Summary
On April 11, 2025, the Biomedical Advanced Research and Development Authority (BARDA) issued Amendment 02 to its solicitation RRPV-24-07, titled “Central Influenza and Emerging Infectious Diseases Vaccine Immunoassay Laboratory Services.” This critical Request for Project Proposals (RPP) under the Rapid Response Partnership Vehicle (RRPV) aims to bolster U.S. preparedness against influenza and other emerging infectious diseases by establishing a U.S. Government centralized immunoassay laboratory capable of supporting vaccine R&D across preclinical and clinical phases.
Why It Matters
The rise of highly pathogenic avian influenza (HPAI) strains like H5N1, their spread to livestock, and increasing zoonotic infections in the U.S. has underscored the need for rapid, accurate immune assay infrastructure. BARDA’s RRPV initiative calls for laboratories with existing capabilities to function as a central immunoassay laboratory and perform quality-assured immunoassays to support advanced research and development of influenza and emerging infectious disease vaccines using samples collected from nonclinical studies and clinical trials.
This effort reflects a strategic pivot from reactive to proactive posture: creating a ready-to-deploy testing platform that can evaluate vaccines against both seasonal and novel strains, generate potency reagents, and support technology transfer across the national public health infrastructure.
Key Technical Capabilities Sought
BARDA’s updated scope outlines six core capabilities that prospective offerors must address:
- Capability 1: Develop, qualify, or validate immunoassays to support clinical trial endpoints and/or nonclinical studies to evaluate immune responses to influenza and emerging diseases vaccines.
- Capability 2: Test samples from clinical trials and/or nonclinical studies using qualified or validated immunoassays.
- Capability 3: Prepare and develop vaccine potency reagents as required.
- Capability 4: Develop, optimize, and perform exploratory assays to support clinical and/or nonclinical sample testing as required.
- Capability 5: Conduct assay concordance as required.
- Capability 6: Conduct technology transfer to (or from) other laboratories as required to support the USG programs.
What’s New in Amendment 02
This second amendment introduces three additional capability areas: potency reagent preparation, assay concordance, and tech transfer. It also reorganizes existing capability areas and updates evaluation factors, signaling a fine-tuning of selection priorities as BARDA gears up for potential on-ramping of new performers.
Strategic Takeaways for Potential Offerors
- Rapid Response Focus: The lab must be ready to scale during an emergency. Proposals must include alternate cost and timeline scenarios for accelerated assay development.
- Regulatory Readiness: Assays must be suitable for FDA BLA or EUA submissions.
- High Throughput & Automation: Labs incorporating automation and advanced systems will be favorably positioned.
- U.S. Presence Required: Labs must be based in the continental U.S. and capable of managing both in-house and partner workstreams.
Deadlines and Next Steps
- Questions Due: April 24, 2025 at 12 PM ET
- Proposals Due: May 30, 2025 at 1 PM ET
- Submission Portal: hhs.gov