Article

2014-08-12 Africa Subsaharan

Anti-Ebola Drug Supply Is Exhausted After Doses Sent to Africa

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Posted by Anguper Hupomosing9418 2014-08-12 00:00|| || Front Page|| [4 views ] Top

#1 The drug is extracted from GMO'ed tobacco plants.
Rough guess: time to grow the tobacco + extraction = a few months.
If you want FDA approval, add N years.

Were you in a hurry?

Posted by SteveS 2014-08-12 01:39|| 2014-08-12 01:39|| Front Page Top

#2 Plus you have to scale up, so add a few more doubling times.

Posted by KBK 2014-08-12 10:19|| 2014-08-12 10:19|| Front Page Top

#3 It's a modified tobacco plant? Each plant will yield a dozen or more cuttings. Root in water, plant out in a greenhouse, and raise the carbon dioxide level. You'll get significantly faster time to maturity, and a good deal more plants. Rinse and repeat... but a base of so few patients is too few to show dangerous side effects, etc. This is still very experimental. Were I the manufacturer, I'd want some guarantees in writing to cover expansion expenses and to protect against law suits later.

And the FDA looks to be about to become even more cautious about approvals.

Posted by trailing wife 2014-08-12 11:29|| 2014-08-12 11:29|| Front Page Top

#4 Excerpt from an infectious disease newsletter:

WHO announces W. African Ebola death toll passes 1,013.

The AP (8/12) reports that the World Health Organization announced that Ebola fatalities in the current outbreak in four countries in West Africa has reached 1,013. There have also been “1,848 suspected, probable or confirmed cases.”

Reuters (8/12) also reports the totals from the WHO announcement adding that of the 52 deaths added from August 7-9, 29 were in Liberia, 17 in Sierra Leone, and 6 in Guinea.

Nigeria Confirms Tenth Case. Bloomberg (8/12) reports that Nigerian Health Minister Onyebuchi Chukwu announced yesterday that a nurse “suspected of contracting Ebola from” Patrick Sawyer, who died of Ebola, is now the eighth person with a confirmed case of Ebola in Nigeria. So far, all eight confirmed Nigerian cases have been in Lagos. [It must be noted that Sawyer seemed to go out of his way to infect health care personnel, based on other reports.]

More on the Final Doses Of ZMapp. The AP (8/11) reports that the Liberian government announced that the US has approved the use of ZMapp. The Mapp company announced that after shipping the treatment, “it had run out of its supply.” In addition, Mapp explained that “it would take months to produce even modest quantities” of the treatment. Liberia also said that it is “receiving an experimental treatment from the World Health Organization.”

Reuters (8/12) reports the request from Liberia for the treatment was approved by President Obama and the Food and Drug Administration, and that further doses were being sent by the WHO.

GSK Vaccine Phase I Trial May Begin In September. The Hill (8/12) reports that GlaxoSmithKline in cooperation with the US National Institutes of Health will begin a Phase I trial of its Ebola vaccine. The company also said that full testing “for a new vaccine is a long, complex process, often lasting 10 or more years.” Crucell is also working with NIH on an Ebola vaccine. It has been proven effective in monkeys.
Reuters (8/11) reports that the US Food and Drug Administration has not yet approved the trial, which is expected to start this year. The US National Institute of Allergy and Infectious Diseases on its website said the trial could start this fall.

A [GSK] company spokeswoman said on Sunday that the trial should get underway "later this year", while GSK's partner the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said in a statement on its website it would start "as early as fall 2014", implying a potential September launch of testing.

Even if is fast-tracked, however, and emergency procedures are put in place, the new vaccine could not be ready for widespread deployment before 2015 - even assuming it works as well as hoped.

"It is right at the beginning of the development journey and still has a very long way to go," the GSK official said, declining to be drawn on a possible timeline for launch.

The investigational vaccine is based on a chimpanzee adenovirus into which two Ebola genes have been inserted, which means it contains no infectious Ebola virus material. Adenoviruses are best known for causing the common cold.

Once the vaccine enters a cell and delivers its genetic payload, the two gene inserts produce a protein that generates an immune response in the body - but the adenovirus carrying the genes does not replicate further.

Posted by Anguper Hupomosing9418 2014-08-12 16:13|| 2014-08-12 16:13|| Front Page Top

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