Throughout much of 2020 and the beginning of 2021, while coronavirus disease 2019 (COVID-19) continued to grow and spread, government and public health officials worldwide focused on the development and deployment of one or more COVID-19 vaccines as a means of ending the global pandemic. While much of the U.S. Food and Drug Administration’s (FDA) attention was correctly placed on ensuring that the vaccines were safe and effective, concern was also growing within the agency that Americans, particularly those most vulnerable to COVID-19, would choose not to receive the vaccine once available.