The United States Food and Drug Administration approved Ervebo, the first vaccine to prevent Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older.
The prevalence and occurance of Ebola virus is less in the US, however, majority of the infections are from immigrants and in people who treat infected patients.
“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,” said Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs.
EVD is a contagious disease transmitted through the contact with blood, blood fluids, and tissues infected with the virus. Symptoms include fever, fatigue, muscle pain, headache and sore throat. Incubation period generally range from 2 to 21 days.
The disease is prevalent in Western African countries (Guinea, Liberia and Sierra Leone), where the 28,000 cases were reported between 2014 to 2016, resulting 11,000 deaths. The Democratic Republic of the Congo is experiencing EVD outbreak at present.
The approval is based on trial conducted in Guinea, individuals of age 18 years and older were selected. The study included 3,537 contacts. The individuals were administered with “immediate” or 21-day “delayed” vaccination. The vaccine with the immediate administration had no onset of symptoms compared to delayed vaccination.
Safety is assessed across 1,500 patients in Africa, Europe and North America.