The Cambridge, Massachusetts biotechnology company says it has worked to ensure involvement of participants historically under-represented in clinical research and disproportionately impacted by COVID-19.
The Phase 3 COVE study was designed in collaboration with the US Food and Drug Administration ( FDA) and the National Institute of Allergy and Infectious Diseases (NIAID), to evaluate Americans at the highest risk of severe COVID-19 disease.
The randomized, 1:1 placebo-controlled Phase 3 trial is studying mRNA-1273 at the100µg dose level. 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 study cohort now comprises over 11,000 people from communities of color, representing 37% of the study population and similar to the diversity of the US at large.
“This includes more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 who identify as Black or African American.”
The trial also involves more than 7,000 Americans over the age of 65, as well as 5,000 people, 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 this Phase 3 study.
Moderna will determine whether to submit a dossier to the FDA requesting Emergency Use Authorization (EUA) based on an assessment of whether the potential benefit of the vaccine outweighs the potential risks once the two months of median safety follow-up have accrued.
“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,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We will continue to work in collaboration with regulators to advance mRNA-1273, which we hope will help defeat the COVID-19 pandemic.”