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Moderna says its COVID-19 vaccine is safe and effective in kids under 6

The company will submit its data for authorization "in the coming weeks."

Moderna announced on Wednesday that its COVID-19 vaccine produced a safe, robust immune response in kids ages 6 months to 6 years. The company said it will submit its data to the Food and Drug Administration for an emergency use authorization "in the coming weeks."

In the KidCOVE clinical trial, the vaccine was about 44% effective at preventing infections in the younger age group (6 months to 2-year-olds) and 38% effective at preventing COVID-19 infections among the older age group (2- to 6-year-olds).

"The efficacy seems a little bit low, it's in the 40% range for this age group," Dr. John Torres, NBC senior medical correspondent, told TODAY. "But what they said in the study — about 7,000 children — was that nobody had serious disease, nobody was hospitalized and nobody died from it. So at the end of the day, that's what we want the vaccines to do."

Moderna also noted that the omicron variant was the dominant version of the virus circulating during these clinical trials. So it's not entirely unexpected for the vaccine to show reduced efficacy compared to what we saw against previous variants earlier in the pandemic. This level of efficacy against infection, while low, is also comparable to what we've seen in adults against omicron so far, the company said.

“We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age. We now have clinical data on the performance of our vaccine from infants 6 months of age through older adults,” Moderna CEO Stéphane Bancel said in a press release. “Given the need for a vaccine against COVID-19 in infants and young children we are working with the U.S. FDA and regulators globally to submit these data as soon as possible." 

The mRNA vaccine (also called Spikevax) is given in two doses 28 days apart. But the dose in children in this age group is only a quarter of the dose that adults receive, Torres explained. Side effects from the vaccine were generally mild or moderate and, as is the case with adults, occurred more frequently after the second dose than the first. This age group didn't show any cases of myocarditis or pericarditis following vaccination, the company said.

The company said it would be submitting data for an emergency use authorization from the FDA within the next few weeks. Moderna also began the process of seeking authorization for its vaccine in older kids between the ages of 6 and 12. The company is also planning to evaluate the possibility of a third vaccine dose for all kids and adolescents aged 17 and younger.

Pfizer's COVID-19 vaccine is available for children as young as 5, but showed reduced efficacy against omicron infections in the most recent data. But the vaccine still provided significant protection against hospitalizations and death in this age group. Pfizer previously pulled its submission for authorization of its vaccine in kids under 5 and is now investigating whether or not a third dose would boost the vaccine's protection against infection in this age group.

There's no vaccine available for kids under 5 in the U.S. right now. So, if the Moderna shots are authorized for this age group, it would be a "huge game-changer," Torres said. "This is the group that we've not been able to protect. And we know they're not as affected by COVID, but they can still be affected. And so we need to protect them. That's going to let us get back to more normal lives."