Domestic Capability Building Activity – Onshoring the Manufacturing of Viral Hemorrhagic Fever Vaccine Candidates

The United States Government (USG) is seeking to expand domestic commercial biopharmaceutical manufacturing capabilities by onshoring the manufacturing of Vesicular Stomatitis Virus (VSV) Delta G based vaccine candidates for protection against viral hemorrhagic fever viruses. The project involves technology transfer of current candidate vaccine production processes from their current manufacturing sites outside the U.S. to one or more domestic Contract Development and Manufacturing Organizations (CDMOs) located within the US. The scope of this effort is strictly to demonstrate tech transfer of manufacturing capability for bulk drug substance and drug product to the U.S. Key aspects of the project include: • Technology transfer of vaccine production processes • Onshoring of manufacturing capabilities to the U.S. • Enhancement of domestic vaccine production to bolster national health security preparedness • Response to known and emerging infectious disease threats • Limited to product sponsors/technology owners with BARDA-sponsored monovalent filovirus vaccine candidates based on the VSV platform technology