Tampa General Hospital, USF Health Contribute to the EUA for the Novavax COVID-19 Vaccine

The continued role TGH and USF have in national clinical research emphasizes steadfast commitment to protecting patients and the community.

TAMPA, Fla., July 22, 2022 /PRNewswire/ -- University of South Florida's (USF) Morsani College of Medicine, in collaboration with Tampa General Hospital (TGH), is pleased to have contributed to the PREVENT-19 trial sponsored by Novavax and the COVID-19 Vaccine Prevention Network, which resulted in the fourth COVID-19 vaccine in the U.S. This vaccine recently received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for individuals 18 years of age and older.

The USF Health Morsani College of Medicine was selected as a trial site in 2020 and began enrolling participants in early 2021. The EUA provides access in the U.S. to the first protein-based COVID-19 vaccine, expanding the options available to the public to include more traditional vaccine technologies.

In total, the pivotal Phase 3 clinical trial enrolled approximately 30,000 participants age 18 and over from the U.S. and Mexico, and demonstrated 90.4% efficacy with a reassuring safety profile.

"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," said Carina Rodriguez, MD, professor and director of the Division of Pediatric Infectious Diseases at USF Health and the principal investigator of the USF study. "The response of our community and the commitment of the study participants has been incredible and made this possible."

"From the start of the pandemic in 2020, our first priority was to keep our community and our health care workers safe," said Kami Kim, MD, professor and director of the Division of Infectious Diseases and International Medicine at USF Health, and Director of Research, TGH Global Emerging Diseases Institute (GEDI). "To be a part of this trial was an opportunity to continue to make a difference during a challenging time. We are proud to say we have participated in various national trials as new information and data has emerged around COVID-19, including the early monoclonal antibody trials, 3D-printed swabs, and several COVID-19 treatment clinical trials."

The Novavax COVID-19 vaccine is administered as a two-dose series, three weeks apart. In addition, compared to mRNA vaccines, which must be shipped and stored frozen, protein-based vaccines like Novavax are refrigerated but not frozen.

"This could mean that the Novavax vaccine may be easier to administer in more rural sites or international sites that do not have the specialized freezers available that can contain specific vaccines at extremely cold temperatures," Dr. Kim said. "Developing effective and safe vaccines and treatments means we can save more lives."

The Centers for Disease Control and Prevention (CDC) found that about 1 in 3 Americans has still not been vaccinated against COVID-19, which is more than 100 million people. In Florida, roughly 67.7% of residents are fully vaccinated, according to CDC statistics. Data from the CDC has found that the BA.5 variant has now surpassed other variants as the dominant cause of COVID-19 in the U.S. – causing almost two out of every three new COVID-19 infections in the U.S.

As the COVID-19 Omicron variant BA.5 spreads across the country, TGH's GEDI team emphasized that vaccines are critical in preventing severe COVID-19 illness, hospitalizations, and death due to infections with the newer variants. Announced in December 2020, Tampa General and USF Health Morsani College of Medicine established the GEDI, a specialized facility on the hospital's main campus that provides world-class care for patients with COVID-19 and other infectious diseases, conducts cutting-edge research and cultivates the next generation of infectious diseases physicians. Currently, the GEDI's efforts are focused on COVID-19 innovation and research to better serve patients and the population at-large.

"This study is another great example of the strength and national expertise in COVID-19 research that the TGH and USF Health partnership provides, and countless lives saved over the last two years thanks to it," said Clifton Gooch, MD, vice president of Clinical & Translational Research at Tampa General Hospital, and professor, chair of the Department of Neurology, and associate dean of Clinical Research at the USF Health Morsani College of Medicine. "TGH has proven it is a national leader in clinical research, especially during the pandemic, from vaccinations to antibody therapies, to anti-viral drugs and everything in between, our COVID-19 researchers and their teams have worked tirelessly to bring innovative treatment to the people of Tampa Bay in record time."

For more information on the Novavax COVID-19 vaccine clinical trials click here.

Tampa General Hospital, a 1,041-bed, not-for-profit, academic medical center, is one of the largest hospitals in America and delivers world-class care as the region's only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News & World Report's 2021-22 Best Hospitals, and one of the top four hospitals in Florida, with five specialties ranking among the best programs in the United States. Tampa General Hospital has been designated as a model of excellence by the 2022 Fortune/Merative 100 Top Hospitals list. The academic medical center's commitment to growing and developing its team members is recognized by two prestigious 2021 Forbes magazine rankings – America's Best Employers by State, third out of 100 Florida companies and first among health care and social organizations, and 13th nationally in America's Best Employers for Women. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal year 2020, provided a net community benefit worth more than $182.5 million in the form of health care for underinsured patients, community education, and financial support to community health organizations in Tampa Bay. It is one of the nation's busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With six medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center, and its 32-bed Neuroscience, Intensive Care Unit is the largest on the West Coast of Florida. It also is home to the Jennifer Leigh Muma 82-bed Level IV neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital's footprint includes 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Brandon Healthplex, TGH Virtual Health, and 21 TGH Imaging powered by Tower outpatient radiology centers throughout Hillsborough, Pasco, Pinellas and Palm Beach counties. Tampa Bay area residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics, and they can even receive home visits in select areas through TGH Urgent Care at Home, powered by Fast Track. As one of the largest hospitals in the country, Tampa General Hospital is the first in Florida to partner with GE Healthcare and open a clinical command center that uses artificial intelligence and predictive analytics to improve and better coordinate patient care at a lower cost. For more information, go to www.tgh.org.

USF Health's mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the Taneja College of Pharmacy, the School of Physical Therapy and Rehabilitation Sciences, the Biomedical Sciences Graduate and Postdoctoral Programs, and USF Health's multispecialty physicians group. The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S. News and World Report's national university rankings than USF. For more information, visit health.usf.edu. 

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SOURCE Tampa General Hospital