The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave the okay for a conditional marketing authorization for V920 Ebola Zaire vaccine developed by Merck.
If affirmed by the European Commission, the vaccine will be authorized under the brand name ERVEBO. The vaccine will protect against the Ebola virus caused by Zaire Ebola virus. The use of ERVEBO should be in accordance with official recommendations. It would be authorized in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein, and Norway. ERVEBO is currently under review in the United States.
“This positive opinion from CHMP represents important progress towards licensure of a vaccine to provide protection from Ebola virus disease to people in areas affected by the Ebola Zaire virus,” Roger Perlmutter, president, Merck Research Laboratories, said. “Our work would not have been possible without the efforts of countless numbers of people, especially those from the World Health Organization and many other government and non-governmental organizations, who have worked tirelessly on the development of this important vaccine. Our top priority is the achievement of registration of our German ERVEBO manufacturing site so that licensed supply can be used to support global public health preparedness.”
V920 was initially engineered by the Public Health Agency of Canada’s National Microbiology Laboratory and licensed to NewLink Genetics Corp. In late 2014, Merck licensed V920 from NewLink Genetics. Since then, Merck has worked with several external collaborators to enable a broad clinical development program with partial funding from the U.S. government.