Which statement is true regarding the emergency use authorization process?

The emergency use authorization (EUA) process is designed to allow for the rapid deployment of vaccines and treatments during public health emergencies, such as pandemics. A critical component of this process involves ensuring that the safety of the product being authorized is effectively monitored. Therefore, manufacturers are required to submit a safety monitoring plan to the appropriate regulatory authorities as part of their EUA application. This plan outlines how the manufacturer will assess any adverse events that may occur after the product is administered, ensuring ongoing oversight and prompt identification of any potential safety concerns.

The other possible choices highlight misunderstandings about the EUA process. For instance, clinical trial data are indeed required, as they help establish a product's safety and efficacy even in an accelerated setting. Furthermore, the evaluation of risks takes place concurrently with ongoing studies and before long-term safety data are fully available. Lastly, EUA is based on the need for rapid availability of medical countermeasures, not solely on cost considerations regarding alternatives. Hence, the requirement for a safety monitoring plan underscores the commitment to patient safety, making this statement accurate within the context of the EUA process.