NIAID recently announced a BAA for the following research areas: (1) advanced development of vaccine candidates for biodefense and emerging infectious disease; (2) development of therapeutic products for biodefense, antimicrobial resistant infections and emerging infectious diseases; and (3) advanced development of sequencing-based diagnostics for biothreats and emerging infectious diseases.

Proposals must be submitted by May 24th, 2021.

The goal of this BAA is to advance vaccines, therapeutics, and diagnostics that can utilized as a method of biodefense and/or as a way to combat emerging pathogens that threaten human health and well-being. By supporting these vaccines, therapeutics, and diagnostics through their early clinical development and manufacturing, NIAID reduces the risk, while enabling the transition to other funding mechanisms to support advanced-stage clinical development and large-scale manufacturing. The aim of this solicitation is to advance research and development of promising new therapeutics, vaccines, and diagnostics that address infections caused by the pathogens specified in each of the three research areas.

Budget: Research areas 1 + 2: up to $11M total; Research area 3: up to $4M total

• Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

The aim of this research area is to advance vaccine technologies and platforms that have sufficient proof of concept data and/or clinical data to support vaccine development through manufacturing, toxicology testing, and testing in phase 1 or 2 clinical trials. The goal is to advance vaccine technologies and platforms which could be deployed against agents important for biodefense and/or emerging pathogens to protect human health and well-being.
Pathogens of particular interest include: a pan-coronavirus vaccine (NOT SARS-CoV-2 alone); Eastern equine encephalitis virus, tick-borne viruses, non-Zaire ebolaviruses/filoviruses.

Total performance period – up to 5 years. Awards will be made around May 2022.

• Development of Therapeutic Products for Biodefense, Antimicrobial Resistant Infections and Emerging Infectious Diseases

The aim of this research area is the development of potential new therapeutics that address infections caused by NIAID Category A, B, and C priority pathogens and select bacterial and fungal infections identified in the 2019 CDC Antibiotic Resistance Threats Report. For the purposes of this solicitation, therapeutic activity is defined as the cure or mitigation of disease, preferably, once signs and symptoms of infection are evident. For the purposes of this solicitation, a therapeutic candidate refers to an advanced lead series, optimized leads, or product candidate, and is either a small molecule (synthetic or natural product) or a biological product (e.g. monoclonal antibodies, recombinant proteins).

Proposals are encouraged for the development of broad-spectrum therapeutics with extended therapeutic activity over more than one pathogen. Therapeutics with a limited spectrum but that target high-priority pathogens for which no standard treatment exists or for which drug resistance poses a significant health concern are also eligible.

Total performance period – up to 5 years. Awards will be made around May 2022.

• Advanced Development of Sequencing-Based Diagnostics for Biothreats and Emerging Infectious Diseases

The goal of this research area is to support the development of promising sequencing-based diagnostics for biothreat pathogens, as well as pathogens causing emerging and re-emerging infectious diseases. Specifically, NIAID is looking to advance the research and development of nucleic acid and protein sequencing solutions on established commercial platforms for the targeted and agnostic detection of bio-threat and naturally emerging infectious pathogens. It is not required to complete the development and FDA clearance of the diagnostic during the project period; however, the targeted metrics for the final diagnostic product should include:

* Turnaround time – pathogen ID within 1-2 hours of specimen collection
* Throughput – minimum of 10 patient samples processed per sequencing run
* Sensitivity – analytical sensitivity of > 97% for infectious pathogen detection;
* Specificity – limited off- target detection of < 3%
* Ease of use – automated nucleic acid or protein extraction and sample preparation; simplified transfer to sequencing system; data analyses operated and interpreted with minimal training
* Regulatory – FDA pre-EUA and/or 510(k) clearance; and
* System utility – other commercially sustainable assays cleared or in development or in planning on same or equivalent system.

Total performance period – up to 5 years. Awards will be made around May 2022.

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