Dr. Gary Kobinger, chief of special pathogens at Canada's National Microbiology Laboratory in Winnipeg, suggested this outbreak — the largest on record — will speed efforts to get emergency use approvals to employ some of the experimental vaccines and therapies in future Ebola epidemics.
"My really, really deepest wish — and I don't want to call this a dream, because it's not a dream — is that there won't be another outbreak like this. (That) this is the last one. Next time, we'll be ready," Kobinger said in an interview Monday.
But Kobinger agreed with others in his field who have argued that it would be unwise to use these untested tools this time, saying the Ebola vaccines and drugs must go through Phase 1 clinical trials in people before they could be used in an outbreak setting. Phase 1 trials involve giving a drug or vaccine to a small number of healthy adult volunteers to ensure that it is safe for human use.
"These are all experimental drugs that have not met the requirements ... even for a Phase 1 (trial) right now in humans. So they have to pass all the toxicity (tests), they have to pass the safety trials," he said.
A case that serves as a reminder of the importance of clearing these regulatory hurdles involves an Ebola drug being developed by Tekmira Pharmaceuticals Corporation of Burnaby, B.C. Their product was one of the Ebola treatments considered to be furthest along in the developmental pipeline.
The company was recently told to suspend its Phase 1 trial by the U.S. Food and Drug Administration, which is demanding more information about a reaction experienced by one of the subjects in the study. On Monday, Tekmira said it was preparing its response to the FDA's clinical "hold" letter.
Kobinger and two other researchers from the Winnipeg laboratory — Allen Grolla and Dr. Jim Strong — returned late last week after nearly a month in Guinea and Sierra Leone, working as part of the international efforts to contain the prolonged outbreak. Grolla and Strong are both specialists in diagnostics for special pathogens, the term used by laboratories to describe deadly viruses such as Ebola and the related Marburg virus.
The team was replaced by a second trio from the Winnipeg lab and plans are already underway to send a third to spell them off when their month-long mission is done.
The Canadian team spent much of its mission at Kailahun, in eastern Sierra Leone, near where the country intersects with Guinea and Liberia. The team set up and operated a laboratory there, testing people suspected of being infected with the virus.
Identifying and isolating infected people is the primary function of response teams in Ebola outbreaks. With limited medical treatment to offer, the goal is to bring outbreaks to an end by stopping transmission.
The most recent update from the World Health Organization says that as of July 17 there had been 1,048 cases in the outbreak and 632 of those people have died. Cases have occurred in Guinea, Sierra Leone and Liberia, reflecting a pattern of movement of people within the three countries that has contributed significantly to the complexity of combating this outbreak.
Kobinger said the outbreak is the most challenging of the six Ebola responses he has been on, but he believes the containment efforts are making progress.
Over the past 15 years or so the Winnipeg lab and several in the United States have made significant headway in developing Ebola vaccines and treatments that look highly promising when studied in non-human primates. The vaccines even appear to prevent death in some cases when given after exposure to the virus, if they are administered quickly enough.
But bringing these treatments to the field has proven to be difficult, with financial and regulatory hurdles frustrating the best efforts of the scientists involved.
The scale of this outbreak is renewing interest in breaking down those barriers, however. A number of experts are now talking of the need, once this outbreak is over, to chart a path so the next time there will be therapeutic options.Suggest a correction