The University of Kentucky and Baptist Health in Lexington and Norton Healthcare in Louisville were chosen as testing locations for a coronavirus vaccine now in its phase three trial.
Infectious disease specialist and system epidemiologist Dr. Paul Schulz said this stage of the trial means the vaccine has been through testing making it safer for broader use.
“That indicates that it's safe to expand testing into a larger population, where you can get enough data to determine if the drug actually works, or is what we would call efficacious, at the same time continuing to monitor for safety,” Schulz said.
Schulz added that safety monitoring is important during any part of the trial.
The study needs 2,000 local participants. Approximately 70 trial volunteers have already been injected: Half with the vaccine and the other half with a placebo.
Richard Greenberg, an infectious disease expert at the University of Kentucky, says the research teams hope people at high risk for the virus will enroll.
“We're especially looking forward through enrollment of people 60 and older, health care workers, nursing home workers, factory workers, daycare workers, restaurant workers, and their patrons, grocery store clerks, school and educational workers, those people on the front line in the public a lot,” Greenberg said. “And of course, since COVID is causing most harm to the black and Latin x communities, we especially hope to engage them.”
The vaccine was developed by Janssen Pharmaceutical Companies of Johnson & Johnson using the company’s AdVac technology, which was also used to develop the company’s Ebola vaccine approved by the European Commission.
Greenberg said participants injected with the vaccine being studied “cannot contract COVID-19.”
Dr. David Dougherty, an infectious disease specialist at Baptist health, said the study will last for two years and is being conducted globally with participants enrolled from countries in Central and South America and South Africa.
“We've never been in the situation before when there's multiple vaccine trials going on at the same time in the setting of a pandemic,” he said.
Final approval of the vaccine is up to the U.S. Food and Drug Administration.