The Biomedical Advanced Research and Development Authority (BARDA), through the Rapid Response Partnership Vehicle (RRPV), has announced an Opportunity Notice for the Bundibugyo virus Outbreak Response Vaccines (BundiVx) Program. The initiative is intended to accelerate the development of vaccine candidates targeting Bundibugyo ebolavirus (BDBV), a species of Ebola virus responsible for the ongoing outbreak confirmed in Ituri Province, Democratic Republic of the Congo in May 2026.
Currently, there are no licensed vaccines or active clinical-stage vaccine programs specifically targeting BDVX, creating an urgent need for countermeasures that can support outbreak response efforts. BARDA plans to leverage the demonstrated efficacy of the vesicular stomatitis virus (VSV) platform to rapidly advance BDBV-specific vaccine candidates into clinical development. Through the BundiVx program, BARDA aims to (1) produce current Good Manufacturing Practice (cGMP) clinical trial material and complete the regulatory activities necessary to support use of investigational vaccines during the ongoing outbreak; and (2) identify promising BDBV vaccine candidates for further development.
Program Scope and Technical Focus
Based on the upcoming opportunity notice, BARDA anticipates supporting activities across the full early-stage vaccine development pathway, including manufacturing, nonclinical studies, Phase 1 clinical evaluation, and outbreak clinical trial support. Planned work areas include:
Manufacturing Development
Awardees are expected to conduct process development activities and produce cGMP Phase 1 clinical trial material (CTM), including manufacturing of up to 10,000 doses for initial clinical evaluation.
IND-Enabling Studies
The program will support critical-path nonclinical studies required to enable successful Investigational New Drug (IND) applications and initiation of Phase 1 clinical trials.
Clinical Development
BARDA anticipates supporting Phase 1 clinical trials to evaluate candidate vaccines and generate data necessary for future development decisions.
Expanded Manufacturing and Outbreak Support
The program may also include manufacturing up to 100,000 doses of cGMP CTM and logistical support for outbreak-related clinical studies, including labeling, shipping, storage, sample management, and immune assay activities.
Important Eligibility Requirements
Although the formal Request for Project Proposals (RPP) has not yet been released, BARDA has indicated several anticipated mandatory eligibility requirements for prospective offerors. These include:
- Use of a VSV-based vaccine platform
- Demonstrated development and manufacturing experience with the platform in the context of a filovirus vaccine
- An established manufacturing relationship between the vaccine developer and proposed Contract Development and Manufacturing Organization (CDMO) at the time of proposal submission
- A commitment to provide materials to BARDA or BARDA-designated partners for nonclinical and clinical testing activities
These requirements suggest BARDA is prioritizing organizations that can move rapidly using established vaccine technologies and existing manufacturing partnerships.
Key Dates
At this time, BARDA has not released a formal Request for Project Proposals or associated submission deadlines.
However, the agency notes that release of the future RPP is anticipated to be imminent, and interested organizations should closely monitor RRPV and BARDA communications for additional details.
Additional Information
The BundiVx program reflects BARDA’s continued focus on strengthening preparedness for emerging filovirus threats. While the only FDA-licensed filovirus vaccine currently available is ERVEBO, which targets Zaire ebolavirus, no comparable vaccine exists for Bundibugyo ebolavirus. The current outbreak has heightened the need for rapidly deployable vaccine candidates capable of supporting outbreak response and protecting at-risk populations.
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