BARDA’s “Protection Before Day One” Initiative Seeks Broadly Protective Influenza Vaccines

Program/Solicitation Overview

The RPP will be issued through the RRPV Consortium, an enterprise partnership supporting research and development activities in collaboration with BARDA, the Administration for Strategic Preparedness and Response, and the U.S. Department of Health and Human Services. Advanced Technology International (ATI) serves as the RRPV Consortium Management Firm under an Other Transaction Agreement with BARDA. Selected work would be executed as a Project Award under RRPV Base Agreement 75A50123D00005.

The government anticipates a multistage, competitive acquisition process:

• Stage 1- Abstract and Quad Chart: Eligible offerors must submit a written abstract and quad chart using the mandatory templates and formatting requirements.
• Stage 2- Invitation Only: Selected Stage 1 offerors will receive an invitation from the RRPV Consortium Management Firm to submit a full technical and cost proposal. Required Stage 2 materials are expected to include a technical proposal, cost proposal narrative, full cost proposal, and statement of work.

For Stage 1, offerors must submit an abstract of no more than 12 pages and a one page quad chart. The cover page and data rights assertions are excluded from the abstract page limit. The abstract must address the executive summary, technical approach, teaming or subcontractors, facilities and personnel qualifications, ROM budget estimation, period of performance and schedule, and data rights assertions. The quad chart must be one page and in landscape orientation.

Mandatory eligibility requirements are substantial. At the time of abstract submission, an offeror must be an RRPV member and must propose a defined lead Before Day One vaccine candidate with supporting data sufficient to demonstrate technical feasibility and maturity for the proposed base period activities. Offerors must identify the vaccine target or targets, platform, formulation, adjuvant or carrier as applicable, route of administration, proposed dose and regimen if established, and proposed mechanism of protection.

The candidate must also have a credible pathway to routine seasonal influenza vaccination while providing potential cross protection against influenza viruses with pandemic potential. Proposals that do not satisfy the mandatory eligibility criteria may be removed before technical evaluation.

Technical Objectives

BARDA is seeking a defined “Before Day One” influenza vaccine candidate capable of supporting both seasonal influenza protection and pandemic preparedness. The candidate must demonstrate routine seasonal use, non inferior or improved seasonal protection relative to currently licensed seasonal influenza vaccines, and inferred or demonstrated cross protection against one or more pandemic potential subtypes, including H2, H5, H7, H9, and H10.

The program’s target product profile establishes a minimal objective of a vaccine indicated for prevention of seasonal influenza with inferred protection against pandemic influenza. BARDA’s minimal target population is adults, including Tier 1 critical healthcare and public health personnel, emergency medical services personnel, and deployed and mission critical personnel. The ideal target population is all individuals ages six months and older. Desired duration is six months to one year with annual administration at the minimal level, with multiyear intermittent coverage identified as the ideal.

Relevant technology areas may include:

• Broadly protective vaccine designs targeting conserved influenza antigens or epitopes, including HA stem, NA, NP/M1, M2e, mosaic, and multivalent constructs.
• T-cell based and multi-antigen vaccine approaches.
• Adjuvanted approaches intended to improve breadth or durability of protection.
• Mucosal or alternative administration strategies with potential to enhance protection or reduce transmission.
• Approaches that incorporate broadly protective components into seasonal influenza vaccines.
• Co-formulated vaccine strategies.
• Novel correlates of protection, biomarkers, and immune bridging strategies that support assessment of pandemic benefit.
• Preclinical models or controlled human infection models that support assessment of breadth and cross protection.
• Vaccine approaches with a plausible regulatory path for both seasonal influenza protection and inferred or demonstrated pandemic benefit.

BARDA is not prescribing a specific vaccine platform. Rather, the government will assess whether each proposed approach can achieve PBD1 outcomes, demonstrates scientific and technical merit and development maturity, is feasible to manufacture, and has a credible pathway to regulatory approval and sustainable seasonal deployment.

The draft RPP also establishes clear exclusions. BARDA will not consider pandemic only, strain matched influenza vaccines without a credible seasonal benefit; heterologous prime boost approaches; nucleic acid vaccine platforms; delivery device technologies without associated vaccine product or immunologic innovation; or candidates without a credible path to routine seasonal deployment. Proposals primarily focused on enabling technologies without a defined relationship to the development, evaluation, or regulatory advancement of a Before Day One vaccine candidate are also outside the scope.

Development Requirements

The planned effort centers on nonclinical work necessary to establish scientific and technical feasibility, demonstrate breadth across relevant influenza strains, complete IND enabling studies, and establish manufacturing feasibility and preliminary CMC support.

To meet the minimum preclinical or nonclinical proof of concept requirement, offerors must provide quantitative data showing:

• Measurable immune responses against relevant seasonal influenza viruses.
• Measurable immune responses against at least one influenza subtype with pandemic potential, in addition to seasonal influenza viruses.
• At least one functional or mechanistically relevant immune assessment, such as neutralization, hemagglutination inhibition, neuraminidase inhibition, antibody dependent cellular cytotoxicity, T-cell response, or another scientifically justified assay.

Supporting data must identify the animal models, vaccine dose and regimen, virus or antigen panel, assay methods, study timepoints, controls or comparators, and quantitative results. Available heterologous nonclinical challenge data should demonstrate protection against relevant influenza viruses through outcomes such as viral load reduction, reduced disease severity, survival, or other justified endpoints. Where those studies remain incomplete, offerors must provide a detailed base period plan, schedule, milestones, and success criteria.

The RPP also requires a credible CMC and manufacturing foundation. Offerors must demonstrate an established or technically feasible drug substance and drug product process, identify current manufacturing scale and available yield and throughput data, describe process controls and critical process parameters, state current cGMP status, and provide a clinical trial material scale up plan. They must distinguish demonstrated manufacturing capabilities from projected capabilities or proposed process improvements.

In addition, offerors must provide available product characterization data and an analytical strategy addressing, as applicable, identity, purity and impurities, potency, sterility or endotoxin, bioburden, critical quality attributes, and stability. They must identify the status of assays and provide available real time or accelerated stability data.

BARDA expects offerors to have internal capability or a qualified CDMO or other partner with a credible path to cGMP manufacture and release of clinical trial material. The proposal must identify the manufacturing organizations and locations, cGMP status, expected clinical scale, fill finish capability, and partner roles and responsibilities.

Key Dates & Submission Timeline

The following dates are stated as approximate or tentative in the draft RPP and are subject to change:

• October 29, 2026, at 12:00 p.m. Eastern: Deadline for technical questions to RRPV.
• November 3, 2026: Tentative teaming event, via Zoom or equivalent.
• January 14, 2027, by 1:00 p.m. Eastern: Tentative deadline for Stage 1 abstracts through the BARDA Digital Resource portal.

Offerors must register for a BARDA Digital Resource portal account before submitting. ATI states that the account request process may take several days and advises offerors to verify access well before the submission deadline. The draft RPP warns that failure to submit on time will result in the submission not being considered for award.

Funding Overview

BARDA estimates approximately $142 million in funding for this effort and anticipates making up to approximately 14 awards. Both the total funding amount and anticipated award count are subject to change based on proposals received, BARDA priorities, and the availability of federal funds. The full period of performance, including the planned work and all potentials, may extend up to five years from award.

Cost sharing is not required for early-stage studies but will be required for Phase 2b and later-stage studies, where BARDA expects an offeror may have a commercially viable product. Cost sharing remains encouraged at earlier stages and must be clearly identified as cash or in-kind, supported by a description, estimated dollar value, and valuation approach.

Offerors should also closely assess intellectual property and data rights implications. The draft states that deliverables are anticipated to be furnished to the government with unlimited data rights under the RRPV Base Agreement unless alternate rights are specified in the abstract and quad chart and agreed to by the government.

BARDA’s PBD1 initiative reflects a shift toward funding influenza vaccine candidates that can contribute to the commercial seasonal market while strengthening national preparedness for a future pandemic. Organizations with credible breadth of protection data, mature CMC and manufacturing strategies, clinical development and FDA engagement plans, and commercialization ready partnerships should begin readiness assessments now.