Next-Generation Anthrax Vaccine Supported
"Fifteen years ago this month, anthrax was used as a weapon of domestic terrorism in the U.S. and its use remains a threat today," said Dr. Richard Hatchett, acting director of BARDA. "BARDA is sponsoring the development of NuThrax to help better protect our nation from this threat."
An anthrax vaccine described by the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response as possibly as effective in just two doses is moving forward in development thanks to a $198.7 million, five-year contract between ASPR's Biomedical Advanced Research and Development Authority (BARDA) and Emergent BioSolutions, a company based in Gaithersburg, Md. The contract funds the remaining development activities required for the company to apply to FDA to have the vaccines licensed.
The development work includes a Phase 3 clinical study to determine the effectiveness of the vaccine candidate NuThrax, as well as a Phase 2 study to evaluate the vaccine's safety and whether it interacts with an antibiotic administered as part of the routine treatment following anthrax exposure.
The contract includes a provision regarding buying vaccine, as well as options to purchase vaccine in the future, for the Strategic National Stockpile, and HHS said before FDA licensure, the stockpiled vaccine could be used after an anthrax attack if authorized for emergency use by FDA.
"Fifteen years ago this month, anthrax was used as a weapon of domestic terrorism in the U.S. and its use remains a threat today," said Dr. Richard Hatchett, acting director of BARDA. "BARDA is sponsoring the development of NuThrax to help better protect our nation from this threat. This vaccine could provide protection in fewer doses than the anthrax vaccine currently available, potentially producing better health outcomes if it was needed during a public health emergency."
NuThrax is also known as AV7909. Studies conducted to date indicate two doses administered 14 days apart appear sufficient to stimulate a protective immune response against anthrax.