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 encouraging applications to address 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 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 the 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 to address the following research areas of interest:

• Studies to identify optimal in vitro culture 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

This notice applies to due dates on or after April 5, 2020 and subsequent receipt dates through April 5, 2021.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice:

PA-19-052 NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
PA-19-053 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
PA-18-591: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp - Clinical Trial Optional)
PA-19-056 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
PA-19-272 - PHS 2019-02 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 - PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

Please note: submissions to PA-18-591: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp - Clinical Trial Optional) will be accepted on a rolling basis effective immediately. Also, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative. In addition, administrative supplement applications to PA-18-591 must use the application form package with the Competition ID of FORMS-E-ADMINSUPP-RESEARCH". This FOA will be reissued with a FORMS-F-ADMINSUPP-RESEARCH package on May 25, 2020. Submissions to PA-18-591 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.

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

For funding consideration, applicants must include "NOT-AI-20-031 (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.

Scientific/Research Contact(s)

Erik J. Stemmy, Ph.D.
Respiratory Diseases Branch
Division of Microbiology and Infectious Diseases (DMID)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3380
Email: [email protected]

Wolfgang Leitner, Ph.D.
Basic Immunology Branch
Division of Allergy, Immunology, and Transplantation (DAIT)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3575
Email: [email protected]

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