Domestic Capability Building Activity – Onshoring the Manufacturing of Viral Hemorrhagic Fever Vaccine Candidates
Closed Special Notice Posted
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- Place of performance
- Summerville, South Carolina, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response has issued a Special Notice seeking to expand domestic biopharmaceutical manufacturing capabilities through the onshoring of viral hemorrhagic fever vaccine production. This initiative specifically targets the manufacturing of Vesicular Stomatitis Virus (VSV) Delta G-based vaccine candidates produced in Vero cells for protection against Marburg virus and Sudan virus. The Special Notice, posted on October 16, 2025, addresses a critical gap in current U.S. domestic capacity for live viral vector manufacturing, which is essential for national health security and pandemic preparedness. The government recognizes that most vaccine production currently occurs at international manufacturing sites, necessitating a strategic effort to strengthen domestic production capabilities. This Special Notice represents a targeted effort to build resilience in the nation's biopharmaceutical supply chain and improve response capabilities to known and emerging infectious disease threats.
The primary objective of this initiative is to demonstrate the successful technology transfer of vaccine manufacturing processes from existing international production sites to one or more domestic Contract Development and Manufacturing Organizations (CDMOs) located within the United States. Eligible participants are strictly limited to product sponsors and technology owners that have BARDA-sponsored monovalent filovirus vaccine candidates based on the VSV platform technology, ensuring focus on qualified, government-backed vaccine programs. Proposals must be submitted by the December 11, 2025 deadline, and the scope encompasses technology transfer for both bulk drug substance production (upstream and downstream processes) and drug product manufacturing (formulation, fill/finish operations). Importantly, this effort is exclusively focused on demonstrating manufacturing capability transfer and does not include procurement of investigational or licensed products or any product purchase options. Successful awardees will play a critical role in establishing sustainable domestic manufacturing infrastructure for pandemic preparedness.
Notice text
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.
Similar open opportunities
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar opportunities
- Ask GovTribe AI about this opportunity