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* GSK's Mosquirix will be approved for babies in Africa
* Vaccine is first human vaccine against parasitic disease
* Mosquito-borne Malaria infects around 200 people a year
* The disease killed 584,000 in 2013, most of them children (Adds quotes, bullets, details on pricing, involvement ofAgenus)
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 should be licensed for use inbabies in Africa at risk of the mosquito-borne disease.
The shot, called RTS,S or Mosquirix and developed by Britishdrugmaker GlaxoSmithKline in partnership with the PATHMalaria Vaccine Initiative, would be the first licensed humanvaccine against a parasitic disease and could help preventmillions of cases of malaria in countries that use it.
Recommendations for a drug licence made by the EuropeanMedicines Agency (EMA) are normally endorsed by the EuropeanCommission within a couple of months.
Mosquirix, also part-funded by the Bill & Melinda GatesFoundation, will also now be assessed by the World HealthOrganization, which has promised to give its guidance on whenand where it should be used before the end of this year.
Malaria infects around 200 million people a year and killedan estimated 584,000 in 2013, the vast majority of them insub-Saharan Africa. More than 80 percent of malaria deaths arein children under the age of five.
Andrew Witty, GSK's chief executive, said EMA's positiverecommendation was a further important step towards making theworld'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 in astatement.
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.
Hopes that Mosquirix would be the final answer to wiping outmalaria were dampened when trial data released in 2011 and 2012showed it reduced episodes of malaria in babies aged 6-12 weeksby only 27 percent, and by around 46 percent in children aged5-17 months.
EMA's recommendation is that the shot should nevertheless belicensed for use in babies in the full age range covered in thetrials - from 6 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 Friday he has nodoubt the vaccine could significantly reduce the toll ofsickness and death 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 marginwhich 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. (Editing by Alison Williams and David Stamp)
