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Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk
Date:3/22/2010

Follow-up tests by GlaxoSmithKline and FDA scientists confirmed the academic team's findings and confirmed that viral components have been present since the early stages of the vaccine's development, including during clinical studies.  Preliminary testing by both the academic researchers and FDA scientists of another licensed vaccine against rotavirus infection, RotaTeq, has not detected components of PCV1.

"We are making clinicians aware of information recently received by FDA about the Rotarix vaccine," said Dr. Margaret A. Hamburg, Commissioner for Food and Drugs. "There is no evidence at this time that there is a safety concern.  FDA is recommending that clinicians temporarily suspend use of Rotarix until we can learn more about the situation.  We will keep the public and the clinical community updated on our findings."

Rotarix and RotaTeq are given by mouth to young infants to prevent rotavirus disease, which can cause severe diarrhea and dehydration and is estimated to be responsible for the deaths of more than 500,000 infants around the world each year, primarily in low- and middle-income countries.  Before the introduction of a rotavirus vaccine, rotavirus resulted in more than 50,000 hospitalizations and several dozen deaths in the United States each year.  FDA licensed RotaTeq in 2006 and Rotarix in 2008.  M
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SOURCE U.S. Food and Drug Administration
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