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Moderna's Phase 3 COVE Trial Of MRNA Vaccine Against COVID-19 Begins

Clinical stage biotechnology company Moderna, Inc. (MRNA) announced Monday that the Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19 has begun dosing participants.

The company conducts the Phase 3 trial, called the Coronavirus Efficacy or COVE study, jointly with the National Institute of Allergy and Infectious Diseases or NIAID, and the Biomedical Advanced Research and Development Authority or BARDA.

NIAID is part of the National Institutes of Health or NIH, and the BARDA is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

Moderna noted that the 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 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. SARS-CoV-2 is the virus that causes COVID-19.

Moderna said it remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.

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