The U.S. Food and Drug Administration (FDA) has approved the first vaccine to prevent Ebola virus disease. The vaccine, Ervedo, by Merck & Co, Inc, was granted approval based on a study conducted during the 2014-2016 outbreak in Guinea. The study involved 3,537 adults who were in contact with people infected by Ebola, or in contact with people wher were in contact with infected individuals. The study found that the vaccine was 100% effective in preventing Ebola virus disease if the vaccine was given within 10 days of being exposed to an infected individual. In one group that received the vaccine within 21 days of being exposed to someone with the virus, 10 persons developed the Ebola virus disease (of 1,429 vaccinated).
In a news release, Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs said, “While the risk of 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.”
Ebola virus is transmitted through direct contact with blood, body fluids and tissues of infected wild animals or people. Early symptoms can include vomiting, diarrhea, rash, impaired kidney and liver function, and possibly internal and external bleeding. Healthcare workers who provide care for infected patients are at the highest risk for infection.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research said, “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.”
Ervebo is administered as a single injection. It is a live, attenuated vaccine that is genetically engineered to include a protein from the Zaire ebolavirus. The most common side effects are pain, swelling and redness at the injection site.
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