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FDA Asks Docs to Suspend Using Glaxo Rotavirus Vaccine
Date:3/22/2010

Rotarix is contaminated with pig virus but poses no known health risk, officials say,,

MONDAY, March 22 (HealthDay News) -- U.S. health officials recommended Monday that doctors temporarily stop using the Rotarix vaccine -- one of two brands available to prevent the diarrhea bug rotavirus -- for children until the source and any potential harm from a contamination of the vaccine has been identified.

Doses of the oral vaccine appear to be contaminated with a benign pig virus, according to officials at the U.S. Food and Drug Administration.

The recommendation comes after independent researchers found porcine circovirus 1 (PCV1) in Rotarix. This virus is not known to cause illness in humans, FDA Commissioner Dr. Margaret Hamburg said during an afternoon teleconference.

"There is no evidence at this time that this material from PCV1 in Rotarix poses any safety risk," Hamburg said. "PCV1 is not known to cause any disease in humans or animals."

Still, vaccines are supposed to be sterile and although Rotarix has a good safety record, finding PCV1 in the vaccine was unexpected, Hamburg said. Rotarix, made by drug giant GlaxoSmithKline, was licensed in 2008.

"While the agency is learning more about the situation, FDA is recommending that clinicians temporarily suspend the use of Rotarix vaccine," Hamburg said.

Rotavirus is a common cause of severe diarrhea among children, hospitalizing approximately 55,000 children each year in the United States. The virus is responsible for more than 600,000 children's deaths each year worldwide. The disease causes vomiting and watery diarrhea for three to eight days, along with fever and abdominal pain, according to the U.S. Centers for Disease Control and Prevention.

Hamburg said that PCV1 may have been present in Rotarix since the vaccine was developed. The contamination was found by independent researchers using new virus-spotting technology, sh
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