Rotavirus Vaccine Gets FDA Nod

A vaccine against rotavirus, a highly contagious bug that causes life-threatening diarrhea in young children, was deemed safe and effective by a U.S. Food and Drug Administration (FDA) advisory panel on Friday. Rotavirus killed 873,000 children last year, largely in underdeveloped countries.

The vaccine was created and patented by virologist and physician Albert Kapikian and his colleagues at the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland. It has been tested successfully on 18,000 children in numerous clinical trials in the United States, Finland, and Venezuela. In the latest trial, reported in the October issue of the Journal of Pediatrics, the vaccine prevented 70% of severe diarrhea cases on American Indian reservations, where incidence rates are higher than in the general U.S. population. "Not only could the routine use of this vaccine save lives and prevent illness, but it could save about $80 million [a year] in direct costs," says Mathuram Santosham, director of the Johns Hopkins Center for American Indian and Alaskan Native Health.

If approved by the FDA, the vaccine will be marketed by Wyeth-Ayerst Laboratories in St. David, Pennsylvania, for U.S. distribution. The vaccine would be administered in three doses at 2, 4, and 6 months of age along with the oral polio vaccine. The company is seeking a recommendation that all children be vaccinated against rotavirus from the Advisory Committee for Immunization Practices at the U.S. Centers for Disease Control and Prevention, which sets the schedule of childhood immunizations.