Modernizing Influenza Vaccine Development: Policy Priorities for Stakeholders

Overview

Influenza is a persistent public health challenge with significant morbidity, mortality, and economic costs. The seasonal influenza vaccine remains the best intervention to reduce disease burden, and numerous opportunities exist to improve the influenza vaccine development process. Improvements at every stage of the vaccine lifecycle—including viral surveillance, vaccine antigen selection, vaccine production, regulatory review, and post market assessments— are possible. Duke-Margolis has published a policy brief, informed by key stakeholders, presents short- and long-term policy priorities and enables organizations to modernize seasonal influenza vaccine development. This policy brief is published ahead of a public webinar to further explore pathways for change and highlight collaborations ahead of the upcoming fall influenza season.

While influenza spreads globally, requiring a multi-national coordinated effort, opportunities exist in the United States to leverage and expand upon technical and infrastructure advancements in recent years that could then stimulate and be linked with global efforts in the future. Therefore, this brief focuses on key priorities for the U.S., while assuring alignment with global needs. Priorities were categorized as either short- or long-term based upon feasibility and viability for earlier initiation, while also acknowledging the need for parallel efforts. The short-term policy priorities focus on strengthening influenza surveillance and real-world evidence generation on vaccine utilization and clinical outcomes. Viral surveillance is the cornerstone for vaccine development and greater investment in sample collection, genomic sequencing, data sharing, and ultimately AI-enabled predictive modeling is needed to better understand the annual viral threat. Opportunities exist to build upon local, state, and regional successes to create a more robust national system through partnerships with federal and state government organizations, commercial laboratories, foundations, and non-government organizations. Simultaneous investment in real-world evidence generation to link immunization data to clinical outcomes and refine meaningful vaccine effectiveness analytical methodologies will also facilitate vaccine developmental efforts and connect the dots between viral surveillance and vaccine outcomes.

In conjunction with improvements in viral surveillance and real-world evidence generation, long-term policy priorities focus on aligning research, manufacturing, and regulatory frameworks, enhancing antigen selection and improving communication and messaging. While much work is needed to advance these areas, initial steps are presented that involve partnerships, communication, and collaboration among federal organizations, state health departments, vaccine developers, patient organizations, and health technology groups. Stakeholder collaboration, supported by coordinated policy reform and targeted investments, can enable a modernized influenza vaccine lifecycle that reduces the current gap between speed of viral evolution and actionable regulatory and manufacturing decision-making. Collectively, these advancements can support next-generation platform development, build a connective data infrastructure for public health surveillance, and help instill provider confidence and public trust in vaccine safety and effectiveness. Duke-Margolis remains interested in exploring how these policy reforms can be implemented and further steps that can be taken to advance innovation, transparency and trust within the seasonal influenza vaccine development process.

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