Merck Says FDA Approves Ebola Zaire Vaccine Ervebo

By Michael Dabaie

Merck & Co. Inc. (MRK) said the U.S. Food and Drug Administration approved Ervebo for the prevention of disease caused by Zaire ebolavirus in individuals 18 years and older.

Merck said it is working to initiate manufacturing of licensed doses and expects these doses to start becoming available in about the third quarter of 2020. The company said it is working closely with the U.S. government; World Health Organization; UNICEF; and Gavi, the Vaccine Alliance.

Merck said that, during this transition period, it is continuing to work with its partners to ensure uninterrupted access to the investigational Ebola Zaire vaccine, V920, in support of ongoing international response efforts in the Democratic Republic of the Congo and neighboring countries.

Merck said it also made submissions to African country national regulatory authorities in collaboration with the African Vaccine Regulatory Forum that will allow the vaccine to be registered in African countries considered to be at-risk for Ebola outbreaks by the WHO.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

December 20, 2019 07:48 ET (12:48 GMT)

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