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UPDATE 1-WHO sees small-scale use of experimental Ebola vaccines in January

Fri, 26th Sep 2014 20:46

* WHO focused on candidate GSK, Newlink shots if shown safe

* Few hundred doses of ZMapp expected by year-end

* Blood transfusions, serum from survivors offer best hope (updates with new death toll in 2nd para)

By Stephanie Nebehay

GENEVA, Sept 26 (Reuters) - The World Health Organisation(WHO) said on Friday it expected to begin small-scale use of twoexperimental Ebola vaccines in West Africa early next year andin the meantime transfusions of survivors' blood may offer thebest hope of treatment.

WHO is working with pharmaceutical companies and regulatorsto accelerate the use of a range of potential treatments tofight the disease, a senior WHO official said. Ebola has no cureand has killed at least 3,091 out of 6,574 people infected inWest Africa since an outbreak began in March.

GlaxoSmithKline has begun clinical trials of itsvaccine in the United States and Britain, to be followed by atrial starting in Mali next week, while NewLink vaccinetrials are about to start in the United States and Germany, saidDr. Marie-Paule Kieny, WHO assistant director-general.

"If everything goes well again we might be able to start touse some of these vaccines in affected countries at the verybeginning of next year, in January. This will not be a massvaccination campaign, let's be clear about that because thequantity which will be available doesn't make this possible,"Kieny told a news briefing in Geneva.

She stressed however that the shots were experimental andhad not yet been shown to work against Ebola: "They have givenvery promising results in monkeys, but monkeys are not humans.

"We could still face a situation where these vaccines wouldbe unsafe in humans or where they would do nothing in terms ofprotection. So we need to be very prudent."

Data will be collected from clinical trials when theexperimental vaccines are being given to healthy volunteers whoare then monitored for adverse side effects and to see if theshot elicits an immune response in their blood.

Regulators at the European Medicines Agency (EMA) said onFriday they would begin reviewing data on experimental Ebolamedicines to support any decisions made on whether to use themfor treating patients.

Canada has given 800 vials of the NewLink candidate vaccineto WHO, expected to yield at least 1,500 doses, Kieny said. TheU.S.-based firm is "working very hard to produce a few morethousand doses in the coming months", she added.

GSK has said it hopes to have 10,000 doses of itsexperimental vaccine by the end of this year.

Kieny said an experimental Ebola vaccine being developed byJohnson & Johnson but not yet ready for trials in humanswas also under consideration.

ZMAPP DOSES BY YEAR-END

Experimental Ebola drugs including compounds from MappBiopharmaceutical, Sarepta and Tekmira will betested in affected states for the first time in a bid tofast-track trials, the Wellcome Trust said on Tuesday.

WHO is taking part in that effort, Kieny said. "We arestarting to discuss with African sites to see which would be themost suitable to test these new drugs and establish as soon aspossible which one gives an advantage for survival to patients."

ZMapp has been used to treat several Ebola patients who havesince recovered, but doctors cannot say for sure whether thedrug helped them or whether they would have recovered anyway.

"In terms of ZMapp the best, as we have known for a fewweeks now, is that maybe a few hundred doses will be availableby the end of the year. But clearly this is not the kind ofscale that can have impact on the epidemic curve," Kieny said ofthe drug by the California-based private biotech firm.

The use of blood transfusion and infusion of human serumfrom Ebola survivors is recognised as a "safe treatment", butdonated blood must be screened for infections including HIV andhepatitis, she said.

There was only anecdotal information on its use inEbola-infected healthcare workers, as there is no system inplace.

"Will it be efficacious? For the time being we don't knowbecause there are not enough people who have been treated,"Kieny said, adding that they could be counted on two hands.

"This is something where the African population doesn't haveto wait for anybody else to develop it for them. This is whythere is a lot of enthusiasm," Kieny said. (Additional reporting by Tom Miles in Geneva by Kate Kelland inLondon and David Lewis in Dakar; editing by Kate Kelland andGareth Jones)

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