Convene a workshop to address regulatory science issues regarding the evaluation of next-generation and broadly protective influenza vaccines for pandemic preparedness and seasonal influenza vaccination and publish a consensus summary report.
WHO and LSHTM are engaged in the FVIVA project, which includes conducting an introductory workshop on regulatory considerations for next-generation influenza vaccines.
EMA and FDA regulators participated in discussions regarding influenza vaccine R&D at the ISIRV Correlates of Protection for Next Generation Influenza Vaccines conference in Seattle, March 1-3, 2023.
Cavaleri 2025 summarized a series of proposed actions for improving efficiencies in ethical and regulatory review of global clinical research needed for rapid responses to future epidemics or pandemics. The actions include leveraging existing clinical trial networks and capacity-building initiatives, advancing joint and parallel regulatory and ethics reviews, improving transparency in approval requirements, and facilitating export/import of investigational products for clinical trials.
GloPID-R 2023, the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R) developed a guide for funding agencies to improve the coordination of clinical trials in response to infectious disease outbreaks, in part to help avoid delays in initiating clinical trials of novel vaccines such as the 2009 influenza A(H1N1) vaccine.
Baylor 2022 reviewed regulatory pathways and processes relevant to pandemic influenza, including how they can be strengthened and globally coordinated, and identified opportunities to provide better approaches, tools, and methods to accelerate and improve vaccine development and evaluation.
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Pecetta 2022 summarized economic and regulatory lessons learned from the COVID-19 pandemic.