Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has completed enrollment of 30,000 participants for the Phase 3 COVE study of mRNA-1273, its vaccine candidate against COVID-19, being conducted in collaboration with 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. To date, more than 25,650 participants have received their second vaccination. Moderna will determine whether to submit a dossier to FDA requesting Emergency Use Authorization based on an assessment of whether the potential benefit of the vaccine outweighs the potential risks once the 2 months of median safety follow-up have accrued.
The Company separately shared its statement at today’s U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting.
Moderna worked closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has also been essential to the successful execution to date of the COVE study. PPD also supported the Phase 2 study of mRNA-1273.
The Phase 3 COVE study was designed in collaboration with the FDA and NIH to evaluate Americans at the highest risk of severe COVID-19 disease. As of today, the COVE study includes more than 7,000 Americans over the age of 65. It also includes more than 5,000 Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease. These medically high-risk groups represent 42% of the total participants in the Phase 3 COVE study.
Moderna has also worked to develop a vaccine for everyone, including communities that have historically been under-represented in clinical research and are disproportionately impacted by COVID-19. In early September, the Company announced a slowing of enrollment to ensure the representation of those minority communities in COVE. Today, Moderna is pleased to share that the study includes more than 11,000 participants from minority communities, representing 37% of the study population and similar to the diversity of the U.S. at large. This includes more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black or African American. A summary of demographic details can be found in the slides issued with this press release.
“Completing enrollment of the Phase 3 COVE study is an important milestone for the clinical development of mRNA-1273, our vaccine candidate against COVID-19. We are indebted to all of the participants in the study.
We would also like to thank the investigators and our partners at clinical trial sites, including our partners from PPD and the NIH, as well as the dedicated Moderna team for their support in completing enrollment,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Moderna is committed to rigorous scientific research and the highest data quality standards. We will continue to work in collaboration with regulators to advance mRNA-1273, which we hope will help defeat the COVID-19 pandemic.”
The randomized, 1:1 placebo-controlled Phase 3 trial is studying mRNA-1273 at the 100 μg dose level in 30,000 participants in the U.S. The primary endpoint is 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. The target vaccine efficacy (VE) against symptomatic COVID-19 disease which was used for powering assumptions is 60% (95% confidence interval to exclude a lower bound >30%). Data will be reviewed by an independent Data Safety Monitoring Board (DSMB) chartered by NIH. Formal study efficacy analysis will be triggered at 151 cases, with two earlier, interim analyses after 53 and 106 cases. The ClinicalTrials.gov identifier is NCT04470427.