2027 NIAID DMID Omnibus Broad Agency Announcement: Development of Medical Interventions for Infectious Diseases

to include drug-resistant pathogens. NIAID/DMID intends to use this BAA to help address goals articulated in a number of strategic plans, such as in the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan (https://aspr.hhs.gov/PHEMCE/2024-PHEMCE-SIP/Pages/default.aspx), as well as current prioritized antimicrobial resistant threats identified by national death and infection estimates as determined by the Centers for Disease Control and Prevention�s (CDC) to prevent and control antimicrobial resistance (https://www.cdc.gov/antimicrobial-resistance/data-research/threats/index.html). In addition, NIAID/DMID intends to use this BAA to encourage projects that align with the NIH priorities of enhancing rigor & reproducibility, improving biosafety and biosecurity, and the use of complementary non-animal testing methods where appropriate. This Broad Agency Announcement (BAA) is soliciting proposals to advance the research and development of promising candidate therapeutics, vaccines, and diagnostics for infectious diseases in each of three (3) Research Areas described below and more thoroughly discussed in the attached BAA Solicitation. An offeror should carefully review the content of the BAA Solicitation No. HHS-NIH-NIAID-BAA2026-1 for the comprehensive information regarding all requirements, the technical objective of each Research Area of this BAA Solicitation, instructions regarding the proposal submission, and a description of the evaluation and award process. Please note, due to the competitive nature of the BAA Solicitation, the NIAID is unable to offer advice or feedback regarding an offeror�s specific technical approach. Offerors should exercise their professional judgment when compiling their proposals in line with the requirements and specifications of the BAA Solicitation. Research Area 001 - Vaccine Candidates: The objective is to develop vaccine candidates through an early phase clinical trial that use a needle free (i.e., alternative to classical needle and syringe, see below for description) route of delivery to protect against infections caused by viral pathogens that include but are not limited to respiratory and vector borne viruses. The scope of this vaccine research area includes the preclinical development of a needle free vaccine candidate, IND enabling studies, limited process development, Good Manufacturing Practice (GMP) compliant manufacturing, regulatory submissions to the U.S. Food and Drug Administration (FDA) and conduct of a Phase 1 or early Phase 2 clinical trial. The scope of work must include a clinical trial. Offerors must propose a single vaccine candidate for protection against a specific viral pathogen. The vaccine candidate may provide a breadth of protection against other viral strains or viruses. A strong justification is required to support (1) the proposed vaccine antigen and platform for the disease indication, (2) the use of a clinically relevant adjuvant (if needed), and (3) a clinically relevant needle free route of delivery. Research Area 002 - Therapeutic Candidates: The objective is to develop safe, effective, new therapeutic products that will improve patient outcomes against serious infectious diseases for which there are no approved therapeutics, or for those that are refractory to treatment despite appropriate antimicrobial therapy or due to pathogen resistance. Infectious diseases caused by the following viruses, bacteria and fungi pathogens are targeted: Viral hemorrhagic fever viruses (e.g., EBOV, SUDV, MARV, LASV, hantavirus) https://www.cdc.gov/viral-hemorrhagic-fevers/about/index.html Encephalitic paramyxoviruses (e.g. hendra virus, nipah virus) Picornaviruses (broad spectrum approaches that include EV68, EV70 and coxsackie virus) At least two of the following (i.e., addressed with a broad spectrum antimicrobial): susceptible and carbapenem-resistant Enterobacteriaceae (CRE), susceptible and multidrug resistant (MDR) Pseudomonas aeruginosa, and susceptible and Carbapenem-resistant Acinetobacter (CRAB), with potential to improve patient outcomes in the clinic; Candida auris, Cryptococcus spp., Aspergillus fumigatus, and/or Mucorales Adjunct medical interventions to support or enhance effectiveness of antimicrobial agents to address underlying pathology that is not resolved after clearance of pathogens, may be considered. Important notice to Offerors: For this Research Area, �therapeutic� activity means curing disease by eliminating or substantially reducing infective pathogens by administering antimicrobial pharmaceutical agents, with or without a host-directed therapy. Additionally, proposed therapeutic products should consider the impact on a healthy microbiome. Preventative treatments are not included in the scope of this Research Area. A therapeutic candidate refers to an advanced lead series, preclinical candidates, or a clinical candidate, that is a new chemical entity. This includes small molecules, natural products, nucleosides, or peptides of </= 40 amino acids, monoclonal antibodies, nanobodies, nanobody conjugate/fusion products, microbiome-based therapeutics or bacteriophages. Research Area 002 will support lead optimization, pre-clinical Investigational New Drug (IND) enabling studies, and Phase 1 clinical trials (or proof of concept Phase 2 clinical trials) of lead candidates with demonstrated therapeutic activities. This includes support for traditional, novel (e.g., small molecules) and non-traditional (e.g., including but not limited to phage, and host-directed) therapeutics for infectious diseases where patients lack effective interventions, as well as therapeutics that promote host-mediated resolution of disease. The scope of support differs depending on the developmental stage of the project being proposed, which is further discussed in the BAA Solicitation. Research Area 003 - In Vitro Diagnostics The objective of Research Area 003 is to develop innovative, technology platforms that will speed detection and identification of infectious viruses covering a broad panel of virus families, including viruses causing acute infections as well as those causing chronic infections. Technology platform innovation to achieve faster actionable sequencing results (approaching 2 hr) direct from primary clinical specimens, as well as more accessible workflow and configuration (i.e., point-of-care) are preferred. Furthermore, full sample-to-answer platform solutions are preferred. The system should accept specimen volumes from 0.5 to 5 milliliters (mL). The system should include nearly full automation (little or no hands-on activity after specimen has been loaded into system). Sample preparation components of the system should yield sufficient analyte recovery from a starting titer of 10-100 genomic copies per mL of biofluid for downstream analysis, including detection, identification, and characterization of the nucleic acid material. Innovations during platform development might include, for example: Automated sample prep for high recovery from low pathogen load. Faster specimen-to-answer for total test time <2 hours. Broad viral pathogen detection capability, covering one or more members of the priority pathogen families (see below). Targeted, or even untargeted pathogen detection and identification via long-read sequencing or other detection methods. Multiple s