Lucylastic -> RE: Should the US close airports from Ebola ravaged countries? (10/22/2014 4:25:43 AM)
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ORIGINAL: DesideriScuri quote:
ORIGINAL: Marini Exactly Lucy, scientists all over the world should be working on a cure/or vaccine, Also, I would love to see a larger GLOBAL focus on assisting those countries, that are struggling to assist and meet the needs of those infected with Ebola. What makes you think scientists all over the world aren't working on a cure/vaccine? Those things don't happen overnight. some of the problems from canadas vaccine.... TORONTO -- The CEO of the company that holds the licence for a Canadian-made Ebola vaccine has a message for people who are frustrated by how long it is taking to get it into use in West Africa. The race to get the vaccine safety tested and made in sufficient quantities so that large studies can be rolled out in affected countries early next year is moving at warp speed, he suggests. "There haven't been any delays. We couldn't go any faster without really doing things dangerously," said Dr. Charles Link, CEO and chief scientific officer of NewLink Genetics, of Ames, Iowa. "I don't think humanity has ever tried to do something this complex, to be quite honest." \ In the circles of people working on plans to contain the devastating Ebola outbreak, there has been a lot of mumbling and some serious grumbling about whether NewLink -- a small biotech focused on developing cancer vaccines -- has the experience and wherewithal to push this important project forward. Earlier this week, Amir Attaran, a University of Ottawa law professor, said the Canadian government should terminate NewLink's licence, or green-light other manufacturers to make the vaccine using the so-called "carve out" clauses in the contract. They permit Canada to enlist other vaccine makers in emergencies. The Public Health Agency dodged the question when asked whether it was considering exercising its carve out options. In an emailed reply to the question, the agency talked at length about Canada's donation of 800 to 1,000 vials of the vaccine to the World Health Organization, but did not indicate if it is considering rescinding NewLink's licence or issuing new ones. NewLink licensed VSV-EBOV, as the vaccine is called, in 2010. With a consensus emerging that vaccines may be the only way to stop the outbreak that has engulfed Guinea, Sierra Leone and Liberia, many eyes have turned to this product, created at the National Microbiology Laboratory in Winnipeg. VSV-EBOV is one of only two experimental Ebola vaccines sufficiently developed at this point to be tested in people. The first human trials with the vaccine began in Bethesda, Md., last week and four more -- in Germany, Switzerland, Gabon and Kenya -- will start in the next few weeks. Dr. Marie-Paule Kieny, the World Health Organization's point person for Ebola vaccines and drugs, said Tuesday that about 250 people will be enrolled in these Phase 1 trials, which are aimed at showing whether the vaccine is safe to use in people. They will also determine how much vaccine is required to induce what should be a protective response. Link said the company has a batch of vaccine that is close to being ready. It is working with two European contract manufacturers to produce more, and anticipates having an American manufacturer signed on to help in the next couple of weeks. The company expects to have between 60,000 and 70,000 vials of VSV-EBOV by the end of the year, Link said. Depending on how much is required per person, those vials could represent 600,000 to 700,000 doses -- or six million to seven million. Link said preliminary work is already underway in Sierra Leone and Liberia to plan for the start of a Phase 3 trial there early in the New Year. The current idea would be to go from Phase 1 trials straight to Phase 3, the large trials meant to show if a drug or vaccines actually works, Link said. The Phase 3 trial would test the vaccine in thousands of volunteers, including health-care workers. Link spoke of a trial design that would see between 30,000 and 40,000 people randomly assigned to get VSV-EBOV, the other experimental vaccine which is being made by GlaxoSmithKline, or a placebo -- probably hepatitis B vaccine. Some argue the placebo arm is needed to show if these vaccines are actually protective. But a number of public health experts have denounced that plan, calling it unethical. "It's the $64,000 question that's being talked about all around the world right now," Link admitted. Hopes are high for the NewLink vaccine. Studies in animals suggest it can be given both to prevent infection before exposure to the virus -- the way childhood vaccines work -- and to mitigate the severity of the illness if given shortly after exposure. Lots more info here... Read more: http://www.ctvnews.ca/health/testing-of-canadian-ebola-vaccine-moving-as-fast-as-possible-newlink-ceo-1.2065137#ixzz3Gs7hZXzU
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