4th COVID-19 Vaccine OK'd With Help Of Tampa General, USF Researchers

TAMPA, FL — University of South Florida's Morsani College of Medicine, in collaboration with Tampa General Hospital, 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 received emergency use authorization from the U.S. Food and Drug Administration for people 18 years old and older on July 13.

The USF Health Morsani College of Medicine was selected as a trial site in 2020 and began enrolling participants in early 2021.

With the emergency use authorization, Americans have access to the first protein-based COVID-19 vaccine.

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 percent efficacy.

"We are proud of the collaborative effort between USF and TGH investigators, along with National Institutes of Health and National Institute of Allergy and Infectious Diseases investigators at other premier institutions in the U.S. and Mexico, which has brought cutting-edge research to Tampa," said Dr. Carina Rodriguez, 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 Dr. Kami Kim, professor and director of the Division of Infectious Diseases and International Medicine at USF Health and director of research at the TGH Global Emerging Diseases Institute. "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. Compared to mRNA vaccines, which must be shipped and stored frozen, protein-based vaccines like Novavax are refrigerated but not frozen.

See related stories:

• Tampa General Coronavirus Institute 1st Of Its Kind in Florida
• Tampa Hospital Offers 1st Coronavirus Antibody Treatment In FL
• USF Health Seeks Participants For Coronavirus Vaccine Trial

"The FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine," said Stanley C. Erck, president and chief executive officer of Maryland-based Novavax. "This authorization reflects the strength of our COVID-19 vaccine's efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues."

"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," Kim said. "Developing effective and safe vaccines and treatments means we can save more lives."

The Centers for Disease Control and Prevention found that about one in three Americans still have not been vaccinated against COVID-19, which is more than 100 million people.

In Florida, roughly 67.7 percent of residents are fully vaccinated, according to CDC statistics.

Data from the CDC shows the BA.5 variant, which emerged in early July, 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 Dr. Clifton Gooch, vice president of clinical and translational research at Tampa General Hospital, professor and chairman 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," Gooch said. "Our COVID-19 researchers and their teams have worked tirelessly to bring innovative treatment to the people of Tampa Bay in record time."

The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, announced an agreement to secure an initial 3.2 million doses of the Novavax' COVID-19 Vaccine. These vaccine doses will be made available for free to states, federal pharmacy partners and federally qualified health centers.

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