According to an official announcment by Moderna, the clinical stage biotechnology company, Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19 has begun dosing participants.
"The Phase 3 study, called the COVE (Coronavirus Efficacy) study", Moderna explained, "is being conducted 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 Response at the U.S. Department of Health and Human Services".
“We are pleased to have started the Phase 3 COVE study,” said Stephane Bancel, CEO at Moderna. “We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic.”
According to Moderna, the Phase 3 study protocol follows the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies. The randomized, placebo-controlled trial is expected to include approximately 30,000 participants in the United States, testing an mRNA-1273 dosage of 100 µg. Moderna says that the primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2 regardless of symptomology. SARS-CoV-2 is the virus that causes COVID-19.
The company explained in their official announcement that the primary efficacy analysis of the Phase 3 study will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. To ensure the ongoing safety monitoring of the participants in the trial, data will be reviewed by an independent Data and Safety Monitoring Board organized by NIAID throughout the study.