As a potential vaccine for COVID-19 moves into the next phase of testing, Cullman native Tonya Pryor will be there, overseeing the trial at her Athens and Huntsville research centers.
Pryor is the director of research at North Alabama Research Center (NARC) and its sister site, Medical-Affiliated Research Center in Huntsville. The centers are among the 150 sites to be be selected for clinical trials for the vaccine being developed by Pfizer and German company BioNTech.
This week, the companies announced a deal with the U.S. government for the purchase an initial 100 million doses at a cost of $1.95 billion if the vaccine is approved by the FDA. The United States has the option of purchasing an additional 500 million doses.
Pryor explained that as a Phase 3 trial, this will mean North Alabamians who are chosen for the study will basically serve as medical heroes, helping researchers as they work to find a solution to a virus that has killed more than 145,000 Americans so far. It also means they’ll be looking for more patients than they were in Phases 1 and 2, and it will serve as an outpatient study that focuses on “confirming and expanding the safety and effectiveness of the results shown in Phase 1 and Phase 2,” Pryor said.
In Athens and Huntsville, the goal is 300 patients per facility with 50% receiving the vaccine and 50% receiving a placebo. Enrollment could begin within the next month, Pryor said.
She said the clinics have long-standing relationships with several pharmaceutical companies, including Pfizer. They have also participated in a vaccine study with Pfizer previously for a different illness and the COVID-19 study will be very similar. “That makes it easier for us and the pharmaceutical company,” she said.
Pryor, who said she was always interested in medical research, but got much more involved in the field about five years ago. The Holly Pond native — and daughter of Carolyn Robbins and Randy Robbins and the late Edsel Sticher — earned her nursing degree at Auburn University. She worked as a nurse until moving to Athens and joining NARC where she could put her medical background to use helping find new cures for patients.
“When you think about it, we wouldn’t have Motrin or Tylenol if somebody a long time ago didn’t do a clinical trial on it,” she said. “I just feel like it’s so important to keep studying, and I feel like those volunteers are medical heroes, especially with this vaccine. I see research as such a rewarding career.”
For this trial, she said they are particularly interested in the people most vulnerable to the coronavirus.
“We are wanting those frontline people, those are the ones who need it,” said Pryor. “People who are older that have more increased risk if they get it and people with underlying medical conditions. The majority of people who get [COVID-19] are not going to get severely sick and be on a ventilator in ICU, but those people who are, they’re the ones who need to be in this study.”
Throughout the course of the study, the clinic will be looking for development of antibodies and monitoring the overall health of participants.
“We will follow those patients who make it into the study for 26 months to make sure they’re doing OK,” said Pryor. “They’ll have a patient diary, and they will report any signs or symptoms that they have, how they’re feeling, if they have anything going on.”
Patients will also receive free medical care related to the study, including COVID-19 testing, antibody testing, EKGs, blood and lab work, physical assessments and more. To participate, patients must meet certain criteria, including: no cancer in the last five years, no previous diagnosis of COVID-19, no autoimmune disorders or unmanaged pre-existing conditions and being an adult under the age of 85. Other restrictions may apply.
Those who qualify will also be financially compensated. As an outpatient study, Pryor said patients could expect to spend two hours on their first visit, then have much shorter visits with staff as the study continues.
Pryor is hopeful that a vaccine for COVID-19 is coming. “It would be life changing for some people,” she said. “It’s such an unknown disease and our bodies don’t know what to do with it. If we could get this vaccine, it’s the only thing that’s going to get us back to normal.
“I was so excited to hear that the FDA has fast-tracked this particular part of Pfizer’s vaccine. That means it’s working, they’re seeing the results, and hopefully we can get it on the market as soon as possible, safely.”
Anyone interested in participating in the trial can go to northalabamaresearch.com for more information.
Jessica Barnett of the Athens News Courier contributed to this report.