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GSK files for approval of world’s first malaria vaccine

GlaxoSmithKline has submitted a regulatory application for its candidate malaria vaccine to the European Medicines Agency which will assess its safety and efficacy for developing countries.

EMA approval for the world’s first vaccine against the Plasmodium falciparum parasite, RTS,S, would support approval by the World Health Organization (WHO) for immunisation schedules. It would also serve as a basis for marketing applications to individual countries. In 2012, malaria caused an estimated 627,000 deaths, mostly among African children, according to the WHO.

The vaccine RTS,S is administered in three doses, one month apart. GSK says its final price will cover the costs of its manufacturing together with a “small return” of around 5% that will be reinvested in research for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065965

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