GlaxoSmithKline (GSK) has reported that its investigational malaria vaccine RTS,S reduced the risk of malaria in children by half during a phase III trial conducted in Africa.
The UK-based pharmaceutical company published the results of the study in the New England Journal of Medicine, with data suggesting that three doses of RTS,S reduced the risk of children experiencing clinical malaria and severe malaria by 56 per cent and 47 per cent, respectively.
The trial involved 6,000 children aged five to 17 months, who were analysed over a 12-month period following vaccination.
The vaccine is being developed in partnership by GSK and the PATH Malaria Vaccine Initiative (MVI), together with African research centres. Funding for clinical development comes from a grant by the Bill & Melinda Gates Foundation to MVI.
Bill Gates, co-chair of the Bill & Melinda Gates Foundation, said: "These results demonstrate the power of working with partners to create a malaria vaccine that has the potential to protect millions of children from this devastating disease."
Andrew Witty, CEO of GSK, commented that the results had brought the company "to the cusp" of the first malaria vaccine.
He said: "The addition of a malaria vaccine to existing control interventions such as bed nets and insecticide spraying could potentially help prevent millions of cases of this debilitating disease. It could also reduce the burden on hospital services, freeing up much needed beds to treat other patients who often live in remote villages, with little or no access to healthcare."
Further information about the longer-term protective effects of the RTS,S vaccine should be available by the end of 2014. This will provide evidence for national public health and regulatory authorities, as well as international public health organisations, to evaluate the benefits and risks of RTS,S 30 months after a child's third dose.
Results are still to be published regarding use of the vaccine in infants aged six to 12 weeks-old, with these expected by the end of 2012.
GSK said that the eventual price of RTS,S, if the vaccine is approved, would cover the cost of manufacturing the product together with a return of around 5 per cent that would be reinvested in research and development for second-generation malaria vaccines or vaccines against other neglected tropical diseases.
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