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

FDA Recommends Clinicians Temporarily Suspend Use of Vaccine as Agency Learns More

SILVER SPRING, Md., March 22 /PRNewswire-USNewswire/ -- FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine.  There is no evidence at this time that this finding poses a safety risk.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The agency recently became aware that an independent U.S. academic research team, using a novel technique, has found DNA from porcine circovirus 1 (PCV1) in Rotarix, which is manufactured by GlaxoSmithKline.  PCV1 is not known to cause illness in humans or other animals.  In addition, Rotarix has been studied extensively, before and after approval, and found to have an excellent safety record.


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SOURCE U.S. Food and Drug Administration
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