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PostPosted: Tue Nov 25, 2014 2:07 pm 
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Anthony Fauci stated that GSK Ebola vaccine data would be released in NEJM paper to be published Thursday, Nov 27, 2014.

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PostPosted: Tue Nov 25, 2014 2:13 pm 
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Fauci's comments 38 minutes into broadcast

http://theforum.sph.harvard.edu/events/ ... dium=email

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PostPosted: Thu Nov 27, 2014 4:03 am 
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Chimpanzee Adenovirus Vector Ebola Vaccine — Preliminary Report
Julie E. Ledgerwood, D.O., Adam D. DeZure, M.D., Daphne A. Stanley, M.S., Laura Novik, M.A., Mary E. Enama, M.A., Nina M. Berkowitz, M.P.H., Zonghui Hu, Ph.D., Gyan Joshi, M.S., Aurélie Ploquin, Ph.D., Sandra Sitar, M.S., Ingelise J. Gordon, R.N., Sarah A. Plummer, C.R.N.P., LaSonji A. Holman, F.N.P., Cynthia S. Hendel, C.R.N.P., Galina Yamshchikov, M.S., Francois Roman, M.D., Alfredo Nicosia, Ph.D., Stefano Colloca, Ph.D., Riccardo Cortese, M.D., Robert T. Bailer, Ph.D., Richard M. Schwartz, Ph.D., Mario Roederer, Ph.D., John R. Mascola, M.D., Richard A. Koup, M.D., Nancy J. Sullivan, Ph.D., Barney S. Graham, M.D., and the VRC 207 Study Team
November 26, 2014DOI: 10.1056/NEJMoa1410863
http://www.nejm.org/doi/full/10.1056/NE ... ured_ebola

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PostPosted: Thu Nov 27, 2014 10:50 am 
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This headlines in the media like "The Daily Mail" saying this new vaccine is successful is highly misleading. To understand more about this vaccine one needs to do more in-depth research. The full article is entitled...

"Chimpanzee Adenovirus Vector Ebola Vaccine : Preliminary Report" (New England Journal of Medicine)

www.nejm.org/doi/full/10.1056/NEJMoa141 ... Discussion

As the title suggest this is a preliminary study. The results are far from conclusive. The line that because chimps share 98.5% of the same DNA as humans means that if they respond favourably to a vaccine then humans must as well is scientifically wrong and very dangerous. With the delicate science of immune response and vaccines it really is a case of “Horses for Courses.” The “kicker” line from the report is on “Table 1. Characteristics of the Participants at Enrollment.”

cAd3 IC90 antibody titer >200 – no. (%) 5 (50) 3(30) 8 (40)

Like with an insurance contract where it looks good on paper but you need to drill down to get to the fine print, this section shows that only 10 people received the higher “successful” dose of the vaccine. Of these only 30% showed a positive “threshold” immune response. This figure may be the same percentage as a person who is infected may respond without being given a vaccine. The report is far from conclusive. For a vaccine against Ebola to be proven 100% safe and effective, it needs to be shown on repeat trials that all vaccinated persons, infected with Ebola, with other appropriate care obviously like hydration, were able to “knock out” the toxic virons through their immune response and be free of the virus after at least 40 days.

There are a series of "hurdles" new drugs must get over before they can be claimed to be successful. See...

www.australianprescriber.com/magazine/29/6/159/61

On the arduous and gruelling 4800 metre race map that is the “Successful Vaccine 24 Hurdle Race” you could describe this study as the first hurdle. There is a long, long way to go in the race to find a successful vaccine. False hopes must not be raised. Wishful thinking is dangerous when the tsunami wave is rolling on, and some islands out in the bay have already been inundated. There has to be a multiple focus, and multitasking approach to dealing with Ebola at the moment.

The search for a truly effective vaccine against Ebola must continue for sure. But many pharmaceutical companies have the ethics of gutter rats. They and their backers hawk the virtues of various miracle snake oil cures when they know the drugs don't work. The solution to the Ebola scourge is a massive up scaling of resources and people to all of the West African nations. Other nations in Africa, like Mauritania, Niger, Togo etc. must also receive resources now.

People like Botswanan Matshidiso Moeti, elected as the new WHO Africa director on Nov. 5, 2014, must get their skates on. UNMEER, WHO, the CDC, the EuroCDC and other “Lead Agencies” must be proactive not reactive. The WHO offices in all the African nations should be boosted NOW with extra funds, for managers, contact tracers, liaison etc. The pattern of new cases of Ebola appearing in a country and then there is a response to set up an office, boost funding, staff numbers, control the media etc. like what has happened in Mali over the past three weeks, is dangerous. Too many horses are bolting. Or to put it another way, too many dark genies are out of their bottles. All African nations must bolster their health infrastructure. This includes stocking of PPE’s etc. and the establishment of proper testing labs.

The wide scale "Health Marshall Plan" collaborative, co-operative international effort must continue.

Being “comfortably numb” to the threat of Ebola is a foolish mode to adopt right now. It is possible to be both centered and vigilant when a threat arises. Ebola must not become widespread throughout the world in 2015/2016 etc. There should be no “normalisation” and/or passive, resigned acceptance to its presence.

P.S. Interested readers should click on this link to see what a bogus vaccine story looks like...

http://edition.cnn.com/2014/09/27/health/ebola-hiv-drug


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PostPosted: Thu Nov 27, 2014 2:01 pm 
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niman wrote:
Fauci's comments 38 minutes into broadcast

http://theforum.sph.harvard.edu/events/ ... dium=email


Fauci is badly compromised and his credibility is a real problem.

See how ready Fauci was to look at an obviously fake report of a successful vaccine in West Africa.

http://edition.cnn.com/2014/09/27/health/ebola-hiv-drug

It seems to be that with Ebola many people have no idea what is going on. Discernment escapes them. Many health "authorities" are following the motto "You can fool most of the people most of the time !"


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PostPosted: Thu Nov 27, 2014 2:54 pm 
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AdamNeira wrote:
niman wrote:
Fauci's comments 38 minutes into broadcast

http://theforum.sph.harvard.edu/events/ ... dium=email


Fauci is badly compromised and his credibility is a real problem.

See how ready Fauci was to look at an obviously fake report of a successful vaccine in West Africa.

http://edition.cnn.com/2014/09/27/health/ebola-hiv-drug

It seems to be that with Ebola many people have no idea what is going on. Discernment escapes them. Many health "authorities" are following the motto "You can fool most of the people most of the time !"

Vaccine looks good. Ebola CFR in Africa is 70%.

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PostPosted: Thu Nov 27, 2014 2:56 pm 
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Ebola vaccine from Glaxo passes early safety test
NEW YORK Thu Nov 27, 2014 3:34am EST
Image
A nurse prepares a syringe containing an experimental Ebola virus vaccine next to a volunteer called Trina Helderman (L) during a media visit at the Lausanne University Hospital (CHUV) in Lausanne November 4, 2014. REUTERS-Denis Balibouse

CREDIT: REUTERS/DENIS BALIBOUSE

(Reuters) - An experimental Ebola vaccine made by GlaxoSmithKline caused no serious side effects and produced an immune response in all 20 healthy volunteers who received it in an early-stage clinical trial, scientists reported on Wednesday in the New England Journal of Medicine.

The trial, which began on Sept. 2 and will monitor the volunteers for 48 weeks, is primarily aimed at assessing how safe the vaccine is. But the immune response offered hope that it would also be effective.

"The safety profile is encouraging, as is the finding that the higher dose of vaccine induced an immune response quite comparable to that which has completely protected (lab) animals from Ebola," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), which is conducting the trial in Bethesda, Maryland.

The intramuscular vaccine was developed at NIAID and Okairos, a biotechnology company acquired by GlaxoSmithKline. It contains genetic material from two Ebola strains - Zaire, responsible for the current outbreak in West Africa, and Sudan - but no virus, so it cannot cause the disease.

Because it is unethical to expose volunteers to Ebola, researchers assess the effectiveness of candidate vaccines by whether they trigger production of anti-Ebola antibodies and immune-system T cells.

The trial enrolled volunteers ages 18 to 50. Half received a lower dose and half a higher dose. All 20 developed anti-Ebola antibodies within four weeks, with those on the higher dose producing more.

Dose also affected production of T cells; seven of 10 people on the high dose produced one crucial kind of T cell, but only two on the low dose did. The higher the dose required to trigger immunity, the more challenging and expensive it will be to produce large quantities of vaccine, manufacturers say.

Dr. Daniel Bausch of Tulane University, who wrote an accompanying commentary, called the results promising but cautioned that there are many more challenges ahead before the vaccine's safety and efficacy are established.

Another GlaxoSmithKline vaccine, against the Zaire strain, is undergoing safety trials in England, Mali and Switzerland, while one from Iowa-based NewLink Genetics is being tested in Maryland. This week, Merck announced that it would buy the rights to NewLink's vaccine for $50 million. A trial of an Ebola vaccine from Johnson & Johnson is scheduled to start in January.

(Reporting by Sharon Begley; Editing by Jonathan Oatis)

http://www.reuters.com/article/2014/11/ ... A720141127

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PostPosted: Thu Nov 27, 2014 3:00 pm 
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Ebola Vaccine Appears Safe In First-Stage Testing
AP | By LAURAN NEERGAARD
Posted: 11/26/2014 11:23 pm EST Updated: 11/26/2014 11:59 pm EST

WASHINGTON (AP) — An experimental Ebola vaccine appears safe and triggered signs of immune protection in the first 20 volunteers to test it, U.S. researchers reported Wednesday.

The vaccine is designed to spur the immune system's production of anti-Ebola antibodies, and people developed them within four weeks of getting the shots at the National Institutes of Health. Half of the test group received a higher-dose shot, and those people produced more antibodies, said the study published in the New England Journal of Medicine.

Some people also developed a different set of virus-fighting immune cells, named T cells, the study found. That may be important in fending off Ebola, as prior research found that monkeys protected by the vaccine also had that combination response.


Stimulating both types of immune response is "a promising factor," said Dr. Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases, whose employees led the work.

The researchers reported no serious side effects. But two people who received the higher-dose vaccine briefly spiked fevers — one above 103 degrees — which disappeared within a day.

Earlier this month, Fauci told Congress this first-stage testing was promising enough that the U.S. planned much larger studies in West Africa, starting in Liberia in early January, to try to prove whether the vaccine really works.

Scientists are racing to develop ways to prevent or treat the virus that has killed more than 5,600 people in West Africa, most of them in Guinea, Liberia and Sierra Leone.

Wednesday's publication offered scientific details about the initial testing of the vaccine candidate furthest along, one being developed by NIH and GlaxoSmithKline. Additional safety studies are underway here and abroad. A different Canadian-made vaccine also has begun small safety studies.

Many questions remain as larger studies are being designed, including the best dose and how soon protection may begin, cautioned Dr. Daniel Bausch, a Tulane University Ebola specialist who wasn't involved in the study. Plus, monkey research suggests a booster shot will be needed for long-term protection.

"The road is still long and there are many challenges but we are nevertheless one step closer to a solution," he wrote in an accompanying editorial.

http://www.huffingtonpost.com/2014/11/2 ... 29684.html

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