NIAID Releases 2027 Omnibus BAA for Vaccines, Therapeutics, and Diagnostics

What Is NIAID’s DMID BAA Funding?

Research Area 001: Needle-Free Vaccine Candidates

NIAID seeks vaccine candidates that use alternatives to conventional needle-and-syringe delivery to protect against viral infections, including respiratory and vector-borne viruses. Delivery approaches may include microneedle or microarray patches, needle-free injection devices, mucosal sprayers, and oral formulations.

Proposals must identify a single vaccine candidate for a specific viral pathogen and include preliminary preclinical data demonstrating immunogenicity. Supported activities include preclinical development, Investigational New Drug (IND)-enabling studies, limited process development, Good Manufacturing Practice (GMP) manufacturing, regulatory submissions, and a required Phase 1 or early Phase 2 clinical trial.

The antigen must already be defined. New antigen or adjuvant discovery is not supported. Other exclusions include adenoviral and DNA-based vaccines, monoclonal antibodies, and vaccines for SARS-CoV-2, Zika, filoviruses, and Lassa virus.

Research Area 002: Therapeutic Candidates

This area supports new therapeutics for serious infectious diseases that lack approved treatments or remain difficult to treat because of resistance or inadequate responses to existing antimicrobial therapy. Target priorities include:

• Viral hemorrhagic fever viruses, including Ebola, Sudan, Marburg, Lassa, and hantaviruses.

• Encephalitic paramyxoviruses, including Hendra and Nipah.

• Broad-spectrum picornavirus approaches covering EV68, EV70, and coxsackievirus.

• Broad-spectrum antimicrobials addressing at least two of the listed bacterial or fungal targets, including resistant Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter, Candida auris, Cryptococcus, Aspergillus fumigatus, and Mucorales.

Supported modalities include small molecules, antibodies, nanobodies, certain peptides, microbiome-based therapeutics, and bacteriophages. The scope depends on development stage. Lead-optimization proposals must select a preclinical candidate and complete non-GLP IND-enabling activities within three years, without GMP manufacturing or a Phase 1 trial. Proposals entering with an identified preclinical candidate are expected to advance through IND-enabling work, GMP manufacturing, and Phase 1 evaluation within three to five years.

Basic discovery, prophylactic and post-exposure prophylactic products, and products derived from or substantially similar to agents that have entered Phase 3 or received approval are excluded.

Research Area 003: In Vitro Diagnostics

NIAID seeks innovative platforms that accelerate detection and identification of infectious viruses directly from clinical specimens. Priorities include nearly automated workflows, broad viral detection, and faster actionable results approaching two hours. Full sample-to-answer solutions and more accessible configurations, including point-of-care approaches, are preferred.

Platforms must detect at least one listed priority agent, with broader coverage preferred. Examples include Lassa, Rift Valley fever, Oropouche, hantaviruses, Crimean-Congo hemorrhagic fever, Ebola, Sudan, Marburg, hepatitis C, West Nile, Nipah, chikungunya, and enteroviruses.

Proposals must include preliminary data beyond proof of concept and a product development plan addressing verification, validation, and regulatory submission. Standalone platform components, host-response-only tests, and tests validated solely with surrogate organisms are excluded.

Key Dates and Submission Requirements

Offerors may respond to more than one research area but must submit a separate proposal for each. Each submission must contain distinct technical and business proposals. Technical proposals are limited to 75 pages, including biosketches, subject to the solicitation’s stated exclusions. This is a full-proposal submission opportunity, not a staged white-paper process.

The opportunity is not a small business set-aside. Offerors must certify the adequacy of their accounting systems for cost-reimbursement contracting. Across all three research areas, contract funds cannot be used to purchase equipment, hardware, or software, or for facility construction, alterations, or renovations.