Merck & Co begins US filing of Ebola vaccine
Pharmaphorum Media Limited | November 14, 2018
Merck & Co has begun a rolling filing in the US of its Ebola Zaire vaccine, known as V920 after the FDA said it could represent a breakthrough in treatment. Known as MSD outside the US, Merck & Co said it will file information bit-by-bit about V920 (rVSV∆G-ZEBOV-GP, live attenuated) and expects all the data to be with the regulator next year. The FDA gave V920 Breakthrough Therapy Designation in July 2016, which is intended to hasten development and review of drugs that treat serious or life-threatening diseases and could be a substantial improvement over existing therapies.
V920 was first engineered by scientists from the Public Health Agency of Canada’s National Microbiology Laboratory and then licensed to a subsidiary of NewLink Genetics Corporation. In late 2014, when the Ebola outbreak in western Africa was at its peak, Merck licensed V920 from NewLink Genetics. Since then, Merck & Co has worked closely with partners on a clinical development programme with partial funding from the US government, including the Department of Health and Human Service’s Biomedical Advanced Research Development Authority (BARDA).