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Ohio State clinical trial doctor explains vaccine process, amid debate over COVID-19 vaccine safety

The lead doctor on vaccine trials at Ohio State, Dr. Susan Koletar, explains the process and safety put in place to get vaccines approved for use.

COLUMBUS, Ohio — COVID-19 Vaccine trials are happening all across the world.

At the Ohio State University, a trial for the AstraZeneca COVID-19 vaccine could be coming soon.

In a CNN poll, only about half of Americans said they would try to get a COVID-19 vaccine once one is available.

The lead doctor on vaccine trials at Ohio State, Dr. Susan Koletar, explained the process and safety put in place to get vaccines approved for use.

Dr. Koletar, the Ohio State Division Director of Infectious Diseases, has worked since the 1980s on trials for treatment trials for HIV, hepatitis and tuberculosis.

She is waiting on approval from the Food and Drug Administration to administer a trial for the AztraZeneca COVID-19 vaccine AZD1222.

"The reason we do trials is because we don't know the answer to a clinical question. All the advances we've made in clinical medicine is usually because somebody has participated in a trial given their time and effort and blood sometimes," Dr. Koletar explained.

That vaccine trial process is done in multiple phases, which at every point requires approval to move forward.

Dr. Koletar said the COVID-19 vaccine is getting a faster push, with the FDA's Emergency Use Authorization.

"In the pre-COVID world, that phase one took a year or a year and a half. Now it's compressed. But still the safety is key," she said.

That rush to find a vaccine is a hot topic of discussion, among many, including parents who've had to make big life changes and decisions in the name of safety.

RELATED: AstraZeneca puts late stage COVID-19 vaccine trial on hold after 'potentially unexplained illness'

"I do worry about it being rushed because of how political it's become," said Jessica McDaniels, who works in the medical field and is a mom of two.

But she trusts the science and professionals administering the vaccine trials.

"If I'm comfortable with the science and what they show in the clinical trials then yes," she said about getting the approved vaccine for her and her kids.

Elizabeth Schirtzinger, who lives in Grandview and is a mom of a two-year-old, said she would vaccinate after talking to her pediatrician.

"I would much rather wait longer for a better vaccine than rush and have one that doesn't work super well or isn't super efficient," Schirtzinger said.

Dr. Koletar said while this vaccine is rushed, people should trust the trial process.

"There are tried-and-true processes for the conduct of clinical trials. Everything in the COVID world has been compressed that should not make anyone think safety is sacrificed. That is the driving factor for all the things that we do. And we will continue to learn things," she said.

Dr. Koletar credits the speed of the process on advancements in science and the large number of people who are participating in trials.

"Stopping enrollment for a short while is a common thing in trials. I can tell you in the trials I've done in the past, there's been pauses because somebody recognized something that didn't seem to be expected," Dr. Koletar explained.

She adds, people should understand how vaccines work.

"They're acting as the spike protein that's the thing that attaches to receptors in the body. You can't take a COVID vaccine or flu vaccine in a test tube or person and grow that pathogen. It's just not there," she said.

She addressed a common misconception saying, "So you're going to give someone COVID and see what happens? No no. I'll go back to influenza. One of the common misconceptions is people get the flu when they get the flu shot. They do not."

She said we can't argue with history about the efficacy of other vaccinations.

"We know that works because of a whole list of vaccines that work. Measles, mumps, rubella, I actually had those diseases. People don't think about that so much because there's not so much disease because of immunizations," she said.

Regarding the timeline of the COVID-19 vaccine, she said, "Do I think it'll happen before next month, before any big events? No, because I do think that's rushing it."

In the meantime, she and her team will continue finding other solutions to help defeat a worldwide pandemic.

"I think what will make us all feel collectively better is when we have a vaccine that seems to work, treatment options that'll help people at risk for disease and oral options too. We're working on some of those too," Dr. Koletar said.

The FDA is currently reviewing the AstraZeneca trial that would be done here at Ohio State and across the United States.

Even when a vaccine is approved, Dr. Koletar said follow-ups with trial participants will be happening to see how long the vaccine is effective.

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