A historic Ebola outbreak occurred in March 2014 in three Western African countries, Guinea, Liberia, and Sierra Leone. Over 28,000 cases were reported and led to more than 11,000 deaths, more than ten times the amount of cases compared to all past outbreaks combined. On August 8, 2014, the World Health Organization declared a Public Health Emergency of International Concern (PHEIC). Merck, partnering with NewLink Genetics, entered into an exclusive worldwide licensing agreement to research, develop, manufacture, and distribute an investigational Ebola vaccine candidate based on recombinant Vesicular Stomatitis Virus (rVSV) technology. Working with multiple partners, Merck has brought forward an efficacious vaccine candidate from Phase I trials in October 2014 to Phase III consistency studies by August 2015. This presentation will provide background into Merck's strategy to bring the vaccine to licensure, product development activities to scale-up the process from clinical to commercial, and the challenges faced during product development.
Lynne Isopi, Principal Scientist, Vaccine Drug Product Development, Merck