The European Medicines Agency gave a positive scientific opinion after assessing its safety and effectiveness.
It represents a ‘green light’ for the Mosquirix jab, developed by GlaxoSmithKline.
The World Health Organization will consider later this year whether to recommend it for children, among whom trials have yielded mixed results.
Malaria kills around 584,000 people a year worldwide, most of them children under five in sub-Saharan Africa.
‘Dream come true’
Mosquirix, otherwise known as the RTS,S vaccine, is the first against a parasitic infection in humans.
Dr Ripley Ballou, head of research at GSK vaccines, said: “This is a hugely significant moment. I’ve been working on this vaccine for 30 years and this is a dream come true.”
The company has not revealed the price of the vaccine, but has pledged not to make a profit from it.
It has been designed specifically to combat malaria infection in children in Africa and will not be licensed for travellers.