The FDA announced on Thursday its first-ever approval of a vaccine for the Ebola virus disease (EVD) meant for individuals age 18 and older. The vaccine, Ervebo, was involved in a two-year study conducted during an Ebola outbreak in Guinea, which along with Sierra Leone and Liberia saw more than 11,000 deaths during that timeframe.
“While the Ebola virus disease in the U.S. remains low, the U.S. government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo,” 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, as well as our international partners, such as the World Health Organization.”
Ervebo is a single-dose injection and was used in 2018 by WHO in the DRC as an investigational vaccine to help combat the world’s second-largest Ebola outbreak. 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. Symptoms may appear as soon as two days or up to 21 days after exposure and can include fever, fatigue, muscle pain, headache and sore throat.
Severe symptoms may include vomiting, diarrhea, rash, kidney issues, liver issues, and bleeding. Following the Guinea study and several investigations in the safety of the vaccine, the FDA granted Breakthrough Therapy designation, which will help facilitate and develop the vaccine.
Abram called the approval a “landmark” decision and said it reflects the health agency’s “unwavering dedication” to developing safe and effective ways to combat infectious diseases.