US-based biotechnology company Moderna pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, has announced that the Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against¬†COVID-19¬†has begun dosing participants. Called COVE (Coronavirus Efficacy) study, this phase 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.
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 includes approximately 30,000 participants in the United States, testing an mRNA-1273 dosage of 100 ¬?g. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by¬†SARS-CoV-2¬†regardless of symptomology.
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. Moderna is working closely with BARDA and the NIH, including NIAID's COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under the auspices of Operation Warp Speed.