An ad hoc committee under the auspices of the National Academies of Sciences, Engineering, and Medicine will examine the technological and scientific advances achieved during the global response to COVID-19 and other outbreaks in vaccine research, development, and manufacturing, including the use of platform technologies, and recommend strategies to harness the science, technology, policy and practice required to improve global influenza pandemic preparedness and response.
Specifically, the committee will:
1) Assess how lessons from COVID-19 and other prior epidemics have changed the research and development ecosystem, and explore how these advances could be applied to pandemic and seasonal influenza planning, including innovative trial design approaches, regulatory approval mechanisms, and R&D capacity in resource-limited settings;
2) Distinguish pandemic-level response from seasonal flu vaccine development and delivery, identify overlapping regulatory and policy concerns, and review need for novel vaccine development platforms beyond traditional processes (i.e. egg-based vaccines);
3) Discuss implications of the existing seasonal flu response ecosystem on future influenza pandemics and consider how emerging technologies can be applied to management of seasonal or pandemic influenza outbreaks;
4) Recommend actions to strengthen and diversify the use of vaccine production facilities and novel vaccine technologies, including platform technologies (e.g., cell-based, recombinant, nucleic acid, and other synthetic technologies), and business strategies that could be sustainably and rapidly adapted to address multiple threats;
5) Consider the impacts of issues such as viral drift, repeat immunization effects, seasonal flu vaccine effectiveness, and intellectual property upon the technical, regulatory, and policy feasibility of recommended actions;
6) Recommend ways to build capacity for accelerated vaccine development and delivery against pandemic influenza viruses, and discuss the applicability of rapid-response procedures for seasonal flu outbreaks;
7) Consider mechanisms to better coordinate and integrate research and development processes for newly developed vaccines with cohesive vaccine distribution and post-approval surveillance efforts. These considerations include streamlining vaccine and drug discovery, clinical testing, intellectual property management, and other international policy barriers that may impede or delay development.