With widespread COVID-19 vaccination underway in the United States (U.S.), it is critically important to continue gathering evidence on vaccine safety, effectiveness, and access. Substantial vaccine surveillance and research efforts are ongoing among a broad range of federal and state agencies and private organizations, each capturing vaccination records and clinical real-world data (RWD) across varied populations. In addition, a range of researchers, health plans, health care systems, data networks, and registries can contribute to ongoing evidence development efforts. Given the variety of public and private evidence development efforts underway, coordinating efforts around high-priority questions and high-quality data and methods is critical to support confidence in COVID-19 vaccines and address vaccine hesitancy.
In January 2021, the Duke-Margolis Center for Health Policy (Duke-Margolis) and MITRE convened expert stakeholders to discuss ongoing vaccine evidence development efforts. Participants identified critical questions about vaccine safety, effectiveness, and access, and challenges impacting efforts to answer them. Participants then discussed steps that might be taken to meaningfully bolster evidence development efforts by improving coordination among stakeholders.
This issue brief describes some of the critical questions about vaccines identified during the January stakeholder discussion, identifies key data sources that can help answer these critical questions, and recommends actions that organizations capturing, sharing, and analyzing vaccine data can take to coordinate efforts and answer critical questions rapidly.