CHMP recommends V920 Ebola Zaire Vaccine ( Ervebo) to protect against Ebola virus disease.- Merck Inc.

Merck Inc., has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a conditional marketing authorization for V920 Ebola Zaire vaccine (rVSVdeltaG-ZEBOV-GP, live). If affirmed by the European Commission, the vaccine will be authorized under the brand name Ervebo (pronounced UR-VEE-BOH) and indicated for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus.

The use of Ervebo should be in accordance with official recommendations. The CHMP�s recommendation, completed under accelerated assessment, will now be considered by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labeling that is valid 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.

Comment;Ervebo, formerly known as V920, has already been tested in 16,000 people in clinical trials in the U.S., Europe and Africa, according to the EMA. It is a single-dose, live attenuated vaccine that is intended for people age 18 and older.