The USF Health Morsani College of Medicine and Tampa General Hospital contributed to the clinical trial research for the new COVID-19 vaccine Novavax.
The Morsani College of Medicine was selected as a site for the late-stage, large-scale phase three study in late 2020 and began enrolling participants in early 2021. Overall, the study included 30,000 participants in the U.S. and Mexico and showed a 90 percent efficacy rate.
“We are proud of the collaborative effort between USF and TGH investigators, along with National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID) investigators at other premier institutions in the U.S. and Mexico, which has brought cutting edge research to Tampa,” Director of the Division of Pediatric Infectious Diseases at USF Health Dr. Carina Rodriguez, the principal investigator of the USF study, says in a press release. “The response of our community and the commitment of the study participants has been incredible and made this possible.”
Novavax received emergency use authorization from the U.S. Food and Drug Administration on July 13 and from the U.S. Centers for Disease Control on July 19. It is the fourth COVID vaccine approved in the U.S. and the first that is a traditional protein-based vaccine, similar to those for human papillomavirus, hepatitis B and shingles. Unlike the other COVID vaccines, protein-based vaccines such as Novavax are shipped refrigerated and do not have to be stored frozen. Novavax is administered in a two-dose series with shots three weeks apart.
Since the onset of COVID, USF Health and Tampa General Hospital have contributed to a series of national trials, including the early monoclonal antibody trials, 3D-printed swabs, and multiple clinical trials for treatments, Morsani College of Medicine Director of the Division of Infectious Disease and International Medicine Dr. Kami Kim says in a press statement.
Kim is also the director of research at the Global Emerging Diseases Institute that USF Health and Tampa General launched in collaboration in the wake of COVID to provide patient care and conduct research on COVID and other infectious diseases.
Kim and other experts from USF Health and TGH were recently part of a town hall meeting the Hillsborough County Medical Association organized to provide practicing physicians with guidance and insights on the latest COVID trends locally and nationally (see related story