On Aug. 28, 1989, a second recombinant hepatitis B vaccine, Engerix-B (SmithKlineBeecham), was approved for use in the U.S. However, even though two vaccine manufacturers had produced two new hepatitis B vaccines that had been licensed by the FDA for use by children and adults, the vaccine was not being used.

Hepatitis B (HBV) is a viral infection that infects the liver and occurs largely in adults with infection transmitted through sexual contact, sharing of needles, syringes and other drug injection equipment