US regulators have cleared Merck & Co’s Ervebo (rVSVΔG-ZEBOV-GP), marking the first vaccine to win marketing approval in the country for the prevention of Ebola virus disease (EVD).
The vaccine, which was developed at Canada’s National Microbiology Laboratory with funding from the US government’s Biomedical Advanced Research and Development Authority (BARDA), specifically protects against the Zaire ebolavirus, and can be used in individuals 18 years of age and older.
“Having an Ebola vaccine approved by the FDA is a significant milestone in Ebola preparedness and prevention efforts,” said Rick Bright, deputy assistant secretary for preparedness and response and director of BARDA.
Merck said it is working to initiate manufacturing of licensed doses and expects these to start becoming available in around the third quarter of 2020.
The firm is also working alongside the US government, WHO, UNICEF, and Gavi (the Vaccine Alliance) “to plan for how eventual, licensed doses will support future public health preparedness and response efforts against Zaire ebolavirus disease”.
The European Commission approved the vaccine last month.
