European Medicines Agency recommends RTS,S, or Mosquirix, developed by GSK and backed by Gates Foundation, for use in young children in Africa
The worldās first malaria vaccine has been given the green light by European regulators and could protect millions of children in sub-Saharan Africa from the life-threatening disease.
The European Medicines Agency recommended RTS,S, or Mosquirix, should be licensed for use in young children in Africa who are at risk of the mosquito-borne disease. The shot has been developed by UK drugmaker GlaxoSmithKline and partly funded by the Bill and Melinda Gates Foundation. It has taken 30 years to develop the shot, at a cost of more than $565m (Ā£364m) to date.
It will now be assessed by the World Health Organisation, which has promised to give its guidance on how and where it should be used before the end of the year. GSK will then apply to the WHO for a scientific review of the vaccine, which will be used by the UN and other agencies to help make purchasing decisions. The rollout of the vaccine, which also has to be approved by national health authorities in sub-Saharan Africa, is expected to be funded by Gavi, the vaccine alliance founded by the Gates Foundation.
According to the WHO, 627,000 deaths from malaria were reported globally in 2013, of which the vast majority (562,000) occurred in Africa, mostly among children under the age of five years (82%).
The EMA said its committee of experts āconsidered that the benefits of vaccination may be particularly important among children in high-transmission areas in which mortality is very highā.
The decision had been widely expected, even though the shot offers only partial protection against malaria in children below the age of five months.
Both the EMA and GSK stressed that the vaccine would need to be used alongside other tools such as bed nets and insecticides.
Sir Andrew Witty, GSKās chief executive, said the EMA decision was a further important step towards making the worldās first malaria vaccine available for young children.
He added: āWhile RTS,S on its own is not the complete answer to malaria, its use alongside those interventions currently available such as bed nets and insecticides, would provide a very meaningful contribution to controlling the impact of malaria on children in those African communities that need it the most.ā
GSK has committed to a not-for-profit price for the vaccine so that, if approved, the price would cover the cost of manufacturing the vaccine together with a small return of around 5% that will be reinvested in research on malaria and neglected tropical diseases. The drugmaker is reportedly looking at pricing the shot at $5 (about Ā£3.20) ā the same as an insecticide-treated bed net.
The vaccine has been developed at GSKās labs in Belgium in collaboration with the international non-profit organisation Path.
Source: The Guardian