The Biomedical Advanced Research and Development Authority (BARDA) recently announced it would provide funding through Project BioShield for manufacturing process validation, regulatory approval, and stockpile purchases for four Ebola vaccines and drugs.
The vaccines and drugs are the first for Ebola to receive Project BioShield funding, which is provided by BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
The U.S. Department of Homeland Security considers Ebola a potential bioterrorism threat, as well as a potential, naturally occurring outbreak.
“Today we are prepared to add four Ebola countermeasures to the stockpile whereas three years ago, very few products were even in early stages of development,” BARDA Director Rick Bright said. “This marks a pivotal moment in U.S. and global preparedness for future public health emergencies from viral hemorrhagic fevers like Ebola. We reached this point at unprecedented speed, and that’s a direct result of innovative approaches to product development and to partnering across the U.S. government, other nations, and private industry.”
BARDA could purchase as much as 1.13 million regimens of vaccines, including a single-dose vaccine from Merck Sharp & Dohme Corp of Whitehouse Station, New Jersey, and a two-dose vaccine from Janssen Vaccines and Prevention B.V. of Leiden, The Netherlands.
BARDA will also provide $45.9 million for late-stage development and initial purchase of the therapeutic drug ZMapp to Mapp Biopharmaceutical, Inc. of San Diego, California. It will also provide $40.4 million for a therapeutic drug from Regeneron Pharmaceuticals, Inc. of Tarrytown, New York.