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

The United States Government (USG) has a requirement to expand domestic commercial biopharmaceutical manufacturing capabilities. To meet this need, the USG is initiating an effort to onshore the manufacturing of Vesicular Stomatitis Virus (VSV) Delta G based vaccine candidates, expressed in Vero cells, for protection against viral hemorrhagic fever viruses such as Marburg virus (MARV) and Sudan virus (SUDV). At present, there is limited domestic capacity for live viral vector manufacturing, including for viral hemorrhagic fever vaccines. Strengthening this capability is critical to enhancing domestic vaccine production to bolster national health security preparedness and ensure a more effective response to known and emerging infectious disease threats. This effort will involve the technology transfer of current candidate vaccine production processes (inclusive of bulk drug substance (upstream and downstream) and drug product (formulation, fill/finish)) from their current manufacturing sites, located outside the U.S., to one or more domestic Contract Development and Manufacturing Organizations (CDMOs) located within the US. Project Awardees for this effort shall be limited to product sponsors/technology owners that have BARDA-sponsored monovalent filovirus vaccine candidates based on the VSV platform technology. 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. This effort does not include any options dedicated or focused on the procurement of investigational or licensed products.