LONDON, March 22 /PRNewswire-FirstCall/ -- GlaxoSmithKline 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(TM). 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.
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.
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."
Additionally, the post marketing surveillance data represents more than 69 million doses of Rotarix vaccine distributed globally and reflects an excellent safety profile.
GSK is now reviewing how best to replace, in a timely way, the cell bank and virus seeds used as base production material. In the meantime, and in accordance with the regulators, the company will continue to manufacture Rotarix to the existing approved production and quality standards to meet public health needs worldwide.
Notes to Editors
Rotarix(TM)
Rotarix is a two-dose, orally-administered vaccine that offers protection against rotavirus to infants. Rotarix is indicated for the active immunisation of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection.
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Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.
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