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First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response |
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First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

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The U.S. Food and Drug Administration has announced the approval of 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.

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. “Ebola virus disease is a rare but severe and often deadly disease that knows no borders. Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research… (FDA, December 19, 2019)

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