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

urope, 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 t
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SOURCE GlaxoSmithKline
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