Moderna has entered the final phase of its clinical trial to test its coronavirus vaccine on 6 to 11-year-olds, creating the potential for a second COVID-19 vaccine to be available to children under 12 this fall.
Approximately 4,000 children across the country are enrolled in Moderna’s KID-COVE study, including 70 from the D.C. area.
The research is long and time-consuming, but doctors say the end game is near and shots could be going into the arms of young people very soon.
“What we do in these trials is first to find out which dose we think is best and then to compare that to placebo in the larger part of the trial. And the main things we’re looking at are side effects,” said Dr. James Campbell of the University of Maryland School of Medicine, one of the sites taking part in the research.
The majority of young volunteers are getting a half-dose of the Moderna vaccine, while others receive a placebo as doctors track their progress and see if the smaller doses produce antibody responses similar to what has been recorded in adults.
Since the trial is randomized, volunteers don’t know who’s gotten the actual vaccine. But Campbell said there haven’t been any surprises. He said some children have already received their second shot after waiting the required 28 days from the first.
“I can tell you just anecdotally, for those children, we haven’t seen anything of concern. They’re tolerating the vaccine, the first dose, and now the second dose as well, as they tolerate any other vaccine,” Campbell said.
Several more weeks of data still need to be collected, but scientists say they’re hopeful thanks to the young children who are volunteering.
“It’s those families and those kids that are really the heroes because all the other kids and the other families are going to get the benefit from these vaccines because of their being in the studies,” Campbell said.
Moderna hopes to submit its final data to the Food and Drug Administration around November or December for children ages 6 to 11. The clinical trial for kids under age 6 may wrap up at the end of this year, or early next year.
When children participate in the vaccine trial, the research team asks them to draw a picture showing what the world will be like when COVID is over. About 200 colorful, hopeful drawings now line the walls.