Fri, 04 Dec 2020

Moderna Enrolls 30,000 Diverse Americans in Phase 3 Trials

Voice of America
23 Oct 2020, 07:35 GMT+10

Moderna Therapeutics, one of many companies conducting COVID-19 vaccine trials, said Thursday that it had completed the enrollment of about 30,000 participants for a third phase. The biotechnology firm said the participants included more than 11,000 who are people of color.

The figure includes more than 6,000 Hispanic participants and 3,000 African Americans. Moderna said these two groups represented 37% of the study population, which reflects the diversity of the U.S. at large.

Moderna Chief Executive Officer Stephane Bancel thanked participants and said assembling the enrollment for Phase 3 of its COVE study is an "important milestone for the clinical development of mRNA-1273, our vaccine candidate against COVID-19."

Other participants include Americans at high risk medically over age 65 and a younger population with chronic health problems, such as diabetes, severe obesity and cardiac issues. These high-risk groups represent 42% of the total participants in the company's Phase 3 COVE study.

The randomized, placebo-controlled Phase 3 trial is studying mRNA-1273 at the 100-microgram-dose level in all 30,000 participants.

So far, more than 25,650 participants have received their second vaccinations. Moderna has not yet applied to the FDA for Emergency Use Authorization.

"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," Bancel said.

The vaccine manufacturer worked closely with the Biomedical Advanced Research Development Authority (BARDA) and two other institutions to conduct the Phase 3 COVE study under Operation Warp Speed.

BARDA is supporting the continued research and development of the vaccine with $955 million in federal funding. The U.S. government has committed up to $1.525 billion to purchase a supply of the vaccine.

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