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Leaked documents reveal behind-the-scenes Ebola vaccine issues

SCIENCE INSIDER

By Jon Cohen and  Kai Kupferschmidt                          OCT.23, 2014

Extensive background documents from a meeting that took place today at the World Health Organization (WHO) have provided new details about exactly what it will take to test, produce, and bankroll Ebola vaccines, which could be a potential game changer in the epidemic.

ScienceInsider obtained materials that vaccinemakers, governments, and WHO provided to the 100 or so participants at a meeting on “access and financing” of Ebola vaccines. The documents put hard numbers on what until now have been somewhat fuzzy academic discussions. And they make clear to the attendees—who include representatives from governments, industry, philanthropies, and nongovernmental organizations—that although testing and production are moving forward at record speed, knotty issues remain. 

Read complete article

http://news.sciencemag.org/health/2014/10/leaked-documents-reveal-behind...

Also see previous posting of three articles on plans  for vaccine and and antibody testing

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WHO says Ebola vaccine plans accelerating as trials advance

WHO ANNOUNCES  EBOLA VACCINE TRIALS WILL BE SPEEDED UP TO DECEMBER.
THREE RELATED STORIES.   (Scroll down)

REUTERS                                       OCT. 24

By Stephanie Nebehay and Kate Kelland

GENEVA/LONDON, Oct 24 (Reuters) - Trials of Ebola vaccines could begin in West Africa in December, a month earlier than expected, and hundreds of thousands of doses should be available for use by the middle of next year, the World Health Organization said on Friday.

Vaccines are being developed and made ready in record time by drugmakers working with regulators, the U.N. health agency said, but questions remain about their safety and efficacy which can only be settled by full clinical trials.

"Vaccine is not a magic bullet, but when ready they may be a good part of the effort to turn the tide against the epidemic," senior WHO official Marie-Paule Kieny told a news briefing after a meeting in Geneva of industry executives, global health experts, drug regulators and funders.

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Ebola kills, but it may be immunizing others at the same time

HOMELAND SECURITY NEWS WIRE                                         Oct. 22, 2014

Two Ebola researchers suggest that as Ebola continues to spread in West Africa, it may be silently immunizing large numbers of people who never fall ill or infect others, yet become protected from future infection. If such immunity is confirmed, it would have significant ramifications on projections of how widespread the disease will be and could help determine strategies that health workers use to contain the disease, according to a letter published last week in The Lancet medical journal.   http://download.thelancet.com/flatcontentassets/pdfs/PIIS014067361461839...

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21-day quarantine for Ebola may not be enough to prevent spread of virus: Study

HOMELAND SECURITY NEWS WIRE                                              Oct. 20, 2014

As medical personnel and public health officials are responding to the first reported cases of Ebola Virus in the United States, many of the safety and treatment procedures for treating the virus and preventing its spread are being reexamined. One of the tenets for minimizing the risk of spreading the disease has been a 21-day quarantine period for individuals who might have been exposed to the virus.

 A new study by Charles Haas, Ph.D., a professor in Drexel’s College of Engineering, suggests, however, that twenty-one days might not be enough completely to prevent spread of the virus.

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http://www.homelandsecuritynewswire.com/dr20141020-21day-quarantine-for-...

Link to the study
http://currents.plos.org/outbreaks/article/on-the-quarantine-period-for-...

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Ebola vaccine trials could start in Africa in January

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

REUTERS                                                                     Oct 22, 2014

By Ben Hirschler

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.

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Long Quest for Ebola Vaccine Slowed by Science, Ethics, Politics

An experimental Ebola vaccine has been developed by the U.S. National Institutes of Health and pharmaceutical company GlaxoSmithKline. Photograph by Steve Parsons, AP

Image: An experimental Ebola vaccine has been developed by the U.S. National Institutes of Health and pharmaceutical company GlaxoSmithKline. Photograph by Steve Parsons, AP

news.nationalgeographic.com - October 14th, 2014 - Karen Weintraub

Ebola vaccines are so effective in monkeys that macaques can be protected or rescued even if they're injected with a hundred times the lethal dose of the Ebola virus after vaccination. But no one knows for certain whether the vaccines will work in humans; the vaccines haven't yet been rigorously tested in people.

Just developing the vaccines to test in monkeys was a grueling, decades-long process that has killed scores of macaques since the 1990s.

(VIEW COMPLETE ARTICLE)

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" 10 drugs that could stop Ebola "

FIERCE BOIOTECH RESEARCH                       Oct. 14, 2014
By Emily Mullin

Before the current Ebola outbreak, the virus had only appeared in Africa in fits and starts since its discovery in 1976, receding back into the jungle almost as quickly as it arrived. This relative rarity and the swiftness with which the disease kills its victims has, up until now, made Ebola an unattractive--not to mention daunting--prospect for drug developers. As a result, no approved drugs or vaccines against Ebola exist.

...the current situation in West Africa... has prompted the World Health Organization to call on international government agencies and the pharmaceutical industry to work together to speed up the development of promising therapies for experimental use for those most at risk of contracting the disease, which causes severe hemorrhagic fever.

Now, a handful of players are racing to get a treatment or vaccine to patients as quickly as possible, even though these drugs remain largely untested in humans.... 

Here is a list of organizations that are in the global spotlight right now with their investigational Ebola program

See full story and list

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Ebola Vaccine Would Likely Have Been Found By Now If Not For Budget Cuts: NIH Director

HUFFINGTON POST

By Sam Stein                                                              Updated Oct. 13 ,2014

BETHESDA, Md. -- As the federal government frantically works to combat the Ebola outbreak in West Africa, and as it responds to a second diagnosis of the disease at home, one of the country's top health officials says a vaccine likely would have already been discovered were it not for budget cuts.

Dr. Francis Collins, the head of the National Institutes of Health, said that a decade of stagnant spending has "slowed down" research on all items, including vaccinations for infectious diseases. As a result, he said, the international community has been left playing catch-up on a potentially avoidable humanitarian catastrophe.

"NIH has been working on Ebola vaccines since 2001. It's not like we suddenly woke up and thought, 'Oh my gosh, we should have something ready here,'" Collins told The Huffington Post on Friday. "Frankly, if we had not gone through our 10-year slide in research support, we probably would have had a vaccine in time for this that would've gone through clinical trials and would have been ready."

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Small drugmakers can't scale up quickly enough to get ahead of the virus

Two overviews of efforts by drug makers to produce Ebola medication.

WASHINGTON POST                 Oct. 10, 014

by Lenny Bernstein and Brady Dennis

WASHINGTON ..."It takes time. You end up with a situation where the companies weren't set up to ramp up productio. You don't just go from that to making 10,000 does overnight."  -- Prof. Thomas Galsbert, University of Texas Medical Branch at Galveston.

Read full story

http://www.washingtonpost.com/national/health-science/small-drugmakers-t...

SCIENCE INSIDER                                        Oct. 8, 2014

By Jon Cohen and  Kai Kupferschmidt

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FDA approves use of experimental Ebola drug

THE HILL                     Oct. 6, 2014
By Sarah Ferris

Washington --The Food and Drug Administration (FDA) on Monday approved the use of an experimental drug that has been hailed as one of the pharmaceutical industry's best chances at fighting the Ebola virus.

Chimerix, a North Carolina-based biopharmaceutical company, announced Monday that it has received approval to administer an antiviral drug called brincidofovir that has successfully treated Ebola in lab tests.

The drug has also been tested by the Centers for Disease Control and Prevention and the National Institutes of Health, though it is not expected to win approval for wide public use until late 2016.

 Another drug that has been used to treat Ebola-infected patients, TKM-Ebola, has also been permitted for emergency use by the FDA.... The drug, produced by Canadian drugmaker Tekmira, was given a "fast track" designation and is still undergoing clinical trials. 

See full story

http://thehill.com/policy/healthcare/219856-fda-approves-use-of-experime...

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