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.
RTS,S is the first malaria vaccine to be assessed by a regulatory agency, following decades of research.
In April, in a report published in the Lancet medical journal, scientists said the drug could make a "substantial contribution" to controlling malaria, which kills hundreds of thousands every year.
But the study's author, Brian Greenwood, of the London School of Hygiene and Tropical Medicine, admitted the vaccine was not "perfect".
He told Sky News: "Everyone accepts that this is not the perfect or the last malaria vaccine. It's not good enough to stop transmission but it will cut the huge burden of disease."
The drug has been developed by GSK in partnership with the Path Malaria Vaccine Initiative, a global programme established through an initial grant from the Bill & Melinda Gates Foundation.
Dr David C Kaslow, vice president of product development at Path, said the "regulatory landmark" was "a credit" to GSK's 30-year commitment to finding a vaccine.
He added: "Today marks a significant scientific milestone for the long-standing partnership to develop a vaccine, yet several more steps remain before a malaria vaccine might reach the young children in Africa who most need protection against this deadly human parasite.
"Path will continue to work with GSK and other partners to ensure that the evidence is available, as soon as possible, to support informed decision-making on those remaining steps."
Justin Forsyth, chief executive of Save the Children, said: "This is an extremely positive step towards being able to vaccinate children against malaria.
"Malaria is one of the biggest killers of children in the world, killing one child every minute, and Save the Children welcomes any treatment or preventative measure that has the potential to reduce the prevalence of this ruthless killer."
He added: "Any new treatment should be made affordable and a part of continued efforts to ensure that comprehensive strategies are in place to prevent and treat malaria, including strengthening the health systems that will help deliver such treatments."
The European Medicines Agency's approval is a requirement for a WHO policy recommendation, but national regulators will take the decision whether to license the vaccine.
WHO will provide its recommendations on the use of RTS,S by November this year, addressing implementation , cost-effectiveness, and the "public health value" of the vaccine compared to other malaria controls.