* Clinical trials now under way to yield data on dosage
* Health workers should get GSK, NewLink vaccines in Jan
* Johnson & Johnson, Russia also have candidate vaccines
By Stephanie Nebehay
GENEVA, Oct 21 (Reuters) - Tens of thousands of people inWest Africa are expected to begin getting experimental Ebolavaccines from January, but population-wide immunisation is stillfar off, the World Health Organization (WHO) said on Tuesday.
Initial clinical trials of vaccines from GlaxoSmithKline and NewLink Genetics are already under way.Some 500 volunteers are due to take part in countries includingthe United States, Britain, Germany, Switzerland, Mali, Gabonand Kenya.
The tests will generate safety and immune-response data inDecember. The vaccines can then be rolled out early next year togroups including frontline healthcare workers, said Marie-PauleKieny, the WHO assistant director-general for health systems andinnovation.
"These data are absolutely crucial to allow decision-makingon what dose level should go into efficacy testing in Africa,"Kieny told a news briefing.
Determining the dosage will dictate the yield or overallamount of vaccine available for the large clinical trials inAfrica, she said.
"There is still a possibility that it will fail, buteverybody is putting things in order in order for being able tomove to West Africa in January," Kieny said. "When I saydeployed, I am not talking about mass vaccination, I am talkingabout utilisation in the tens of thousands of doses in the firstcouple of months of the year."
West Africa's Ebola outbreak, which began in March, haskilled 4,546 out of 9,191 known cases in Guinea, Liberia andSierra Leone, according to WHO, which has declared outbreaks inSenegal and Nigeria over.
There have been a handful of Ebola cases in Spain and theUnited States, which on Monday issued stringent new protocolsfor health workers treating Ebola victims.
FUNDING THE ROLL-OUT
Vaccine makers and regulatory authorities are moving quicklyto speed up trials and approval for the vaccines, Kieny said.Donors stand ready to help finance the roll-out, expected tocost hundreds of millions of dollars, she added.
"The funding scenario has not been worked out. But what weare working on for the time being is the assumption that thefunding will come from the countries who are helping with theresponse, so indeed the U.S., UK, France, Norway, Germany andmany others as well as from the GAVI," she said.
The Geneva-based GAVI alliance procures vaccines ataffordable prices for use in developing countries.
While the GSK and the NewLink vaccines, the latter developedby Canada's Public Health Agency and licensed to the U.S. firm,are considered "lead candidates", others are being developed.
Johnson & Johnson has a candidate vaccine that isexpected to start clinical trials in January, Kieny said.
Inovio Pharmaceuticals is developing a DNA vaccinethat would enter clinical tests early next year. ProteinSciences is developing a vaccine that should reach trials in thefirst quarter of 2015, she said. Both are U.S.-based companies.
Russia has been developing Ebola vaccines, but their statusis less clear, Kieny said.
"The best that I know is that one of the vaccines is eithercurrently or has already been in clinical trials, in Phase Iclinical trials, to assess safety and immunogenicity in Russia,"she said. "We are currently discussing with them to know a bitmore about what are the results and what are their plans."
Experimental drugs against Ebola include Fujifilm's flu drug Avigan, or favipiravir, the safety and efficacy ofwhich the French government will evaluate in a clinical trial inGuinea, she said. The trials are expected to start in comingweeks, she said.
Asked whether this would be the first drug used in trials inEbola-affected West African countries, Kieny said: "If it startson time, as far as I am aware, yes."
British scientists said on Tuesday that Avigan might alsohave potential against norovirus, or the winter vomiting bug.{ID:nL6N0SG324]
The U.S.-made drug ZMapp from Mapp Biopharmaceutical hasbeen given to a handful of infected health workers evacuatedfrom the region, but this has been on an ad hoc basis, she said. (Additional reporting by Tom Miles and Ben Hirschler; Editingby Larry King)
Glaxosmithkline (GSK)