The U.S. Food and Drug Administration on Aug. 31 granted licensure for Rotashield® Rotavirus vaccine, a live, tetravalent vaccine for use in the prevention of rotavirus gastroenteritis. The rotavirus vaccine is approved for oral administration to infants in a three-dose series at 2, 4, and 6 months of age.

The approval of the rotavirus vaccine was based on evaluation of efficacy data from three large scale, placebo-controlled clinical efficacy trials conducted in the United States and Europe. The rotavirus vaccine will be distributed by Wyeth Lederle Vaccines, a unit of Wyeth - Ayerst Laboratories, and was available for marketing in Sept. 1998.

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