Moderna’s Statement on Phase 3 Study of COVID-19 Vaccine Protocol Update
Moderna has posted an updated protocol for its Phase 3 study of the Moderna COVID-19 Vaccine. The protocol reflects inclusion of Amendment 6 from Dec. 23, 2020. The purpose of this amendment is to inform all ongoing study participants of the availability of and eligibility criteria of any COVID-19 vaccine made available under an Emergency Use Authorization (EUA) and to offer participants who originally received placebo in this study the potential benefit of vaccination against COVID-19, given that the primary efficacy endpoint for the Moderna COVID-19 Vaccine was met per the protocol-defined interim analysis. The protocol is available here.