Next-Generation Influenza Vaccines and the Pandemic Horizon: Challenges, Innovations, and the Road Ahead

Next-generation influenza vaccines have the potential to overcome the limitations of current seasonal influenza vaccines by providing more efficacious, broader, and longer-lasting protection and enhanced pandemic preparedness. However, their development is constrained by regulatory, financial, and scientific challenges. This study aimed to better understand these barriers and enablers from the perspective of vaccine developers.

We employed a mixed-methods approach, collecting data through an online survey and follow-up interviews with 17 developers engaged in next-generation influenza vaccine R&D. Thematic analysis was used to identify key scientific, regulatory, and financial challenges, enablers and priorities for advancing development.

Developers reported a range of scientific and regulatory challenges, particularly the lack of established correlates of protection and uncertainty around evaluation criteria for novel platforms. High development costs and limited access to sustained funding were consistently cited as key barriers. Developers emphasized the need for clearer regulatory guidance, harmonized approval pathways, and validation of alternative immune markers. Collaborative approaches, including partnerships, consortia, and trial networks, emerged as critical enablers. Most respondents also reported leveraging their influenza vaccine R&D to support COVID-19 vaccine development, underscoring their relevance to broader pandemic preparedness.

Next-generation influenza vaccines have the potential to significantly improve both seasonal influenza control and pandemic response. Realizing this potential requires coordinated action to address scientific, regulatory, and financial hurdles. Investment in regulatory innovation, sustainable financing, and collaborative R&D platforms will be essential to accelerate progress and ensure global access to improved influenza vaccines.