The evidence base for emergency use authorizations for COVID-19 treatments: A rapid review.

ABSTRACT:

Background and aims

During the COVID-19 pandemic, US Food and Drug Administration (FDA) permitted emergency use authorizations (EUAs) for vaccines/treatments with promising data. Eight treatments were issued EUAs by May 31, 2021; one of these was approved (Remdesivir for certain populations) and two were revoked (chloroquine phosphate/hydroxychloroquine and bamlanivimab) by September 30, 2021. The aim of this study is to find out what evidence the EUAs were based on and how many studies were published while they remained active (up to September 30, 2021).

Methods

A review of published clinical studies for the 6 months before each EUA was issued, and the time after (until September 30, 2021, or until revoked). PubMed and the identified systematic reviews were the sources for

SUBMITTER: Knowlson C 

PROVIDER: S-EPMC9831114 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature