This second International Alliance for Biological Standardization COVID-19 webinar brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable participation from low- and middle-income countries, to discuss the use of controlled human infection models to accelerate development and market authorization assessment of a vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Highlights • The development of a SARS-CoV-2 CHIM does not deviate from the standard viral challenge model development process. • The sponsor decides what challenge agent will be used; however, all challenge agents will be reviewed by regulators. • Risks can be minimized but not excluded: e.g. rescue therapy may not protect everyone. • No consensus could be reached on whether challenge studies should begin before a rescue treatment is available. • The longer we wait to set up challenge studies, the lower the chance that they will add to regular phase 1–3 trials.
【저자키워드】 SARS-CoV-2, Ethics, CMC, Controlled human infection models,