Ebola Vaccines, Drugs Added to U.S. Stockpile
"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, Ph.D., said. "This marks a pivotal moment in U.S. and global preparedness for future public health emergencies from viral hemorrhagic fevers like Ebola."
HHS on Sept. 29 announced the first purchase of vaccines and therapeutic drugs for the Ebola virus by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response. These are first vaccines and drugs for Ebola to receive Project BioShield funding, which supports late-stage development toward licensing and stockpile purchases.
"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, Ph.D., 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."
The U.S. Department of Homeland Security considers Ebola a potential bioterrorism threat, as well as a naturally occurring public health threat. Under the agreements announced Sept. 29, BARDA will provide Project BioShield funding for each company to validate its manufacturing processes and undertake the final preparations needed to apply for approval through the U.S. Food and Drug Administration; as that work is completed, BARDA can purchase the vaccines and drugs for potential use in a public health emergency.
The HHS agency could buy up to 1.13 million regimens of vaccine, including a single-dose vaccine from Merck Sharp & Dohme Corp of Whitehouse Station, N.J., and a two-dose vaccine from Janssen Vaccines and Prevention B.V. of Leiden, The Netherlands. BARDA also will buy a therapeutic drug from Mapp Biopharmaceutical, Inc. of San Diego, Calif., and a therapeutic drug from Regeneron Pharmaceuticals, Inc. of Tarrytown, N.Y.
The announcement said Merck Sharp & Dohme Corp's single-shot vaccine would be used to protect people at high risk of exposure to Ebola, and BARDA will provide $39.2 million for late-stage development and purchase. Janssen Vaccines and Prevention B.V.'s vaccine is a two-dose vaccine regimen that would be used to prevent illness in people who have not been exposed to Ebola but could be, such as health care workers and the general public; BARDA will provide $44.7 million for late-stage development and purchase under Project BioShield. And for Mapp Biopharmaceutical, BARDA initially will provide $45.9 million for late-stage development and initial purchase of the therapeutic drug ZMapp™ under Project BioShield.