June 11, 2020 -- Moderna has finalized phase III clinical study protocols for its mRNA-1273 COVID-19 vaccine candidate in coordination with the U.S. Food and Drug Administration (FDA) and expects the study to begin in July.
The study is designed as a randomized, placebo-controlled trial including approximately 30,000 participants in the U.S. Based on the results of the phase I trial, the optimal dosage of the phase III study was selected at 100 µg. Moderna has already completed manufacture of the vaccine required to start the phase III study. It will be conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH).
With the plan to begin the phase III study, the company remains on track to deliver 500 million doses per year -- and possibly up to 1 billion doses per year -- beginning in 2021 from an internal U.S. manufacturing site and in collaboration with strategic partner Lonza.
Currently, the first cohort of healthy adults ages 18-54 (300 participants) and older adults ages 55 and above (50 participants) has been fully enrolled in the phase II study of mRNA-1273. This study will evaluate safety, reactogenicity, and immunogenicity of two mRNA vaccinations given 28 days apart. Moderna will enroll an additional 600 participants to follow through a 12-month period after second vaccination.
The FDA completed its review of the investigational new drug application for mRNA-1273 on May 6 and granted fast-track designation to the drug on May 11. On May 18, Moderna announced data from a phase I study of mRNA-1273 that was led by the NIAID. The study is ongoing with long-term follow-up of original cohorts and enrollment in nine of 12 cohorts complete. The NIH plans to submit phase I data to a peer-reviewed clinical publication.
The planning and execution of phase II/III studies and manufacturing scale-up of mRNA-1273 was in part funded by the U.S. Biomedical Advanced Research and Development Authority, a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.
Moderna will fund costs required to complete the development of mRNA-1273 including portions of the phase III study and the scale up of manufacturing capacity at the final established dosage in order to obtain licensure for the vaccine.
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