Nonclinical and clinical evaluation of monoclonal antibodies and related products intended for the prevention or treatment of COVID-19

Overview

SARS-CoV-2 is an enveloped positive-sense single-stranded RNA virus belonging to the genus Betacoronavirus. The virus first emerged in Wuhan, China in 2019, with sustained human-to-human transmission confirmed shortly afterwards, followed by its rapid spread worldwide. Evidence of sustained global transmission led WHO to declare COVID-19 a pandemic in March 2020. COVID-19 was subsequently officially declared to no longer be a public health emergency of international concern by WHO on 5 May 2023. Nevertheless, the disease remains a major threat, with SARS-CoV-2 still in circulation in most regions of the world.