Merck gets FDA green light for Ervebo
Merck has received the Food and Drug Administration’s approval for Ervebo (Ebola Zaire Vaccine, Live) for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older.
“Approval of this vaccine by the FDA represents another important milestone in the global response to Ebola Virus Disease and stands as a tremendous accomplishment by a unique global partnership,” said Roger Perlmutter, Merck Research Laboratories president. “In acknowledging this event, I wish in particular to recognize the heroic efforts being made by frontline responders to the ongoing outbreak in the Democratic Republic of the Congo. We are proud and honored to play a role in supporting their vital activities, and we remain focused on the important work ahead.”
“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 the Biomedical Advanced Research and Development Authority. “At BARDA, we are tremendously proud to have been a part of this unprecedented collaboration between private and public sectors in multiple countries that has led to this important moment in public health history.”
As previously announced, Merck is working to initiate manufacturing of licensed doses and expects these doses to start becoming available in approximately the third quarter of 2020. Merck is working closely with the U.S. 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