Merck (MRK) announced two regulatory milestones for the company's investigational vaccine for Ebola Zaire, V920: the U.S. Food and Drug Administration has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency has granted PRIME status.

V920 was initially engineered by scientists from the Public Health Agency of Canada's National Microbiology Laboratory and subsequently licensed to a subsidiary of NewLink Genetics Corporation. In late 2014, when the peak of the Ebola outbreak in western Africa was at its worst, Merck licensed V920 from NewLink Genetics, with the goal of accelerating the development, licensure, and availability of this candidate vaccine.

Since that time, Merck has worked closely with NewLink Genetics (NLNK) and a number of external collaborators to enable a broad clinical development program with funding from the U.S. Government including the Department of Health and Human Service's Biomedical Advanced Research Development Authority and the Department of Defense's Defense Threat Reduction Program/Joint Vaccination Acquisition Program among others.

Additional research evaluating V920 is ongoing. Merck is responsible for the research, development, manufacturing, and regulatory efforts in support of V920. The company has committed to working closely with other stakeholders to accelerate the continued development, production and, if licensed, distribution of the vaccine.