GSK seeks approval for world's first malaria vaccine
GSK has applied for regulatory approval to European Medicines Agency (EMA) after trial results showed that malaria vaccine candidate RTS,S, reduced the deaths of children dying from malaria by half. Photo/FILE
What you need to know:
Malaria, a mosquito-borne parasitic disease, kills more than 600,000 people a year.
Around 90 per cent of estimated deaths from malaria occur in sub-Saharan Africa.
British drug-maker GlaxoSmithKline has applied for regulatory approval for the world's first vaccine against malaria.
The drug, GSK says, is designed for use in children in Africa.
They added the shot, called RTS,S, is intended exclusively for use outside the European Union but will be evaluated by the European Medicines Agency (EMA) in collaboration with the World Health Organisation (WHO).
Data from a phase III vaccine trial programme conducted at 13 research centres in eight African countries, including Kenya, has also been included to support the filing. The trial covered over 16,000 infants and young children.
Malaria, a mosquito-borne parasitic disease, kills more than 600,000 people a year. Around 90 per cent of estimated deaths from malaria occur in sub-Saharan Africa, and 77 per cent of these are in children under the age of five.
"An effective vaccine for use alongside other measures such as bed nets and anti-malarial medicines would represent an advance in malaria control," GSK said in a statement. The company has been working on a malaria vaccine for more than three decades.
Dr Sophie Biernaux, Head of the Malaria Vaccine Franchise, 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 malaria vaccine.”
The WHO has previously indicated it may recommend use of RTS,S from as early as 2015 if EMA drugs regulators back its licence application.
Developed in partnership with PATH Malaria Vaccine Initiative, and supported by grants from the Bill & Melinda Gates Foundation, the vaccine aims to trigger the immune system to defend against the malaria parasite, Plasmodium falciparum. GSK has invested more than $350 million in the vaccine to date and expects to invest a further $260 million until development is completed. More than $200 million of this was provided in grant monies by their partners.
