GlaxoSmithKline has submitted potentially world's first malaria vaccine against malaria with regulators in Europe.

The vaccine, called RTS,S, is intended exclusively for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa. Around 90% of estimated deaths from malaria occur in that region, and 77% of these are in children under the age of five.

The assessment is being done by the European Medicines Agency in collaboration with the World Health Organisation but it will be evaluated for use in Africa only. The filing is supported by data from Phase III trials conducted at 13 African research centres in  Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania, including over 16,000 infants and young children.

Sophie Biernaux, head of the malaria vaccine franchise at GSK, said “this is a key moment in GSK’s 30-year journey to develop RTS,S and brings us a step closer to making available the world's first vaccine that can help protect children in Africa from malaria”. The company has invested more than $350 million to date and expects to spend a further $260 million until development is completed. It has been helped by $200 million in grants from the Bill & Melinda Gates Foundation and the PATH Malaria Vaccine Initiative.

GSK says the price of RTS,S will cover the cost of manufacturing the vaccine “together with a small return of around 5%” that will be reinvested in R&D for second-generation malaria vaccines or against other neglected tropical diseases. If a positive opinion from the EMA is granted, the WHO has indicated a policy recommendation may be possible by end of 2015.