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Notice to Readers: FDA Approval of
Havrix® (Hepatitis A Vaccine, Inactivated) for Persons Aged 1--18 Years
On October 17, 2005, the Food and Drug Administration approved an application to allow use of the
pediatric/adolescent formulation of
Havrix® (hepatitis A vaccine, inactivated) (GlaxoSmithKline Biologicals, Rixensart, Belgium) for persons
aged 1--18 years. Previously, pediatric use of Havrix was approved for use in persons aged 2--18 years.
Vaccine Description
The formulation, dosage, and schedule for Havrix were not changed. Each 0.5-mL dose of pediatric/adolescent
Havrix contains 720 enzyme-linked immunosorbent assay units of formalin-inactivated hepatitis A viral antigen adsorbed
onto aluminum hydroxide. The formulation contains 0.5%
2-phenoxyethanol as a preservative.
The pediatric/adolescent formulation of Havrix is indicated for vaccination of persons aged 1--18 years against
disease caused by hepatitis A virus. Recommendations for hepatitis A vaccination have been published previously
(1) and are periodically updated. The primary vaccination schedule is
unchanged and consists of 2 doses, administered on a 0,
6--12-month schedule.
In a study presented as part of the labeling change application, 99% of 218 children aged 11--13 months and 100% of
200 children aged 15--18 months who received 2 doses of Havrix developed a vaccine response. The approval
included concomitant use of Havrix with Haemophilus influenzae
type b conjugate vaccine (PRP-T Hib). Data regarding
concomitant use with other routinely recommended childhood vaccines are limited. According to general recommendations of the
Advisory Committee on Immunization Practices, inactivated vaccines usually do not interfere with the immune
response to other inactivated or live vaccines
(2).
Among the 723 healthy children who received 1 or more dose of Havrix, the most common adverse events were
similar among children aged 11--18 months and children aged 23--25 months. Havrix is contraindicated in persons with
known hypersensitivity to any component of the vaccine. Additional information is available from the manufacturer's package
insert and GlaxoSmithKline Biologicals at telephone 888-825-5249.
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