Gates Foundation Issues RFP for Universal Flu Vaccine Development Grand Challenge

The Bill & Melinda Gates Foundation has issued an Request for Proposals for research that will lead to the development of universal influenza vaccines.

This year marks the hundred-year anniversary of the most severe influenza pandemic in recorded history, an event that killed an estimated 50 million people worldwide â€” more than the total deaths caused by World War I. The subsequent influenza pandemics of 1957, 1968, 1977, and 2009, though milder, demonstrated the potential of influenza viruses to cause excessive morbidity, mortality, and, more generally, severe disruptions of healthcare systems. Clearly, the threat of pandemic influenza is real, and influenza viruses pose a significant threat to humankind, with seasonal influenza disease causing an estimated 290,000 to 650,000 deaths annually.

Part of the foundation's Grand Challenges program, the goal of the foundation's Ending the Pandemic Threat: A Grand Challenge for Universal Influenza Vaccine Development initiative is to identify novel, transformative concepts that will lead to the development of universal influenza vaccines that offer 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.

While other funders are supporting development of universal influenza vaccines, three things set this Grand Challenge apart. The Gates Foundation seeks to fund ideas that are bold and innovative, bridging the funding "valley of death" so as to translate these novel approaches into products ready for human clinical trials. It also seeks to encourage interdisciplinary collaboration and cross-fertilization of ideas from outside the traditional influenza research community. And it seeks completely transformative vaccine research approaches rather than support incremental research.

All projects must be aligned with the Gates Foundation’s intervention Target Product Profile (iTPP). The iTPP 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 program is seeking 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.

Projects also should 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 or addressed by the influenza vaccine field; and present concepts and strategies that are "off the beaten track," significantly radical in conception, and daring in premise. Grantees will have access to a wide-range of Gates Foundation-funded resources and technology platforms to support their projects

In addition, the program will consider 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.

The program intends to fund pilot awards of up to $2 million over two 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 of up to $10 million. Full awards would be intended to fund IND-enabling and clinical studies.

See the Gates Foundation website for complete program guidelines and proposal submission instructions.