Emergency use authorisation for COVID-19 vaccines: lessons from Ebola

The Lancet
Nov 28, 2020 Volume 396 Number 10264 p1703-1776


Emergency use authorisation for COVID-19 vaccines: lessons from Ebola
Maxwell J Smith, Samuel Ujewe, Rachel Katz, Ross E G Upshur
Russia and China have begun COVID-19 vaccinations outside of clinical trials. This move has been met with widespread criticism because the safety profiles of these candidate COVID-19 vaccines remain uncertain without data from phase 3 trials.1,2 Emergency use authorisations—a regulatory mechanism that enables the public to gain access to promising investigational medical products when those products have not yet received regulatory approval and licensure3 —have previously been used for unlicensed vaccines in public health emergencies and can be ethically justified provided that certain conditions are met. So why have the actions of Russia and China drawn such criticism? And how can other national regulatory authorities ensure future emergency use authorisations for COVID-19 vaccines are issued in a way that is scientifically and ethically sound? Experience of emergency use authorisations for investigational Ebola virus vaccines in Guinea and the Democratic Republic of the Congo (DRC) can elucidate key lessons that can guide ethical emergency use authorisations for COVID-19 vaccines…