How Does the EUA for the COVID-19 Vaccines Work?

"1 The HHS secretary can declare an emergency upon determining the existence of a public health emergency that "affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad and that involves . . . a biological agent or a disease or condition that may be attributable to such agent. [...]based on the totality of scientific evidence available to FDA, it is reasonable to believe that [the] vaccine may be effective in preventing COVID-19. Because the EUA does not give the vaccines "FDA approval" status but merely authorizes their use for the duration of the emergency, the vaccines must continue to undergo clinical trials as they otherwise would. In addition to requiring the submission of biologics license applications, vaccine manufacturers must ensure their facilities comply with current good manufacturing practices, submit certificates of analysis to the EUA file within 48 hours before the release of each lot, and submit quarterly manufacturing reports to the EUA file.9,10 The CDC has also ensured that the COVID-19 vaccines comply with the "FDA's rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support [EUA].