The results of the phase III clinical trial of RTS,S, the first malaria vaccine candidate, were presented at the 6th Multilateral Initiative on Malaria Pan-African Conference (MIM) in Durban, South Africa on Tuesday, October 8. The data presented confirm the results published in the New England Journal of Medicine several months ago, showing that the vaccine was efficacious in close to 50% of African children aged 5 to 17 months and in 30% of infants vaccinated between 6 and 12 weeks. The results presented in Durban were from an independent evaluation of the efficacy of RTS,S by the 11 centres participating in the trial. The RTS,S trial, which is being conducted in seven countries, is the largest ever to be conducted in African children.
The new data, which are very much in line with results published to date, have led the main forces behind the development of the vaccine—the pharmaceutical company GlaxoSmithKline, the PATH Malaria Vaccine Initiative, and the Bill & Melinda Gates Foundation (which provided part of the necessary funding)—to confirm their plans to apply to the European Medicines Agency for marketing authorisation for RTS,S in 2014. If authorisation is granted, the World Health Organisation will then be faced with the challenge of deciding how to include a vaccine with moderate efficacy in its global strategies to control and eventually eliminate malaria.
Speaking in South Africa, Pedro Alonso, Director of ISGlobal, said that even though the vaccine has shown only partial efficacy, it still has an important role to play in malaria control strategies, particularly in countries with the highest burden of disease. The vaccine will complement not only existing malaria prevention tools, such as insecticide-impregnated mosquito nets, but also the timely administration of suitable treatment of confirmed cases. Dr. Alonso also highlighted that fact that this first generation of malaria vaccines represents a giant step for science and the fight against malaria.