evidence: - When the phase 3 portion of the human clinical trial reaches a predetermined point that informs how well a vaccine prevents COVID-19, as discussed and agreed to in advance with FDA, an independent group (called a data safety monitoring board) will review the data and inform the manufacturer of the results. Based on the data and the interpretation of the data by this group, manufacturers decide whether and when to submit an EUA request to FDA, taking into consideration input from FDA. [...] In public health emergencies, such as a pandemic, the development process may be atypical. For example, as demonstrated by the response to the COVID-19 pandemic, the U.S. government has coalesced government agencies, international counterparts, academia, nonprofit organizations and pharmaceutical companies to develop a coordinated strategy for prioritizing and speeding development of the most promising vaccines. In addition, the federal government has made investments in the necessary manufacturing capacity at its own risk, giving companies confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine. However, efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety.