CEO NewLink Charles Link
PHOTO: AP PHOTO / CHARLIE NEIBERGALL
In the race to develop a vaccine against Ebola, little NewLink Genetics has been in the shadow of the pharmaceutical giant GlaxoSmithKline (GSK).
the two companies rushed vaccine candidates in small trials at an early stage. Hopes are high that vaccines can be prepared for efficacy testing in hard-hit West Africa in January and if they work, for use in the real world in the spring. GSK's efforts have received wide media attention, and with its capacity of production and substantial experience, the huge base-R.U society. is widely assumed to be in the lead. However, NewLink, a pharmaceutical company based cancer in Ames, Iowa, with only 0 employees, had until recently avoided the media coverage and attracted criticism for delaying the launch of its studies.
But a different picture emerged after NewLink broke his media silence following a high-level meeting on the Ebola virus vaccines held by the World Health Organization on October 23. At the meeting, the Newlink leaders said that in the best case, the company could have 12 million doses by April. This number would far exceed the estimate of 230,000 doses of GSK by that date.
There are many caveats. If NewLink vaccine requires a high dose to be effective, far fewer people could be vaccinated. And NewLink vaccine, which combines an Ebola gene with a weakened vesicular stomatitis virus (VSV), a pathogen of livestock, has unique risks.
NewLink CEO Charles Link Jr., an oncologist who has worked at the National Cancer Institute, spoke with science about late fees and why he is optimistic about the higher projections. This interview has been edited for brevity and clarity
Q :. You recently completed a $ 1 billion contract with Genentech to develop cancer immunotherapy. That these negotiations are delaying work on a vaccine against Ebola and influence your decision to avoid the media
A: I do not feel really not that there were delays. Things change so rapidly that we are on the verge of moving too quickly. There is a huge push and pull between the desire to do the right thing for humanity and who need to make things safe, scientifically and ethically in healthy volunteers receiving the vaccine. Our view was that we did not want to hype anything. We just wanted to work on the project. Ebola came first, [the Genentech] negotiation came second, and PR was third. We tried to play discreet, but it is difficult to play discreet with all the attention
Q :. You allowed the Canadian government vaccine for a mere $ 0,000. Although you received small contracts from the US government to develop the vaccine, have you had trouble getting substantial funding to support the Ebola program
A: definitely. Initially, the board has not seen a lot of commercial potential in it. But when the crisis began to evolve, everyone was, "Come, let it happen" There was no hesitation when the crisis started
. Q :. What about your projection of 12 million doses available in April
A: the key question is what will be the dose of the vaccine
Q :. ongoing studies are looking at doses of 10 particles 6 virus to 10 8 . The 12 million is based on 10 6 right
a: Yes, so if a dose should be 10 6 or 10 5 virus particles, we will have plenty of vaccines for Africa West if it works.
Q: Why do you think that lower doses may be sufficient
a: Although the vaccine is based on an attenuated virus, it replicates at least some humans. Speaking to the experts who have worked with many attenuated vaccines, you may only need 10 4 [virus particles] to create the effect and immunological we can modify our studies to examine these lower doses.
Q: do you think the vaccine will be safe and effective
has: in the primate model, a variety of these vaccines work I really believe one of them will be effective in humans. That is my hope and dream by us or someone else
Q :. What about side effects? VSV vaccine was used in 09 to treat a laboratory worker who had an injury from needles in Germany. What happened
A: The woman developed a temperature of 38.5 ° [C]. I do not think you can have a vaccine that causes high fever in a significant portion of subjects, especially when the fever is the first indication of the Ebola virus. But she received a dose of 5 x 10 7 [virus particles], based on an extrapolation from monkey studies. We hope that the lower doses people might have a low fever, but there will be no high-grade fevers
Q: is there a risk of spread of VSV vaccinated and infected cattle
has: This is a legitimate concern and we are looking for means to evaluate that
Q :. production of the bulk vaccine will require a large-scale manufacturing capacity. Have you considered links with major pharmaceutical companies who know vaccine mass production, including placing bottles
A: We are is in active discussions with a large company about all this potential.
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