CSTE Position Statement(s)
Great progress has been made in identifying hepatitis B surface antigen (HBsAg)-positive pregnant women and immunizing their infants with Hepatitis B (HepB) vaccine and Hepatitis B immune globulin (HBIG) to prevent vertical infection, but there are still infants who acquire hepatitis B virus (HBV) infection. This is because either their mothers are not recognized as infected and the infant does not receive HBIG and the full Hep B vaccine series or the intervention does not prevent infection. Without post-exposure prophylaxis with HBIG and HepB vaccine, approximately 45% of infants born to HBV-infected mothers will become infected and up to 90% of those infected will develop chronic, life-long infection. Among infants who do develop infection, 25% will die prematurely of liver cirrhosis or cancer. It is estimated that 1,000 newborns are infected annually.1 Although, treatment of HBV infection is now possible and can attenuate the impact of infection, hepatitis B cannot yet be cured.2
It is important to assure adequate immunity in infants of HBV-infected mothers and to determine if infection of the infant occurred with or without post-exposure prophylaxis. The Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) recommend universal testing of pregnant women for HBsAg, post-exposure prophylaxis within 12 hours of birth with HBIG and the first dose of HepB vaccine for infants born to HBV-infected mothers, universal birth dose administration to all infants regardless of the mother’s HBsAg status, completion of a valid three dose vaccine series in all infants, and post-vaccination serologic testing (PVST) for HBsAg and anti-HBs at 9-12 months for infants born to HBV-infected mothers or infants born in regions of high and intermediate HBV endemicity.3 The CDC Perinatal Hepatitis B Prevention Program helps promote these recommendations and provides case management of HBV-infected mothers and their infants. Evaluation of the program depends on the follow-up of exposed infants.
Clinical CriteriaPerinatal HBV infection in a child ≤ 24 months of age may range from asymptomatic to fulminant hepatitis.
Laboratory Criteria For Diagnosis
Laboratory evidence of HBV infection in an infant consists of one or more of the following:
- positive hepatitis B surface antigen (HBsAg) test (only if at least 4 weeks after last dose of Hep B vaccine)
- positive hepatitis B e antigen (HBeAg) test
- detectable HBV DNA
Epidemiologic LinkageBorn to a HBV-infected mother.
ProbableChild born in the US and positive for HBsAg at ≥ 1 month of age and ≤ 24 months of age OR positive for HBeAg or HBV DNA ≥9 months of age and ≤ 24 months of age, but whose mother’s hepatitis B status is unknown (i.e. epidemiologic linkage not present).
ConfirmedChild born in the US to a HBV-infected mother and positive for HBsAg at ≥ 1 month of age and ≤ 24 months of age OR positive for HBeAg or HBV DNA ≥9 months of age and ≤ 24 months of age.
Infants born to HBV-infected mothers should receive HBIG and the first dose of HepB vaccine within 12 hours of birth, followed by the second and third doses of HepB vaccine at 1 and 6 months of age, respectively. PVST for HBsAg and anti-HBsAg is recommended 1 to 2 months following completion of the vaccine series, but not earlier than 9 months of age.
If the mother is known to not be infected with HBV, refer to the case definition for acute Hepatitis B.
1. CDC. (1997). Case Definitions for Infectious Conditions Under Public Health Surveillance. MMWR, 46(RR-10), 1-55. https://www.cdc.gov/mmwr/preview/mmwrhtml/00047449.htm
2. Ko SC, Fan L, Smith EA, Fenlon N, Koneru AK, Murphy TV. Estimated Annual Perinatal Hepatitis B Virus Infections in the United States, 2000–2009. Journal of the Pediatric Infectious Diseases Society. 2014 Dec 18:piu115.
3. Terrault NA, Bzowej NH, Chang K-M, et al. AASLD Guidelines for Treatment of Chronic Hepatitis B. https://www.aasld.org/sites/default/files/2019-06/Terrault_et_al-2016-Hepatology.pdf.
4. Mast EE, Margolis HS, Fiore AE, Brink EW, Goldstein ST, Wang SA, Moyer LA, Bell BP, Alter MJ; Advisory Committee on Immunization Practices (ACIP). A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) part 1: immunization of infants, children, and adolescents. MMWR Recomm Rep. 2005 Dec 23;54(RR-16):1-31.