Moderna, Inc., a biotechnology company specializing in mRNA therapeutics and vaccines, has announced the commencement of the Phase 3 COVE study for its COVID-19 vaccine candidate, mRNA-1273. This pivotal study is conducted in partnership 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), under the U.S. Department of Health and Human Services.
The Phase 3 COVE study is a randomized, placebo-controlled trial designed to assess the efficacy and safety of the mRNA-1273 vaccine. It aims to enroll approximately 30,000 participants across the United States, focusing on the prevention of symptomatic COVID-19 disease as its primary endpoint. Secondary endpoints include the prevention of severe COVID-19 disease and infection by SARS-CoV-2, irrespective of symptoms.
Stephane Bancel, CEO of Moderna, expressed gratitude towards the collaborative efforts that have enabled the initiation of this crucial study. The company is committed to ensuring the study's participants are representative of communities at high risk for COVID-19, reflecting the diverse society. Moderna is also on track to scale up its manufacturing capabilities, aiming to produce up to 1 billion doses annually starting in 2021, supported by strategic collaborations with Lonza, Ltd., Catalent, Inc., and ROVI of Spain.
The study's progress and safety data will be continuously monitored by an independent Data and Safety Monitoring Board organized by NIAID, ensuring the integrity and safety of the trial. Moderna's efforts are part of the broader Operation Warp Speed initiative, aiming to accelerate the development, manufacturing, and distribution of COVID-19 vaccines and therapeutics.
