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FDA Grants Approval For Merck's Ebola Vaccine Ervebo - Quick Facts

The U.S. Food and Drug Administration announced Friday the approval of Merck & Co., Inc.'s (MRK) Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. Cases of EVD are very rare in the U.S.

EVD is contagious and is transmitted through direct contact with blood, body fluids and tissues of infected wild animals or people, as well as with surfaces and materials, such as bedding and clothing, contaminated with these fluids.

Ervebo is administered as a single-dose injection, and is a live, attenuated vaccine that has been genetically engineered to contain a protein from the Zaire ebolavirus.

The FDA granted this application Priority Review and a Tropical Disease Priority Review Voucher under a program intended to encourage development of new drugs and biologics for the prevention and treatment of certain tropical diseases.

The FDA also granted Breakthrough Therapy designation for Ervebo to facilitate the development and scientific evaluation of the vaccine.

The approval of Ervebo is supported by a study conducted in Guinea during the 2014-2016 outbreak in individuals 18 years of age and older.

The study was a randomized cluster (ring) vaccination study in which 3,537 contacts, and contacts of contacts, of individuals with laboratory-confirmed EVD received either "immediate" or 21-day "delayed" vaccination with Ervebo.

Ervebo was determined to be 100% effective in preventing Ebola cases with symptom onset greater than 10 days after vaccination.

The Democratic Republic of the Congo (DRC) is currently experiencing the world's second largest EVD outbreak.

In 2018, the World Health Organization (WHO) and the DRC began to use Ervebo as an investigational vaccine under an expanded access program to help mitigate this outbreak.

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