Notice of Special Interest (NOSI): Development of Nucleic Acid-based Vaccines Against Seasonal and/or Pandemic Influenza NOT-AI-20-017

Key Dates

Related Announcements

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)

PA-18-858 Advancing Research Needed to Develop a Universal Influenza Vaccine (R21 Clinical Trial Not Allowed)

PA-18-859 - Advancing Research Needed to Develop a Universal Influenza Vaccine (R01 Clinical Trial Not Allowed)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

Background:

Every year, the composition of influenza vaccines is recommended by the World Health Organization (WHO) based on surveillance data used to forecast which influenza strains will likely be circulating at the time of seasonal outbreaks. Recommendations are made in February for the northern hemisphere and September for the southern hemisphere to allow the necessary time for vaccine production and deployment prior to the start of each influenza season. However, circulating viral strains are difficult to predict due to co-circulation of antigenically drifted strains creating a possible risk of vaccine mismatch. In addition, viral strains with pandemic potential continue to be isolated from avian species further underscoring the on-going global threat of an emerging influenza strain to public health.

Currently, one of the challenges to influenza outbreak response is the inability to shift influenza vaccine manufacturing when antigenic variants emerge late in the season. In 2014, evidence of a potential mismatch between the H3N2 vaccine virus component and the circulating H3N2 strain became known after vaccine manufacturing had already commenced, resulting in low vaccine effectiveness for that season. The lack of flexibility in vaccine manufacturing to respond to changes in virus circulation becomes more evident during a pandemic. For example, during the 2009 H1N1 pandemic, vaccine was not available until the peak of illness had already passed. Although new vaccine technologies have recently become available that may help reduce the time to availability of vaccine, the speed and scalability of these technologies may still be insufficient to mount an effective and timely response.

On September 19, 2019, the White House issued Executive Order 13887 on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health in order to focus federal efforts to transform the domestic influenza vaccine enterprise to be highly responsive, flexible, scalable, and more effective at preventing the spread of influenza viruses. The executive order also calls for the full implementation of the NIAID’s strategic plan and research agenda for development of broadly protective vaccine candidates that provide more effective and longer lasting immunity (i.e., universal influenza vaccines) as part of a long term strategy to reduce the risk of an emerging pandemic.

Research Objectives

The purpose of this Notice is to announce that the NIAID seeks to further implement its strategic plan through a diverse and comprehensive portfolio of vaccine platforms and approaches. This Notice is intended to achieve that goal by encouraging new applications to support the preclinical development of nucleic acid-based vaccine approaches that can protect against seasonal and/or pandemic influenza. Nucleic acid-based approaches are promising platforms that allow for flexible, nimble, large-scale production of vaccines that can also meet the rapid manufacturing requirements needed during an influenza pandemic. While several candidates are entering clinical trials, additional preclinical development is warranted. NIAID is issuing this Notice to highlight interest in the development of preventive nucleic-acid based vaccines. However, nucleic-acid based vaccines that encode prophylactic monoclonal antibodies may also be considered.

Application and Submission Information

Applications should be submitted through the funding opportunity announcements (FOAs) listed below:

This notice applies to due dates on or after February 5, 2020 and subsequent receipt dates through September 8, 2021.

• 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
• PA-18-858 Advancing Research Needed to Develop a Universal Influenza Vaccine (R21 Clinical Trial Not Allowed)
• PA-18-859 - Advancing Research Needed to Develop a Universal Influenza Vaccine (R01 Clinical Trial Not Allowed)

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-20-017 (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.

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

Inquiries

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

Jennifer L. Gordon, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6805
Email: [email protected]