What is Emergency Use Authorization (EUA) and how does it relate to clinical trials?

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Emergency Use Authorization is a mechanism that allows the use of an unapproved medical product or an approved product for an unapproved use during a declared public health emergency when there isn’t time for full regulatory approval. It lets people access potentially beneficial interventions based on available evidence, while recognizing uncertainty about safety and efficacy. Importantly, an EUA is not the same as full regulatory approval; full approval requires comprehensive data from robust clinical trials and a full review of benefits, risks, and labeling. Under an EUA, ongoing data collection and post-use surveillance are typically required, and the authorization can be updated or withdrawn if new information changes the risk–benefit assessment. While often discussed in the context of vaccines, EUAs can apply to therapies, diagnostics, and devices as well, not just vaccines.