Bundibugyo virus Outbreak Response Vaccines (BundiVx)

Solicitation Description

The purpose of this RPP is to advance investigational BDBV vaccine candidates leveraging the VSV vaccine platform, which has demonstrated single dose protection in past EBOV outbreaks.

Work includes manufacturing process development through production of initial current Good Manufacturing Practice (cGMP) Phase 1 clinical trial material (CTM), with a goal of up to 10,000 doses. Early regulatory engagement will inform the critical-path IND-enabling nonclinical. The proposed approach must describe how any available platform efficiencies from prior or ongoing platform development and manufacturing to accelerate the path towards cGMP CTM production and IND submission under the U.S. FDA. Additional activities include a Phase 1 safety and immunogenicity trial as well as options for production of up to 100,000 doses of cGMP CTM.

The end goal of this effort is (1) to produce cGMP CTM and meet regulatory requirements to enable use of investigational candidate(s) in a clinical trial for the ongoing 2026 BDBV outbreak and (2) to identify successful BDBV vaccine candidates for potential further development.

Submission Information

All RRPV submissions must be submitted to the BARDA Digital Resources (BDR) RRPV Portal.

The account request process is simple but may take several days for approval and access. To request a BDR RRPV Portal account (first-time user), please complete the BDR Access Request Form. If you already have an account, please ensure you have access several days ahead of the submission deadline, if you have difficulty accessing your account please reach out to [email protected].

Documentation and reference materials for the BDR RRPV Portal are available to RRPV Member Organizations from the RRPV Members Only Site (for new users, request access here), and upon request from [email protected].

Neither the Government nor the RRPV CMF will make allowances/exceptions for submission problems encountered by the Offeror using system-to-system interfaces. If the Offeror fails to submit the full submission prior to the deadline, the submission may not be accepted. It is the Offeror’s responsibility to ensure a timely and complete submission. Failure to propose your submission on time for any reason may result in the submission not being considered for award.

Solicitation Details

Amendment 01:

Issued: 17 June 2026

Extends Submission deadline to 2 July 2026 by 1PM EDT; All other terms and conditions remain unchanged.

Original RPP Release:

Issued: 11 June 2026

Questions Due: 16 June 2026 3pm EDT

Due: 02 July 2026 1pm EDT