MU School of Medicine Completes Enrollment of Volunteers for Phase 3 Study of COVID-19 Vaccine Candidate

The University of Missouri School of Medicine’s Clinical & Translational Science Unit in collaboration with the Division of Infectious Diseases has enrolled more than 100 participants in a Phase 3 COVID-19 vaccine clinical trial in the fight against coronavirus. The clinical trial is testing the safety and effectiveness of NVX-CoV2373, developed by U.S. biotechnology company Novavax, Inc. Novavax is a biotechnology company developing next-generation vaccines for serious infectious diseases.

The Clinical & Translational Science Unit enrolled 103 participants in the clinical trial in less than six weeks. Participants randomly received either the vaccine or placebo in two doses, 21 days apart. Two-thirds of volunteers received the vaccine and one-third received the placebo. Everyone who participates in the trial will eventually receive the actual vaccine. Researchers will follow the vaccine recipients for two years.

“We are excited to play an important role in the fight against this virus,” said MU Health Care infectious disease physician Dima Dandachi, MD, principal investigator and assistant professor at the MU School of Medicine. “This study is another milestone in the unprecedented worldwide response that has resulted in the rapid deployment of products designed to end this pandemic as quickly as possible. The potential benefit of this vaccine is its less stringent storage temperature requirements, which would be useful in areas without access to specialized storage or for those with allergy issues related to the other approved vaccines.”  

The Phase 3 clinical trial design is harmonized with those of other leading COVID-19 vaccine companies and quickly enrolled 30,000 participants in the U.S. and Mexico. This clinical trial includes representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age and those living with co-morbidities.

“When we take part in clinical trials, we are fostering an environment where we advance knowledge,” Dr. Dandachi said.  “By participating in research on the COVID-19 vaccine, we are able to support the truth and counter myths and rumors. We owe a debt of gratitude to these participants who are moving science forward and being part of the effort to fight COVID-19.”