SARS-CoV-2 controlled human infection models: Ethics, challenge agent production and regulatory issues

Biologicals. 2020 Sep:67:69-74. doi: 10.1016/j.biologicals.2020.08.006. Epub 2020 Aug 15.

Abstract

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).

Keywords: CMC; Controlled human infection models; Ethics; SARS-CoV-2.

MeSH terms

  • Betacoronavirus*
  • COVID-19
  • COVID-19 Vaccines
  • Coronavirus Infections / prevention & control*
  • Drug Development / ethics*
  • Drug Development / legislation & jurisprudence
  • Human Experimentation / ethics*
  • Human Experimentation / legislation & jurisprudence
  • Humans
  • Pandemics / prevention & control*
  • Pneumonia, Viral / prevention & control*
  • Quality Control
  • Reference Standards
  • SARS-CoV-2
  • Viral Vaccines / therapeutic use*

Substances

  • COVID-19 Vaccines
  • Viral Vaccines