The company said more than 11,000 trial participants, 37%, are from communities of color, including 3,000 Blacks and 6,000 who identify as Hispanic. File Photo by CJ Gunther/EPA-EFE
Oct. 22 (UPI) -- Biotech firm Moderna said Thursday it has reached its target enrollment for participants in its late-stage COVID-19 vaccine trial and is on track to ask for federal approval in a few weeks.
Moderna said all participants have received their first shot of the mRNA-1273 vaccine candidate and most have also already received the required second shot.
Company President Dr. Stephen Hoge said the vaccine is on schedule to request approval from the Food and Drug Administration to bring it to market, possibly in December.
Moderna is one of four stage-three trials in the United States, with Pfizer, AstraZeneca and Johnson & Johnson. Moderna was the first to start in late July.
People older than 65, part of the virus' high-risk group, make up a quarter of Moderna's Phase 3 study for the mRNA-1273 candidate, the company noted, and people of color represent more than a third of all 30,000 volunteers.
Members of the Black and Latino communities have been disproportionately affected by the pandemic in the United States and vaccine trials have been monitored for their inclusivity.
"We are indebted to all of the participants in the study," Moderna CEO Stephane Bancel said in a statement Thursday.
"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 company said more than 11,000 participants, 37%, are from communities of color, including 3,000 Blacks and 6,000 who identify as Hispanic.
Moderna is conducting the late-stage trial with the National Institute of Allergy and Infectious Diseases and the U.S. Department of Health and Human Services.
"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," the company said.
A number of potential coronavirus vaccines are now in various stages of development worldwide. Click here for our COVID-19 vaccine tracker.