DELAND, Fla. — Accel Clinical Research in DeLand is now more than six months into coronavirus vaccine trials, deep into work on the Pfizer and Moderna products and in the early stages of trials of the Johnson & Johnson and Novavax vaccines.
Staffers are working seven days a week, vaccinating hundreds of people from various age groups and ethnicities.
What You Need To Know
- Participants who got placebo in Pfizer, Moderna shots getting real vaccine
- Volunteers in Johnson & Johnson trials receiving second shots
- Groups of various ages and racial groups are part of the trials
- Johnson & Johnson awaiting approval from FDA
Right now, they're unblinding people from the Pfizer and Moderna trials that started over the summer — letting them know whether they were receiving doses of actual COVID vaccine or placebos. Those who got the placebo are coming in for the real thing.
As Johnson & Johnson and Novavax wait for Federal Drug Administration (FDA) approval of their COVID vaccines, the trials of those products are in earlier, Phase 3, stages.
For Ingrid Verstraeten, science is a passion. Her job with the U.S. Geological Survey took her to Afghanistan in 2005, where she met Thomas Allen.
"Science is what brought us together," he said.
Sixteen years later, the couple, now married, are contributing to science at Accel Clinical Research as part of the Johnson & Johnson vaccine trial. Their first vaccines were in December, and they are now returning for their second dose.
"I had some chills, and I had a headache,” Verstraeten said. “I took a Tylenol, that was good. The next day, I still had a headache. I took a Tylenol again, and I was just fine thereafter. So, no issues. I'd rather have the vaccine than being sick of COVID."
Johnson & Johnson has submitted for FDA approval for emergency use, citing 85% effectiveness in preventing severe illness.
"Johnson & Johnson's original trial that started earlier was a single dose, and so Johnson & Johnson also decided to do two-dose testing, and so that's what we're enrolling now," Accel Clinical Research Medical Director Dr. Bruce Rankin said.
"We finished enrolling the one-dose, so now we're at the two-dose. So, everybody coming at this time will be getting a two-dose scheme, and those doses are about 60 days apart."
Regulatory agencies also are looking over the Novavax vaccine. Trials in the United Kingdom show 89.3% effectiveness.
"We bring a lot of people in, and we follow them after we either give them placebo or vaccine, and we see what the incidence of COVID illness would be in those groups," Rankin said.
Both the patient and providers are blinded, or are not told whether they are receiving actual vaccine or placebo, until months later.
"We always look for safety,” Rankin said. “We want to know how safe it is, whatever we're testing, and all of these vaccines look to be extremely safe."
Accel is also ensuring minority representation in their studies, with at least 20%.
After their second dose, Verstraeten and Allen are feeling well.
"Less anxious because you really welcome the second shot and feeling safer about the virus," Verstraeten said.
They hope their contribution to science makes a difference.
"As I am a scientist, I actually like to contribute to the science, to the knowledge, and help people fight this disease, so the more we can do, the better for everyone," she said.
Johnson & Johnson plans to distribute vaccine to the U.S. government once its vaccine is approved. The company expects to supply 100 million doses to the country in the first half of 2021.
Novavax leaders said their rolling review process continues, while Phase 3 trials are underway in the United States and the U.K.