The world's first malaria vaccine, backed by Bill Gates, has received a green light for future use in babies in sub-Saharan Africa.
The European Medicines Agency gave the Mosquirix vaccine a favorable review after 30 years of research by GlaxoSmithKline (GLAXF) and the PATH Malaria Vaccine Initiative.
The drug will now be examined by the World Health Organization. Individual countries will need to give the vaccine their final approval before it can be administered to children.
The trials showed the vaccine was most effective in newborn children between the ages of five and 17 months, cutting the number of malaria cases by almost a half. The number of cases in younger babies dropped by 27%.
Mosquirix is aimed at young children because their immune system is still developing.
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Unlike other vaccines that tackle viruses and bacteria, Mosquirix has been designed to prevent illness caused by a parasite. It works by stopping the malaria parasite maturing and multiplying in the liver, after which it would normally enter the patient's bloodstream and trigger the disease symptoms.
The vaccine is given out in three doses one month apart, with an additional booster dose a year and half later to maintain protection.
Even though malaria is preventable and treatable, the mosquito born disease killed 584,000 people in 2013, with 90% of the deaths occurring in sub-Saharan Africa. Of the victims, 83% were children under the age of five.
The World Health Organization lists malaria as the fifth biggest killer in sub-Saharan Africa.
Path is funded by the Bill and Melinda Gates Foundation, which poured more than $200 million into the project. GSK said it has spent more than $365 million on the effort. GSK said it will not make a profit from the vaccine. Its price would cover the manufacturing costs and a small return that would be reinvested in malaria research.
The vaccine is not yet licensed in countries where malaria is endemic, and the WHO says 2017 is the soonest that could happen.
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-- CNN's Debra Goldschmidt contributed to this article.
