HHS, Emergent BioSolutions enter into contract for anthrax vaccine development

The U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) recently moved forward with the development of the anthrax vaccine NuThrax.

ASPR’s Biomedical Advanced Research and Development Authority (BARDA) and Emergent Biosolutions, Inc., recently entered into a five-year contract worth $198.7 million. The funding will cover the remaining development actions needed to apply for vaccine licensure from the U.S. Food and Drug Administration (FDA). The contract covers Phase 2 clinical studies to evaluate the vaccine’s safety as well as any Phase 3 studies to examine the vaccine’s effectiveness.

The vaccine is intended to be used over two doses administered 14 days apart.

The contract also contains options to purchase the vaccine in the future to be used in the U.S. Strategic National Stockpile (SNS).

“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,” Dr. Richard Hatchett, acting director of BARDA, said. “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.”