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Merck & Co.'s Ebola vaccine gets FDA's priority review

The U.S. Food and Drug Administration granted priority review to Merck & Co. Inc.'s application seeking approval of the investigational Ebola vaccine V920.

The Kenilworth, N.J.-based pharmaceutical giant had submitted a biologics license application for V920 — which received the FDA's breakthrough-therapy designation in July 2016 — to prevent the disease caused by the Ebola Zaire virus. The FDA is expected to make a decision on the vaccine by March 14, 2020. In March, the European Medicines Agency accepted a request to review an application seeking approval of V920.

Merck's vaccine is being used to fight the Ebola epidemic in the Democratic Republic of Congo. As of Aug. 1 — which marks one year since the first case was recorded — 1,813 deaths have been reported. The World Health Organization has declared the Ebola crisis in Congo a public health emergency of international concern, while certain members of the U.S. Department of Health and Human Services has also called the epidemic a national security concern.

In August, Merck said it would receive $23 million from the HHS to develop and manufacture V920, amid the ongoing outbreak in Congo. The company has donated and shipped over 245,000 doses of the experimental vaccine to the WHO, and it said it has 190,000 doses that are available and ready to ship at the WHO's request.