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Notice To Readers: FDA Approval of
VAQTA® (Hepatitis A Vaccine, Inactivated) for Children Aged
>1 Year
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.
VAQTA is now indicated for active immunization of persons aged
>12 months to protect against disease caused by
hepatitis A virus. The primary vaccination schedule is
unchanged and consists of 2 doses, administered on a 0, 6--18 month
schedule. The Advisory Committee on Immunization Practices (ACIP) has issued recommendations for hepatitis A vaccination
(1).
Results from the study to lower the age indication for VAQTA indicated that 100% of 343 initially seronegative
children aged 12--23 months who received 2 doses of VAQTA had seroconverted to antibody levels previously indicated to
be protective. The study also indicated that VAQTA may be
administered concomitantly with M-M-R II (measles, mumps,
and rubella virus vaccine live). Insufficient data are available to evaluate the concomitant use of VAQTA with other
routinely recommended childhood vaccines. According to the general recommendations of ACIP, inactivated vaccines generally do
not interfere with the immune response to other inactivated or live vaccines
(2).
In combined clinical trials reported as part of the labeling change application, 706 healthy children aged 12--23
months received >1 doses of VAQTA alone or in combination with other routinely recommended pediatric vaccines. The
most commonly reported complaints after 1 or both doses of VAQTA were similar to those reported among older children
(1). VAQTA is contraindicated in persons with known hypersensitivity to any component of the vaccine.
Additional information is available from the manufacturer's package insert and at telephone 800-672-6372.
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