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A look inside two COVID-19 pediatric clinical trials

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Posted at 4:07 AM, May 24, 2021
and last updated 2021-05-24 06:56:01-04

NORFOLK, Va. - Watching little arms receive doses of COVID-19 vaccines is a new sight for many families participating in pediatric clinical trials.

The University of Maryland School of Medicine is one of about 100 sites across the country participating in the studies.

On April 27, UMSOM began enrolling children ages 6 months to 11 years old in a clinical trial of the Moderna mRNA-1273 COVID-19 vaccine, which has already received Food and Drug Administration emergency use authorization to prevent COVID-19 in people ages 18 and older.

James Campbell is a professor of pediatrics and the principal investigator at the UMSOM site. "Not only is this for [the participants], but it really is a service to our community," he told News 3.

The pediatric study, KidCOVE, is designed to test the safety and effectiveness of the Moderna vaccine on willing participants.

Campbell said, "Since this is the younger children, there are no opportunities under emergency use authorization or under licensure, so really the only way at this point that they have the opportunity to potentially get vaccinated is through the trials."

Those involved will receive two doses 28 days apart, and the UMSOM site is expected to enroll 120 children. Overall, Moderna reports 6,750 participants.

The study lasts approximately 14 months and includes phone calls, telemedicine visits and up to seven visits to the study site.

Families are expected to remain in regular contact with doctors and study investigators. Parents and guardians are also asked to keep an eDiary of potential symptoms or complications the child experiences.

"It's not just - get the vaccine and go your merry way. We need to follow you, which means make sure that there are no safety problems, check what the immune response is, if they get sick could it be COVID? We need to find out, is it COVID-19 or not?" Campbell said. "Right now we're still in the portion of the dose finding. Figuring out the optimal dose for kids."

Also underway, the Novavax trial, which Xiaoyin Home and her 16-year-old son David are taking part in.

"My son received his first dose injection. I don't know if it was placebo or the real vaccine but he has no side effects," Home said. "I'm a very careful person. I read a lot, I compare different products. I'm very careful in terms of protecting myself and my family."

Home is a physician in Virginia and said her family held off on getting another vaccine so they could participate in the trial.

"We talked about this vaccine and we both feel comfortable that the Novavax vaccine is the way to go for us for our family," she said. "I weighed the benefit and the risk and I think that I made the good decision. Even with the mutation protection, the data looks really good."

Over the course of the trial, the UMSOM site is expected to recruit up to 500 participants. Campbell said for the Novavax teenager trial, the participants stay with the program for about two years.

"[With nearly every new vaccine,] the questions come up about 'Well, how long does the vaccine last?' The only way we know how long the vaccine lasts is if the people in the trials are willing to stay a long time so we can see what about in six months, what about at a year what about at two years?"

Critics of the pediatric clinical trials point to the unknown when it comes to long-term effects.

Campbell, who has been studying and working on vaccines for decades, said, "We've never had a vaccine that then five years or 10 years later, we discovered that there's some long-term effect. So you have to take this theoretical, very unlikely, could something happen in five years or 10 years from now versus we know it will protect you against COVID now, which is a really bad disease and weigh that in your mind."

Click here to check your child's eligibility in the KidCOVE trial.