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Chrissie Cole
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FDA – GSK's Rotavirus Vaccine Suspended

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Health officials from the U.S. Food and Drug Administration are warning doctors and parents against using the Rotarix rotavirus vaccine until further testing can determine if it is safe.

Rotarix, made by GlaxoSmithKline, contains pig virus (called porcine circovirus 1, or PCV1), according to researchers. The FDA said the virus is most likely harmless and that the vaccine appears to be safe. However, the recommendation will stand until the agency is able to determine how the virus got into the vaccine.

An estimated 69 million doses of the vaccine have been administered globally.

According to the FDA, the vaccine is given to young infants to prevent rotavirus disease, which can cause severe diarrhea and dehydration. Rotavirus disease kills more than 500,000 infants around the world each year, primarily in low- and middle-income countries

For more information visit FDA’s Update on Rotarix Vaccine page.