For many in public health and medicine, the coronavirus disease 2019 (COVID-19) pandemic in the US has been a frustrating journey from one disappointment to the next: late access to testing, insufficient staff and inadequate funding for contact tracing, jumbled communications, and, at the end of 2020, a chaotic launch of vaccination efforts. But in one area, from the beginning of the pandemic to the present, the US has excelled: facilitating the rapid development of COVID-19 vaccines. Much of the credit has justifiably gone to the scientists who adopted and created the technology, to the companies that made the vaccines, to the participants who volunteered for clinical trials, to the National Institutes of Health, and to Operation Warp Speed, which funded several candidate vaccines, minimizing financial risk for the companies. A less recognized partner in this effort—but no less essential to its success—is the US Food and Drug Administration (FDA).