Clinical trials of an experimental Ebola vaccine developed in Canada will start within weeks, confirm officials with the company licensed to commercialize it as well as the World Health Organization.
This comes just days after scientists around the world raised concerns safety tests were being needlessly delayed because of intellectual property concerns.
"Treatment of the first patients in clinical trials is imminent at both the [U.S.] Department of Defence and the National Institute of Allergy and Infectious Disease," Brian Wiley, vice-president of business development at NewLink Genetics, stated in an email to CBC News on Friday.
"Emergency use protocols for humans have also been implemented. There are NO intellectual property issues or disputes."
The issue was raised by an article published this week on ScienceInside, a news website of the journal Science.
'We have to hurry'
Some of the strongest concerns came from Stephan Becker, head of the Institute of Virology at the University of Marburg.
"I had the feeling there is more delay than necessary, and then it was sometimes difficult to get in contact with the company and this was then after some weeks I got a bit irritated," he told CBC News.
Zita Somakoko of Winnipeg, who has family in Sierra Leone, says she's frustrated that politics is delaying the vaccine that could save people's lives. (Josiane Pelosse/Radio-Canada)
"I had hoped as well the outbreak is over until we have a vaccine at hand, but now with the developments in the last weeks, I don't think so. This outbreak will most likely take months until it will stop and therefore I guess we have to hurry with the vaccine and maybe it will help."
Becker said he couldn't understand the delays in getting the vaccine to clinical trials, especially since the Canadian government donated up to 1,000 doses of the experimental inoculation to the World Health Organization more than six weeks ago.
"I have the feeling this VSV vaccine is an ideal vaccine for an emergency because the time from vaccination until you get protection was very short in the animal model, the non-human primate, and this is exactly what you need in an emergency," he said.
"Moreover, even after the infection, it was possible in the non-human primate studies to give protection. This is really good," he added. "Therefore, I thought that this vaccine is very good and we shouldn't miss the opportunity it gives to us."
Situation is changing
In the last few days, though, after the journal article was published, Becker said the situation has changed.
"I currently have the feeling the company is really on board and providing everything necessary to get this clinical trial application together, so that I'm really confident we can start with this clinical trial within a certain amount of weeks," he said.
A spokesperson for the World Health Organization has also confirmed that Phase 1 clinical trials are underway or about to begin.
"This Canadian vaccine is one of two candidate vaccines that are undergoing quick evaluation to generate safety data for decision-making," Daniel Epstein said from Washington.
"A series of co-ordinated trials is going to be initiated, underway in North America as well as sites in Africa and Europe to… test their safety. The first Phase 1 trial of the Canadian vaccine is due to start early in October in the U.S."
Epstein denied there are any concerns about intellectual property or ownership.
"It's a question of science," he said. "Even though we're rushing the process as much as possible, the vaccines have to be safe and effective before they can be used, and that's what the process is going through now."
'People are dying,' says Winnipeg woman
The issue isn't just academic for Zita Somakoko, a Winnipeg resident with family in Sierra Leone and the organizer of a prayer vigil.
"I'm frustrated. I'm discouraged. There is no word to describe how we feel. There is a hope, but that hope is so far to our reach just because people have time for politics or they have time to debate matters. In the meantime, people are dying," she said.
"That's the reason why we are calling on God, because we don't know what else to do. We cry all the tears of our body at this point. How long will this continue — like, how? What will it take for people to know that people are dying every minute?"
In the House of Commons,the opposition NDP asked questions about the issue for a second day Friday during question period.
"The American pharmaceutical company NewLink Genetics said it wants to, quote, 'Be in control of clinical trials.' Because of the deal the Conservatives signed with the company in 2010, now the lawyers are holding it up," NDP MP Libby Davies said.
"The situation is very dire and Canada's vaccine could help now. Will the government tell NewLink Genetics to allow this vaccine to move or will they cancel the deal today so we can get this life-saving vaccine to where it's needed?"
'Canada owns the doses'
Eve Adams, parliamentary secretary for the minister of health, replied, "Let me be very clear about this: Canada owns the doses. We own the intellectual property rights to these doses. We have fully and completely donated up to 1,000 of these doses to the WHO. It is up to them to manage the logistics and dispense this as quickly and efficiently as possible."
CBC News has asked for a copy of the contract selling the licence to commercialize the vaccine to NewLink Genetics, but the Public Health Agency of Canada has refused, saying the documents are protected because they contain proprietary business information.
"The Canadian government owns the intellectual property associated with the VSV-EBOV vaccine and has licensed the rights to NewLink Genetics through its wholly owned subsidiary BioProtection Systems to further develop the product for use in humans," a spokesperson at the Public Health Agency of Canada wrote in an email.
"The Canadian government holds the patent for this vaccine and has licensed the rights to NewLink Genetics through its wholly owned subsidiary BioProtection Systems to commercialize the product. The agency retained rights related to research and emergency response."
NewLink Genetics says clinical trials were developed with experts at the U.S. National Institutes of Health, the U.S. Department of Defence, the Centers for Disease Control, the World Health Organization and the U.S. Food and Drug Administration, as well as European counterparts.
"NewLink is balancing the immediate need for urgency and compassionate use with the highest principles of ethical, scientific and regulatory standards to respond to this tragic human crisis," Wiley wrote.
Anda sedang membaca artikel tentang
Ebola vaccine trials will start in weeks, say WHO and company
Dengan url
http://pentingsehat.blogspot.com/2014/10/ebola-vaccine-trials-will-start-in.html
Anda boleh menyebar luaskannya atau mengcopy paste-nya
Ebola vaccine trials will start in weeks, say WHO and company
namun jangan lupa untuk meletakkan link
Ebola vaccine trials will start in weeks, say WHO and company
sebagai sumbernya
0 komentar:
Posting Komentar