GSK participates in FDA advisory committee's rotavirus vaccine meeting

GlaxoSmithKlineMay 10 2010

GlaxoSmithKline (NYSE: GSK) today participated in a U.S. Food and Drug Administration (FDA) advisory committee meeting convened to discuss recent findings of porcine circovirus (PCV) in rotavirus vaccines. Although the committee did not issue any formal recommendations, members widely acknowledged that the benefits of vaccinating infants worldwide against rotavirus disease clearly outweigh the theoretical risks associated with the presence of porcine circovirus type 1 (PCV-1) in the vaccines.

The advisory committee also discussed current and emerging techniques to detect viruses and the implications of using such techniques to test vaccines currently licensed or in development.

GSK presented data from investigations conducted since the finding of material from PCV-1 in Rotarix® (Rotavirus Vaccine, Live, Oral). GSK had previously informed worldwide regulatory authorities of the finding. According to the FDA and other regulatory agencies around the world, there is no evidence that these findings pose a safety risk. As a precautionary measure, on March 22, 2010, FDA recommended that US healthcare practitioners temporarily suspend the use of Rotarix.

The European Medicines Agency (EMA) and the World Health Organization (WHO) have not recommended any change to the way that healthcare practitioners in Europe and the developing world use Rotarix.

According to scientific literature, PCV-1 is a common virus that has been found in pork products. It is not known to cause illness in humans or any other animals, including pigs. Testing of clinical samples conducted by GSK has not shown any indication of PCV-1 infection in infants who received Rotarix. This is consistent with the body of literature that has not shown any evidence of PCV-1 infection in humans.

GSK stands behind the safety profile of Rotarix. The company will work with regulatory authorities to continue to provide the vaccine to help protect children from rotavirus disease. GSK is committed to producing Rotarix that does not contain PCV-1.

Thomas Breuer, Head of Global Development, GSK Biologicals stated: "Evolving technologies can lead to new findings that were not known at the time of licensure. Decisions on the application of these new technologies must continue to be based on sound science and consideration of the benefit/risk profile of the respective vaccine. GSK is committed to an ongoing dialogue to ensure the worldwide availability of life-saving vaccines."

After considering the input of the committee's experts and the available scientific information, FDA will make further recommendations on the use of the licensed rotavirus vaccines in the United States.