HepB Vaccine Guidance: Getting to Zero by 2020

Shilpi Chabra, MD, FAAP
Associate Professor
Division of Neonatology, Department of Pediatrics
University of Washington & Seattle Children’s Hospital

Hepatitis B virus (HBV) infection causes chronic liver disease and remains an important public health concern, however, approximately 15-30% of HBV-infected people have no known or acknowledged risk factors. Immunization with HepB vaccine is the most effective means to prevent perinatal HBV transmission and it is the only vaccine that is reliably immunogenic in the newborn period generating an antibody response within 4-21 days.

The American Academy of Pediatrics Committee on Infectious Diseases and the Committee on Fetus and Newborn have endorsed the recommendation of the Advisory Committee on Immunization Practices (ACIP) for giving the birth dose of Hepatitis B (HepB) vaccine within the first 24 hours of life in all medically stable infants weighing ≥2000 g. In Oct 2016, ACIP rescinded the previously recommended permissive language for delaying the birth dose of hepatitis B vaccine and, in 2017, the CDC and AAP endorsed this new recommendation of initiation of the birth dose of HepB vaccine within 24 hours after birth. This updated immunization schedule from the ACIP aligns with World Health Organization recommendations for HepB vaccination at birth. Since vaccine response is lower among infants with birth weights <2000 g, infants weighing <2000 g at birth and born to HBsAg-negative mothers should have their first vaccine dose delayed to time of hospital discharge, or age 1 month (even if weight is still <2000 g). Only single-antigen HBV should be used for the birth dose.

The timing of the birth dose is critical as HepB vaccine alone is 75-95% effective in preventing perinatal hepatitis B transmission when given within 24 hours of birth and it serves as post-exposure prophylaxis to prevent perinatal HBV infection among infants born to HBV-infected mothers not identified at birth because of lack of maternal HBsAg testing or failures in reporting test results (for eg. if maternal HBsAg results misinterpreted, falsely negative, inaccurately transcribed or reported to the infant care team, technical delays in receiving mother’s positive results, errors in testing, or mother seroconverted after testing). Hep B birth dose also provides protection from postnatal horizontal transmission (from infected caretakers in households and daycare settings) and in cases where unexpected surgery or blood transfusions are needed. Receipt of Hep B vaccine at birth prevents missed opportunities for vaccination and there is increased likelihood of completing the 3-dose HepB series (and other future vaccines).

The US Department of Health and Human Services has set a goal of ‘zero’ perinatal hepatitis B transmission by 2020. To achieve this goal, all States and hospitals should establish case-management programs with appropriate policies, procedures, laws, and regulations to ensure that all pregnant women are tested for HBsAg to ensure identification of at-risk infants along with initiation of birth dose of HepB vaccine for infants weighing ≥ 2000 g within 24 hours of birth. The hospital policies and procedures should also include standing orders and electronic medical record reminders or prompts to ensure the timely receipt of HepB vaccine birth dose.


  1. Elimination of Perinatal Hepatitis B: Providing the First Vaccine Dose Within 24 Hours of Birth. Committee On Infectious Diseases, Committee On Fetus and Newborn. Pediatrics Volume 140, number 3, 2017:e20171870
  2. CDC. Prevention of Hepatitis B virus in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2018;67(1).
  3. Schillie S, Vellozzi C, Reingold A, Harris A, Haber P, Ward JW, Nelson NP. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018 Jan 12;67(1):1-31
  4. World Health Organization. Hepatitis B vaccines: WHO position paper, July 2017-Recommendations. Vaccine 2017; pii:S0264-410X (17) 30954-4.
  5. Mcintosh ED, et al. Horizontal transmission of hepatitis B in a children’s day-care centre: A preventable event. Aust N Z J Public Health. 1997;21(7):791–2.
  6. Washington State Department of Health. Hepatitis B. Available at: https://www.doh.wa.gov/ForPublicHealthandHealthcareProviders/NotifiableConditions/HepatitisB.
  7. U.S. Department of Health and Human Services. Immunization and Infectious Diseases. Available at: https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives.
  8. Anderson TA et al. States report hundreds of medical errors in perinatal hepatitis b prevention: Avoid tragic mistakes—vaccinate newborns against HBV in the hospital. Immunization Action Coalition, 2003. Avail at: http://immunize.org/catg.d/p2062.pdf.