Abstract
Therapies have been developed in the last couple of years to allow vaccination against, or treatment of patients with, COVID-19 using pathways such as Emergency Use Authorization (EUA) in the USA and Conditional Marketing Authorization (CMA) in the EU and UK. However, nonclinical studies were performed to allow such authorization and these were reviewed for 6 vaccines, 7 biological (monoclonal antibodies [mAbs]) and 4 small molecule therapies to examine whether the number and types of studies normally needed for regulatory agency authorization have been reduced. Results showed that the short answer is generally no. Thus, a battery of immunogenicity/efficacy or related pharmacology/biological activity studies showing utility against SARS-CoV-2 were performed as well as general toxicity studies across all 3 compound classes along with pharmacokinetic studies for mAbs and small molecules and, reproduction toxicity testing for vaccines and small molecules; additionally, genotoxicity testing occurred for small molecules. What was different from conventional, lengthy drug development, was that for vaccines and small molecules, leverage to existing platform technology or data available for other development programs, respectively, occurred. Recognition that mAbs can target the spike protein leading to neutralization allowed rapid development into clinical candidates.