Extensive information materials from a meeting that took place today at the World Health Organization (wHO) have provided new details about exactly what he has to test, produce and finance vaccines for Ebola, which could be a potential game changer in the epidemic.
science Insider obtained materials vaccinemakers, governments and WHO has provided the 100 or so participants in a meeting on "access and financing" of vaccines Ebola virus. the documents precise figures on what until now have had little blurry academic discussions. and they make clear to participants-including representatives of governments, industry, philanthropies and NGOs that, although the testing and production grew at a record pace, thorny issues remain.
at the meeting, GlaxoSmithKline (GSK) Rixensart, Belgium, which has the most developing vaccine spelled how it could increase production in parallel with the safety testing and ongoing efficiency so the product could be ready for wider distribution by April if warranted. the company expects to have preliminary information in November in from phase I studies that analyze the safety and immune response in a small number of people not at risk of contracting Ebola. If these data are positive efficacy trials could begin as early as January in Guinea, Sierra Leone and Liberia, the countries of West Africa hardest hit by the epidemic.
Earlier discussions have suggested that the efficacy trials should recruit health care workers and first responders, such as those that are funerals or contacts pathway known infected individuals. WHO estimates that there are about 12 000 health workers in the three affected countries and another 17,500 "community" stakeholders.
GSK is planning two efficacy trials. The largest would be held in Liberia and involved 12,000 people. This study, which could begin in mid-January, would randomize half of the participants receiving the vaccine and the other half a placebo. The study may also have a third arm, GSK said: A vaccine manufactured by NewLink Genetics of Ames, Iowa, who has just entered Phase I studies in the United States. The US National Institutes of Health said it was interested in leading this study.
A second trial would begin simultaneously in Sierra Leone, Ripley Ballou, who heads the project GSK Ebola vaccine, said Science Insider. "One of the tests can fail for reasons of logistics," he said. "We have only one shot to get it right." The trial in Sierra Leone would not use a placebo group but would offer health workers at different points in time vaccine. This "stepped wedge" test could affect up to 8,000 people, and the US Centers for Disease Control and Prevention has had preliminary discussions with the affected countries about the staging of these studies. Although Guinea is also hit hard, he has the least infrastructure in place for a trial, said Ballou. "This would be the place most difficult to do a Phase III study."
GSK estimates (see table below, and here) it has 24,000 doses of its vaccine ready for testing in January efficiency. If it cranks production at full capacity before these tests are completed, the company could have 230,000 doses available in April and could gradually increase the capacity to produce more than 1 million doses per month by December 2015.
GSK has made small investments in increased production of the vaccine, and the table of projects that might be able to produce next year if all went outside and added several new production lines. the "at risk" noted by asterisks refers to the business of making quality control without having to wait for the regulators to repeat the tests.
In one database, GSK noted that a "critical issue" is called the filling capacity. GSK said there is a shortage of facilities that can fill vaccine vials under sterile conditions in a facility that meets the so-called biosafety level 2 conditions. He suggested that regulators relax their biosecurity requirements. If GSK only has to fill this will affect the ability of the company to produce other vaccines already on the market, including those that protect against rotavirus, measles, mumps and rubella, the document said.
the GSK paper also presents a number of proposals to make the first batches of vaccine available quickly, as running some of parallel quality control tests and changing the criterion used to prove the sterility of the vaccine to one that takes 14 days for a test that takes half the time.
further studies of the NewLink vaccine soon begin in Geneva, Switzerland, and Hamburg, Germany. A first batch of vaccine arrived in Geneva Wednesday, Marie-Paule Kieny, Assistant Director-General of WHO, said Science Insider. The Canadian government has donated 800 bottles of vaccine to the WHO, but is to send them in three separate shipments, Kieny said. "It just felt too risky to put all eggs in one basket," said Kieny, who has volunteered as subjects to test the vaccine itself.
Janssen, a division of Johnson & Johnson, described plans to speed the development of another Ebola vaccine strategy that has yet to enter human studies. a delegation of Russia planned to discuss Ebola vaccine being made, too .
a very detailed 28-page document by the Norwegian Institute of public health has offered "an estimate of crude oil costs" to intensify Ebola vaccine mass production. By these calculations, 27 million doses of vaccine would cost up to $ 73 million, and the cost of vaccination campaigns themselves add another $ 78 million to the bill.
Several analyzes posed regulatory issues and complex responsibility. The UK government has argued that "it is necessary to provide some form of relief from liability for producers and distributors of vaccines" and that WHO should coordinate discussions with regulators. The British government has also noted that "affected African countries will have the main role to allow or permit the use of experimental vaccines" and says "buy" these communities on clinical trials should be obtained as soon as possible.
regarding funding, the Government of the United Kingdom argues that a "multi-donor club" should pay for the development of vaccines "medium term". But for now, the UK said it will "unilaterally" cover the cost of purchasing vaccines in Sierra Leone, and asked the US government and France to make the same commitment to Liberia and Guinea, respectively.
in a planning document, the WHO reported several logistical problems, including "the ability to safely transport the intervention on the site of delivery, the existence of safe storage facilities a capacity of cold chain proper, the availability of sterile equipment to administer injections. "Ballou But the biggest question hanging over vaccine trials is the stability of the country. "The thing that will have the greatest impact is what happens to the trajectory of the epidemic curve," he said. "If current trends you progress two months into the future we are still in an environment where you can even consider doing a trial?"
* Ebola files: Given the current Ebola outbreak unprecedented in terms of the number of people killed and the rapid geographic spread, science and science Translational Medicine made a collection of research articles and news on the viral disease available for researchers and the General public.
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