The world's first malaria vaccine is to be considered for use in national immunisation programmes after being given the scientific seal of approval.
The medication, developed by GlaxoSmithKline (GSK), has been awarded "positive scientific opinion" by the European Medicines Agency, passing tests for safety and effectiveness.
The vaccination, known as RTS,S, has been approved for children aged six weeks to 17 months.
The World Health Organisation (WHO) will now produce guidance on use of the vaccine in immunisation programmes once it is passed by national regulatory authorities.
GSK chief executive Sir Andrew Witty said: "Today's scientific opinion represents a further important step towards making available for young children the world's first malaria vaccine.
"While 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.
"The work doesn't stop here and GSK remains committed to investing in R&D for malaria vaccines and treatments to find more ways to tackle this devastating disease."
Tests of the vaccination found that over the first 18 months, following three doses of RTS,S, malaria cases were reduced by almost half in children aged 15-17 months at the time of their first vaccination, and by 27% in children aged 6-12 weeks.
In areas where malaria was most prevalent, 6,000 cases were prevented over the study period for every 1,000 children vaccinated, according to results from the clinical trial.
GSK has said it will not make profit from the vaccine, but has not yet confirmed its cost.
The latest WHO figures show there were about 198 million cases of malaria in 2013 and an estimated 584,000 deaths.
Most fatalities occur among children living in Africa, where a child dies every minute from malaria, and the current most effective prevention measure is mosquito nets, while no licensed vaccine exists.