FDA Approval of an Alternate Dosing Schedule for a Combined Hepatitis A and B Vaccine (Twinrix®)

In April 2007, GlaxoSmithKline Vaccine Division (GlaxoSmithKline Biologicals, King of Prussia, Pennsylvania) received approval from the Food and Drug Administration (FDA) for an alternate schedule for Twinrix®, a combined hepatitis A and hepatitis B vaccine. Twinrix was first licensed by FDA in 2001 on a 3-dose schedule (0, 1, and 6 months) for vaccination of persons aged >18 years (1). Using the newly licensed, alternate 4-dose schedule, Twinrix doses can be administered at 0, 7, and 21--30 days, followed by a dose at 12 months.