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.
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 Europe, Latin America, Asia, Africa and the US.
Additionally, the post marketing surveillance data represents more than 69 million doses of Rotarix vaccine distributed globally and reflects an excellent safety profile.
Retrospective testing of Rotarix, using new molecular detection techniques, has confirmed that material from PCV-1 has been present since the initial stages of the vaccine's development in the cell bank and rotavirus seeds used as base production material.
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.
Rotavirus is the leading cause of severe gastroenteritis among children below five years of age and it is estimated that more than half a million children die of rotavirus gastroenteritis each year- a child a minute worldwide. It is predicted that rotavirus vaccination could prevent more than 2 million rotavirus deaths over the next decade. The continued availability of rotavirus vaccines around the world remains critical from a public health perspective to protect children from rotavirus disease.
Notes to Editors
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.
Worldwide Rotarix sales in 2009 were 282million pounds Sterling with US representing 76million pounds Sterling.
GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
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.
1. Linlin Li, Journal of Virology, Feb. 2010, p. 1674–1682
2. Hattermann, Kim. Xenotransplantation 2004: 11: 284–294
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