximately 18,000 babies and children in the U.S. were infected with HBV each year because of a failed risk-based HBV vaccination strategy. Nearly half of these pediatric HBV infections were transmitted from mother to child at birth.

Since the implementation of CDC-recommended universal birth dose and childhood HBV vaccination, transmission rates of HBV infection among babies and children have significantly declined by approximately 95% in the U.S., preventing over 500,000 children from developing HBV infection and preventing an estimated 90,000 deaths.

The HBV vaccine saves lives and is our best tool to prevent and eliminate HBV infection in the U.S. Universal HBV vaccine recommendations work, and the HBV vaccine has been instrumental in reducing rates of chronic HBV infection and liver cancer in our nation.

This week, the CDC’s Advisory Committee on Immunization Practices is scheduled to vote on HBV vaccine recommendations, as well as on the HBV vaccine in the Vaccines for Children program, which will have direct implications on whether infants and children will have access to the HBV vaccine in the U.S.

Robust scientific evidence and safety data have unequivocally shown that universal birth dose HBV vaccination saves lives and is safe to administer in newborns. It is critical for all newborns to have continued universal access to the HBV vaccine with no out-of-pocket costs, if their parents want them to receive the vaccine.

Universal administration of the birth dose HBV vaccine is safe and highly effective in preventing perinatal transmission of HBV to infants and reduces the subsequent risk of developing liver cancer, liver failure and cirrhosis. It is, therefore, critical to ensure that evidence-based clinical guidelines are maintained so that newborns continue to universally receive the birth dose HBV vaccine in the U.S. and infants achieve lifelong immunity by completing the universally recommended multidose HBV vaccine series to keep our children healthy and prevent a national resurgence in chronic HBV infection and associated liver cancer.

References:

• AAP. Fact checked: Hepatitis B vaccine given to newborns reduces risk of chronic infection. https://www.aap.org/en/news-room/fact-checked/fact-checked-hepatitis-b-vaccine-given-to-newborns-reduces-risk-of-chronic-infection/. Updated June 25, 2025. Accessed Sept. 16, 2025.
• American Cancer Society. Liver cancer survival rates. https://www.cancer.org/cancer/types/liver-cancer/detection-diagnosis-staging/survival-rates.html. Updated Feb. 11, 2025. Accessed Sept. 16, 2025.
• CDC. Clinical overview of perinatal hepatitis B. https://www.cdc.gov/hepatitis-b/hcp/perinatal-provider-overview/index.html. Updated July 2, 2025. Accessed Sept. 16, 2025.
• CDC. Hepatitis B vaccine safety. https://www.cdc.gov/vaccine-safety/vaccines/hepatitis-b.html. Updated Dec. 30, 2024. Accessed Sept. 16, 2025.
• Children’s Hospital of Philadelphia. Hepatitis B: The disease and vaccines. https://www.chop.edu/vaccine-education-center/vaccine-details/hepatitis-b-vaccine. Updated Aug. 14, 2025. Accessed Sept. 16, 2025.
• Hepatitis B Foundation. Hepatitis B facts and figures. https://www.hepb.org/what-is-hepatitis-b/what-is-hepb/facts-and-figures/. Accessed Sept. 16, 2025.
• Zhou F, et al. MMWR Morb Mortal Wkly Rep. 2024;doi:10.15585/mmwr.mm7331a2.

For more information:

Rita K. Kuwahara, MD, MIH, FACP, is a primary care internal medicine physician and member of the Healio Primary Care Peer Perspective Board. She can be reached at primarycare@healio.com.