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August 23, 1995

Licensure of Inactivated Hepatitis A Vaccine and Recommendations for International Travelers' Use

JAMA. 1995;274(8):603. doi:10.1001/jama.1995.03530080019015

MMWR. 1995;44:559-560

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IN FEBRUARY 1995, Havrix(R),* an inactivated hepatitis A vaccine distributed by SmithKline Beecham Pharmaceuticals (Philadelphia, Pennsylvania) was licensed by the Food and Drug Administration for use in persons aged ≥2 years to prevent hepatitis A virus (HAV) infection. The vaccine is licensed in adult and pediatric formulations, with different dosages and administration schedules and should be administered by intramuscular injection into the deltoid muscle.

Immunogenicity studies have indicated that virtually 100% of children, adolescents, and adults develop protective levels of antibody to hepatitis A virus (anti-HAV) after completing the vaccine series.1,2 Based on a controlled clinical trial, the efficacy of two doses of vaccine (360 enzyme-linked immunosorbent assay units) administered 1 month apart in preventing hepatitis A in children was estimated to be 94% (95% confidence interval=79%-99%).3 Vaccine recipients have been followed for as long as 4 years and still have protective levels

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