Phase III Trial of Novavax COVID-19 Trial Open for Enrollment in the US and Mexico

January 4, 2021
Pharmaceutical Technology Editors

Part of Operation Warp Speed, the trial will enroll 30,000 people ages 18 to 64 and 65 and older at 115 sites.

The National Institutes of Health (NIH) announced on Dec. 28, 2020 that a Phase III trial of Novavax’s COVID-19 vaccine candidate, NVX-CoV2373, is now open for enrollment in the United States and Mexico.

Part of Operation Warp Speed, the trial will enroll 30,000 people ages 18 to 64 and 65 and older at 115 sites, an NIH press release said. Participants will receive an injection of either the vaccine or a saline placebo followed by a second injection 21 days later. The trial will determine whether or not the vaccine can prevent symptomatic COVID-19 seven or more days after the second injection relative to placebo, according to the press release.

The trial is sponsored by Novavax and will be funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response.

“Addressing the unprecedented health crisis of COVID-19 has required extraordinary efforts on the part of government, academia, industry, and the community,” said NIAID director Anthony S. Fauci, MD, in the press release. “The launch of this study—the fifth investigational COVID-19 vaccine candidate to be tested in a Phase III trial in the United States—demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines.”

Source: NIH