Moderna announced on Thursday that it had enrolled 30,000 participants in its Phase 3 COVID-19 vaccine trial, with more than 11,000 of those participants from communities of color.
More than 25,650 participants have already received their second vaccination, the company said in a press release.
The company added that the study also includes 7,000 participants over the age of 65.
“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 in the news release. "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 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.”
CNN reported that for Moderna to apply to the FDA for emergency use authorization, the following three things need to happen:
- 53 of the 30,000 participants would need to become sick with COVID-19, which is expected to occur in the second half of November.
- 40 of the 53 participants who do become ill with COVID-19 need to have received the placebo, which would show that the vaccine is 75% effective.
- Make sure enough time has passed to see if participants develop side effects.
According to CNN, Moderna is the first company to start US clinical trials of a COVID-19 vaccine.