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news.GlaxoSmithKline has said that its rotavirus vaccine, Rotarix, has been awarded prequalification status by the World Health Organization making it the first vaccine against rotavirus gastroenteritis that has received such clearance.
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The WHO prequalification endorses the vaccine's quality, safety and efficacy, and its ability to fulfill tender specifications. This allows UN agencies, such as the Pan American Health Organization (PAHO), UNICEF and others to make large purchases and to use the vaccine in mass vaccination programs.
Rotavirus infects virtually every child in the world within the first five years of life and it is the most common cause of severe diarrhea in children worldwide.
Dr Jon Andrus, lead technical adviser for Immunization Unit, PAHO said the decision would help speed their delivery of these vaccines to the children who need them most and start saving more lives now.
WHO prequalification is an established mechanism to facilitate the supply of new vaccines to regions where they are most urgently needed.
“Prequalification will allow UN agencies to purchase and meet an ambitious goal of immunizing 80% of the world's children against rotavirus by 2015,” said Dr Ciro de Quadros, president and CEO of the Albert Sabin Vaccine Institute.