The world’s first vaccine against malaria has been recommended to be licensed for use in babies in Africa.
Mosquirix is being developed by GlaxoSmithKline and backed by the Bill and Melinda Gates Foundation.
The European Medicines Agency endorsed the drug in what could be one of the final steps in a 30-year project, which has cost GSK more than £360m so far.
The vaccine was submitted for the committee’s review a year ago but will now need the approval of health officials in sub-Saharan Africa, where the disease affected 198 million people in 2013.
The vaccine could be a game changer, helping stem the 500,000 child deaths from the disease each year – most of them from Africa.
The World Health Organisation will also have to examine the vaccine, which could cost as little as $5, according to reports.
Andrew Witty, chief executive of GSK, said that while the vaccine alone was not a complete answer to malaria, it would provide “a very meaningful contribution” to fighting it alongside bed nets and insecticides.
Joe Cohen, a GSK scientist who has led the development of Mosquirix since 1987, added: “I have absolutely no reservations in terms of rolling this vaccine out.
“Why? Because the efficacy, when translated into cases averted and deaths averted, is just tremendous. It will have an enormously significant public health impact.”
Malaria is caused by a parasite carried in mosquito saliva and the vaccine is made to work at the point when the parasite enters the bloodstream after a bite.
It stimulates an immune response, trying to prevent the parasite from multiplying in the liver.
Without that response, the parasite goes back into the blood, infecting red blood cells, causing fever, aching and sometimes death.
While Mosquirix is the first big hope for protecting millions from the rampant disease, it has still come in for criticism.
Results published in the Lancet medical journal in April showed the vaccine only offers 50% protection for children aged between five and 17 months.
In babies around three months, it drops to 30%.
This would probably prevent it from being added to the infant vaccination programme.
It also needs a booster shot, as its effect weakens over time.
In April, Brian Greenwood of the London School of Hygiene and Tropical Medicine, said it was accepted that Mosquirix was not perfect and not the last vaccine that will be produced in order to fight malaria.
But he added that it would “cut the huge burden of disease” and preventing even some of the disease’s casualties “is not insignificant”.