mRNA Vaccine Platform Production Capability for Rapid Pandemic and Priority Threat Response
This project supports the establishment of a long-term, shared programmatic and financial partnership that develops and provides a sustained mRNA preparedness and response capability for influenza and emerging infectious diseases. The primary focus of this project is the development of an mRNA vaccine platform production capability applied first to influenza viruses that can be exercised over time to respond rapidly and flexibly to pandemic influenza and develop vaccines to other priority threats. The project will support domestic manufacturing of investigational product and clinical trial(s) to test the safety and immunogenicity of vaccines targeted to various influenza and emerging infectious disease subtypes/strains as specified by BARDA and as required for FDA authorization/approval (emergency use authorization [EUA] or BLA). The project will also support commercial scale-up as necessary in response to a PHE.
Central Influenza and Emerging Infectious Diseases Vaccine Immunogenicity Laboratory
Laboratories to provide centralized immunogenicity assay capabilities to support advanced research and development of pandemic influenza virus vaccines and emerging infectious diseases vaccines, including support for Phase 1, 2, 3 clinical trial endpoints. Immunogenicity assays sought include, but are not limited to, influenza virus hemagglutination and microneutralization assays, functional and neutralizing antibody assays, flow cytometric assays, binding and enzyme-inhibition assays, or additional exploratory assays such as surface plasmon resonance, B and T cell repertoire analyses, biolayer interferometry, etc.
Biothreat Diagnostic Rapid Response (DxR2)
Biothreat diagnostic test development and ready-production capacity to rapidly produce tests
NextGen Vaccines: Statistical Support, Correlates of Protection, and Meta-analysis
This Request for Proposals (RPP) aims to provide statistical and data coordination support, including vaccine correlates of protection (CoP) analysis and meta-analysis, to support the advanced clinical development and assessment of next-generation COVID-19 vaccines and capabilities.
The purpose of this solicitation is to stimulate and accelerate the adoption of innovative solutions to decentralized clinical trials by focusing on conducting BARDA’s first clinical study exclusively at a retail pharmacy.
Project NextGen: Innovation in Clinical Manufacturing of COVID-19 Vaccines
The purpose of this initiative is to partner with developers and other organizations to implement novel solutions to cGMP manufacturing hurdles and enable clinical trials for next-generation COVID-19 vaccines.
BARDA is requesting project proposals from product developers for the advanced clinical development and assessment of Next-Generation Therapeutics for COVID-19. BARDA has previously identified a capability gap for therapeutics that provide protection through pre-exposure prophylaxis (PrEP) and treatment against new SARS-CoV-2 variants. The purpose of this project is to partner with developers and other organizations to advance the clinical development of Next-Generation Therapeutics for COVID-19, specifically treatment.