The Emergency Use Authorization of Pharmaceuticals: History and Utility During the COVID-19 Pandemic
| Autor: | Theodore J. Witek, Allan Tran |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
2019-20 coronavirus outbreak
Emergency Use Authorization Canada COVID-19 Vaccines Coronavirus disease 2019 (COVID-19) Civil defense Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Leading Article Antiviral Agents History 21st Century Pandemic Drug approval medicine Humans Pharmacology (medical) Drug Approval Pandemics Pharmacology Authorization COVID-19 Civil Defense medicine.disease Bioterrorism United States COVID-19 Drug Treatment Europe Business Medical emergency Emergencies |
| Zdroj: | Pharmaceutical Medicine |
| ISSN: | 1179-1993 1178-2595 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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