Sustaining Local Production of Influenza Vaccines: A Global Study of Enabling Factors Among Vaccine Manufacturers.

Background/Objectives: Local production is a global priority for increasing access to routine, outbreak, and pandemic vaccines and leads to a variety of direct and indirect benefits for countries. This study aimed to characterize the enabling environment for the sustainable production of influenza vaccines, including for epidemic and pandemic preparedness. Methods: National/local vaccine manufacturers were surveyed to capture data on influenza vaccine market contributions, government support for local production, and involvement in national pandemic preparedness activities. Using a conceptual framework for sustainable local production of influenza vaccines for epidemic and pandemic preparedness, manufacturers described 41 global/regional, national, and institutional sustainability factors across policy, health system, research and development (R&D), and regulatory thematic domains. In addition to the survey, key findings from country-level sustainability assessments of vaccine production in Bangladesh, Brazil, Indonesia, Serbia, and Viet Nam were analyzed to complement survey results. Results: This study included 12 participants representing 11 manufacturers from 10 countries. Of the 11 manufacturers, six reported that their countries have policies that support local production, but most manufacturers reported benefiting from some level of direct or indirect support by the government. Manufacturers considered 40/41 factors as important for sustainable production of influenza vaccines, and among the four domains, influenza prevention and control policies, influenza burden data, quality management, and regulatory filing capacity ranked highly. Additionally, manufacturers ranked factors related to cohesive policies for local production promotion and business/strategic planning at the manufacturer level as the top sustainability factors. Conclusions: Manufacturers broadly agreed on the importance of cohesive policies, evidence-based public health priorities, robust R&D and manufacturing investments, and regulatory readiness, though perceptions varied across contexts and company characteristics. Sustainable local production of influenza vaccines should be driven by the alignment of policies, investments, and demand.