On June 30, 2020 the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research released its first “Guidance for Industry” document for the development and licensure of COVID-19 vaccines. While the procedures and recommendations set forth in the Guidance are nonbinding and subject to change, the document nevertheless provides interested stakeholders with a comprehensive overview of FDA’s current thinking on what benchmarks will need to be met before a COVID-19 vaccine is approved for widespread use.