The U.S. Food and Drug Administration (FDA) has approved a vaccine for the prevention of the deadly Ebola virus disease for the first time. Ervebo, a single-dose, injectable vaccine manufactured by American pharmaceutical company Merck, has been approved for use for individuals age 18 and older. Anna Abram, FDA deputy commissioner for policy, legislation, and international affairs, said in a news release, “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 (HHS), as well as our international partners, such as the World Health Organization (WHO).”
The Ebola virus is one of the most deadly viruses on the planet, causing an often-fatal type of hemorrhagic fever that causes bleeding inside and outside the body. The virus is transmitted through direct contact with blood, body fluids, and tissues of infected people or animals, as well as contact with surfaces and materials contaminated with the virus. The virus has an incubation period that ranges from 2 to 21 days, after which symptoms including vomiting, diarrhea, rash, fever, fatigue, muscle pain, and bleeding may appear. The disease has a fatality rate of 50 to 90 percent.
Ervebo was involved in a two-year study conducted during an Ebola outbreak in Guinea and was used in 2018 by WHO in the Democratic Republic of the Congo (DRC) as an investigational vaccine. More than 258,000 people have been vaccinated in the outbreak zone so far. Following the Guinea study and several investigations in the safety of the vaccine, the FDA granted it a Breakthrough Therapy designation. The FDA approval comes a month after the European Union and the WHO both approved the Ebola vaccine.
Ervebo is a live, attenuated vaccine that has been genetically engineered to contain a protein from the deadly Zaire strain of the virus, which killed more than 11,000 people during the 2014 West Africa outbreak. The Zaire ebolavirus is also behind more than 2,200 deaths in the current outbreak in the eastern DRC. Another 1,089 people sickened with the virus have recovered, officials said.