The latest volunteers in COVID-19 vaccine trials are squeezing in their doctor’s appointments between virtual play dates and doing their homework.
They’re the more than 6,700 children across the country who are taking part in the study of the efficacy of the Moderna vaccine in children.
The trial is now underway at the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health.
“The oldest children are 11 years old, and the youngest are 6 months,” said Dr. James Campbell, professor of pediatrics at the University of Maryland School of Medicine.
The trials are done in stages, starting with 11-year-olds, and then, step by step, the testing will shift to the younger children in the study.
Campbell said each child will be in the study for about a year, but the actual trial will take longer.
So far, he said, 75 children between the ages of 6 and 11 have received half of the adult dose.
“And that was shown to be safe,” he said.
So with that review, the trial has shifted to the same group getting an adult dose. Then, the next group of younger children, ages 2 to 5, will get half doses and the data will be reviewed, Campbell said.
The process continues “until a dose can be chosen that is appropriate and considered optimal” for each age group.
Only then, Campbell said, would there be a large randomized control study.
According to Campbell, it’s hard to predict when the vaccine could be approved, but he said it might not be until 2022. He said the Food and Drug Administration tends to be conservative in approving vaccines for children, and he adds, “rightly so.”
The study involves children from across the U.S. and Canada and includes demographic groups that reflect the populations of both countries.
“You know, any family or individual wants to know — were people like me involved in these studies?” Campbell said.
That’s important, because when parents know that members of their demographic groups were part of the study, it instills confidence that the vaccines will be safe for their children.
Campbell said parents who allow their children to take part in the study haven’t come to the decision lightly.
“It’s a difficult decision for families when you have vaccines that are not yet proven to be safe and effective in children.”
But in the case of the COVID-19 vaccines, “their parents understand that these are very safe in adults, and some of the most effective vaccines that we’ve ever developed. So when they see that, I think that gives them hope and gives them confidence” to enroll children in the studies.
Campbell points out that even after parents agree to enroll their children in the vaccine trial, the children themselves are given what Campbell calls a “mini-consent form” to sign.
Campbell said that’s written in language that makes it simple for the children to understand.
Once enrolled in the study, the children will have blood drawn and undergo other tests. Campbell said he wants to find a way to make the center’s setting “a little less sterile” and a little more “kid friendly.”
So, he decided that the children themselves should create artwork to decorate the walls of the clinics. Now, both of the sites used in the study are “essentially an art gallery, where the children coming in and other children are making drawings of what the world will be like when we beat COVID.”
Campbell said the children taking part in the study have had great — and sometimes tough —questions. The toughest, he said, had to do with why pregnancy tests are done on some of the girls in the study.
Campbell said that’s because some of the girls already had their first period, so the trial’s sponsor required pregnancy tests as a precautionary measure. And, Campbell said, “So that’s an interesting conversation to have with tweens, if you will, like 10- and 11-year-olds.”
Campbell was asked if any of the children seem to realize the historic nature of their participation. He said they know it’s an important study, but their biggest concerns center around things like whether having blood drawn or noses swabbed would be painful.
He said doctors frequently use a cream that can be put on the site where they’ll draw blood.
“And if you put it on like a half hour before, it kind of numbs the skin,” and it’s a bit of “magic cream” that helps the kids through the process.
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