Moderna announced that the 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, 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 US Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies. The randomised, placebo-controlled trial is expected to include approximately 30,000 participants in the US, testing an mRNA-1273 dosage of 100 µg. 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 hospitalisation) 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 organised by NIAID throughout the study. The clinicaltrials.gov identifier is NCT04470427.
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.
With its collaborators, Moderna has selected nearly 100 clinical research sites with representative demography and is partnering closely with those sites to ensure that volunteers at increased risk for COVID-19 disease are enrolled in the study.
The company informs that it remains on track to be able to deliver approximately 500 million doses per year, and possibly up to one billion doses per year, beginning in 2021