Glaxo Seeks Approval for World’s First Malaria Vaccine

GlaxoSmithKline Plc (GSK) applied for regulatory approval of its experimental malaria vaccine, bringing it closer to becoming the first shot against the world’s deadliest mosquito-borne disease.

Glaxo is seeking approval to sell its RTS,S vaccine exclusively outside the European Union, London-based Glaxo said in a statement today. The request is part of a process in which the European Medicines Agency can assess a product made in an EU member state against a disease recognized by the World Health Organization as a major public health interest, for use in the rest of the world.

Malaria killed about 627,000 people in 2012, mostly children in sub-Saharan Africa, according to the WHO. A trial of Glaxo’s vaccine, which took three decades to develop, showed it reduced infections by 46 percent in infants ages 5 months to 17 months, and by 27 percent for 6-to-12-week-old babies.

This “brings us a step closer to making available the world’s first vaccine that can help protect children in Africa from malaria,” Sophie Biernaux, head of Glaxo’s malaria business, said in the statement.

Glaxo has invested more than $350 million in developing the shot and expects to spend a further $260 million on it, according to the statement. The company has said it plans make about a 5 percent profit on sales of the vaccine, which it will reinvest in research on malaria or other neglected tropical diseases.

To contact the reporter on this story: Simeon Bennett in Geneva at sbennett9@bloomberg.net

To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net Thomas Mulier, Robert Valpuesta

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