In early 2020, the US Department of Health and Human Services (HHS) recognized the threat to public health posed by COVID-19, the disease caused by Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2), that quickly circled the globe. On January 31, 2020, HHS declared a formal public health emergency,1 and a few days later, on February 4, 2020, the HHS secretary invoked section 564(b)(1) of the Food, Drug, and Cosmetic Act to empower the US Food & Drug Administration (FDA) to implement Emergency Use Authorizations (EUAs).2