Moderna Reaches Full Enrollment for its COVID-19 Vaccine
Its phase 3 COVE trial enrollment is complete and the company is working towards its goal of FDA approval.
Moderna announced yesterday that it has completed enrollment of 30000 participants for the Phase 3 COVE study of mRNA-1273, its investigational COVID-19 vaccine.
“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,” Moderna CEO Stéphane Bancel said.
The company said that more than 25650 participants have received their second vaccination.
As the world awaits the approval of COVID-19 vaccines, Moderna will determine whether to submit a dossier to the US Food and Drug Administration (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.
This timetable has been suggested to be sometime towards the end of next month.
The randomized, 1:1 placebo-controlled trial is studying their vaccine at the 100 µg dose level in the US with the goal of administering it to 30000 participants. 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 2 earlier, interim analyses after 53 and 106 cases.
“Moderna is committed to rigorous scientific research and the highest data quality standards,” Bancel said. “We will continue to work in collaboration with regulators to advance mRNA-1273, which we hope will help defeat the COVID-19 pandemic.”