GSK malaria vaccine cuts disease risk by half
pharmafile | October 19, 2011 | News story | Research and Development | malaria, malaria vaccine
Results from GSK’s malaria vaccine trial have excited observers after it reduced the risk of the disease by half.
Data from the Phase III trial, published in the New England Journal of Medicine, shows the RTS,S vaccine reduced the risk of malaria by half in 6,000 African children aged between five months and 17 months in the year after vaccination.
This is highly significant, since children under five years old in sub-Saharan Africa are thought to make up the majority of the more than 700,000 deaths worldwide from the disease each year.
Three doses of RTS,S reduced the risk of clinical malaria by 56% and severe malaria by 47%, where most children (75%) were also using insecticide-treated bed nets.
Results of the drug in infants aged six to 12 weeks is expected to be available by the end of 2012. Analysing severe malaria episodes in all 15,460 infants and children enrolled in the trial showed 35% efficacy for RTS,S.
The vaccine, which was invented by GSK Biologicals in the 1980s, is being developed in partnership with the PATH Malaria Vaccine Initiative (MVI), which gets the majority of its funding from the Bill & Melinda Gates Foundation.
GAVI Alliance, the public-private partnership which has all the leading pharma companies as members, said the results “deserve a hearty round of applause”.
Andrew Witty, chief executive of GSK, said: “These data bring us to the cusp of having the world’s first malaria vaccine, which has the potential to significantly improve the outlook for children living in malaria endemic regions across Africa.”
Severe adverse events such as seizures (thought to be related to fever) and meningitis (considered unlikely to be vaccine-related) were higher in the malaria vaccine group.
Further information about the longer-term protective effects of RTS,S, 30 months after the third dose, should be available by the end of 2014.
Assuming all goes well with the further Phase III programme, the World Health Organization has suggested that it could make a policy recommendation on the drug as early as 2015.
GSK has already said that the eventual price of RTS,S will cover the cost of manufacture plus a 5% return to be reinvested in R&D for second-generation malaria vaccines or vaccines for other tropical diseases.
Research into other anti-malaria drugs seems to be bearing fruit. In September, a Phase II trial of the candidate vaccine FMP2.1/AS02A in Mali found children receiving it were well protected against parasites that had a similar genetic make-up to the malaria strain used in the drug.
The vaccine would kill the malaria parasite as it emerges from the liver into the bloodstream.
Adam Hill
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