Development Of Priority Vaccines For Disease-Endemic Countries: Risk And Benefit

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Abstract
Decisions regarding vaccine regulation and use made by institutions in industrialized countries can have an unintended impact on vaccines’ availability in disease-endemic countries. However, regulatory and programmatic decision making by such countries, taking into consideration local risks and benefits, requires adequate resources, both human and financial. Such differing risk-benefit determinations between industrialized and disease-endemic countries will increase product divergence. We propose a single universal standard for risk assessment, based on maximizing net benefit, and an action plan to improve access to priority vaccines through a more robust determination of risk and benefit.