Safe for babies?

The world's first malaria vaccine got a green light on Friday from European drugs regulators who recommended it as safe and effective to use in babies in Africa at risk of the mosquito-borne and lifer-threatening disease.

The shot, called Mosquirix and developed by British drug maker GlaxoSmithKline and the PATH Malaria Vaccine Initiative, would be the first licensed human vaccine against a parasitic disease and could help to prevent millions of cases of the killer disease in countries that use it, Reuters reported.

Mosquirix, whose scientific name is "RTS,S" has been designed to prevent malaria caused by the Plasmodium falciparum parasite, which is most prevalent in sub-Saharan Africa. It is the first vaccine to be developed which counters the effects of a parasite.

According to the WHO, 627,000 deaths from malaria were reported globally in 2013, of which the vast majority (562,000) occurred in Africa, mostly among children under the age of five years (82%).

Mosquirix, which is part-funded by the Bill and Melinda Gates Foundation, will now be assessed by the World Health Organisation (WHO), which said on Friday it would begin a review in October on when and where it could be used. The WHO aims to make a recommendation by November.

"We will look at the vaccine from the point of view of public health," WHO spokesman Gregory Hartl was quoted by Reuters as saying. "We need to think closely about how best to add - and if to add - a malaria vaccine across certain malaria endemic areas."

Andrew Witty, GSK's chief executive, said the European Medicines Agency's (EMA) positive opinion was an important step towards making the world's first malaria vaccine available.

"While RTS,S on its own is not the complete answer to malaria, its use alongside those interventions ... 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," he said. 

Mosquirix was assessed for quality, safety and efficacy under a special procedure that allows the EMA to evaluate a product even if it will not be marketed in the European Union.

Beyond the WHO's November recommendation, Mosquirix would still have to be reviewed by national regulatory authorities in any country wishing to use it. The WHO's Hartl said this meant it is unlikely to be rolled out anywhere until at least 2017. –End-

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