FDA APPROVAL OF HAVRIX® (Hepatitis A Vaccine, Inactivated) for Persons Aged 1--18 Years.

On 17Oct05, 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. 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 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.

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).
[CDC. Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1999;48(No. RR-12).
CDC. General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51 (No. RR-2).]  [CDC, MMWR, 9Dec05 / 54(48);1235-1236]