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 ( rVSVΔG-ZEBOV-GP, live; Ervebo ).

Ervebo is 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 is in accordance with official recommendations.

In September 2019, the U.S. Food and Drug Administration ( FDA ) accepted the Biologics License Application ( BLA ) and granted priority review for V920.
The Prescription Drug User Fee Act ( PDUFA ), or target action date, is set for March 14, 2020. In parallel, and in close collaboration with FDA and EMA, submissions have also been made to the World Health Organization ( WHO ) to achieve prequalification status and to African health authorities in collaboration with the African Vaccine Regulatory Forum ( AVAREF ).

On July 25, 2016, Merck announced that the FDA had granted the vaccine candidate Breakthrough Therapy Designation, and that EMA had granted PRIME ( PRIority MEdicines ) 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 Ebola outbreak in western Africa was at its peak, Merck licensed V920 from NewLink Genetics.
Merck is responsible for the research, development, manufacturing and regulatory efforts in support of V920. ( Xagena )

Source: FDA, 2019

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