Scientific Basis for Current Hepatitis B Vaccine Strategy

AS Lok et al. Gastroenterology. (In press) Open Access! Hepatitis B Vaccination: A Remarkable Success Story That Must Continue

For those trying to understand the success of the current HBV immunization strategy and why altering the timing of HBV vaccinations is a bad idea, this is a worthwhile article.

Key points:

  • “To date, more than 1 billion doses of HepB vaccines have been administered worldwide, and they are considered one of the safest and most effective vaccine ever made.1,2,6
  • “Because of the high risk for chronic HBV infection, the CDC/Advisory Committee on Immunization Practices (ACIP), WHO, and health ministries of many countries recommend universal HBV vaccination of all infants beginning with a “birth dose” for newborns, preferably within the first 24 hours of birth, followed by completion of the 3-dose infant vaccination schedule…Implementation of routine infant and childhood vaccination, including birth dose HBV vaccine, prevented an estimated 210 million infections globally between 1980 and 2015.4
  • In 1991, with evidence showing substantial number of infants and others at risk were missed by a risk-based approach to HepB vaccination, the ACIP recommended universal HepB vaccination for all infants, with the first dose administered before hospital discharge along with hepatitis B immune globulin (HBIG) for infants born to mothers who tested positive for HBsAg or whose HBsAg status was unknown.5,6,14
  • “In 2018, the CDC/ACIP recommendation specified that the birth dose of HepB vaccine should be administered within 24 hours of birth including for preterm infants, regardless of maternal HBsAg status.14 …Timely birth dose HepB vaccination regardless of maternal HBsAg status serves as a safety net for perinatal transmission from HBsAg-positive mothers missed by HBsAg screening programs and protects against the small but non-zero risk of HBV infections from household and other exposures for infants born to HBsAg-negative mothers.”
  • “HepB vaccination alone prevents 75% to 80% of perinatal HBV transmission.2 The addition of maternal HBsAg screening and further testing for hepatitis B e antigen or HBV DNA if HBsAg test is positive allows for additional interventions to eliminate mother-to-child transmission of HBV.”
US CDC recommendations for HBV vaccination. Decline in reported number of acute HBV infections in the United States in association with CDC recommendations for HBV vaccination, 1980–2022.

My take (borrowed in part from authors): It would be a big mistake to resume the risk-based approach to newborn HepB vaccination. “HepB vaccine is a safe and highly effective vaccine. HepB vaccination prevents an incurable chronic infection and related morbidity and mortality from cirrhosis and HCC. Indeed, HepB vaccine is the first cancer-prevention vaccine…Universal HepB birth dose vaccination regardless of maternal HBsAg status is the most effective as well as the most cost-effective strategy in eliminating HBV infection. Newborns and infants are those at highest risk of chronic HBV infection. Delaying the first dose of HepB vaccine even by a few days exposes the infants to increased risk of developing lifelong infection,18 chronic liver disease, and premature death.”

NASPGHAN has sent a letter urging the ACIP committee to continue the current immunization schedule:

Delaying the first vaccine in the series to one-month, four years, or 12 years of age will
undermine the vaccine’s effectiveness, and relying on just screening pregnant women for
hepatitis B is insufficient.

Although some of the changes that have been discussed by ACIP sound small, they are not
grounded in new evidence and would undo more than three decades of a prevention
strategy that has nearly eliminated early childhood hepatitis B in the United States.

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