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October 2011

Promising results from malaria vaccine trial

October 21, 2011 --  The first results from a large-scale Phase 3 trial of the RTS,S malaria vaccine published online in the New England Journal of Medicine (NEJM), show the vaccine candidate provides young African children with significant protection against clinical and severe malaria with an acceptable safety and tolerability profile.

 

The trial, conducted at 11 trial sites in seven countries across sub-Saharan Africa, showed that three doses of RTS,S reduced the risk of children experiencing clinical malaria and severe malaria by 56% and 47%, respectively. This analysis was performed on data from the first 6,000 children aged 5 to 17 months, over a 12-month period following vaccination.

 

The trial is ongoing, and efficacy and safety results in 6 to 12 week-old infants are expected by the end of 2012. Further information about the longer-term protective effects of the vaccine, 30 months after the third dose, 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 organizations, to evaluate the benefits and risks of RTS,S.

 

Christopher Elias, president and CEO of PATH, said, “This trial represents a powerful example of the high-quality science that is moving us toward controlling and someday potentially eliminating malaria." GlaxoSmithKline, the PATH Malaria Vaccine Initiative (MVI) and the Bill & Melinda Gates Foundation have partnered together on the RTS,S, vaccine. "These data bring us to the cusp of having the world's first malaria vaccine," said Andrew Witty, chief executive of GSK.

"We are very happy with the results. We have never been closer to having a successful malaria vaccine," said Christian Loucq, director of PATH (MVI).

 

Insecticide-treated bednets, anti-malaria drugs and other tools have helped curb the number of cases of malaria around the world, but an effective vaccine has been a critical missing link in the fight against malaria. While this is an unprecedented success, global health experts cautioned against counting on the tool to fully eradicate malaria.

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