January 23, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
GlaxoSmithKline announced Friday that the first shipment containing 300 vials of its candidate Ebola vaccine is expected to arrive in Liberia later today, Jan. 23. This shipment is the first of a candidate vaccine to arrive in one of the primary countries affected by Ebola and will be used to launch the first large-scale efficacy trial of an Ebola candidate vaccine.
Currently being administered in five Phase I clinical trials involving a total of 200 healthy volunteers in the United Kingdom, the United States, Switzerland and Mali, the candidate vaccine has shown “an acceptable safety profile,” according to GSK.
“The initial Phase I data we have seen are encouraging and give us confidence to progress to the next phases of clinical testing, which will involve the vaccination of thousands of volunteers, including frontline healthcare workers,” Moncef Slaoui, chairman of Global Vaccines at GSK, said in a statement. “If the candidate vaccine is able to protect these people, as we hope it will, it could significantly contribute to efforts to bring this epidemic under control and prevent future outbreaks.”
The U.S. National Institutes of Health (NIH) which co-developed the candidate vaccine with and Okairos, a biotechnology company acquired by GSK in 2013, will lead the Phase III clinical trial. The trial will eventually include 30,000 volunteers, the team expects, and one third of these volunteers will receive the candidate vaccine. The candidate vaccine will be compared to a control vaccine in order to test whether the immune response observed in the phase I trials, “actually translates into meaningful protection against Ebola,” GSK said in a statement. Subject to regulatory approval, the trial will begin in Liberia within the next several weeks.
Slaoui also issued a caveat that regulators would have to approve the vaccine before it could be put into widespread use. “It is important to remember that this vaccine is still in development and any potential future use in mass vaccination campaigns will depend on whether WHO [World Health Organization], regulators and other stakeholders are satisfied that the vaccine candidate provides protection against Ebola without causing significant side effects and how quickly large quantities of vaccine can be made.”
Experts have expressed concern, however, that because the number of Ebola cases are falling, opportunities to test vaccines in a meaningful way are also falling.
“Because case numbers are starting to come down it will become harder and harder to show if the vaccine is having any impact,” Jonathan Ball, a virus expert based at Nottingham University, told the BBC. “Ultimately we may be in position in a few months’ time where we don’t know whether this vaccine is effective in humans.” Still, Ball said efforts must continue because “it is important to get answers if we can—if not for this outbreak, for future outbreaks. We need to be prepared.”
Others have also warned against slowing down efforts to test, manufacture and distribute the vaccine. “This is certainly not the time for...efforts to be reduced,” Jeremy Farrar, director of Britain’s Wellcome Trust health charity, was quoted as saying by Reuters. “There is no doubt that we need vaccines and therapeutics for this epidemic and to try to prevent and respond to the inevitable future epidemics.”
BioSpace Temperature Poll
What Are Your Predictions for the Price Bidding War? The market has been buzzing about an escalating price war between large payers like Express Scripts and Big Pharma. Multiple deals last week showed Gilead forming exclusive pacts and smaller companies like Kite Pharma starting talks early. What do you think will be the effect on prices? BioSpace wants your opinion!
| Read at BioSpace.com |
