Institute of Health Policy, Management, and Evaluation, University of Toronto, 155 College Street, Suite 425, Toronto, M5T 3M6, Canada.
Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
Pharmaceut Med. 2021 Jul;35(4):203-213. doi: 10.1007/s40290-021-00397-6. Epub 2021 Aug 28.
The Emergency Use Authorization (EUA) originated in 2004 because of the need for emergency medical countermeasures (MCMs) against potential bioterrorist attacks. The EUA also proved useful in dealing with subsequent pandemics and has emerged as a critical regulatory pathway for therapeutics and vaccines throughout the Coronavirus Disease 2019 (COVID-19) pandemic. With the EUA process in the USA, we witnessed emergency authorizations, their expansions, as well as withdrawal of previously authorized products, which exemplifies the dynamic nature of scientific review of EUA products. EUAs proved vital for the first group of COVID-19 vaccines, including the temporary pause of one vaccine while emergency safety issues were evaluated. Although this review on the EUA is primarily focused on the USA, distinctions were made with other jurisdictions such as Europe and Canada with respect to the emergency authorizations of the vaccines. Finally, we discuss some important differences following EUA and formal new drug/vaccine application (NDA/BLA) approvals.
紧急使用授权（EUA）起源于 2004 年，是因为需要针对潜在的生物恐怖袭击采取紧急医疗对策（MCM）。EUA 在应对随后的大流行时也被证明是有用的，并且在整个 2019 年冠状病毒病（COVID-19）大流行期间已成为治疗方法和疫苗的关键监管途径。在美国，通过 EUA 流程，我们见证了紧急授权、授权扩展以及先前授权产品的撤回，这体现了 EUA 产品科学审查的动态性质。EUA 对于第一批 COVID-19 疫苗至关重要，包括在评估紧急安全问题时暂停使用一种疫苗。虽然对 EUA 的审查主要集中在美国，但在疫苗的紧急授权方面，也与欧洲和加拿大等其他司法管辖区进行了区分。最后，我们讨论了 EUA 和正式新药/疫苗申请（NDA/BLA）批准后的一些重要区别。
