NIAID is issuing this Notice of Special Interest (NOSI) to highlight the need for research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). NIAID is particularly interested in projects focusing on viral natural history, pathogenicity, transmission, as well as projects developing medical countermeasures and suitable animal models for pre-clinical testing of vaccines and therapeutics against SARS-CoV-2/COVID-19.

NIAID is therefore offering Competitive Revisions to active NIAID grants addressing research objectives described below.

Background

Coronaviruses are a diverse family of viruses that cause a range of disease in humans and animals, and there are currently no approved coronavirus vaccines or therapeutics. In January 2020, a novel coronavirus was identified as the causative agent of a now global pandemic of viral pneumonia. Current information regarding confirmed cases is changing daily and can be found on the Centers for Disease Control and Prevention website (https://www.cdc.gov/coronavirus/index.html) and through other sources. Transmission characteristics and the associated morbidity and mortality are not completely understood, but there is clear evidence of human-to-human transmission. Many other aspects of viral pathogenesis, natural history, and host range are poorly understood. Given this, there is an urgent public health need to better understand SARS-CoV-2/COVID-19, particularly to improve understanding of fundamental virology, immunology, and the development of animal models and medical countermeasures.

Research Objectives

In order to rapidly improve our understanding and available control measures for SARS-CoV-2 and COVID-19, NIAID is encouraging the submission of applications for Competitive Revisions to active grants to address the following research areas of interest:

• Studies to identify optimal in vitroculture requirements and conditions;
• Development of reagents and assays for virus characterization;
• Studies to understand critical aspects of viral infection, replication, pathogenesis, and transmission;
• Studies to identify viral epitopes critical for binding neutralization;
• Studies to examine virus stability and persistence;
• Production of molecular clones of SARS-CoV-2, reporter viruses and recombinant viral proteins;
• Development of animal models of SARS-CoV-2 infection suitable for screening vaccine and therapeutic candidates and/or pathogenesis studies;
• Studies on the evolution and emergence of SARS-CoV-2 viruses including the identification of factors that affect viral host-range and virulence;
• Virologic and serologic surveillance studies of the distribution and natural history of SARS-CoV-2 viruses in animal populations and in humans at the human/animal interface with particular emphasis on host reservoirs and understanding cross-species transmission events;
• Development of sensitive, specific, and rapid clinical diagnostic tests for SARS-CoV-2;
• Development of SARS-COV-2 therapeutic candidates; broad-spectrum therapeutics against multiple coronavirus strains; examination of SARS-CoV-2 antiviral activity of existing or candidate therapeutics initially developed for other indications;
• Identification and evaluation of the innate, cellular and humoral immune responses to SARS-CoV-2 infection and/or candidate vaccines, including, but not limited to: cross-reactive antibodies from individuals exposed to SARS-CoV-2 and other coronaviruses; viral epitopes critical for antibody binding and neutralization; immune-mediated pathology or host factors that might predispose to severe infection; and
• Development of SARS-CoV-2 vaccine candidates that include emerging antigen design strategies, novel platforms or delivery approaches, adjuvants, or assessing cross-neutralization potential of SARS-CoV vaccine candidates.

Application and Submission Information

Applications in response to this NOSI must be submitted using the following targeted funding opportunity:

• PA-20-135; Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional), which is intended to provide funds for NIH grantees applying to expand the scope of their active grant.
• The funding instrument, or activity code, will be the same as the parent award. All activity codes of currently funded NIAID grants are eligible.
• Please note: NOT-AI-20-034 is specific for PA-20-135. NIH grantees seeking additional funds for research responsive to the SARS-CoV-2/COVID-19 outbreak that falls within the scope of an ongoing grant should instead apply for an administrative supplement under NIH PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements FOA (https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html).

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide and PA-20-135 must be followed, with the following additions:

• The Research Strategy section of the application is limited to 6 pages.
• The award project period of the Competitive Revision must not exceed two years.
• Application budgets should not exceed the annual amount of the current parent award and should reflect the actual needs of the proposed project. Exceptions will be considered on a case-by-case basis.
• Recipients may apply for work that is related to your funded project, whether within the scope or outside of the scope of the current project, regardless of the time remaining on the current project. Grants currently in an extension are eligible to apply.
• Applications will be accepted on a rolling basis 03/25/2020 from 03/25/2021 through 5:00 PM local time of the applicant organization. An application submitted in response to this NOSI that is received on 03/25/2021 or later, will be withdrawn.
• Competitive revision applications to PA-20-135 must use the application form package with the Competition ID of NOT-AI-20-034-FORMS-E." This FOA will be reissued with a NOT-AI-20-034-FORMS-F package on May 25, 2020. Submissions to PA-20-135 must be completed by June 25, 2020 (see NOT-OD-20-026 for details). Submissions to the reissued FOA will be accepted on or after May 25, 2020 through the expiration date of this Notice.
• IMPORTANT: For funding consideration, all applicants must designate NOT-AI-20-034 (without quotation marks) in the Agency Routing Identifier field (Box 4b) of the SF424 (R&R) Form. Applications without this information in Box 4b will not be considered for this initiative.
• Investigators planning to submit an application in response to the NOSI are strongly encouraged to contact the program officers listed below to discuss the proposed project in the context of the parent award.
• Review criteria, in addition to those described in PA-20-135: As applicable for the project proposed, reviewers will evaluate the following additional items and their responsiveness to the immediate need to help address a specific, public health crisis in a timely manner in accordance with the associated Emergency Guide Notice but will not give separate scores for these items.
  • Do the investigators have immediate access to the resources (e.g. patient samples, isolates, etc.) at sufficient quantities to achieve the aims of the proposed research?
  • If the proposed research will generate unique resources or data that may impact the public health response or medical countermeasure development, is the resource sharing plan adequate?

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Scientific/Research Contact(s)

Diane Post, Ph.D.
Respiratory Diseases Branch
Division of Microbiology and Infectious Diseases (DMID)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3348
Email: [email protected]

Halonna Kelly, Ph.D.
Basic Immunology Branch
Division of Allergy, Immunology, and Transplantation (DAIT)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:240-627-3519
Email: [email protected]

Martin Gutierrez
Division of AIDS (DAIDS)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4844
Email: [email protected]

Financial/Grants Management Contact(s)

Donna R. Sullivan
Grants Management Program, DAIT Coordinator
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2979
Email: [email protected]

Vandhana Khurana
Grants Management Program, DMID Coordinator
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2966
Email: [email protected]

Ann Devine
Grants Management Program, DAIDS Coordinator
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: [email protected]