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GlaxoSmithKline Statement on New Information Relating to Manufacture of Rotarix (Rotavirus Vaccine)
Date:3/22/2010

LONDON, March 22 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today confirmed  that it has notified regulatory authorities of the presence of material from a virus called PCV-1 in its oral rotavirus vaccine, Rotarix™.  PCV-1 does not multiply in humans and is not known to cause illness in humans (1)(2). It is found in everyday meat products and is frequently eaten with no resulting disease or illness.

The material was first detected following work done by a research team in the US using a novel technique for looking for viruses and then confirmed by additional tests conducted by GlaxoSmithKline.  

Having reviewed the information and data submitted by GlaxoSmithKline, as well as information available regarding PCV-1 from the world's literature, the European Medicines Agency (EMA) and the World Health Organization (WHO) will also be issuing statements today confirming the positive balance of benefits and risks of the vaccine despite the presence of the material from PCV-1 and have not  recommended any change to the way that healthcare practitioners in Europe and the developing world use Rotarix.  


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