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FDA Approves Ervebo Vaccine For Prevention Of Ebola Virus Disease

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The Food and Drug Administration Thursday said it has approved an Ebola vaccine developed by Merck, the first prevention vaccine for the deadly disease to be approved in the United States.

FDA approved 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.

"While the risk of Ebola virus disease in the U.S. remains low, the U.S. government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo," said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs.

"Today's approval is an important step in our continuing efforts to fight Ebola in close coordination with our partners across the U.S. Department of Health and Human Services, as well as our international partners, such as the World Health Organization. These efforts, including today's landmark approval, reflect the FDA's unwavering dedication to leveraging our expertise to facilitate the development and availability of safe and effective medical products to address urgent public health needs and fight infectious diseases, as part of our vital public health mission."

The FDA's decision follows similar decision taken earlier by the European Commission, which licensed the vaccine on November 11.

Ebola virus is contagious and is transmitted through direct contact with blood, body fluids and tissues of infected wild animals or people. Onset of symptoms of EVD can be sudden and can include fever, fatigue, muscle pain, headache and sore throat.

Ebola Zaire is the virus responsible for the current long-running outbreak in the Democratic Republic of the Congo.

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