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From the Centers for Disease Control and Prevention
December 26, 2007

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

JAMA. 2007;298(24):2863. doi:10.1001/jama.298.24.2863

MMWR. 2007;56:1057

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.

In immunogenicity studies among adults aged ≥18 years, the first 3 doses of the alternate schedule provided equivalent protection to the first 2 doses in the standard 3-dose Twinrix series.2 The first 3 doses of the alternate schedule also have proven effective in providing protection equivalent to a single dose of monovalent hepatitis A vaccine and to 2 doses of monovalent hepatitis B vaccine, administered using the licensed schedules for the monvalent vaccines.3 Thus, the alternate 4-dose schedule can be useful if vaccination with Twinrix has been initiated and travel or other potential exposure is anticipated before the second dose of Twinrix (or monovalent hepatitis B vaccine) is due, according to the standard 3-dose schedule (i.e., 1 month after the first dose). Additional information is available from the manufacturer's package insert4 and GlaxoSmithKline Vaccines, telephone 800-366-8900.

REFERENCES: 4 Available