In May 1986, the vaccine Recombivax HB, which protects against hepatitis B infection, was approved for marketing in West Germany; approval by the U.S. Food and Drug Administration followed two months later.

Recombivax HB marked a milestone in the development of medical biotechnology. Manufactured by Merck Sharp & Dohme, it was the first vaccine to be produced using recombinant DNA technology, and only the third recombinant product to be licensed for human use (following human insulin in 1982 and human growth hormone in 1985 and just preceding alpha interferon in Jun. 1986).