PriMed in Dayton is recruiting 250 adults for a phase 3 clinical trial that will involve 30,000 Americans. Volunteers will receive the vaccine in two doses given a month apart, have multiple follow-up visits, blood drawn and keep a diary of their health for two years. But the study may have results before then, said Dr. William Randall, principal investigator for PriMED Clinical Research. He declined to reveal the developer of the vaccine being tested by PriMED.
Researchers at the University of Cincinnati and UC Health plan to enroll 500 patients in a study of the vaccine created by Moderna, a biotechnology company. And Ohio State Wexner Medical Center is recruiting 500 adults for a trial of a vaccine co-developed by the University of Oxford and AstraZeneca, a biopharmaceutical company.
Under Operation Warp Speed, the U.S. government has bankrolled three vaccine candidates for phase 3 trials, including the vaccines being tested by the University of Cincinnati and Ohio State Wexner Medical Center.
“It’s important that people participate in trials like these,” Randall said. “I think the vaccine is going to be very important helping us get out of this pandemic and get our life back to what we all consider to be more normal.”
He said there is an inherent risk involved in taking any newer treatment whether it’s been approved by the FDA or not, but the risk in a phase 3 trial is relatively low.
One of the patients participating in the UC trial is Dr. Brett Kissela, a professor in the Department of Neurology and Rehabilitation Medicine at the UC College of Medicine. He has had two appointments, the second one on Tuesday. He said each visit has lasted about two hours. He has been impressed by the “level of detail” to the testing and the follow-up questions.
“We need to get back to a normal life again and take control of this virus,” Kissela said. “The risk is worth it to me.”
In the history of medicine, few vaccines have been developed in under five years.
Dr. Zach Jenkins, associate professor of pharmacy practice at Cedarville University, said several factors are making this unprecedented rate of advancement possible: better technology, government support, political pressure and an urgent need to get back to normal.
“You don’t normally have like 160 [vaccine] candidates brought forward in a matter of months,” he said.
The Centers for Disease Control and Prevention recently told states in a letter sent to governors to prepare for a coronavirus vaccine to be ready to distribute by Nov. 1.
The timeline raised concern among public health experts about a vaccine approval driven by political considerations ahead of a presidential election, rather than science.
Food and Drug Administration Commissioner Stephen Hahn stated earlier this week he is willing to consider approving a coronavirus vaccine before phase 3 trials were complete as long as regulators believe the benefits outweigh the risks. Russia and China have already approved three vaccines for limited use before phase 3 trials were completed.
“I understand the hesitancy if we skip phase 2 or 3 trials,” Jenkins said. “But part of it is without a doubt somewhat political and somewhat I would say mired in mistrust of information right now. A lot [of hesitancy to accept a vaccine] may be based on how the White House and the Coronavirus Task Force handles disseminating information about that subject.”
The U.S. has never before approved a vaccine while phase 3 trials were still going on but Jenkins said it’s not entirely unprecedented and has happened with other treatments such as antibiotics.
“I would be very hopeful about where we’re going with this,” Jenkins said. “Projections imply that probably by the end of December we’ll have a vaccine that’s approved. Now the question to ask is, is [the first approved vaccine] going to be the best vaccine of the bunch? That we don’t know yet.”
Once a coronavirus vaccine is ready, the government will prioritize distributing it to healthcare workers and emergency responders, followed by Americans in a high-risk category.
“Know that there’s still a good amount of time for more developments to come before [coronavirus vaccines] might be available to the general public,” Jenkins said.
The Associated Press contributed to this story.
How to participate in a vaccine trial
To find out more information and enroll in the coronavirus vaccine trial being conducted by PriMED, visit www.primedphysicians.com/research/covid-19-vaccine-study.
It is not necessary to be a PriMED patient.
All study-related care and evaluations will be conducted at the PriMED Clinical Research office at 948 Patterson Road in Dayton. There will be no cost to you and you will be compensated for your time and travel.
The study seeks diverse candidates who have not previously had COVID-19 and are at higher risk of exposure, such as teachers, first responders, college students, factory workers, restaurant employees and those age 65 or older.
PriMED aims to complete enrollment by Friday, Sept. 11, and participants will start their trial activities soon after completing registration.
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