CAMBRIDGE, MA (WECT) - Following advancement to Phase 3 of its coronavirus vaccine trial in June 2020, Moderna, Inc. announced Thursday it had completed enrollment of 30,000 trial participants.
Moderna’s coronavirus efficacy (COVE) study enrollment process was executed by PPD, a contract research organization (CRO).
Early Phase 3 participants received the first dose of the trial vaccine beginning the week of July 27, 2020.
To date, more than 25,650 participants have received a second vaccination. After two months of median safety follow-up has accrued, Moderna will determine whether to file for Emergency Use Authorization with the FDA.
The Phase 3 study was designed to evaluate those at highest risk of COVID-19, so enrollment included more than 7,000 Americans over the age of 65 and 5,000 Americans under 65 who have high-risk chronic diseases like diabetes, heart disease or chronic obesity.
Moderna also enrolled 37 percent of participants from minority communities to reflect the demographics of the United States at large.
“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,” said Stéphane Bancel, Chief Executive Officer of Moderna. “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,”
Enrollment was conducted in collaboration 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).
In June 2020, after the success of Moderna’s Phase 1 study, Wilmington N.C. was among ten sites nationwide chosen for the second phase of the COVID-19 vaccine trial.
According to the press release from Moderna, the U.S. government has committed up to $1.525 billion to purchase supply of mRNA-1273 under U.S. Department of Defense Contract.
Dr. John Fleming, a physician and member of the White House coronavirus task force, said in an interview Thursday, he believes the first doses of coronavirus vaccines could go out to the most vulnerable patients by the end of the year.