NIH Coronavirus Funding Opportunities

Updated – June 2020

National Institute of Allergies and Infectious Diseases (NIAID)

  1. Standard PARs for Clinical Trials

Two funding opportunities:

Communication with NIAID is required well in advance

Expiration Date (for both opportunities): January 14, 2021

      2. Emergency Awards

There are 4 emergency awards available – 2 through NIAID, and 2 through NIAID+NCI. This is an emergency funding opportunity due to the SARS-CoV-2 global pandemic; therefore, applicants do not need to provide extensive background information or preliminary data in this application.

NIAID:
  • Rapid Investigation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) (R01 Clinical Trial Not Allowed) – EXPIRATION DATE: August 14th, 2021
  • Rapid Investigation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) (R21 Clinical Trial Not Allowed) – EXPIRATION DATE: August 14th, 2020

Applications will be handled on an expedited review and award basis to meet the goals of this program. R01 budgets are not limited.

Please Note! NIAID-funded researchers are expected to share research data to enhance the rigor and reproducibility of research results and secondary use per the NIAID Data Sharing Guideline.

Areas of interest include (but not limited to):
  • Understanding critical aspects of viral infection, replication and pathogenesis (predictors of disease severity, shedding, molecular markers etc)
  • Virus transmission
  • Immunity in healthy and at-risk populations
  • Virologic and serologic surveillance
  • Characterization and assessment of the natural history and long-term consequences of SARS-CoV-2 in human populations
  • New or improved clinical diagnostic tests
  • Therapeutics
  • Vaccines
  • Vaccine strategies for at risk populations
  • Comparison of animal models and human infection
  • Comparison of SARS-CoV-2 and other coronaviruses
  • Interactions with other respiratory pathogens
  • Computational modeling to identify and evaluate interventions for public health decisions
  • Animal models for transmission experiments
  • Organoid culture models and/or ex vivo explant models
  • Data science approaches towards clinical predictions, remote monitoring, data collection
NIAID and NCI:
  1. SARS-CoV-2 Serological Sciences Centers of Excellence (U54 Clinical Trial Optional)
  2. Research Projects in SARS-CoV-2 Serological Sciences (U01 Clinical Trial Optional)
Areas of interest include (but not limited to):
  • Developing novel assays and preclinical and computational model systems to test immune responses to SARS-CoV-2 that inform immune parameters and serological markers associated with asymptomatic vs symptomatic infection, disease severity, risk of re-infection or vaccine efficacy
  • Understanding the mechanisms underlying immune responses to SARS-CoV-2
  • Determine if therapeutics and passive antibody therapies used to treat COVID-19 modulate serologic and immune responses to SARS-CoV-2
  • Characterizing the serologic differences resulting from natural infection vs. vaccination against SARS-CoV-2
  • Identifying genetic and epigenetic determinants that modulate the development and durability of immune responses against SARS-CoV-2 and associated serological correlates.
  • Understanding what factors affect the SARS-CoV-2 immune response or pathogenesis
  • Understanding how precancerous conditions, cancer, and/or cancer therapies affect serologic and immune responses to SARS-CoV-2 infection and the clinical course of infection, and vice versa
  • Understanding how demographic, behavioral, and environmental factors affect immune or serological responses to SARS-CoV-2 infection
  • Researching the clinical and public health implementation of validated serologic assays, their interpretation, and follow-up for health outcomes.
  • Approaches to promoting and ensuring equitable access to serologic testing, identification of factors associated with the uptake of SARS-CoV-2 serologic testing, and whether differential access further exacerbates health disparities and health outcomes.
  • Determining the ethical, legal and social implications of serologic testing for SARS-CoV-2 in diverse populations and best methods for communication of results and interpretation at various levels

3. R01: Partnerships for Countermeasures against Select Pathogens (R01 Clinical Trials Not Allowed)

Deadline: June 29, 2020 (late submission accepted until July 13 under NOT-AI-20-053)

The aim of this funding opportunity is to identify milestone-driven projects focused on preclinical development of therapeutics, vaccines, and related countermeasures against select NIAID Emerging Infectious Diseases/Pathogens. Applications must include a Product Development Strategy attachment and demonstrate substantive investment by at least one industrial participant.

Recommended budget for direct costs: up to $750,000 per year. Applicants may also request up to an additional $300,000 in the first year of the award for major equipment to ensure that research objectives can be met. Projects submitted by academic institutions must include substantive investment by at least one industry participant. No requirement for an academic participant on applications submitted by industrial organizations.

Select therapeutic areas of interest:
  • Lead optimization; medicinal chemistry; structure/activity relationships
  • Synthesizing, purifying, and testing lead candidates for efficacy and toxicity in vitro assays and preclinical in vivo model systems
  • Performing preliminary pharmacokinetic and pharmacodynamics analyses
  • Preclinical testing for efficacy and safety in animals
  • Testing and validation of efficacy in in vitro or in vivo models
  • Optimization of dose, dosing interval, and route of delivery in preclinical evaluation or in animal models
  • Modification of existing drugs/therapeutics to improve economy of production, half-life in vivo, target affinity, neutralization potency, microbial clearance rates, or tissue accessibility; or to decrease adverse side effects of administration
  • Evaluation of potential drug/therapeutic resistance in model systems
  • Assessing bioavailability and mechanism of action
  • Process development for manufacturing of a therapeutic, including QA/QC, methods for product recovery, characterization, purification, identity, stability etc.
  • GLP or cGMP production to generate sufficient product to conduct pre-clinical and for future Phase I clinical studies
  • Benchmarks for successful submission and review of an IND application by the FDA
Select vaccine-related areas of interest:
  • Lead vaccine candidate optimization
  • Evaluation of safety, toxicity and immunogenicity in animals
  • Evaluation of efficacy in challenge models where appropriate animal models are available
  • Optimization of dose and route of delivery in preclinical evaluation
  • Optimization of production methodology including process development
  • Scale up and production of candidate vaccines including cGMP production
  • Process development for the production of vaccine components, including Quality Assurance /Quality Control, methods for product recovery, characterization, etc.
  • Manufacturing under GLP or cGMP to provide quantities sufficient for preclinical and early clinical evaluation
  • Performing preclinical testing for safety, toxicity, and efficacy in animal models and other benchmarks required for successful submission of an Investigational New Drug (IND) application by the FDA
  • Optimization of delivery platforms, antigen and adjuvant combinations/formulations
  • Advanced development of non-needle vaccine delivery systems
  • Advanced development of formulation methodologies that obviate the need for cold-storage of the resulting product and/or extend shelf-life.

Notices of Special Interest (NOSI)

Both NIAID and NIBIB have issued Notices of Special Interest (NOSI) highlighting the urgent need for accelerating the development, translation, and commercialization of technologies to address COVID-19 for the following funding mechanisms:

  • PA-19-272 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
  • PA-19-270 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
Information regarding NIAID’s Notice of Special Interest:

In effect until September 8, 2021

Applications addressing the following research areas of interest:

  • Studies to understand critical aspects of viral infection, replication, pathogenesis, and transmission
  • Studies on the evolution and emergence of SARS-CoV-2 viruses including the identification of factors that affect viral host-range and virulence
  • Development of sensitive, specific, and rapid diagnostic tests for SARS-CoV-2;
  • Development of SARS-COV-2 therapeutic candidates
  • Identification and evaluation of the innate, cellular and humoral immune responses to SARS-CoV-2 infection
  • Development of SARS-CoV-2 vaccine candidates
Information regarding NIBIB’s Notice of Special Interest:

The NIBIB is seeking applications to develop life-saving technologies that can be ready for commercialization within one to two years. Example technologies include, but are not limited to:

  • Rapid point-of-care and home-based testing/diagnostics
  • Wearable, implantable, and remote sensors/imagers for physiological monitoring
  • Medical imaging technologies and algorithms/artificial intelligence (AI) for rapid detection, diagnosis, and monitoring of lung infection
  • Non-contact sensing and imaging for rapid mass screening and vital sign assessment
  • Digital health platforms and models that integrate data, assess risk, and provide illness surveillance and management tools
  • Technologies (including simulation platforms) for training healthcare workers and optimizing clinical workflows
  • Robotic and automation technologies to limit caregivers’ exposure and/or reduce burden on the healthcare system
  • Technologies for protecting healthcare workers, first responders, and caregivers
  • Oxygenation systems (e.g. ECMO, ventilators, intubation) and components designed for rapid deployment, access, and potential operation by minimally trained personnel
  • High-confidence disinfection technologies
  • Novel therapeutic strategies using engineered biological systems, including cell-based and synthetic biology technologies

Office of Strategic Coordination – The Common Fund

NIH Director’s Emergency Transformative Research Awards (R01 Clinical Trial Optional)

Office of Strategic Coordination – the Common Fund

Due: Aug 30, 2020

Transformative Research Awards: New, innovative perspectives and approaches to the prevention of, preparation for, or response to coronavirus SARS-CoV-2, domestically or internationally. Any relevant area of research is welcome. As with all High-Risk High-Reward Research Program applications, innovation may be technological or conceptual.

National Institute of Biomedical and Bioengineering (NIBIB)

NIBIB POCTRN Rapid Acceleration of Diagnostics (RADx) (a direct detection of the SARS-CoV-2 virus)

Submission is open on a rolling basis until further notice

The aim of this funding opportunity is to address the COVID-19 pandemic as quickly as possible, NIBIB is expanding the focus of POCTRN to encompass both point-of-care and more traditional laboratory-based approaches. NIBIB will consider innovations at all stages of readiness, including:

  • Early stage: transformative innovations based on novel testing strategies that have potential for major scale up
  • Advanced stage: modification and optimization of existing SARS-CoV-2 testing approaches, including clinical laboratory tests, that can dramatically increase testing capacity

Design features might include technical innovations that:

  • Improve analytical performance, e.g., sensitivity, specificity, dynamic range, limit of detection, reliability, accuracy, speed (time to test result) and throughput
  • Enhance operational performance e.g., development of a patient- and user-friendly design, use of alternative sampling strategies, integration with mobile-devices, designs for home-based use or strategies to overcome bottlenecks with current testing approaches
  • Improve access and reduce the cost of testing