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Moderna says its low-dose COVID shot works for kids 6 to 11

UW Health participated in a Moderna study on children under 12.
Published: Oct. 25, 2021 at 10:14 AM CDT|Updated: Oct. 25, 2021 at 10:18 AM CDT
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MADISON, Wis. (WMTV) - Moderna said Monday that a low dose of its COVID-19 vaccine is safe and appears to work in 6- to 11-year-olds, as the manufacturer moves toward expanding shots to children.

Competitor Pfizer’s kid-sized vaccine doses are closer to widespread use, undergoing evaluation by the Food and Drug Administration for nearly the same age group — starting at age 5. Its vaccine already is authorized for anyone 12 or older.

Moderna hasn’t yet gotten the nod to offer its vaccine to teens but is studying lower doses in younger children while it waits. Researchers tested two shots for the 6- to 11-year-olds, given a month apart, that each contained half the dose given to adults.

The University of Wisconsin School of Medicine and Public Health was one of the hospitals that was participating in pediatric clinical trials, dubbed the KidCOVE study, for Moderna. Children as young as six-months and as old as 11 years old were selected for the study, UW Health said when it announced its selection.

NBC15 checked back in with UW Health’s co-principal investigator Dr. William Hartman. He says the research Moderna is referring to are based on the study results at UW Health and other participating sites around the nation.

“Here at UW these little heroes stepped up to the plate,” Hartman said. “There’s a very good immune response similar to what young adults get with the full dose of the Moderna vaccine. That’s very encouraging and means that this is most likely going to be a very effective vaccine as well.”

UW Health reported being flooded with calls from families wanting to enroll eligible children in the trial and ended up halting registration within days, saying they were full.

The study included 4,753 kids ages 6 to 11, who got either the vaccine or dummy shots. Moderna said that like adults, the vaccinated youngsters had temporary side effects including fatigue, headache, fever and injection site pain.

“Certainly when you lower the dose of the vaccine, you hope that you have fewer side effects, fewer of the serious side effects, none of which showed up in this trial to this point,” Hartman said of the trial at UW.

The study was too small to spot any extremely rare side effects, such as heart inflammation that sometimes occurs after either the Moderna or Pfizer vaccines, mostly among young men.

Now, the UW will begin testing the vaccine in kids from an even younger age group.

“We’ve started looking at the next age group, the 2 to 5 year olds to see if it is safe and effective in them as well,” Hartman said. “Getting this group vaccinated really will help get this pandemic under control.”

Moderna said it plans to submit its pediatric data to the FDA and global regulators soon. The FDA hasn’t yet ruled on the company’s application to expand its vaccinations to 12- to 17-year-olds, although some countries have cleared Moderna’s shots for adolescents.

But the U.S. is expected to begin vaccinating kids under 12 sometime next month, if the FDA clears small doses of the Pfizer and BioNTech vaccine for 5- to 11-year-olds. Pfizer reported last week that its kid-sized doses proved nearly 91% effective at preventing symptomatic COVID-19 in the younger age group, even as the extra-contagious delta variant was spreading widely.

FDA’s advisers will deliberate Pfizer’s evidence in a public meeting Tuesday. If the agency authorizes Pfizer’s kid shots, the Centers for Disease Control and Prevention the following week is set to recommend who should receive them.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Copyright 2021 WMTV. All rights reserved. The Associated Press contributed significantly to this report.