NAN — Aug 14, 2014
Dr Charles Link, Chief Executive, NewLink Genetics Corp, said in Geneva on Thursday that they have enough doses of Ebola vaccines on hand to launch the first human safety trial this summer.

NewLink Genetics Corp is the company that licensed an Ebola vaccine developed by Canadian government scientists.

Link said the company has also lined up two contract manufacturing companies and possibly a third one to be able to produce tens of thousands of vaccine doses within three months.

“Before that, I’d have said it would take eight to 10 months before we could launch human studies, but now it’s a matter of weeks.”

He said the move had become imperative because the largest Ebola outbreak in history had lent an unprecedented urgency to efforts to develop vaccines and treatments, which for years had largely languished.

Link said last week, the Ames, Iowa-based company’s wholly owned subsidiary, BioProtection Systems Corp, received one million dollars from the United States Defense Threat Reduction Agency (DTRA) for more pre-clinical toxicology studies.

He said it included stepped-up manufacturing, to allow human trials to begin quickly for the vaccine that was developed by scientists at the Public Health Agency of Canada.

Link said the company was in discussions with the U.S. Center for Disease Control and Prevention (CDC), the National Institutes of Health and Walter Reed Army Medical Center about where to conduct that trial and how to recruit volunteers.

“To get robust data, Link said the vaccine should be given to between 20 and 100 healthy volunteers, all of whom would give informed consent.

“Members of the military as well as medical workers on the front lines of the Ebola outbreak are the most likely participants’’, he added.

Link said before the trial can go forward, it needed FDA approval, which he expects to come quickly.

FDA spokeswoman Erica Jefferson said she could not confirm that the agency was in discussions with NewLink, because they were not generally allowed to disclose information about any medical product under development.

Link said at least one site for the human safety trial would be in the U.S.

He said the possibility of conducting a trial in Africa and recruiting medical workers had also been raised in frequent conversations between his company and the CDC, WHO and other agencies.

Source:
Nigeria News: Ebola Vaccine Trial Starts Soon – Official - http://leadership.ng/news/381026/ebola-vaccine-trial-starts-soon-official