FDA Approval for a Combined Hepatitis A and B Vaccine

On May 11, 2001, the Food and Drug Administration (FDA) licensed a combined hepatitis A and B vaccine (Twinrix®) for use in persons aged >18 years. Twinrix is manufactured and distributed by GlaxoSmithKline Biologicals (Rixensart, Belgium), and is made of the antigenic components used in Havrix and Engerix-B (GlaxoSmithKline). The antigenic components in Twinrix have been used routinely in separate single antigen vaccines in the United States since 1995 and 1989 as hepatitis A and B vaccines, respectively.