Here's the difference between vaccine trials and COVID-19 trials

Wednesday, September 16, 2020
Difference between vaccine trials and COVID-19 trials
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Once the vaccine is created, it first must undergo chemical testing and clinical trials before being tested on humans.

HOUSTON, Texas (KTRK) -- From masking, to social distancing, to illnesses, to loss, COVID-19 has affected us all.

It's why researchers are rushing to get a vaccine.

Doctor Hana El Sahly has been working on the Moderna trial. It's one of three vaccines furthest along in the effort to stop the spread of COVID-19.

"The path of the epidemic so far has been unpredictable," said El Sahly, the associate professor of molecular virology and microbiology and medicine at Baylor College of Medicine.

Developing a vaccine in a lab is just the beginning.

"This vaccine is comprised of the RNA which is a code that, once injected into the body, will express a protein from the virus. The body will see this protein and start manufacturing antibodies and cell responses against this particular protein with sort of the hope or the prediction that if we are exposed later to the virus, those antibodies that we made because of the vaccine will protect against infection or moderate the vaccine," said El Sahly.

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Once the vaccine is created, it must first undergo chemical testing.

Next, it is tested on animals to make sure it's safe before going to the next step which is the clinical trial phase where humans are involved in the testing.

Once the vaccine enters clinical development, it goes through three phases.

According to the FDA, typically phase one would include a group of up to 80 people to study the safety and side effects of the drug.

In phase two, a larger group of up to 300 people will help further determine the safety. In phase three, up to 3,000 people are involved.

But in the case of COVID-19, the sample size is 10 times that, with 30,000 participants. The larger the sample size, the quicker experts can gather data to determine if the vaccine is working.

The experts track the participant's progress along the way.

SEE MORE: Houston doctors began working on coronavirus vaccine a decade ago

"We will follow everyone, and if they get symptoms suggestive of COVID-19, we will test them and some will turn out positive and some will turn out negative," said El Sahly.

Houstonian Kimmel is participating in the Moderna trial. She's had two injections.

Along the way, she's been sharing how she's feeling with the researchers.

"The technology really makes the reporting easy. They are tracking everything just to make sure that there's no extenuating circumstances, so I do feel super safe," said Kimmel.

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The Moderna trial Christene is in is part of Operation Warp Speed, the government partnership with private manufacturers.

The goal is to have 300 million doses of the vaccine by January 2021.

Some have been concerned the rush could lead to risks.

"It was an expedited process, but no corners were cut," said El Sahly.

With multiple companies working on the vaccine, there could be several ready to go.

"I'm pretty confident we'll have multiple COVID-19 vaccines that are effective and safe, but we can't rush it. We have to give it the time to confirm safety and efficacy," said Dr. Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine.

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