Investigational Ebola Vaccine Gets ‘Breakthrough Therapy’ Designation by FDA

Officials with Merck have announced that their investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated) has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA), and PRIME (PRIority MEdicines) status by the European Medicines Agency. 

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a candidate vaccine that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition. PRIME is an approach from the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. 

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 and a number of external collaborators to enable a broad clinical development program with funding from the US Government including the Department of Health and Human Service’s Biomedical Advanced Research Development Authority (BARDA) and the Department of Defense’s Defense Threat Reduction Program/Joint Vaccination Acquisition Program (DTRA/JVAP) among others. Additional research evaluating V920 is ongoing, according to information from the company.

Reference

1. Merck Media.  Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920). News release. 2016.