The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), has released a new Sources Sought Notice (SSN) and Request for Information (RFI) focused on vaccine medical countermeasures (MCMs) for pandemic influenza preparedness and response. This initiative underscores BARDA’s ongoing commitment to strengthening the nation’s biosecurity posture by ensuring rapid access to safe, effective, and scalable vaccines when a public health emergency arises. The agency is exploring long-term partnerships with qualified vaccine developers capable of supporting a resilient domestic manufacturing base for pandemic response.
Overview of the Solicitation
BARDA’s SSN/RFI aims to refine program requirements and assess current industry capabilities to support its Vaccine MCMs for Pandemic Influenza Preparedness and Response Program. This program represents a strategic effort to build and sustain vaccine platforms that can pivot quickly to counter emerging pandemic threats, including influenza and other high-consequence viruses.
Selected contractors will be expected to furnish comprehensive vaccine development and manufacturing services, including personnel, equipment, and facilities (with U.S. facilities preferred). Contractors must be able to produce antigens, adjuvants, and vaccines to support both ongoing preparedness and emergency response needs. Additionally, participants will be required to generate and submit to the U.S. Food and Drug Administration (FDA) all relevant analytical, nonclinical, clinical, and chemistry, manufacturing, and controls (CMC) data needed to enable rapid regulatory decision-making.
This structure ensures that regulatory readiness and manufacturing capability are maintained even during interpandemic periods. BARDA anticipates awarding multiple long-term contracts to organizations that can demonstrate end-to-end vaccine development capacity and operational agility.
Specific Goals and Eligibility Requirements
At its core, the SSN/RFI seeks to identify partners who can advance vaccine medical countermeasures for pandemic influenza and support innovation in vaccine design, production, and readiness. To qualify, offerors must demonstrate proven experience in the manufacture of influenza vaccines through one of the following:
- Holding a U.S. influenza vaccine license, or
- Having developed an influenza vaccine, evidenced by the submission of a Biologics License Application (BLA) for either a seasonal or pandemic influenza vaccine.
Failure to demonstrate compliance with these criteria will result in disqualification from further consideration. BARDA emphasizes that this market research phase is critical to understanding the current state of the science and identifying contractors with scalable, regulatory-ready vaccine platforms.
Key Dates and Submission Details
Interested organizations must respond by submitting required documentation via email no later than 3:00 p.m. Eastern Standard Time on December 19, 2025. Submissions must include:
- Evidence of compliance with mandatory eligibility criteria;
- A vendor capabilities statement; and
- A request to participate in the RFI.
Advancing Global Health Security
This effort represents a critical step in enhancing the United States’ pandemic preparedness infrastructure. By maintaining a state of manufacturing readiness and strengthening domestic vaccine production capacity, BARDA’s program will enable faster, more coordinated responses to future pandemic events. These investments in vaccine science and infrastructure directly translate into lives saved, reduced healthcare burdens, and improved resilience in the face of biological threats.
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