COVID-19 vaccine: How does the clinical trial process all work?

ATLANTA — Channel 2 Action News is getting more insight into COVID-19 studies happening in metro Atlanta. Channel 2′s Michael Seiden spoke with medical experts on how the vaccine trial process all works.

After spending 72 hours under the care of hospital staff, President Donald Trump left Walter Reed Medical Center Monday night and headed back to the White House for the first time since testing positive for COVID-19.

During his short stay in the hospital, doctors treated him with a series of drugs, including a dose of Regeneron’s experimental antibody cocktail, which has not been authorized for emergency used by the Food and Drug Administration.

“I think it’s important not to read too much into the president’s specific experience. He is obviously a very unusual patient. And so his experience, the quality of care he’s receiving, the type of monitoring he was receiving is different than what we can expect for most patients,” said Zoe McLaren.

[MORE: Experimental drug given to President Trump for COVID-19 treatment has limited availability in metro]

McLaren is an associate professor and a health policy researcher in School of Public Policy at the University of Maryland, Baltimore County. When she isn’t teaching, she’s studying clinical trials.

“It’s really important part of the process. If nobody wanted to volunteer to take an experimental vaccine, then we wouldn’t have the information we wouldn’t be able to get the vaccine or other treatments out to the public.”

But in the race to find a COVID-19 vaccine, most people are asking the same question: When will it be available to the public?

“Most experts in this field don’t have a lot of information because a lot of it depends on factors that are outside our control," McLaren told Seiden.

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McLaren said while we’re talking about potential vaccines, it’s important to understand the clinical trial process. Before a drug is given to the public, it must undergo three phases.

“So Phase 1 will be between 20 and 100 patients. Basically Phase 1 is going to be how the vaccine is developed. We will check to make sure that it’s safe and see if there are any side effects.”

Then it’s onto Phase 2.

“Maybe a few hundred, one to 300 patients, that are going to be getting a vaccine and so we get a little bit more information about safety, potentially some about effectiveness and more information about side effects," McLaren said.

But the most important part of the clinical trial is Phase 3.

“Most of our safety and effectiveness data comes from Phase 3. Phase 3 involves 1,000 or more patients," she said. Then it’s up to the FDA for the final approval.

“But remember that the important endpoint is not when the vaccine is approved. That’s not going to change our lives significantly," McLaren said. "How long it

Right now, Wake Research is looking for 10 to 15 volunteers who live in a home where someone in their household just tested positive for the coronavirus. It want the volunteers to take part in the Regeneron study and offering up to $3,200 for participants.

Here is how you can contact Wake Research’s Atlanta office for more information: Visit www.CovidStudies.org, call 404-843-4440, or text “COVID” to 470-863-1968.

Cox Media Group