RRPV #RRPV 26-08-PBD1

Development of broadly protective seasonal influenza vaccines with pandemic cross-protection

BARDA is planning a multi-stage effort to advance broadly protective influenza vaccines for routine seasonal use and pandemic preparedness. - Government buyer: U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Center for the Biomedical Advanced Research and Development Authority (BARDA), Contracts Management & Acquisition. - Program focus: Develop “Protection Before Day One” vaccine candidates for seasonal administration that may also protect against pandemic-potential influenza subtypes, including H2, H5, H7, H9, and H10. - Planned work: Nonclinical and IND-enabling studies, clinical-trial material manufacturing, early clinical trials, manufacturing process improvements, and potential Phase 2b trials. - Key requirements: Candidates should have supporting preclinical evidence, demonstrate broad protection, offer a feasible regulatory and scalable manufacturing pathway, and have credible potential for seasonal use and commercialization. BARDA does not prescribe a platform; nucleic acid platforms and pandemic-only vaccines without seasonal benefit are outside the anticipated scope. - Funding and duration: Approximately $142 million is anticipated for up to 14 awards. The overall program may run for up to five years, with later stages contingent on technical milestones, funding, and Government approval. - OEMs and vendors: No vaccine OEMs, vendors, products, or part numbers are identified.

Description

This is a draft Request for Project Proposals (RPP) for developing and advancing broadly protective influenza vaccine candidates that provide routine seasonal protection and cross-protection against influenza viruses with pandemic potential. The anticipated scope includes advancing candidates from preclinical development through manufacturing and clinical evaluation, with emphasis on breadth of protection, IND readiness, scalable manufacturing, and clinical evidence. The notice is for advance information and teaming purposes only; proposals are not being solicited or accepted, and the draft requirements and dates are preliminary and subject to change. A virtual Proposers Conference and Teaming Connect is scheduled for November 3, 2026.

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