Rotarix rotavirus vaccine contaminated, officials say

clipped from edition.cnn.com (CNN) -- Federal health authorities recommended Monday that doctors suspend using Rotarix, one of two vaccines licensed in the United States against rotavirus, saying the vaccine is contaminated with material from a pig virus. "There is no evidence at this time that this material poses a safety risk," Food and Drug Administration Commissioner Dr. Margaret Hamburg told reporters in a conference call. Rotarix, made by GlaxoSmithKline, was approved by the FDA in 2008. The contaminant material is DNA from porcine circovirus 1, a virus from pigs that is not known to cause disease in humans or animals, Hamburg said. About 1 million children in the United States and about 30 million worldwide have gotten Rotarix vaccine, she said. Rotavirus disease kills more than 500,000 infants around the world each year, primarily in low- and middle-income countries, she said. Before rotavirus vaccine became available, the disease was blamed for more than 50,000 hospitalizations

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FDA warns doctors about Glaxo rotavirus vaccine

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clipped from news.yahoo.com WASHINGTON – U.S. health officials urged pediatricians Monday to temporarily stop using one of two vaccines against a leading cause of diarrhea in babies, after discovering that doses of GlaxoSmithKline's Rotarix were contaminated with bits of an apparently benign pig virus. Glaxo's vaccine has been used in millions of children worldwide, including 1 million in the U.S., with no signs of safety problems — and the pig virus isn't known to cause any kind of illness in people or animals But vaccines are supposed to be sterile, and because there is a competing vaccine against diarrhea-causing rotavirus that has tested clean — Merck's RotaTeq — the FDA decided to err on the side of caution. Rotavirus causes severe diarrhea and is a leading child killer in developing countries. In the U.S., with better health care, about 55,000 children a year were hospitalized for rotavirus infections and several dozen died each year before vaccination began

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