The Biomedical Advanced Research and Development Authority (BARDA) has released a new Request for Proposals, Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response. The solicitation seeks partners to support the development, manufacturing, stockpiling, regulatory readiness, and rapid deployment of influenza vaccine medical countermeasures during a pandemic or other public health emergency.
BARDA’s objective is not simply to secure access to vaccine doses after a threat emerges. The agency is seeking to sustain a national readiness posture that keeps critical vaccine manufacturing capabilities, regulatory data packages, supply chains, and response processes prepared between emergencies.
BARDA's Program Overview
BARDA’s Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response Program supports the rapid production of influenza vaccines and adjuvants by manufacturers of FDA-licensed vaccines in the event of a public health emergency. The program is intended to maintain a pipeline of pandemic-ready vaccine capabilities, including vaccine seed stocks, bulk antigen, adjuvant, and final-container product.
The solicitation seeks multiple contractors able to provide vaccines, antigens, and adjuvants for pandemic preparedness and response. Awardees may also be required to produce countermeasures against influenza virus strains or other viruses with pandemic potential, support feasibility-backed improvements to influenza vaccines, and generate the analytical, nonclinical, clinical, and chemistry, manufacturing, and controls data necessary to enable timely FDA decision-making.
BARDA emphasizes the importance of commercially sustainable domestic manufacturing capacity. The agency is looking for a warm-base model where production capability remains active and viable during interpandemic periods, rather than relying solely on capacity maintained by the U.S. Government. U.S. facilities are preferred.
Technical Areas and Activities
The RFP spans the end-to-end operational requirements needed to make, test, fill, store, and deploy pandemic influenza vaccines. Key activities include:
Candidate Vaccine Virus development: Development and support for candidate vaccine viruses used as the starting point for pandemic vaccine production.
Seed lot and research lot manufacturing: Production of CGMP influenza vaccine master and working seed lots, as well as research lots to support development and readiness activities.
Bulk vaccine and adjuvant manufacturing: Production of investigational and commercial-scale CGMP influenza vaccine bulk lots, plus clinical- and commercial-scale adjuvant lots.
Formulation and fill-finish: Formulation and filling of antigen, adjuvant, or co-formulated antigen-adjuvant products, including potential access to fill-finish capacity or disruption fees where commercial production lines are affected.
Labeling, packaging, storage, and stability: Support for final-container preparation, product storage, ongoing stability programs, and inventory management for both bulk and finished materials.
Testing and studies: Analytical laboratory testing, assay support, nonclinical studies, and clinical studies that inform product development, release, stability, and regulatory decisions.
Response and manufacturing readiness: Shipping, emerging pathogen response, technology transfer, validation activities, manufacturing enhancements, and product disposal when necessary.
Reporting and program management: Standard monthly data reporting and additional reports that support BARDA’s oversight of capacity, risk, inventory, and program execution.
Many of these activities may be ordered through future task orders. That means organizations should evaluate not only their current product and platform capabilities, but also their ability to provide pricing, timelines, technical data, and operational commitments that can hold up under task-order competition.
Manufacturing and Regulatory Expectations
The solicitation makes clear that manufacturing readiness is a central evaluation consideration. Offerors must identify their manufacturing sites and validated production lines, describe available capacity across bulk production and fill-finish, and state whether those lines would be available to BARDA during a public health emergency. They must also provide facility diagrams and estimate the maximum dose quantity each line can produce within 180 days.
BARDA expects contractors to maintain the evidence needed to support rapid regulatory action. This includes data from analytical testing, nonclinical studies, clinical studies, and CMC activities generated during interpandemic periods. Contractors must also be prepared to work with BARDA and FDA’s Center for Biologics Evaluation and Research on potency reagent production, calibration, release testing, and stability testing.
The RFP also requires a level of operational transparency that companies should assess early. Contractors must rapidly notify BARDA of critical programmatic issues, schedule or cost risks, and security incidents, with some notifications required within 24 to 48 hours.
Key Dates and Submission Deadline
| Milestone | Date |
|---|---|
| RFP released | August 17, 2026 |
| Initial questions due | August 31, 2026, at 12:00 p.m. ET |
| Supplemental questions due | September 24, 2026, at 12:00 p.m. ET |
| Proposal submission deadline | October 30, 2026, at 5:00 p.m. ET |
Questions should be submitted to the contracting contacts identified in the RFP: [email protected] and [email protected].
Who Should Consider Responding
This opportunity is best suited for FDA-licensed influenza vaccine manufacturers and organizations with commercial-scale influenza vaccine manufacturing experience that have submitted a Biologics License Application to FDA. Relevant capabilities may include antigen and adjuvant production, CGMP manufacturing, formulation and fill-finish, quality control, analytical testing, clinical development, CMC regulatory support, cold-chain storage, and domestic supply chain execution.
Companies with strong capabilities in one part of the requirement should also consider whether a teaming arrangement can create a more complete response. The work requires coordination across manufacturing operations, regulatory affairs, clinical and nonclinical development, quality systems, logistics, and program management.
EverGlade is a national advisory firm helping innovators navigate the federal funding ecosystem. We support companies across the funding lifecycle, from early-stage strategy through proposal development, negotiations, and post-award execution, ensuring you win the award and deliver the program.
For additional information on where your capabilities could plug into this program, schedule a conversation with our team.
