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

USF Health Morsani College of Medicine was selected as a trial site in 2020 and began recruiting participants in early 2021. EUA provides access to the United States 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 ages 18 and older from the United States and Mexicoand demonstrated 90.4% efficacy with a reassuring safety profile.

“We are proud of the collaborative effort between USF and TGH investigators, as well as National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID) investigators at other institutions. leading in the United States and Mexicowho brought cutting-edge research to Tampa,” said Carina Rodriguez, MD, professor and director of the Division of Pediatric Infectious Diseases at USF Health and principal investigator of the USF study. “The response from our community and the engagement of study participants has been incredible and has made this possible.”

“Since the start of the pandemic in 2020, our first priority has been to keep our community and healthcare workers safe,” said Kim-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). “Being part of this trial was an opportunity to continue making a difference during a difficult time. We are proud to say that we have participated in various national trials as new information and data have emerged around COVID-19, including the first monoclonal antibody trials, 3D-printed swabs, and several clinical trials for treating COVID-19.”

The Novavax COVID-19 vaccine is given as a series of two doses, three weeks apart. Also, 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 might be easier to administer in more rural sites or international sites that don’t have specialized freezers that can hold specific vaccines in 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 have still not been vaccinated against COVID-19, or more than 100 million people. In Florida, about 67.7% of residents are fully vaccinated, according to CDC statistics. CDC data revealed that the BA.5 variant has now overtaken other variants as the leading cause of COVID-19 in the United States – causing nearly two out of three new COVID-19 infections in the United States.

As the Omicron BA.5 COVID-19 variant spreads across the country, TGH’s GEDI team stressed that vaccines are essential to prevent serious COVID-19 illnesses, hospitalizations and deaths from infections. by the new variants. Announced in December 2020, Tampa General and USF Health Morsani College of Medicine established GEDI, a specialty facility on the hospital’s main campus that provides world-class care for patients with COVID-19 and other infectious diseases, conducts research and cultivates the next generation of infectious disease physicians. Currently, GEDI’s efforts are focused on innovation and research on COVID-19 to better serve patients and the general population.

“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 the countless lives saved over the past two years because of it.” , said Clifton Gooch, MD, vice president of clinical and translational research at Tampa General Hospital, and professor, chair of the department of neurology and associate dean of clinical research at USF Health Morsani College of Medicine. “TGH has proven to be a national leader in clinical research, especially during the pandemic, from vaccinations to antibody therapies, antiviral drugs and everything in between, our COVID-19 researchers and their teams have been working tirelessly to bring innovative treatment to the people of Tampa Bay in a record time.”

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


Tampa General Hospital, a 1,041-bed nonprofit academic medical center, is one of America’s largest hospitals and provides world-class care as the region’s only trauma center. level I 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 Floridawith five specialties ranked among the best programs in United States. Tampa General Hospital was named a Model of Excellence by the 2022 Fortune/Merative list of Top 100 Hospitals. The University 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 Florida’s 100 Companies and First Among Healthcare Organizations and and 13th nationally among America’s Top Employers. for women. Tampa General is the safety net hospital for the region, caring for everyone regardless of ability to pay, and in fiscal year 2020 provided 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 the primary teaching hospital for 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 is home to a nationally accredited comprehensive stroke center, and its 32-bed neuroscience and critical care unit is the largest on the west coast of Florida. It also houses the 82-bed Jennifer Leigh Muma 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 Ambulatory Radiology Centers Hillsborough, Not co, pinelles and palm beach counties. Tampa Bay Area residents also receive world-class care from the TGH Urgent Care network of clinics powered by Fast Track, 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 nation, 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 lower cost. For more information, visit www.tgh.org.


USF Health’s mission is to imagine and implement the future of healthcare. It is the partnership of USF Health Morsani College of Medicine, College of Nursing, College of Public Health, Taneja College of Pharmacy, School of Physical Therapy and Rehabilitation Sciences, Curriculum graduate and postdoctoral fellowships in biomedical sciences and USF Health. group of multi-specialist physicians. 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 nation has moved up the US News and World Report national university rankings faster than USF. For more information, visit health.usf.edu.

Media Contact: Karen Barrera
Deputy Director of Communications and Partnerships
(813) 928-1603 (cell) | [email protected]

SOURCE Tampa General Hospital


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