COVID-19 Vaccine Candidate mRNA-1273 (94.5%) beats BNT162b2 (90%) in Interim Analysis: Moderna Prepares to Submit Application for EUA with FDA

COVID-19 Vaccine Candidate mRNA-1273 (94.5%) beats BNT162b2 (90%) in Interim Analysis Moderna Prepares to Submit Application for EUA with FDA

Moderna Inc. (Nasdaq: MRNA), the developer of the messenger RNA-based vaccine candidate known as mRNA-1273, reports that the independent NIH appointed Data Safety and Monitoring Board (DSMB) for the Phase 3 clinical trial of the vaccine candidate against COVID-19 reports that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This upbeat news actually improves on the Pfizer/BioNTech interim analysis, which came in a 90% effective rate. The news involving vaccines out of the U.S. and Europe continues to stay upbeat. Moderna prepares to submit an application for an emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA).

TrialSite provides a breakdown of this important update.

What study does the data originate from?

The COVE study, which enrolled over 30,000 participants in the United States, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Re...

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