The development of a vaccine to prevent severe diarrhoea caused by rotavirus has been a very complex process that has marked landmarks in the world and generated new rules for vaccine development. The studies of Venezuela have been critical for the development and registration of the first rotavirus vaccine (RotaShield) and also in the studies with the new vaccine (Rotarix), recently registered in Mexico (July 2004) for GlaxoSmithKline (GSK). This process constitutes an innovative registration, commercialization and production strategy of a biological product that it has been carried out from studies of effectiveness, mainly, in latinamerican countries, where the vaccine is needed. In this work the current situation of the human vaccine Rotarix is described.
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