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Pin to quick picksGlaxosmithkline Share News (GSK)

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UPDATE 2-WHO says Ebola vaccine plans accelerating as trials advance

Fri, 24th Oct 2014 16:32

* Trials could begin in West Africa in December

* Drugmakers working with regulators to speed up development

* Hundreds of thousands of doses expected by mid-2015 (Recasts, adds quotes, detail)

By Stephanie Nebehay and Kate Kelland

GENEVA/LONDON, Oct 24 (Reuters) - Trials of Ebola vaccinescould begin in West Africa in December, a month earlier thanexpected, and hundreds of thousands of doses should be availablefor use by the middle of next year, the World HealthOrganization said on Friday.

Vaccines are being developed and made ready in record timeby drugmakers working with regulators, the U.N. health agencysaid, but questions remain about their safety and efficacy whichcan only be settled by full clinical trials.

"Vaccine is not a magic bullet, but when ready they may be agood part of the effort to turn the tide against the epidemic,"senior WHO official Marie-Paule Kieny told a news briefing aftera meeting in Geneva of industry executives, global healthexperts, drug regulators and funders.

"We are talking now about starting in December and notJanuary. So this shows again how everything is really pushedforward and the massive effort which is undertaken by everybodyto make this happen."

While financing was discussed, there were no details ofspecific funding pledges for Ebola vaccines' development,distribution and deployment.

"There is a broad understanding that money will not be anissue," said Kieny, the WHO's assistant director general forhealth systems and innovation. "And on commitment of vaccinemanufacturers, of course there is commitment for affordableprices."

Kieny said the World Bank would help to put together a fundto indemnify companies in case people had adverse reactions tothe new Ebola shots, with financing from development agencies.Britain had suggested setting up the fund and others had shownthey were also in favour of contributing, she said.

Two leading vaccine candidates from GlaxoSmithKline and NewLink Genetics are already in human clinicaltrials, and another five experimental vaccines would beginclinical trials in the first quarter of next year. One fromJohnson & Johnson will start trials in January.

Experts aim to conduct a range of different clinical trialsin Liberia, Sierra Leone and Guinea to produce the firstefficacy data by around April, she said. Plans are most advancedfor Liberia, where 20,000-30,000 volunteers would receive one oftwo Ebola vaccines or a placebo -- likely a vaccine forhepatitis, influenza or rabies.

At least 4,877 people have died in the world's worstrecorded outbreak of Ebola, and at least 9,936 cases of thedisease had been recorded as of Oct. 19, the WHO said onWednesday, but the true toll may be three times as much.

FINANCIAL BACKING

Mali on Thursday became the sixth West African country tohave a confirmed Ebola case in the worst outbreak on record ofthe haemorrhagic fever.

If data from accelerated safety trials in human volunteerssuggests they are safe to use, the plan is that several thousanddoses will be given to high risk groups such as frontline healthworkers in Guinea, Sierra Leone and Liberia by early next year.

"The message we heard from WHO that the people fighting theepidemic will be among the first to test Ebola vaccines andtreatments is exactly the one we needed to hear," said BertrandDraguez, medical director for international medical charityMedecins Sans Frontieres (Doctors Without Borders).

"Today, doctors and nurses involved in the struggle againstEbola are getting more and more frustrated as they have notreatment for patients with a disease that kills up to 80percent of them."

MSF and some of the WHO's donor countries have pledged tofinance vaccines, Kieny said, and the World Bank and GAVI, whichfunds vaccines for developing countries, were also interested. AGAVI board meeting is set for December on the issue, she said.

A mass immunisation programme would not happen until muchlater, when vaccine production has been ramped up.

A key unknown is how much vaccine each individual will needto get protection. If all goes well, and dosing per person ismoderate, drugmakers hope to produce millions of vaccines shotsby the end of 2015, reflecting an expected steep ramp-up inproduction during the year.

Despite the sense of urgency, one person involved in thisweek's discussions in Geneva said coordinating all the partiesin the process was not easy and there was still considerabledebate about how clinical trials should be designed and thestandard of evidence needed for regulatory approval. (Additional reporting by Ben Hirschler in London and Tom Milesin Geneva; Editing by Alison Williams)

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