FDA approves Ebola vaccine

The Food and Drug Administration (FDA) announced its first approval of an Ebola virus disease (EVD) vaccine called Ervebo in December. Because of the public health importance of a vaccine to prevent EVD, the agency stated, the FDA worked closely with the pharmaceutical company, completing its evaluation of the safety and effectiveness of the vaccine in less than six months. Ervebo’s safety was assessed in 15,000 people on three continents. “The FDA’s approval of Ervebo is a major advance in helping to protect against the Zaire ebolavirus as well as advancing U.S. government preparedness efforts,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “The research approach used to study the effectiveness and safety of this vaccine was precedent-setting during a public health emergency and may help create a model for future studies under similar circumstances.” (FDA news release, 12/19/19)