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FDA approves Merck’s Ebola vaccine, Ervebo
Merck’s Ebola vaccine, Ervebo, has been approved by the FDA, the company announced, calling it “another important milestone in the global response to Ebola virus disease.”
Merck also won approval for Ervebo in Europe last month, making it the world’s first approved Ebola vaccine. WHO followed by making it the first prequalified Ebola vaccine, giving countries speedier access to doses.
The vaccine has been given to more than 258,000 people in the ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC), where it has been estimated to be more than 97% effective.
“Having an Ebola vaccine approved by the FDA is a significant milestone in Ebola preparedness and prevention efforts,” Rick A. Bright, PhD, U.S. deputy assistant secretary for preparedness and response and director of the Biomedical Advanced Research and Development Authority, said in a statement.
Merck said it expects to make Ervebo available in approximately the third quarter of 2020. The company is working with the U.S. government, WHO, UNICEF, and Gavi, the Vaccine Alliance to plan for how the vaccine will support future public health preparedness and response efforts against Ebola.
Gavi has said it will fund a global emergency stockpile of Ebola vaccine that countries will be able to use for outbreak prevention and response.
Disclosure: Bright reports no relevant financial disclosures.