As the global health landscape evolves, so too must the United States’ ability to respond rapidly to biological threats. To strengthen its readiness posture, the Biomedical Advanced Research and Development Authority (BARDA), in coordination with the Administration for Strategic Preparedness and Response (ASPR), has released a new opportunity under the BioMaP Consortium OT Vehicle. This solicitation focuses on the Domestic Capability Building Activity, titled Onshoring the Manufacturing of Viral Hemorrhagic Fever Vaccine Candidates. The goal is to transfer production of critical vaccines from international facilities to U.S.-based manufacturing organizations.
Overview of the Solicitation
The solicitation seeks to address a significant gap: there is currently no domestic U.S. manufacturing capability for vaccines targeting viral hemorrhagic fevers (VHFs), such as Marburg and Ebola Sudan. To close this gap, BARDA will fund efforts to transfer the manufacturing technology for Vesicular Stomatitis Virus (VSV) Delta G-based vaccine candidates, which are currently produced overseas, to one or more U.S.-based Contract Development and Manufacturing Organizations (CDMOs). These vaccines use Vero cells and require manufacturing capabilities for both bulk drug substance and drug product, including formulation and fill/finish.
Awardees will be required to:
- Demonstrate full technology transfer of the existing drug substance and drug product manufacturing process (inclusive of formulation, fill/finish)
- Ensure manufacturing under BSL-2 and cGMP conditions
- Include analytical method transfer, engineering runs, and metrics validation to ensure equivalence with the original processes
- Maintain frozen material storage at -80°C
Given the complexity of the process, teaming arrangements are strongly encouraged. These arrangements must include the product sponsor or technology owner, CDMO(s), and the U.S. Government (USG) as active stakeholders in all technical discussions.
Program Structure and Requirements
BARDA expects the complete technology transfer effort to be executed within 18 months of award. Each awardee must ensure the domestic site replicates the existing manufacturing process, including yields and dosage concentration, without the need for further product development or optimization. Success will be defined by at least one full engineering manufacturing run under GMP-like conditions that meets pre-negotiated acceptance criteria.
All CDMO facilities involved must be current or soon-to-be members of the BioMaP Consortium, and all awarded efforts must include a Quality Management Plan, Security Plan, and Project Risk Register as part of the deliverables. A full Integrated Master Project Schedule (IMPS) and regular reporting (monthly, semi-annual, annual) will ensure continued oversight and accountability throughout the project.
Key Dates and Deadlines
While the document does not list specific calendar deadlines such as a Proposers’ Day or proposal submission due dates, it does specify the following timeline-based deliverables:
- Kick-Off Meeting: Within 14 days of award
- Initial IMPS, Project Budget, Security Plan, and Quality Management Plan: Within 30 days of award
- Semi-Annual In-Process Review (IPR): Every 6 months
- Monthly Progress Reports and Meetings: Starting one month after award and continuing throughout performance
- Final Report: Due 30 days before the end of the period of performance
If specific proposal deadlines are announced later, they will likely be coordinated through the BioMaP Consortium.
Funding Details
The solicitation supports awards for up to two vaccine candidates, and offerors can propose one or more. While the exact number of awards is not specified, it is implied that multiple awards may be made to accommodate the complexity and need for diverse CDMO partnerships. The period of performance is strictly capped at 18 months. Funding amounts are not stated in the SOO, but offerors are required to submit detailed cost models for drug substance and drug product activities as part of their proposal.
Advancing U.S. Health Security
This effort will significantly enhance the U.S. Government’s ability to prepare for and respond to viral hemorrhagic fever outbreaks by securing onshore production of life-saving vaccines. In an increasingly uncertain global health environment, building domestic capability for VHF vaccines is not just prudent. It is essential. By reducing reliance on foreign facilities, the U.S. ensures greater speed, control, and resilience in emergency response scenarios.
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