Calvin Ho on COVID-19 Vaccine Trial Designs in the Context of Authorized COVID-19 Vaccines and Expanding Global Access: Ethical Considerations (a Contributor of Policy Brief of the World Health Organization, 29 November 2021)

"COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: ethical considerations"
Calvin Ho
Policy Brief of the World Health Organization, 29 November 2021

Introduction of Executive Summary: 
     In June 2020, global regulators convened under the auspices of the International Coalition of Medicines Regulatory Authorities (ICMRA) and co-chaired jointly by the European Medicines Agency (EMA) and United States Food and Drug Administration (FDA) reached consensus on the study design requirements for Phase 3 COVID-19 vaccine clinical trials. The ICMRA noted that phase 3 clinical trials should be randomized, double-blinded and controlled with a placebo or active comparators. In September 2020, the World Health Organization (WHO ) advised: “Phase IIB/III efficacy trials should be randomized, double-blinded and placebo controlled.” Since then, multiple COVID-19 vaccines have been authorized worldwide based on interim results of pivotal placebo-controlled efficacy trials, and billions of COVID-19 vaccine doses have been administered under emergency use/conditional marketing authorization or full approval regulatory mechanisms.