GSK Seeks Approval for World's First Malaria Vaccine

Source: Reuters

By: Kelland, Kate


British drugmaker GlaxoSmithKline is applying for regulatory approval for the world’s first malaria vaccine, called RTS,S, which is intended for use in children in Africa. Although aimed exclusively for use outside the European Union, the vaccine will be evaluated by the European Medicines Agency (EMA) in collaboration with the World Health Organization (WHO). Glaxo scientists have been working on the vaccine for 30 years, but a final-stage trial in babies aged six to 12 weeks showed that it provided only modest protection, reducing episodes of malaria by 30 percent compared to a control vaccine. The WHO has indicated that it may recommend use of RTS,S starting in 2015 if EMA regulators support its license application.

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