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WITHDRAWAL DATE: October 15, 1999
LOT NUMBER / EXPIRATION DATE:
All marketed lots.
MANUFACTURER:
Wyeth Laboratories Incorporated
A Wyeth-Ayerst Company
Marietta, PA 17547
MARKETED BY:
Wyeth-Lederle Vaccines and Pediatrics
Wyeth-Ayerst Laboratories
Philadelphia, PA 19101
REASON:
On July 16, 1999, Wyeth-Lederle Vaccines temporarily suspended further distribution and administration of RotaShield until more data on the potential association between vaccine administration and intussusception became available. The action was taken in consultation with the Food and Drug Administration following a recommendation from the Centers for Disease Control and Prevention to postpone administration because of reports to the Vaccine Adverse Events Reporting System (VAERS) of a possible association between the use of RotaShield and the development of intussusception.
At that time it was hoped that conclusive data would become available before the 1999-2000 rotavirus season. Evaluation of the additional cases of intussusception reported to VAERS, as well as preliminary date from ongoing epidemiological studies conducted by CDC, suggest a temporal association between the use of RotaShield and the development of intussusception. Additional studies are planned or in progress to better understand this relationship.
Available data do not indicate an ongoing risk to children given RotaShield in the past. This data will be publically discussed at the upcoming Advisory Committee on Immunization Practices meeting on October 22, 1999.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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