Medical University of South Carolina to launch next phase of kids Moderna trial

MUSC is one of about 100 pediatric-centered sites across the world chosen to help with the...
MUSC is one of about 100 pediatric-centered sites across the world chosen to help with the Moderna pediatric trial.(Medical University of South Carolina)
Published: Aug. 9, 2021 at 6:00 PM EDT|Updated: Aug. 9, 2021 at 6:26 PM EDT
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CHARLESTON, S.C. (WCSC) - With a majority of kids returning to face-to-face learning for the new school year, many are wondering when a COVID vaccine will be approved for kids younger than 12.

According to doctors at the Medical University of South Carolina, the Delta variant now accounts for more than 92% of all cases there. As of Thursday, MUSC said 8 children were in the hospital who tested positive for COVID-19, all of whom were unvaccinated.

MUSC is one of about 100 pediatric-centered sites across the world chosen to help with the Moderna pediatric trial. The trial targets children between the ages of six months and 12 years. In total, about 6,500 kids will be enrolled in the trial across all sites.

MUSC Doctor Allison Eckard specializes in pediatric infectious disease and said 15 children participated in Part 1 of MUSC’s trial to find the appropriate dosing for those under 12. Those children were between two and six years old.

“It does look like, moving forward, that children will be vaccinated with half of the dose that is currently recommended for adults,” Eckard said. “We’ll see if that’s effective. But it seems, in the early preliminary data, that is the right dose for children.”

Doctors are now getting ready for the next phase which is vaccinating 105 children through the trial. The trial for children ages 6 to 12 will start this week and those younger than six are expected to be vaccinated in September.

“There’s no reason to think that the vaccine won’t work in the younger kids,” Eckard said. “But we are always much more careful sometimes in children to make sure that we keep them as safe as possible. But the data looks good.

Eckard said 75% of participants will receive the active vaccine and 25% will receive a placebo. Those children will be followed over the next few months to see how many are protected and how many end up with COVID.

“We have early prelim data that suggests that it is highly effective even in the younger kids, and very safe,” Eckard said.

Eckard said the gender, in this next group, was split evenly between male and female. She said it is also a very diverse group with distribution of race and ethnicity representative of the breakdown of race and ethnicity across the Charleston community.

“We worked really hard to make sure that those 105 had a very diverse racial and ethnic makeup, so that we can really see if it’s safe and effective in all children,” Eckard said.

Eckard said the second part is expected to last three weeks for the first vaccine dose in all participants. She also said both Moderna and Pfizer have been asked by the FDA to increase their study enrollment numbers, so the expected approval for those younger than 12 has been pushed back until at least mid-winter.

Eckard said some side effects recorded in the kids that were involved in the first part of the trial include:

  • 2 children had fevers without any other symptoms that resolved quickly with no problem;
  • 2 children had sore arms that also resolved quickly

Eckard said she knows it’s a very contentious issue, but they feel strongly that masks are safe and effective. She added the vaccine is also safe and effective and those are the best things we can do to move forward and keep everybody safe.

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