Experimental Ebola vaccine that Canada has donated to the World Health Organization will be shipped to Geneva next week, the global health agency said Thursday.
The WHO is finalizing the legal agreement needed for it to take possession of between 800 and 1,000 vials of donated vaccine. Once that contract is signed the vaccine will then be shipped, a senior official told The Canadian Press.
"We are negotiating the final agreement and we should have it signed, I hope, by the beginning of next week. And we should be able to move the vaccine next week," said Dr. Marie-Paule Kieny, the WHO's assistant director general for health systems and innovation.
"This is why the vaccine is not yet in Geneva, and not then distributed further."
The Public Health Agency of Canada — whose scientists invented the vaccine and which paid to have the vials produced — said the vaccine will be sent when the request comes.
"PHAC is confirming the details with the WHO and stands ready to ship," a spokesperson from the agency said in an email.
Soon-to-start clinical trials will establish if the vaccine is safe to use in people and how much — or little — is needed to protect a person. It is hoped the results will show that a low dose can be used, which would mean each vial might contain up to 100 doses of vaccine.
If Canada transfers 1,000 vials to the WHO and if 100 doses can be obtained from each vial, the Canadian donation could turn out to be 100,000 doses of vaccine. The studies may show each person will need two doses of vaccine to gain protection, a priming and a boosting dose.
Kieny said the vaccine was left at the National Microbiology Laboratory in Winnipeg while plans were being worked out on who would conduct clinical trials of the experimental vaccine and where those trials would take place.
Until those plans were nearing completion, there was no need to have the vaccine in Geneva, Kieny said. The Winnipeg lab had the capacity to safely store the vials and the Geneva hospital that will hold the vaccine for the WHO had to purchase a special freezer to store it at -80 C.
The vaccine, called VSV-EBOV, was created by scientists at the Winnipeg lab.
Canada holds the intellectual property rights to the vaccine but has licensed the rights to a small American biotech company, NewLink Genetics. Based in Ames, Iowa, the company's primary focus — until recently — has been the development of cancer vaccines. It does not have its own vaccine production facility and has never brought a product through the expensive and onerous process of gaining regulatory approval.
But because it holds the licence to one of a very few experimental Ebola vaccines — and one of only two ready for human safety trials — NewLink has found itself at the centre of a storm.
While the company has been getting assistance from a U.S. government agency — the Biomedical Advanced Research and Development Authority, or BARDA — frustrated scientists and others have questioned whether the company has the resources, finances and clout to push the vaccine forward.
In an interview earlier this week, NewLink's vice-president of business development, Brian Wiley, said the company has been working as fast as it can.
"Our primary goal is to do this in the most accelerated, most ethical way possible to ensure the likelihood of success," Wiley said.
Meanwhile clinical trials of the other vaccine being tested in people started last month. That vaccine, called cAd3, was designed by scientists at the U.S. National Institute for Allergy and Infectious Diseases.
On Thursday, investigators studying cAd3 started injecting the vaccine into volunteers — health-care workers and other health sector front-line workers — in Mali, in West Africa. This is the first time a clinical trial of an Ebola drug or vaccine has been conducted in Africa.
The clinical trial is a joint venture of the University of Maryland School of Medicine, the Center for Vaccine Development of Mali and the Ministry of Health of Mali.
Mali borders on Guinea — where the outbreak began late last year — making it a country at high risk of having cases. But to date it has not reported any.
NewLink's Wiley said five clinical trials of the VSV-EBOV vaccine will soon be under way in the United States (two), Germany, Switzerland and in an unnamed African country which is not battling Ebola.
As well, Canada wants to conduct a clinical trial in this country.
Kieny says researchers who will conduct the European and African clinical trials should be submitting their proposals to their regulatory agencies next week, which means they will soon need supplies of vaccine.
"This is why we are finalizing this agreement in order to be able to move it, so that we can provide it on time," Kieny said.
This Ebola outbreak is the largest in history. The WHO is currently pegging the case count at 8,033 infections and 3,865 deaths. But it noted in a grimly worded report Wednesday that the ability to record accurate counts is declining, especially in Liberia.
Because the number of cases has far outstripped the capacity to care for the ill, infected people are being cared for — and in many cases, dying — in the community, without coming to the attention of authorities.