Via The Globe and Mail: U.S. sends experimental Canadian Ebola vaccine to trial.
Regulators in the United States have officially granted permission for the first human clinical trial of Canada’s experimental Ebola vaccine, a step that comes as experts from around the globe convene in Geneva to figure out how and to whom the world’s minuscule supply of barely tested Ebola drugs should be distributed.
NewLink Genetics Corp., the Iowa-based drug company the Public Health Agency of Canada licensed to produce the vaccine, announced Thursday that it has received approval from the U.S. Food and Drug Administration to start Phase 1 safety trials, the first of which is expected to be conducted south of the border in the coming weeks and involve about 40 healthy adult volunteers.
Subsequent human trials will also take place in Switzerland, Germany, Gabon and possibly other countries, said Brian Wiley, the vice-president of business development for NewLink Genetics, which sent representatives to the meeting in Geneva.
“These will all be Phase 1 trials in healthy volunteers and enroll between 40 and 100 patients each and will test the safety of the vaccine as well [as] measure whether volunteers develop the same levels of antibody response shown in monkeys that were protected against the virus in preclinical studies,” Mr. Wiley said by e-mail.
Canada announced in mid-August that it would donate to the World Health Organization (WHO) between 800 and 1,000 doses of an experimental vaccine developed at the National Microbiology Laboratory (NML) in Winnipeg, where the doses remain in storage.
Since then, the Ebola crisis in West Africa has grown steadily worse, with the WHO now reporting a death toll of nearly 1,900 and warning the outbreak could kill as many as 20,000 and take as long as nine months to quell.
That bleak assessment means there could still be time for experimental drugs – which are in short supply and generally take months to make – to be used more widely used during this outbreak, although the WHO has been careful to stress that supportive health care and the tracking of each patient’s contacts are the best way to halt the virus.