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The Vaccines Are Coming!

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jdljr1 View Drop Down
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    Posted: September 25 2014 at 2:43pm
     They really are!  It is good to have some good news for a change.  Who could have imagined that these companies would divert such resources into this heroic effort?  Maybe there is hope for humanity afterall-and I am not just talking about Ebola.

http://www.bloomberg.com/news/print/2014-09-25/ebola-shot-turned-down-by-who-is-best-hope-as-virus-rages.html


Ebola Shot Turned Down by WHO Is Best Hope as Virus Rages

By Shannon Pettypiece and Makiko Kitamura - Sep 25, 2014

The calls started coming in August to the office of GlaxoSmithKline Plc Chief Executive Officer Andrew Witty from the head of the World Health OrganizationMargaret Chan. The Ebola outbreak was raging out of control and Chan needed the drugmaker’s vaccine as quickly as possible.

The sudden sense of urgency for an Ebola vaccine was an about face from a few months earlier when Glaxo contacted the WHO, asking whether its vaccine could help with the outbreak. At that time, the company was told the focus was on containment and the WHO didn’t have a policy for using vaccines in this type of situation. “We’ll get back to you” was the message, said Ripley Ballou, head of Glaxo’s Ebola vaccine program.

As those months passed and containment efforts failed, the epidemic spun out of control, claiming more lives than all past outbreaks combined. So far, more than 6,200 people have been infected and 2,900 have died, and the virus could sicken more than 1.4 million people by January under the worst-case scenario projected by the U.S. Centers for Disease Control and Prevention.

With no approved Ebola medicines, and experimental treatments in short supply, a vaccine is now one of the best hopes for halting the virus’s spread before it becomes entrenched in the region. That puts pressure on the few drugmakers with a vaccine in development as they shift resources, delay other projects, and spend millions in a race to immunize patients. Glaxo and Johnson & Johnson are preparing thousands of doses of their experimental vaccines to test in Africa as early as January.

Traditional Measures

“It may be that without a vaccine we can’t really stop this epidemic,” said Peter Piot, a co-discoverer of the Ebola virus in 1976 who is now the director of the London School of Hygiene and Tropical Medicine, at a news conference in London this week.

When Glaxo contacted the WHO in March, the vaccine was seen as a “diversion of energy” at a time when it was believed the outbreak would be controlled with traditional measures, such as contact tracing and safe burials, that have helped contain every previous outbreak, said Marie-Paule Kieny, the WHO’s assistant director-general for health systems and innovation. At the end of March, there were about 100 cases of Ebola in Guinea, with early reports the virus was spreading to Liberia and Sierra Leone, according to the U.S. Centers for Disease Control and Prevention.

“We were in a situation where GSK had a vaccine which had been tested in animals, and that was it,” Kieny said in a telephone interview. “It was only then when the situation started to be quite worse, and people understood that we’re not going to make it, that the effort came to a higher level.”

Human Testing

After receiving the request from Kieny and Chan last month, Glaxo pulled 20 people off various projects, many from its malaria vaccine program, one of its most highly publicized research initiatives, and assigned them full-time to the Ebola vaccine. The company is aiming to have 10,000 to 15,000 doses by January to start vaccinating health-care workers as part of the next stage of testing. Glaxo will need six months to figure out how to eventually produce hundreds of thousands of doses for wider use, Ballou said.

Glaxo is among at least five companies that have announced plans to start human testing of an Ebola vaccine, including Johnson & Johnson, Inovio Pharmaceuticals Inc.NewLink Genetics Corp., and Profectus Biosciences Inc.

Healthy Volunteers

Glaxo started giving doses to healthy volunteers in the U.K. and U.S. this month. Within the next four weeks, as many as six different trials will be under way in the U.S., U.K., Switzerland and Mali. Early results on the safety and efficacy of the Glaxo and NewLink shots, the most advanced in development, should be available by November, Kieny said. The agency plans to meet with the two companies next week to discuss the simultaneous roll out and testing of the vaccines in Africa, which may happen in January, Kieny said.

“This is unprecedented, because you are talking about quite a big financial investment into something which has not proven anything for the time being,” she said.

Until a few months ago, Glaxo’s vaccine got little attention out of the London-based company’s hundreds of experimental compounds, and the drugmaker has been “essentially starting from ground zero,” said Ballou. Glaxo acquired the vaccine last year as part of its $324 million purchase of Okairos AG, which has inoculations in more advanced stages of testing for hepatitis C and malaria.

‘Very Different’

“It wasn’t really until the first week in August when it was clear that the epidemic was something very different from what we had ever seen before that WHO came to us and said we really need you to accelerate this vaccine,” Ballou said. “Within 24 hours, we had all of our partners on the phone.”

Three weeks later, the first patient received the vaccine to kick off the early-stage human trials. “That’s an amazingly fast process,” he said.

Glaxo’s vaccine is a chimpanzee cold virus that is injected with a small piece of the Ebola virus gene, which tricks the body into making an immune response against Ebola, even though it hasn’t been infected with the disease. The virus is grown in an Okairos facility in Rome in plastic so-called wave bags, which rock back and forth on a platform.

Not far behind Glaxo in the race to get a vaccine to patients is Johnson & Johnson, which plans to start human testing in March. J&J expects to have hundreds of thousands of doses available through the course of 2015 and more than a million in 2016, said Paul Stoffels, the New Brunswick, New Jersey-based company’s chief scientific officer.

Virus Accelerates

Stoffels began ramping up work on the vaccine on his own, without the prodding of the WHO, as he saw the Ebola virus beginning to accelerate and making its way into cities in West Africa.

He knew first-hand the devastation it could cause: In 1995, a few years after completing his training as an infectious disease doctor at a hospital in Kikwit, in what is now the Democratic Republic of Congo, Stoffels got a call from the nuns he’d worked alongside there. They were in desperate need of antibiotics for what they believed was bloody diarrhea. He would soon learn it was much worse: his former colleagues were infected with Ebola and would be among more than 250 who died in that outbreak.

“No one could have ever foreseen that this could happen,” said Stoffels. “Now history is history and we have to start solving the problem.”

Cold Virus

J&J’s vaccine has been more than a decade in the making and started in the labs of Netherlands-based Crucell, which J&J bought in 2010. Starting in 2002, researchers at Crucell began work on an Ebola vaccine. After four years, the work was halted when an initial study in humans found it wasn’t potent enough to trigger the body’s immune system to develop the necessary antibodies.

So the company went back to the drawing board in 2006 and came up with the current version of the vaccine. It uses a disarmed version of a cold virus to get Ebola’s genetic information into cells. It’s then combined with a second booster shot from biotechnology companyBavarian Nordic A/S of Denmark.

“We will have a good chance it will work, but there is no guarantee,” said Stoffels. “We know we have to do our work step by step to get to the solution.”

Sept. 11

While Ebola was discovered in the 1970s, few researchers were pursuing a vaccine until after the Sept. 11, 2001, attacks when the U.S. began funneling millions to protect against bioterrorism.

The U.S. government passed an act in 2004 to set aside $5.6 billion over 10 years for the stockpiling of drugs and vaccines that could protect against a bioterrorism attack, creating a potential buyer for any company able to prove it had a safe and effective vaccine. It has also set aside millions in research grants from the National Institutes of Health.

Thomas Geisbert, a professor of microbiology and immunology at the University of Texas, was one of the early pioneers of Ebola vaccine research and has been hunting for a vaccine since the 1990s. At that time, he said, there were few labs with the capabilities to do testing on a pathogen as deadly as Ebola and not enough money to do the necessary experiments.

‘All This Money’

“All of a sudden there is all this money,” said Geisbert, who has worked on the technology behind the vaccines being developed by NewLink and Profectus. “When you have more money, you can take more risks.”

In recent years, the biggest barrier has been getting past the government bureaucracy to begin human testing -- something the urgency around the latest outbreak has helped cut down, Geisbert said.

The next steps won’t be cheap or easy, said Stoffels. J&J must develop manufacturing capabilities for the vaccine, which must be made in a carefully controlled environment, and develop and implement a plan for testing it in volunteers.

“We will have to mobilize significant resources for this and we are doing that as we speak,” said Stoffels. “It is a significant amount of work but the senior leadership is committed to doing it.”

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Technophobe Quote  Post ReplyReply Direct Link To This Post Posted: September 25 2014 at 3:28pm
So the WHO rejected it.  Sounds like a recommendation to me.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote jdljr1 Quote  Post ReplyReply Direct Link To This Post Posted: September 25 2014 at 3:51pm
    Oh, yeah.  The WHO has been really doing just great with Ebola.  John L.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote krystar1 Quote  Post ReplyReply Direct Link To This Post Posted: September 25 2014 at 5:43pm
If they are going to be1.4Million cases by January and GSK may have only 15,000 vaccines...the math is not adding up to stop the epidemic...Money should not be the motive here because...at 1.4million cases and doubling every month...it will be tough....GSK should give the vaccine to world governments and have each country bear the burden of manufacturing in their pharmaceutical companies to achieve capacity to make the vaccines to give immunity to the entire populations...
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Post Options Post Options   Thanks (0) Thanks(0)   Quote jdljr1 Quote  Post ReplyReply Direct Link To This Post Posted: September 25 2014 at 6:01pm
    Good points, Krys.  My biggest nightmare is that Ebola spreads to some of the other giant city/slums of our planet, in South/Central America, or India, or China.  Then whether it becomes airborne and to what degree is academic-under those conditions it is already contagous enough to become in effect "The Omega Man Virus."   Charlton Heston and Will Smith will not save us.  Vaccine production is going to have to ramp up FAST, just as if we had pandemic flu-or else be left behind. 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote mjm1 Quote  Post ReplyReply Direct Link To This Post Posted: September 25 2014 at 6:57pm
My understanding is that there isn't sufficient refrigeration capacity in Africa to store the vaccine in the numbers needed at the places it is needed most.
 
At best, the vaccine will be used to protect front line doctors and nurses.  It will be some time before any infrastructure can be put in place to do anything of substance re the spread of this menace and the numbers involved.
 
I think the thread title is wildly optimistic with little to no bearing re the current situation.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote admin Quote  Post ReplyReply Direct Link To This Post Posted: September 25 2014 at 7:12pm
Good job John.   You've been on it for awhile.  Let's hope the next 10 here are uneventful. 

Best,
A
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Post Options Post Options   Thanks (0) Thanks(0)   Quote jdljr1 Quote  Post ReplyReply Direct Link To This Post Posted: September 26 2014 at 1:02am
    MJM1 are you fully aware of the complexity of the current situation?  Protecting the medical staff and soldiers fighting ebola has been said to be critical as this would both keep them in the fight as well as encourage more to join it.  They would then be using infection control practices to at least try to escape our worst-case scenarios.
     Thanks, Albert.  I hope we have 24 hours without more skyrocketing case reports.  John L.
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