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* EU regulators back GSK's Mosquirix for babies in Africa
* Product is first human vaccine against a parasitic disease
* Mosquito-borne malaria infects 200 million people a year
* WHO to assess vaccine in October before possible rollout (Adds WHO giving date for its review, WHO quotes)
By Kate Kelland, Health and Science Correspondent
LONDON, July 24 (Reuters) - The world's first malariavaccine got a green light on Friday from European drugsregulators who recommended it as safe and effective to use inbabies in Africa at risk of the mosquito-borne disease.
The shot, called Mosquirix and developed by Britishdrugmaker GlaxoSmithKline and the PATH Malaria VaccineInitiative, would be the first licensed human vaccine against aparasitic disease and could help to prevent millions of cases ofthe killer disease in countries that use it.
It still faces hurdles before being rolled out in Africa,including winning agreement from governments and other fundersthat it is worth using, since it offers only partial protection.
Mosquirix, also known as RTS,S and part-funded by the Bill &Melinda Gates Foundation, will now be assessed by the WorldHealth Organization (WHO), which said on Friday it would begin areview in October on when and where it could be used. The WHOaims to make a recommendation by November.
"We will look at the vaccine from the point of view ofpublic health," said WHO spokesman Gregory Hartl. "We need tothink closely about how best to add - and if to add - a malariavaccine across certain malaria endemic areas."
Malaria is one of the biggest killers of children in theworld, claiming the life of one child every minute. It infectsaround 200 million people a year and killed an estimated 584,000people in 2013, the vast majority of them babies in sub-SaharanAfrica.
Andrew Witty, GSK's chief executive, said the EuropeanMedicines Agency's (EMA) positive opinion was an important steptowards making the world's first malaria vaccine available.
"While RTS,S on its own is not the complete answer tomalaria, its use alongside those interventions ... such as bednets and insecticides would provide a very meaningfulcontribution to controlling the impact of malaria on children inthose African communities that need it the most," he said.
Mosquirix was assessed for quality, safety and efficacyunder a special procedure that allows the EMA to evaluate aproduct even if it will not be marketed in the European Union.
Beyond the WHO's November recommendation, Mosquirix wouldstill have to be reviewed by national regulatory authorities inany country wishing to use it. The WHO's Hartl said this meantit is unlikely to be rolled out anywhere until at least 2017.
Global health experts have long hoped scientists would beable to develop an effective malaria vaccine, and researchers atGSK have been working on RTS,S for 30 years. The shot alsocontains an adjuvant, or booster, made by U.S. biotech companyAgenus.
Expectations that Mosquirix could be a final answer towiping out malaria were dampened when trial data released in2011 and 2012 showed it reduced episodes of malaria in babiesaged 6-12 weeks by only 27 percent, and by around 46 percent inchildren aged 5-17 months.
The EMA recommendation is that the shot should neverthelessbe used in babies in the full age range covered in the trials,from six weeks to 17 months.
Some malaria specialists have expressed concern that thecomplexities and potential costs of deploying this first vaccinewhen it provides only partial protection make it less attractiveand more risky.
"The timing, duration, and outcomes of some of the criticalsteps to possible vaccine implementation in African countriesare not yet known," said David Kaslow, PATH's vice president ofproduct development.
However Joe Cohen, a GSK scientist who has led thedevelopment of Mosquirix since 1987, said on he had no doubt thevaccine could significantly reduce the toll of sickness anddeath caused by the malaria among African children.
"I have absolutely no reservations in terms of rolling thisvaccine out," he told Reuters. "Why? Because the efficacy, whentranslated into cases averted and deaths averted, is justtremendous. It will have an enormously significant public healthimpact."
GSK has promised it will make no profit from Mosquirix,pricing it at the cost of manufacture plus a 5 percent margin,which it will reinvest in research on malaria and otherneglected tropical diseases.
Sources involved in planning for Mosquirix's potentialfuture use have told Reuters they've been advised to work with aprice tag of around $5 per dose, which would bring the cost of arecommended four-dose immunisation to $20. (Additional reporting by Ben Hirschler in London and StephanieNebehay in Geneva, editing by Alison Williams and David Stamp)
