Here's What It's Like To Run A Clinical Trial During A Pandemic
USF and Tampa General Hospital are helping run Phase 3 trials for a vaccine developed by Novavax. But it’s hard to get volunteers to take an experimental shot.
Just in time for the end of 2020, Coronavirus vaccines have arrived. The U.S. Food and Drug Administration has granted emergency approval to immunizations from Pfizer and Moderna. But work on other coronavirus vaccines continues.
On this week's episode of "Florida Matters," it's all about the challenges of running a clinical trial during a pandemic.
The University of South Florida and Tampa General Hospital are helping to run clinical trials for a vaccine developed by pharmaceutical company Novavax. USF and TGH are looking to enroll 30,000 people in what is called a Phase 3 clinical trial.
Officials say it’s hard to recruit volunteers to take an experimental shot. And it’s especially challenging to recruit older adults and people of color.
First, host Bradley George speaks with Dr. Carina Rodriguez, chief of the Division of Pediatric Infectious Diseases at USF’s Morsani College of Medicine. She’s also principal investigator for the Novavax vaccine trial.
"The principal investigator role is actually to oversee the enrollment and recruitment of the patients in the trial, and to make sure that all the study procedures are done safely, and they are communicated to the sponsors," Rodriguez said.
She made sure to point out that the makers of the vaccine believe it is safe.
"And it is important to review that the vaccine cannot cause infection, it does not contain an active or inactivated virus, and cannot make new viruses," she said.
Dr. Kami Kim, director of the Division of Infectious Disease and Internal Medicine at USF’s Morsani College of Medicine, is also working with Rodriguez on the Novavax clinical trial.
Kim was also on hand when the first dose of the Pfizer coronavirus vaccine was administered at Tampa General Hospital. She reflected on the experience.
"I think for it to be so effective and be sort of developed so quickly, is really, all stars seemed aligned," she said.
Among other things that need to be tested about the Novavax vaccine, Kim said its staying power is also as important as whether it works.
"We want to know how long this vaccine is protective. For other coronaviruses, it's known that you can get reinfected after a year or two. So maybe the vaccine will work fine, but will be like the flu vaccine, that you need to get one every year or every two years," she said.
George also speaks with Dr. Lisa Merritt, executive director of the Multicultural Health Institute in Sarasota, which works to educate Black and Latino communities on health issues. Merritt says she’s been busy during the pandemic.
She says patients speak about similar fears of the COVID vaccine as other standard vaccines like the ones for measles and the flu.
"There's always a fear of something new and different. This is not the first time we've been here," Merritt said. "When polio was rampant in the country for years and they had the first version of the polio vaccine, that was a live attenuated virus. Unfortunately, some of the samples were not fully attenuated and people got live virus...children got sick and children died. And it was terrible."
But, she added, "parents still lined up because they knew how horrible polio was and continued with the next phase, which was a successful one...We were able to get the polio epidemic under control."
To hear the full conversation, click the "Listen" button above.
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