TAMPA, Fla — A fourth COVID-19 vaccine has recently been approved for emergency use, and the University of South Florida's Morsani College of Medicine and Tampa General Hospital contributed to the trials that made it possible.
Sponsored by biotech company Novavax and the COVID-19 Vaccine Prevention Network, the vaccine received emergency use authorization for 18-year-olds and up from the Food and Drug Administration in July, according to a news release.
This EUA expands the options for protection against COVID-19 as this vaccine will be the first protein-based COVID-19 vaccine available in the U.S. The news release describes it as a "more traditional" vaccine technology.
The vaccine injects a protein into the human body and uses a combination of spike proteins that form nanoparticles, which group together, according to a Q-and-A published with William Moss, the executive director of the International Vaccine Access Center. It also has an immune stimulant to fuel a better immune response.
It differs from the other COVID-19 vaccines because the protein is created outside of the body and then injected, which induces the immune response according to Moss. Conversely, the vaccines with which we are familiar create a "genetic recipe for the spike protein into our cells" which enables our own cells to make the protein to which our immune system responds.
This same technology was used in the Human Papillomavirus, tetanus toxoid and diphtheria toxoid vaccines. These protein-based vaccines tend to not have serious side effects aside from soreness and redness where the shot was injected.
The Novavax vaccine is a two-dose vaccine with each dose administered three weeks apart. Because it is protein-based, it does not have to be shipped and stored frozen like mRNA vaccines such as Moderna or Pfizer but rather refrigerated.
“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 in the release.
At the end of 2020, TGH and USF Health established the Global Emerging Diseases Institute, which is a specialized facility that conducts COVID-19-related care and research. It's current efforts are focused on COVID-19 innovation and research to be able to better serve patients and the general population, the news release reads.
In 2020, USF's Morsani College of Medicine was selected as a site for the PREVENT-19 trial. This clinical trial was a study to evaluate the "efficacy, immune response and safety of a COVID-19 vaccine" in adults 18 and up as well as adolescents aged 12 to 18 at risk for COVID.
In 2021, USF began enrolling participants for the trial.
In total, the Phase 3 trial enrolled about 30,000 people age 18 and over from the U.S. and Mexico, according to the release. It had a 90.4% efficacy and a "reassuring safety profile."
“This study is another great example of the strength and national expertise in COVID-19 research that the TGH and USF Health partnership provides," Clifton Gooch, vice president of clinical and translational research at Tampa General Hospital, wrote in the release. “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.”
You can find more information on the Novavax vaccine trials here.
So, when will this vaccine be available?
States will not be able to order from the Biden administration's supply of Novavax vaccines until the week of July 25, according to a CDC planning document released this week.
CBS reports that this could mean the first shots won't be available until August.