Merck & Co.'s vaccine against Ebola is the first to win FDA approval, the agency announced late Thursday.
The single-dose, live attenuated vaccine, Ervebo (rVSVΔG-ZEBOV-GP), is specifically approved to prevent infection caused by Zaire ebolavirus in adults ages 18 and older, the FDA said
HHS Secretary Alex Azar called the approval "a triumph of American global health leadership."
"From research and development to support for manufacturing, the U.S. government played an integral role in advancing the development of Merck's vaccine," he said in a statement. "The newly approved vaccine, as well as investigational therapeutics and other tools supported by the U.S. government, is playing a huge role in saving lives during the current Ebola outbreak in the Democratic Republic of the Congo."
Indeed, Ervebo is the primary vaccine that has been used in the "ring vaccination" strategy during the current Ebola outbreak in the DRC under a compassionate use protocol. The vaccine was approved based on a ring vaccination that found the vaccine was "100% effective" in preventing Ebola cases with symptom onset more than 10 days after vaccination, the agency said.
The European Medicines Agency Ervebo last month for administration in the European Union.
While FDA officials noted that cases of Ebola are "very rare" in the U.S., they did occur during 2014's major Ebola outbreak in West Africa.
"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," Peter Marks, MD., PhD, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
He added that the approach used to study the safety of the vaccine was "precedent-setting during a public health emergency" and "may help create a model for future studies under similar circumstances."