Presolicitation Notice - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response

The U.S. Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), is seeking qualified contractors to support the ongoing Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response Program. Contractors must be capable of furnishing all necessary services, personnel, equipment, materials, and U.S.-based facilities to produce vaccines, antigens, and adjuvants for pandemic influenza and other viruses with pandemic potential. To be eligible, offerors must either hold an active U.S. influenza vaccine license from the FDA or have submitted a Biologics License Application for a seasonal or pandemic influenza vaccine. The program demands the generation and submission of comprehensive regulatory data—including analytical, nonclinical, clinical, and chemistry, manufacturing, and controls (CMC) information—to the FDA to enable rapid decision-making and maintain manufacturing readiness during interpandemic periods. The anticipated contract is an indefinite delivery, indefinite quantity (IDIQ) vehicle with a base performance period of 60 months and the potential to extend up to 120 months if all option periods are exercised, combining both cost-reimbursement and firm-fixed-price task orders. Performance is expected to occur primarily within the United States, with the place of performance designated as Washington, D.C., and the contracting office located at 400 7th Street SW. Proposals must be submitted electronically via SAM.gov by the deadline of August 15, 2026, and are subject to evaluation based on mandatory qualification requirements, with full evaluation factors and source selection criteria expected to be detailed in the forthcoming Request for Proposals. The solicitation number is 75A50126R00001, and the NAICS code is 541714 for research and development in biotechnology. The primary point of contact for inquiries is Laura Saddison, BARDA Contracting Officer, reachable at Laura.Saddison@hhs.gov. No set-aside is planned, and full and open competition is anticipated. While packaging, marking, inspection procedures, and specific invoicing methods are not defined in this presolicitation, contractors should prepare to comply with FDA regulatory standards and anticipate the use of federal systems such as WAWF for payment processing. No contracting officer’s representative or technical representative has been designated yet, and all certifications and representations will be required upon formal proposal submission.