Merck recently announced that the U.S. Food and Drug Administration has accepted the Biologics License Application (BLA) and granted priority review for its investigational Ebola vaccine (V920), under review for the prevention of disease caused by the Ebola Zaire virus. The target action date, is set for March 14, 2020. In July 2016, the FDA granted Breakthrough Therapy Designation to V920.
"Merck has worked with government partners and the global health community to accelerate development of our investigational V920 Ebola vaccine," said Paula Annunziato, vice president, Merck Research Laboratories. "FDA’s priority review designation underscores our long-standing partnership with the U.S. government toward its development and licensure."
According to Merck, it has remained committed to scaling up the number of investigational V920 Ebola vaccine doses being produced to help international public health officials and government authorities meet ongoing outbreak response needs in the Democratic Republic of the Congo (DRC) and neighboring countries. Since May 2018, Merck has donated and shipped more than 245,000 1.0mL investigational V920 Ebola vaccine doses to the World Health Organization (WHO) in response to requests by the WHO. Beyond doses already delivered, more than 190,000 additional 1.0mL investigational doses are currently available and ready to ship to the outbreak region at WHO's request.
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