Thursday, January 13, 2022

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)

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.

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