Wyeth-Lederle withdraws RotaShield vaccine - updated story

Wyeth-Lederle says it has voluntarily withdrawn its rotavirusgastroenteritis vaccine RotaShield (live oral tetravalent rotavirus) from the market and requested the immediate return of all doses of the product following reports of intussusception in infants.

Earlier this year, Wyeth-Lederle suspended distribution and administration of the vaccine after the Vaccine Adverse Events Reporting System received 15 reports of intussusception (Marketletter July 26). An additional five cases had also been documented by the Minnesota Department of Health.

However, the company received more bad news from the US Food and Drug Administration on September 14, after an agency medical reviewer reported that it had logged 99 cases - two of them fatal - of intussusception that may have been related to the firm's vaccine (Marketletter September 20). An estimated 1.5 million doses of rotavirus vaccine have been administered to infants since it was licensed on August 31, 1998. RotaShield was also approved for use throughout Europe but was never launched, pending a decision about the vaccine's future (Marketletter June 7).