Heptavax-B

Heptavax-B was the first commercially available vaccine for hepatitis B, approved by the FDA in 1981 and released in 1982. Developed by Merck & Co., it is a plasma-derived vaccine composed of purified, inactivated hepatitis B surface antigen (HBsAg) harvested from the plasma of chronic hepatitis B virus (HBV) carriers. The manufacturing process involved three rigorous inactivation steps—treatment with pepsin at pH 2, 8M urea, and 1:4000 formalin—to ensure the elimination of all known viruses, including HBV and HIV. Although highly effective and safe, the vaccine faced public hesitation due to concerns over its human-plasma origin. It was largely superseded in the late 1980s by recombinant DNA-based vaccines, such as Recombivax HB, which are produced in yeast and do not require human blood products.

Brand names

Heptavax-B

Other names

plasma-derived hepatitis B vaccineHepatitis B vaccine (inactivated)Hepatitis B surface antigen (plasma-derived)