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.

 Public health experts hypothesized that U.S. Government agencies had a major role in understanding and addressing the concerns of the vaccine hesitant.

 FDA, in recognizing that they would need to communicate with the public about any authorized or approved vaccine, wanted to better understand those concerns and be prepared with message(s) that would respond to those concerns.

In the fall of 2020, FDA approached the Reagan-Udall Foundation for the FDA (FDA Foundation) with a request to conduct a series of listening sessions with target populations to gauge the level and nature of concern in these groups. FDA furthermore asked that the FDA Foundation develop messages that would address the questions and hesitations that these populations expressed.