The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), has issued a new Request for Project Proposals (RPP-26-10-VHF) under its Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium). This solicitation represents a key step in building domestic capacity for advanced vaccine manufacturing to strengthen the nation’s biosecurity infrastructure. BARDA’s latest effort seeks to onshore the production of Vesicular Stomatitis Virus (VSV) Delta G-based vaccine candidates, targeting deadly viral hemorrhagic fever (VHF) pathogens such as Marburg virus (MARV) and Sudan virus (SUDV). By relocating vaccine manufacturing capabilities from overseas to the U.S., BARDA aims to enhance public health preparedness and reduce dependence on foreign supply chains for critical countermeasures.
Overview of the Solicitation
Through the BioMaP-Consortium, BARDA is leveraging its Other Transaction Agreement (OTA) with Advanced Technology International (ATI) to fund projects that expand the domestic industrial base for medical countermeasures. This specific RPP invites proposals from BARDA-sponsored product sponsors or technology owners developing monovalent filovirus vaccine candidates using the VSV platform. The scope of the effort is narrowly defined: offerors must demonstrate the technology transfer of existing vaccine production processes covering both bulk drug substance (upstream and downstream) and drug product (formulation, fill/finish) to one or more U.S.-based Contract Development and Manufacturing Organizations (CDMOs).
Each proposed project will involve close coordination between the product sponsor and selected CDMO(s) to ensure that manufacturing processes established domestically mirror existing foreign processes, maintaining consistency in yield, purity, and potency. BARDA anticipates that the technology transfer will include engineering runs, analytical testing, and quality assurance to meet Current Good Manufacturing Practice (cGMP) and Biosafety Level 2 (BSL-2) requirements. The U.S. Government will monitor performance through frequent technical meetings, milestone-based deliverables, and risk management reporting throughout the 30-month period of performance.
Key Objectives and Program Structure
BARDA’s primary goal is to make one or more awards to onshore manufacturing for up to two vaccine candidates, one for Marburg virus and a potential second for Sudan virus. The effort begins with Marburg virus as the priority candidate, allowing subsequent Sudan virus work to benefit from the established technology transfer framework.
The solicitation outlines a clear milestone-based structure, including proof-of-concept and full-scale demonstration phases for both bulk drug substance (BDS) and fill/finish drug product (FDP) manufacturing. Each milestone will be tied to Go/No-Go decision points based on performance criteria such as titer yields, successful analytical transfer, and GMP run results. The program also emphasizes transparency, risk management, and collaboration, requiring a formal Teaming Arrangement Plan that ensures effective communication between the U.S. Government, the product sponsor, and the CDMO partner(s).
Important Dates and Deadlines
Offerors should be mindful of the following key dates in the RPP timeline:
- November 12, 2025 (3:00 PM ET): Deadline for submitting questions to BARDA via [email protected]
- December 11, 2025 (1:00 PM ET): Full proposals due via the ATI submission portal
BARDA will not hold a proposer’s day or live Q&A session; however, responses to submitted questions will be posted publicly on the BioMaP-Consortium website to ensure transparency and equal access to information.
Funding and Award Information
Funding for this initiative is contingent upon federal appropriations, but BARDA anticipates making one or more awards under this RPP. Offerors are encouraged to propose budgets that align with the scope and complexity of their projects, and cost sharing, while not required, is strongly encouraged to demonstrate industry commitment. Each award will be executed as a Project Agreement under OTA Number 75A50123D00003, with terms governed by the BioMaP-Consortium Base Agreement.
The anticipated period of performance will not exceed 30 months, expected to begin in Q2 of Fiscal Year 2026. Both the product sponsor and the CDMO must be members of the BioMaP-Consortium prior to award, ensuring all participants are aligned with BARDA’s mission to expand the U.S. medical countermeasure manufacturing base.
Advancing Health Security Through Domestic Vaccine Capability
BARDA’s RPP 26-10-VHF represents a pivotal opportunity to bolster domestic vaccine readiness against emerging infectious diseases. By investing in U.S.-based production of filovirus vaccine candidates, this initiative strengthens the nation’s preparedness for outbreaks like Marburg and Sudan virus, both of which have demonstrated epidemic potential in Africa and pose serious threats to global health security.
Through this effort, BARDA continues to advance the U.S. Government’s long-term goal of reducing reliance on foreign manufacturing and establishing resilient, scalable biopharmaceutical infrastructure capable of rapid response in future emergencies.
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