TAMPA, Fla. — Enrollment started this week for the USF Health/Tampa General Hospital Phase 3 clinical trial testing of the Novavax vaccine intended to protect against COVID-19.
Results from Phase 1 and Phase 2 show promising results and the principal investigator for the trial, Dr. Carina Rodriguez said, "Results exhibit a good immunological response and a good safety profile."
Rodriguez needs roughly 250 Tampa Bay area volunteers to participate in the trial, specifically people over the age of 65 and others at a higher risk for COVID-19 including minorities and people with co-morbidities.
Unlike the Pfizer and Moderna vaccines currently approved for emergency use, the Novavax vaccine triggers the body's immune system by injecting a spike protein and adjuvant so the body can make antibodies to fight COVID-19. Pfizer and Moderna use mRNA technology which gives the body instructions to produce the spike protein.
Basically, it's a different approach to getting the same result.
"All the vaccines in development are targeting the spike which is the primary antigen, the protein our body recognizes as an immune response against this infection," said Dr. Rodriguez.
Although we have two vaccines already being distributed, medical experts say it's critical to get more vaccines in the rotation.
Distribution challenges, manufacturing demands, and complicated transportation and storage of these vaccines all pose as obstacles in the fight against the pandemic.
The Novavax vaccine is two doses given three weeks apart. The vaccine can be stored in a regular refrigerator.
More than 800 sites across the country are recruiting participants to reach the 30,000 people Novavax hopes to enroll in Phase 3. Once they have their volunteers, shots will be given, some placebo, some the real vaccine. From there, participants are asked to live their lives as they previously were while also keeping an electronic diary of symptoms and side effects that might come up.
"Because of the incidence of COVID-19 in the community, the exposure is high, we consider the efficacy points would be reached in a reasonable timeline," explained Dr. Rodriguez.
Learn more about the enrollment process at Tampa General/USF Health by clicking here.
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