Comparison and Compilation of the Vaccine Approval Process of the United States of America and the European Union: A Road Map for the Emerging and Developing Countries in COVID-19 Crisis

Abstract: Background: Vaccines are the-omit complex biological preparations that meant to be used as a treatment or preventive measures against any specific disease condition. Vaccine research and development is tedious, time cost consuming process because of stringent quality assessment procedures. Every year approximately 80-85 % the world’s children receive vaccines; however, regardless this success rate each year, more than 3 million die from vaccine-preventable diseases in most developing countries. Today entire world facing pandemic COVID-19 researchers putting their best effort bring vaccine into market. Developing tedious emerging market requires whole lot process. Purpose: The current study aimed evaluate approval processes two international pharmaceutical regulatory giants develop road map for progress vaccines countries face challenges posed by COVID-19. Methods: This article expresses brief updated report pathways involved registration United States America (USA) European Union (EU). comparison serves understand issues during life-cycle USA EU. Authors advocate necessity harmonised guidelines Conclusion: insist on broad global partnerships between developed supply affordable across globe called Key words: Vaccines, Marketing authorization application, USA, EU,