“In parallel to the ongoing Phase I clinical trial, GSK is manufacturing approximately 10,000 additional doses of the vaccine candidate which could be immediately made available by GSK to the WHO to create an emergency immunization program for healthcare workers or other high risk groups,” GSK spokeswoman Mary Rhyne told BioPharma-Reporter.com.
“Beyond that, we will assess all options to scale up production as required with the potential to support stockpiling for future outbreaks.”
The Phase I study of the GSK vaccine, which began Sept. 2 at the NIH Clinical Center in Bethesda, Maryland, is expected to produce results “by the end of this calendar year,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases said in testimony before the Senate Appropriations Subcommittee.
Manufacturing Process
GSK is working alongside Okairos, which it acquired in May 2013, to scale up the production of the vaccine. “We are working with the information and manufacturing insights they developed,” Rhyne told us.
Okairos told Science the company grows its virus in a human cell line in up to 200-liter wave bags, and that it will take about two months to grow, harvest, and prepare the promised 10,000 doses.
“The financial support from a new international consortium is helping us quickly ramp up manufacturing so that, if it is shown to be safe and effective in trials, it can be quickly made available to WHO,” Rhyne told us.
Ripley Ballou, head of GSK’s Ebola vaccine program, told Science it would take about 1.5 years at the current pace to manufacture the hundreds of thousands of doses that would be necessary to control the outbreak.
Okairos founder Riccardo Cortese added that with a $10m investment, the company could begin using several 400-liter bags simultaneously and scale up to making 100,000 doses per month. Ballou, meanwhile, said that even with the most optimistic timeline, it will take about nine months to produce between 100,000 and 500,000 doses and cost $25m.
“The current public health emergency we are facing requires us to act very fast, and to begin manufacturing at a scale and in a timeframe that we would not have planned or predicted just a couple of months ago,” Rhyne told us. “We have been able to find capacity to do the manufacturing in a short space of time, and the external funding has helped us to do that.”
EMA Review of Treatments
Meanwhile, the EMA (European Medicines Agency) announced last week that it would begin a review of developing treatments to provide an overview of the current state of knowledge about the various experimental medicines to support decision-making by health authorities.
The companies identified so far include:
- Biocryst, a US-based company developing BCX 4430;
- Fab’entech, from France, developing Hyperimmune horse sera;
- MAPP Biologicals, a US-based company developing ZMAPP;
- Sarepta, a US company developing Sarepta AVI-7537;
- Toyama Chemicals, Fujifilm Group, based in Japan and MediVector Inc, based in the US, who are jointly developing Favipiravir; and
- Tekmira, a Canadian company developing TKM-Ebola.
Also this fall, NIH is collaborating with DOD (Department of Defense) and NewLink Genetics on Phase I safety studies of an investigational Ebola vaccine based on vesicular stomatitis virus (VSV). “The VSV vaccine will serve as a vector or carrier for an Ebola gene similar to how the Chimp adenovirus served as a vector or carrier as described above for the NIAID/GSK vaccine,” Fauci said in testimony.