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

The US Food and Drug Administration (FDA) similarly has issued a statement confirming that there is no evidence that this finding poses a safety risk based on the excellent safety profile of Rotarix and evidence that PCV-1 is a known virus that does not multiply in humans and is not known to cause illness in humans. Rotarix has been produced according to FDA standards as reviewed and approved for US licensure in 2008. This notwithstanding, the FDA is recommending that US clinicians and public health professionals temporarily suspend the use of Rotarix as a precautionary measure. The FDA have also stated that they intend to convene an advisory committee, within approximately four to six weeks, to review the available data and make recommendations on rotavirus vaccines licensed in the USA.  The FDA will also seek input on the use of new techniques for identifying viruses in vaccines.

Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals stated: "No safety issue has been identified by external agencies or GSK.  GSK is committed to patient safety and to the highest manufacturing standards for all our vaccines and medicines. We are already working closely and discussing this finding with regulatory agencies around the world."

The safety profile of Rotarix is based on extensive clinical data from the largest vaccine clinical trial programme conducted by GSK, enrolling more than 90,000 participants in E
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SOURCE GlaxoSmithKline
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