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Information on vaccines to counter Ebola and other diseases

The Mission of this group is to follow the development of vaccines and other medications to counter Ebola and other diseases.

Members

Kathy Gilbeaux mdmcdonald MDMcDonald_me_com mike kraft

Email address for group

vaccines_global@m.resiliencesystem.org

There's an Ebola Vaccine in Africa. Now What?

A scanning electron micrograph of the Ebola virus. The first large-scale trials of an Ebola vaccine are underway in Africa.(NIAID / Flickr)

Unprecedented: In four months, the Ebola vaccine has gone from concept to field trial. Success is not assured.

 THE NATIONAL JOURNAL  by Brian Resnick                      Jan. 28, 2015

Detailed description of the problems issues and procedures for fieldingand testing Ebola vaccines in West Africa.

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..."Without the (Ebola) virus circulating, there's no way to prove the vaccine is effective. At current infection rates, trial researchers would need to see 100 cases of Ebola over a four-month period to achieve statistical significance. That time frame may stretch, or fall apart altogether.

"It's a real dilemma," says Margaret Harris, an MD and spokeswoman for the World Health Organization. "It's extremely good news that the cases are coming down, but it does mean we may not have clear phase III data."

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First GSK Ebola vaccine shipment due to arrive in Liberia

REUTERS by Kate Kelland                                     Jan. 23, 2015

LONDON-- The first batch of GlaxoSmithKline's experimental Ebola vaccine has been shipped to West Africa and is expected to arrive in Liberia later on Friday, the British drugmaker said.

The shipment, of an initial 300 vials of the vaccine, will be the first to arrive in one of the three main Ebola-affected African countries, GSK said in a statement.

It will be used in the first large-scale vaccine trials in coming weeks, in which healthcare workers helping to care for Ebola patients will be among the first to get it...

The vaccine, co-developed by the National Institutes of Health in the United States and Okairos, a biotechnology firm acquired by GSK in 2013, is currently being tested in five small phase I safety trials in Britain, the United States, Switzerland and Mali involving around 200 healthy volunteers in total.

Read compete story.

http://uk.reuters.com/article/2015/01/23/uk-health-ebola-gsk-idUKKBN0KW0DU20150123

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Fast Track on Drug for Ebola Has Faltered

NEW YORK TIMES by Andrew Pollack                               Jan. 23, 2015

As Ebola raged through West Africa last summer, an experimental drug was tried for the first time on two American aid workers in Liberia who were gravely ill with the virus. Both recovered, one of them rapidly.

 

Medicago, in North Carolina, is gearing up for possible production of the Ebola drug ZMapp using its plant-based technology. Credit Gerry Broome/Associated Press

Though it could not be said for sure that the drug, ZMapp, was responsible, patients and doctors began clamoring for it. But there was enough to treat only a handful of patients. Federal officials vowed to produce more.

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Ebola mutations could make some drugs ineffective

BALTIMORE SUN     by Scott Dance                                                   Jan. 20, 2015

In the year since Ebola began spreading across West Africa, the virus has mutated in more than 600 ways that change it slightly from versions studied in labs and used to develop treatments, according to researchers at Fort Detrick. And 10 of the mutations could make some drugs used to treat the virus ineffective, they wrote in research published Tuesday.

The "genomic drift," as the scientists called it, could make agents similar to the experimental drug ZMapp unable to bind to the virus anymore.

While the changes affect only a tiny fraction of Ebola's genome, they offer new lessons about the virus that might not have been learned because of the wide scope of the outbreak, larger than all others combined
Read complete story.
http://www.baltimoresun.com/health/bs-hs-ebola-mutation-20150120-story.html

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Fast track development of Ebola Vaccines

Principles and target product criteria

THE CENTER FOR INFECTIOUS DESEASE AND POLICY                                              Jan 12, 2015

The unprecedented morbidity and mortality from the 2013- 2015 Ebola virus disease (EVD) epidemic in West Africa has challenged every aspect of our global ability to effectively detect, respond to, and control such a rapidly emerging infectious disease crisis.

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Ebola Clue Lurks in 10 Million Zambian Bats

BLOOMBERG       by  Matthew Hill                        Jan. 12, 2015                                    

At 4:50 a.m. at the Kasanka National Park in northern Zambia, tourists watch from a platform in a tree as the sound of millions of wings accompanies the sunrise.

Straw-coloured Fruit Bats fly in Kasanka National Park, Zambia. Photographer: Fabian von Poser/Getty Images

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Extreme measures' needed to see Ebola shot development through

REUTERS     by  Kate Kelland                                          Jan.12, 2015 
LONDON --Developing and bringing to market effective Ebola vaccines requires extreme measures and unprecedented international cooperation, global health experts said on Monday.

A health worker wearing protective gear stands outside a quarantine zone in a Red Cross facility in the town of Koidu, Kono district in Eastern Sierra Leone December 18, 2014.Credit: Reuters/Baz Ratner

In an interim report on a roadmap for vaccines against the current and any future outbreaks of the deadly virus, infectious disease specialists Jeremy Farrar and Mike Osterholm said the scope of effort was "too complex for any single government, organization or company". They called for sustained public-private sector partnership and commitment.

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WHO experts chart next steps for Ebola vaccine trials

CENTER FOR INFECTIOUS DISEASE AND POLICY RESEARCH     by Lisa Schnirring                                 Jan. 9, 2015

The next steps in testing Ebola vaccines as well as a picture of how they might be used in West Africa's outbreak region became clearer today as officials from the World Health Organization (WHO) shared the outcome of yesterday's (Thursday's) high-level meeting in Geneva.

Large phase 3 trials in West Africa's outbreak setting will be next up to see if the vaccines work, with the studies designed to collect more safety data, a task usually covered in phase 2 trials, experts involved in the meeting said today at a WHO media telebriefing. However, as Ebola infections drop off in the outbreak region, scientists face a closing window of opportunity to see how the vaccines perform in a real-life setting.

Experts also signaled a possible role for two Ebola vaccine formulations: a single-dose vaccine providing shorter-term immunity that could be used to tamp down Ebola flare-ups and a prime-boost vaccine that may provide more durable immunity and could be used for other immunization strategies.

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In Africa, a Decline in New Ebola Cases Complicates Vaccine Development

NEW YORK TIMES      by Andrew Pollack                                                           Jan. 9, 2015

As authorities and drug companies hurriedly prepare to begin testing Ebola vaccines in West Africa, they are starting to contemplate a new challenge: whether an ebbing of the outbreak could make it more difficult to determine if the experimental vaccines are effective.

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Health 2 Leading Ebola Vaccines Appear Safe, Further Tests Starting

ASSOCIATED PRESS  by Maria Cheng                                                                          Jan. 9, 2015
LONDON --The World Health Organizationsays the two leading Ebola vaccines appear safe and will soon be tested in healthy volunteers in West Africa.

After an expert meeting this week, WHO said there is now enough information to conclude that the two most advanced Ebola vaccines ? one made by GlaxoSmithKline and the other licensed by Merck and NewLink ? have "an acceptable safety profile."

In a press briefing on Friday, Dr. Marie-Paule Kieny, who heads WHO's Ebola vaccine efforts, said "the cupboard (for Ebola vaccines) is filling up rapidly."

She said further trials in healthy people in West Africa, including health workers, are scheduled to start soon. Kieny added several other vaccines were being developed in the U.S., Russia and elsewhere.

Read complete story.
http://abcnews.go.com/Health/wireStory/leading-ebola-vaccines-safe-tests-starting-28107527

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