The Bill & Melinda Gates Foundation is launching the "Universal Influenza Vaccine Development Grand Challenge" during the centenary year of the 1918 flu pandemic.  The goal of this Grand Challenge is to identify novel, transformative concepts that will lead to development of universal influenza vaccines offering protection from morbidity and mortality caused by all subtypes of circulating and emerging (drifted and shifted) Influenza A subtype viruses and Influenza B lineage viruses for at least three to five years. It is envisaged that such a universal influenza vaccine would address the threat from both seasonal and pandemic influenza, thus alleviating the need for annual seasonal influenza vaccination campaigns, averting significant global morbidity and mortality, and better preparing the world for the next influenza pandemic. The Foundation is looking for unconventional approaches that effectively drive or harness immune responses in desired ways and develop universal influenza vaccines that are ready to start clinical trials by 2021.

All proposals must be aligned with the Gates Foundation’s intervention Target Product Profile (iTPP). The iTPP (detailed in the Supporting Materials) describes the desired characteristics of a universal influenza vaccine. Most importantly, new vaccines should have the potential to be used in all age groups around the world, especially in developing countries. The Foundation is looking for affordable, effective vaccines that are suitable for delivery through existing immunization programs in-country, which has implications for product presentation and stability as well as for dosing route and schedule. The vaccines need to be broadly protective across Influenza A and B strains for a minimum of three to five years. Technologies will need to be scalable to meet worldwide demand.

The Foundation is looking for proposals that:

• Engage scientists across a variety of disciplines, including those new to the influenza field
• Demonstrate innovative thinking by incorporating concepts or technologies not currently being used within/addressed by the influenza vaccine field
• Present concepts and strategies that are “off the beaten track,” significantly radical in conception, and daring in premise.

Please note: grantees will have access to a wide-range of Gates Foundation-funded resources and technology platforms to support their projects

Examples may fall into broad categories:

1. Antigen-centric: discovering new antigens/targets through Artificial Intelligence, Machine Learning, and/or Deep Learning approaches to get beyond traditional surface hemagglutinin
2. Host-centric: approaches that (a) generate, enhance, or modify human immune protection, including sterilizing immunity (b) ensure longer term (possibly life-long) immune response (c) describe surrogates for longevity of immune response and (d) that target specific tissue or cell types for appropriate induction of local and systemic immunity leading to broader and longer protection
3. Technology-centric: including (a) novel vaccine concepts, targets and constructs inspired by new observations or understanding about the nature of the influenza virus or the human response to it and (b) applications of radically new technologies for disease protection, such as production of immunogens using synthetic biology or radical genetic engineering approaches
4. Enabling advances: including challenge models to quickly demonstrate safety and proof-of-concept for influenza vaccines

The Foundation is happy to receive proposals that describe approaches for employing multiple interventions in combination.

In addition, the Foundation will accept concept proposals related to use of DNA/RNA based delivery of longer acting universal influenza monoclonal antibody for passive prophylaxis or use of such monoclonals for exploring appropriate epitopes for universal influenza vaccine, if generally aligned with the iTPP.

Pilot awards ($250,000 up to $ 2 million)

This request for proposals intends to fund pilot awards of up to USD $2 million over 2 years, with the anticipation that one or more pilot projects, on demonstration of promising proof-of-concept data (e.g., from animal models), may be invited to apply for a full award up to USD $10 million. Full awards would be intended to fund IND-enabling and clinical studies.

Pilot awards do not include a requirement for an industry or translation partner but such partnerships would still be welcome. Industry is also welcome to apply directly for the pilot award. Successful pilot award recipients will have the opportunity to apply for additional funding, which could include grants, program related investments and/or contracts and must include a biopharmaceutical industry or other translational partner.

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