Ebola vaccine trials could start in Africa in January

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Tue, 2014-10-21 18:21 — mike kraft

UPDATE: Drugmakers to join forces to make millions of Ebola vaccine doses

REUTERS Oct 22, 2014

LONDON -- Leading drugmakers plan to work together to speed up the development of an Ebola vaccine and hope to produce millions of doses for use next year.

U.S. firm Johnson & Johnson said on Wednesday that it aims to produce at least 1 million doses of its two-step vaccine next year and has already discussed collaboration with Britain's GlaxoSmithKline, which is working on a rival vaccine.

The economics of an Ebola vaccine are still unclear but drug companies with an eye on their reputations are under pressure to respond to the major international health crisis now ravaging one of the poorest corners of Africa.

J&J's head of research Paul Stoffels said it was important to have several experimental vaccine candidates in development, since it is not clear which ones will work, but resources could in future be focused on one clear winner.

GSK's chief executive Andrew Witty told reporters on Wednesday that a meeting of experts in Geneva this week would discuss ways to ensure that all companies, including those with no direct involvement in the Ebola work, pulled together to help remove supply bottlenecks.

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U.S.meanwhile asks drug companies for their production plans for Ebola drug ZMapp

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(USA TODAY Oct. 21, 2014

By Liz Szabo

Trials of Ebola vaccines could begin as early as January in the West African countries most affected by the virus, a World Health Organization official said Tuesday.

Although there are no approved vaccines or treatments for Ebola, experts have said that vaccines are the best hope of getting the outbreak in West Africa under control and preventing it from spreading across the rest of the continent.

(Photo: Michel Comte, AFP/Getty Images)

Scientists are racing to test the leading vaccine candidates. Others are in earlier stages of development.

The first human Ebola vaccine study began in September at the National Institutes of Health in Bethesda, Md., where the vaccine was developed. U.S. health officials say they expect to have preliminary data on safety and effectiveness by the end of this year. Human studies of this vaccine are also underway in the United Kingdom and the African nation of Mali, and it will be used in clinical trials in Switzerland by February, said Marie-Paule Kieny, WHO assistant director-general.

If the vaccine proves safe and effective in these early trials, the NIH vaccine could be shipped to West Africa early next year for "compassionate use," even if it's not yet approved, U.S. officials have said. The experimental vaccine could be made available to people at high risk for Ebola -- such as health workers -- just as companies have made the unapproved drugs ZMapp and TKM-Ebola available to infected patients.

Canada also has developed an Ebola vaccine and began shipping 800 vials to the WHO's headquarters in Switzerland Monday. The shipment is expected to arrive Wednesday. That vaccine, which has been licensed to NewLink Genetics in Iowa, will be used for clinical trials in Switzerland, Germany and the African nations of Gabon and Kenya, Kieny said.

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U.S. requests production plans for Ebola drug ZMapp

By Sharon Begley Oct. 17, 2012

Reuters) - U.S. officials have asked three advanced biology laboratories to submit plans for producing the experimental Ebola drug ZMapp, which ran out after it was given to a handful of medical workers who contracted the disease in West Africa, government and lab officials said on Friday.

The "task order" issued on Thursday by the Biomedical Advanced Research and Development Authority (BARDA) asks that detailed plans, including budgets and timetables, be submitted by Nov. 10.

Separately, Amgen Inc said on Friday that it will help create production lines for ZMapp using mammalian cells, a more traditional technique than the tobacco plants used to produce previous doses of ZMapp.

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