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News From the Centers for Disease Control and Prevention
November 9, 2005

FDA Approval of VAQTA® (Hepatitis A Vaccine, Inactivated) for Children Aged ≥1 Year

JAMA. 2005;294(18):2296. doi:10.1001/jama.294.18.2296

MMWR. 2005;54:1026

On August 11, 2005, the Food and Drug Administration (FDA) approved an application of a pediatric/adolescent formulation of VAQTA® (hepatitis A vaccine, inactivated) (Merck & Co., Whitehouse Station, New Jersey) for use among persons aged 12 months–18 years. Previously, the pediatric/adolescent formulation of VAQTA was approved for use in persons aged 2-18 years. The approved labeling change applies only to VAQTA and not to other licensed hepatitis A vaccines.

The formulation, dosage, and schedule for VAQTA have not changed. Each 0.5 mL dose of the pediatric/adolescent formulation of VAQTA contains approximately 25 units of formalin-inactivated hepatitis A virus antigen, adsorbed onto aluminum hydroxyphosphate sulfate, in 0.9% sodium chloride. The formulation does not contain a preservative.