FDA Approves Vaccine Against Childhood Diarrhea

The U.S. Food and Drug Administration (FDA) this week approved the first vaccine against a leading cause of childhood diarrhea. The vaccine fights off infection by rotaviruses, which each year hospitalize more than 50,000 U.S. children and kill nearly 1 million children worldwide.

Rotaviruses attack the lining of the small intestine, often leading to severe diarrhea, vomiting, fever, and dehydration. The oral vaccine contains crippled live viral particles that trigger the body to produce antibodies, which fight off later infections by the bug. In clinical studies, the vaccine prevented 50% of rotaviral illnesses and cut severe diarrhea cases by 80% or more.

The vaccine was developed in the 1980s by virologist and physician Albert Kapikian and his colleagues at the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, and received an initial nod from an FDA advisory panel last December (ScienceNOW, 15 December 1997). The vaccine's approval makes it the best hope for combating a virus that is so prevalent that it infects 75% of children before age 5, says Kapikian.

The vaccine "could have a major impact in developing countries," adds National Institutes of Health virologist Catherine Laughlin. But she and others are concerned about just how quickly the vaccine can be distributed. Wyeth-Ayerst, the vaccine's manufacturer, says it plans to charge $38 a dose for the three-dose vaccine in the United States, but is awaiting regulatory approval in other countries before setting prices overseas. "It would be a tragedy if the price kept it from getting to the developing world," says Kapikian. But a Wyeth-Ayerst spokesperson says that the company has previously offered other vaccines at sharply reduced prices for developing countries and may follow that strategy here as well.