Vaccine Development: From Laboratory to Policy

Vaccines are one of the greatest public health achievements, protecting children and adults against numerous infectious diseases; however, the complex, rigorous process of vaccine development is unknown to many. A candidate vaccine undergoes extensive evaluation of safety and efficacy to meet licensure requirements before recommendations for use become policy. This time-consuming process involves an intricate collaboration among academia, public and private organizations, and federal agencies to ensure that safety is prioritized in every step. Vaccine safety continues to be monitored after licensure through a robust system. Yet, vaccine hesitancy remains a major challenge, especially now with the coronavirus disease 2019 (COVID-19) pandemic and concerns about the speed with which candidate vaccines are being developed. This article reviews the vaccine development process and the systems in place to ensure safety and effectiveness. A better understanding of these topics is necessary to address concerns and improve public acceptance of all vaccines, particularly COVID-19 vaccines. [ Pediatr Ann . 2020;49(12):e509–e515.]