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What Is the Origin of the Hepatitis B Vaccine?

Vaccines to protect people from hepatitis B virus infection have been available in the U.S. since 1981. The hepatitis B vaccines currently licensed for use in this country are recombinant vaccines (produced from a cloned gene).

  1. Manufacturing Process

    • Genetically engineered cells of common baker's yeast (Saccharomyces cerevisiae) are cultured through several steps so the cells produce hepatitis B surface antigen, or HBsAg. The cultured cells release HBsAg proteins, which are harvested and purified.

    Ingredients

    • The final vaccine product contains at least 95% HBsAg protein, while yeast-derived proteins may make up to 5%. The vaccine does not contain a preservative or any substances of human origin. It comes as a suspension that should be shaken before administration.

    Two U.S. Manufacturers

    • In the U.S., Merck produces the hepatitis B vaccine Recombivax HB, and GlaxoSmithKline makes Energix-B.

    Formulations

    • Each brand of hepatitis B vaccine is available in both pediatric and adult formulations.

    Vaccine Schedule

    • The first dose of hepatitis B vaccine is usually given to a newborn baby before hospital discharge, and the next doses are recommended at two and six months of age.

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