GSK seeks approval for the world's first malaria vaccineDrug maker GlaxoSmithKline is seeking regulatory approval for the world's first malaria vaccine after trial data showed that it had reduced cases in African children.
Known as RTS,S, the vaccine was found to have almost halved the number of malaria cases in young children in the trial and to have reduced the number of malaria cases in infants by about 25 percent.
GSK is developing RTS,S with the non-profit Path Malaria Vaccine Initiative (MVI), supported by funding from the Bill & Melinda Gates Foundation.
"Results from a large-scale Phase III trial, presented today in Durban, show that the most clinically advanced malaria vaccine candidate, RTS,S, continued to protect young children and infants from clinical malaria up to 18 months after vaccination," GSK said in a statement. "Based on these data, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA). The World Health Organization (WHO) has indicated that a policy recommendation for the RTS,S malaria vaccine candidate is possible as early as 2015 if it is granted a positive scientific opinion by EMA."
The malaria trial was Africa's largest-ever clinical trial involving almost 15,500 children in seven countries.
GSK has been developing the vaccine for three decades,
"In Africa we experience nearly 600,000 deaths annually from malaria, mainly children under five years of age," said Halidou Tinto, a lead investigator on the RTS,S trial from Burkina Faso. "Many millions of malaria cases fill the wards of our hospitals. Progress is being made with bed nets and other measures, but we need more tools to battle this terrible disease."
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