The file's text, extracted by GovTribe without its formatting.
Updated 6/17/26
| Question # |
| Question |
| Response |
| 1 |
| Are non-vaccine therapeutic medical countermeasure modalities, including antiviral candidates, responsive under RPP 26-13-BundiVx, or is the RPP limited strictly to vaccine candidates? |
| Non-vaccine therapeutic medical countermeasure modalities are out of scope. |
| 2 |
| Are other platforms than VSV considered for RPP 26-13-BundiVx? Would you be willing to consider a single dose Ad-based vaccine for this RPP? |
| Non-VSV vaccine platforms are out of scope. |
| 3 |
| Based on the basket provision being open, can BARDA please inform if it anticipates making any additional awards in FY27? |
| It is possible to make awards from the basket provision. |
| 4 |
| Can BARDA please confirm if RRPV Members can submit a proposal under a teaming agreement to meet the Mandatory Eligibility Criteria? |
| Teaming is acceptable. |
| 5 |
| Can BARDA please confirm what constitutes a demonstrated manufacturing relationship or what evidence would need to be provided. |
| For purposes of this RPP, a "demonstrated manufacturing relationship" means that the vaccine developer and the proposed CDMO have a pre-existing and currently active working relationship involving the VSV platform technology with the manufacturing system/process proposed under this effort. The intent of this requirement is to reduce execution risk associated with initiating a new manufacturing partnership during an outbreak response by verifying that the developer and CDMO have already established the technical, operational, and contractual interactions necessary to support rapid advancement of a candidate. |
Offerors should clearly describe the nature, scope, and status of the existing developer-CDMO relationship and provide sufficient documentation to demonstrate that the relationship is already established.
| 6 |
| Can BARDA please clarify if the "platform technology" is specific to the rVSV construct or is it sufficient that the proposed CDMO partner has prior experience with rVSV platforms and plans to manufacture this construct in the same manufacturing system? |
| As described in the RPP, platform technology refers to the VSV vaccine platform that has demonstrated single-dose protection in prior Ebola virus outbreaks, or a closely related version of that vector backbone. VSV vector backbones that differ materially from the one that has demonstrated single-dose protection against other ebolaviruses in prior outbreaks should not assume such candidates would be considered responsive to the platform requirements of this RPP. |
As described in the RPP, the proposed CDMO partner is not required to have prior experience manufacturing the specific BDBV vaccine candidate included in the proposal. However, the CDMO should have prior experience manufacturing the same VSV platform technology and manufacturing system/process proposed for this effort.
| 7 |
| Can BARDA please confirm if there is a target timeframe in which base tasks should be completed, specifically Task 1a Process development to engineering run (Base)? |
| No specific timeframe is prescribed for completion of Task 1a. However, Offerors should note that a stated objective of the RPP is to produce cGMP clinical trial material (CTM) and meet regulatory requirements to enable use of investigational candidate(s) in a clinical trial for the ongoing 2026 BDBV outbreak. Accordingly, offerors should describe both their steady-state and accelerated manufacturing timelines, along with the key assumptions and critical-path activities underlying those timelines. |
| 8 |
| Can BARDA please confirm if Optional Tasks 4a and 4b can extend outside of the 5-year Period of Performance? |
| All proposed options should be within the 5-year period of performance. |
| 9 |
| Can BARDA please confirm if Optional Tasks 4a and 4b should account for manufacturing 100k doses in total or two separate runs of 100k doses each? |
| Each Task should individually account for manufacturing 100k dose; i.e., |
· Task 4a. Manufacturing up to 100,000 doses of CTM
· Task 4b. Manufacturing up to 100,000 doses of CTM
| 10 |
| Noting that EUA would only be in play if the HHS secretary declared one and would typically apply to more advanced products. Can BARDA please clarify if deliverable 8.5 is intended to simply relay that any and all correspondence with the FDA, including any pre-EUA activity triggered by the government sponsor, will be provided? |
| Yes. The regulatory deliverables are intended to capture any correspondence and interactions with the FDA relevant to activities conducted under the award, if applicable. |
| 11 |
| Can BARDA please consider extending the proposal submission deadline by two weeks to allow sufficient time to develop a comprehensive and competitive cost proposal? |
| The RPP close will be extended to July 2nd at 1pm EDT. |
| 12 |
| Would it be reasonable to assume that a VSV-BDBV manufacturing process be technology transferred to the USA following delivery of 100,000 doses? |
| No assumptions should be made regarding future technology transfer requirements beyond those specified in the RPP. |
The RPP does not restrict offerors to U.S.-based developers or CDMOs; however, all offerors must comply with applicable consortium, contractual, statutory, regulatory, and security requirements. BARDA cannot speculate on or commit to any future requirements, activities, or decisions beyond the scope of this RPP.
| 13 |
| Is it acceptable for an offeror to include non-clinical NHP studies to evaluate specific objectives that are outside of the RFP requirement "Must commit to providing materials to BARDA or BARDA-designated partners for testing in nonclinical and/or clinical assays." For example, durability of protection, onset of protection. |
| Offerors should propose the nonclinical activities they consider reasonably necessary to support successful submission of a Phase 1 IND under the U.S. FDA. Proposed activities should be justified in the context of the solicitation objectives and the information needed to support IND submission. The specific nonclinical activities ultimately conducted under any resulting award will be informed by FDA feedback obtained through pre-IND and other regulatory interactions. |
| 14 |
| Would BARDA support studies focused on process improvement and optimization prior to scale up? |
| The primary objective of this solicitation is the timely advancement of investigational VSV-BDBV vaccine candidate(s) to support submission of a Phase 1 IND under the U.S. FDA and production of stage-appropriate cGMP clinical trial material for potential use in an outbreak clinical trial. Offerors may propose process development activities necessary to achieve these objectives; however, BARDA does not anticipate supporting extensive process improvement or optimization efforts that are not directly tied to these objectives. |
| 15 |
| Would BARDA be open to an offeror engaging with EMA in addition to FDA interactions? |
| The proposed approach should focus on regulatory engagement and submissions necessary to support a U.S. FDA Investigational New Drug (IND) application, consistent with the objectives of this solicitation. However, BARDA recognizes that data, documentation, and activities generated under any resulting award may also support future interactions with, or submissions to, other regulatory authorities, such as the European Medicines Agency (EMA). |
| 16 |
| Can BARDA extend the submission deadline to Thursday, July 2nd? |
| Yes. The RPP close will be extended to July 2nd at 1pm EDT. |
| 17 |
| Does BARDA anticipate evaluating GMP vaccine material in preclinical efficacy studies? |
| Offerors should propose the nonclinical activities they consider necessary to support successful submission of a Phase 1 IND under the U.S. FDA. BARDA does not prescribe whether preclinical efficacy studies should use GMP or non-GMP material; offerors should justify their proposed approach. Specific activities conducted under any resulting award will be informed by FDA feedback obtained through pre-IND and other regulatory interactions. |
| 18 |
| Would BARDA support development of immunologic assays and analytical assays to support this program? |
| As described in Task 1, offerors should conduct analytical assay development and testing necessary to support product release and stability studies for Phase 1 cGMP clinical trial material. |
In addition, under Task 2, offerors should propose all nonclinical activities that could reasonably be required to support successful submission of a Phase 1 IND under the U.S. FDA. The specific activities ultimately conducted under any resulting award will be informed by FDA feedback obtained through pre-IND and other regulatory interactions.
