Vaccine Update: The History of Hepatitis B Vaccines and the Importance of Universal Vaccination in Infancy

The first hepatitis B vaccine, Heptavax, was plasma-derived and was approved by the Food and Drug Administration (FDA) in 1981. It was used in targeted populations of high-risk individuals, including infants born to infected mothers. In 1986, the FDA approved the first recombinant vaccine, Recombivax HB. This vaccine was derived from yeast and was used for the same high-risk populations. In 1989, a second recombinant vaccine was approved, Engerix-B. Unfortunately, the targeted vaccination strategy did not have an impact on reducing the overall incidence of the disease. Efforts to identify high-risk individuals were further complicated by data that showed 35%-65% of hepatitis B surface antigen (HBsAg) positive mothers had no identifiable high-risk factors. Vertical (mother-to-child) transmission was the most common route of infection. Approximately 90% of babies born to mothers with hepatitis B become infected, and an estimated 25%-40% die prematurely in adulthood due to complications such as cirrhosis or hepatocellular carcinoma.¹ This led the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP) to recommend the vaccine for all newborns, starting in 1991.

Since the introduction of universal newborn hepatitis B vaccine in the United States, vertical transmission rates have declined by 94%-98%.² While hepatitis B screening is recommended for all pregnant individuals by the CDC and the American College of Obstetricians and Gynecologists (ACOG), only 82%-86% have the screening performed, and just 35% of those who test positive receive all recommended follow-up care.³ This leaves a gap for 2.9-3.1 million infants per year who are born to mothers not screened for hepatitis B. The universal hepatitis B vaccine dose serves as a critical safety net, providing protection to infants born to hepatitis B infected mothers who were not identified at the time of delivery.

The Advisory Committee on Immunization Practices (ACIP) voted in December 2025 to change the recommendation for universal newborn hepatitis B vaccination in infants born to mothers who test negative for hepatitis B infection. The updated recommendation now allows parents to decide when or if they want their child to receive the hepatitis B vaccine at birth. It also recommends that hepatitis B serology testing should be offered to determine whether further doses of vaccine are needed after a single dose is given at 2 months of age. On May 29, a presidential executive order directed the CDC and ACIP “to take any appropriate steps to update the United States childhood and adolescent vaccine schedule” to align with the decision made in December.⁴ This has caused confusion for parents and questions regarding which guidance to follow and has also raised questions about vaccine administration, liability and reimbursement for hepatitis B vaccines in infants.

The AAP relies on scientific research and proven long-standing safety data to continue to recommend universal vaccination at birth, followed by subsequent doses at 1-2 months and 6-18 months of age. Additionally, the AAP recommends that for infants born to mothers who are HBsAg positive, both hepatitis B vaccines and hepatitis B immune globulin should be administered within 12 hours of birth to essentially eliminate the risk of infant infection. The AAP also does not recommend routine serologic testing in infancy, as the significance of protective Hep B surface antibody levels in early infancy is unknown, and adds that, “There is also insufficient evidence regarding the significance of antibody levels obtained mid-series and the relationship with long-term immunity against hepatitis B, particularly in this age group. These laboratory results would not reliably represent immune status or a scientific basis for a decision to continue or forego subsequent vaccination.”⁵ The introduction of serologic testing may create additional barriers to timely immunization, such as adding a laboratory procedure, a potential access and logistical issue for families, and the possibility of delayed immunity.

Chronic hepatitis B infection remains a significant public health concern, as many chronic carriers are often undiagnosed and may unknowingly transmit the infection to others. Hepatitis B virus is highly infective and can easily be transmitted through blood and body fluids as well as live on surfaces outside of the body for seven days or longer. Children with chronic hepatitis B infection may remain asymptomatic for years and reach adulthood without a diagnosis, putting them at risk of transmitting the virus to others and of developing serious long-term complications, including cirrhosis, liver failure and hepatocellular carcinoma, all of which can dramatically impact their health and lifespan.

The CDC and ACIP have used recommendations from other countries as a basis for recommendations in the U.S. However, comparisons between the U.S. approach to universal vaccination and strategies of some European countries, which do not have this recommendation, should be made with caution. Many of these countries have significantly smaller populations, universal health care systems, and higher rates of prenatal screening and adherence to follow-up care. These health care infrastructure differences may facilitate the identification and management of pregnant individuals with hepatitis B infection and reduce the likelihood of missed opportunities for prevention. Consequently, strategies that may be effective in those settings may not be directly applicable to the diverse and more complex health care environment of the United States.

The AAP has developed Immunization Discussion Guides that provide health care providers with information to help educate patients and families, as well as evidence for the recommendations for childhood vaccines. There are also guides developed directly for families to help them understand vaccine recommendations and to answer the most commonly asked questions. These can be found at https://www.aap.org/babyvaxguide, https://www.aap.org/childvaxguide and https://www.aap.org/teenvaxguide.

References:

1. Clinical overview of perinatal hepatitis B. Centers for Disease Control and Prevention. September 18, 2025. Accessed June 4, 2026. https://www.cdc.gov/hepatitis-b/hcp/perinatal-provider-overview/index.html
2. Liu JF, Chen TY, Zhao YR. Vertical transmission of hepatitis B virus: propositions and future directions. Chin Med J (Engl). 2021;134(23):2825-2831. doi:10.1097/CM9.0000000000001800
3. Pham T, Maria N, Cheng V, et al. Gaps in prenatal hepatitis B screening and management of HBsAg positive pregnant persons in the U.S., 2015–2020. Am J Prev Med. 2023;65(1):52-59.
4. Realigning United States core childhood vaccine recommendations with best practices from peer, developed countries. Executive order 14407. May 29, 2026. Whitehouse.gov. Accessed June 4, 2026. https://www.whitehouse.gov/presidential-actions/2026/05/realigning-united-states-core-childhood-vaccine-recommendations-with-best-practices-from-peer-developed-countries/
5. Hepatitis B vaccine frequently asked questions. American Academy of Pediatrics. Last updated January 2, 2026. Accessed June 4, 2026. https://www.aap.org/en/patient-care/hepatitis-b/hepatitis-b-vaccine-frequently-asked-questions/