The Emergency Use Authorization of Pharmaceuticals: History and Utility During the COVID-19 Pandemic.
Pharmaceut Med
; 35(4): 203-213, 2021 07.
Article
in English
| MEDLINE | ID: covidwho-1375861
ABSTRACT
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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Antiviral Agents
/
Drug Approval
/
Emergencies
/
COVID-19 Vaccines
/
COVID-19
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
Topics:
Vaccines
Limits:
Humans
Country/Region as subject:
North America
/
Europa
Language:
English
Journal:
Pharmaceut Med
Year:
2021
Document Type:
Article
Affiliation country:
S40290-021-00397-6
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