The potential benefits of a licensed vaccine in developed countries such as the United States are noted by Drs. Keusch and Cash. "Studies in the United States indicate that the rhesus rotavirus-based quadrivalent vaccine is safe and can prevent nearly half of all rotavirus infections, 80 percent of severe episodes, and virtually all cases of dehydrating rotavirus illness."

The candidate vaccine is currently being reviewed by the Food and Drug Administration (FDA) for licensure in the United States. An FDA advisory committee will meet in early December to consider all the data and make their recommendation regarding licensure to the FDA.

The World Health Organization is following closely developments here and in the European Union in an effort to determine how and when the vaccine might also be made available in the developing world.

***Study Details***

The Venezuelan study, which began in March 1992, was conducted at a hospital specializing in obstetrics and pediatrics in a poor urban area southwest of Caracas. The hospital team enrolled 2,207 full-term, healthy infants, each assigned at random to receive three doses total of either the vaccine or a placebo. A small amount of reconstituted pink liquid vaccine or its look-alike was given by mouth to the infants at 2, 3 and 4 months of age. Neither the study investigators nor the infants' parents knew which product a child received until the study ended.

The babies were monitored at home by their parents and caretakers for episodes of diarrhea, defined as the presence of three or more liquid or semiliquid stools, or a single stool with blood, during a period of 24 hours, with or without vomiting. Those who had significant illness were brought to the
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Contact: Laurie K. Doepel
ldoepel@nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
22-Oct-1997