The FDA announced the approval of Merck & Co.'s Ervebo (rVSVΔG-ZEBOV-GP) as the first vaccine authorised in the US for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. Last month, the World Health Organization prequalified the vaccine, also known as V920, shortly after the product gained clearance in Europe.
"While the risk of Ebola virus disease in the US remains low, the US government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo," remarked Anna Abram, FDA deputy commissioner for policy, legislation and international affairs. The agency previously granted the filing priority review, assigning a target review date of March 14 next year.
According to the FDA, the approval of Ervebo was supported by a study conducted in Guinea during the 2014 to 2016 outbreak in individuals 18 years of age and older, with subjects either receiving "immediate" or 21-day "delayed" vaccination. Results showed that in a comparison of cases of EVD among 2108 individuals in the "immediate" vaccination arm and 1429 individuals in the "delayed" vaccination arm, Ervebo was determined to be 100% effective in preventing Ebola cases with symptom onset greater than 10 days after vaccination.
Ervebo is administered as a single-dose injection, and is a live, attenuated vaccine that has been genetically engineered to contain a protein from the Zaire ebolavirus. Merck licensed Ervebo from NewLink Genetics in 2014.
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