FLICKR, NIAIDLast Thursday (January 22), the National Institutes of Health (NIH) announced that the first Ebola vaccine trials in West Africa would begin in Liberia in two weeks. As many as 27,000 Liberians will be treated with vaccine candidates that have already passed Phase 1 safety training in trials held outside the heart of the ongoing Ebola epidemic, which has kill more than 8,500 people, according to the World Health Organization.
“The number of reported Ebola cases has gone down, but the outbreak is not over until there are no cases in the area,” Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, told The Wall Street Journal.
The decline in new Ebola cases could make it more difficult for the trials in West Africa to demonstrate efficacy, but Fauci noted that as long as the vaccine candidates continue to prove safe and if they show evidence of an appropriate immune response, that data, along with results of animal studies, may be sufficient to earn approval from the US Food and Drug Administration.
GlaxoSmithKline said that the first doses of its chimp adenovirus-based vaccine candidate were shipped on a commercial flight from Belgium on Friday, though it may take a few weeks before the first patients are treated, Fauci noted during the press briefing last week. Moreover, the drug companies and the NIH are still working with the FDA on a few last trial details, he said. But in nine months to a year, Fauci said he expects the trail process will be complete.
NIH officials also noted at last week’s press briefing that another trial—albeit a much smaller one, involving only 150 patients or fewer—would soon begin in Liberia: one to test the Ebola drug candidate ZMapp, which has been used to successfully treat two American aid workers. But so far, very little ZMapp has been produced, The New York Times (NYT) reported, reducing the chances that—even if shown to be effective in clinical trials—the drug would be available in time to treat patients in the current epidemic.
“I think it’s inexcusable that they haven’t moved on it,” Philip Russell, a retired major general who once ran the United States Army Medical Research and Development Command, told NYT. “They’ve had months.”