Moderna seeks emergency authorization from FDA for doses for toddlers

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MILWAUKEE (CBS 58) -- A big step today in the fight against COVID. Moderna says its low-dose vaccine is safe for children ages six months to six years old, and they're planning to seek emergency use authorization from the FDA.

The pediatric Moderna trial showed no major side effects in this age group, but it's not ready to go on the market just yet.

Twin brothers Sam and Theo got vaccinated at UW Health. They're among the 4,200 kids ages two to six who participated in the Moderna clinical trial in Madison.

"I'd always tell them that they're someday going to have a story that they'll be able to tell the world that they helped save the world," said Dr. Ben Hartman of UW Health, pediatric Moderna COVID vaccine trial.

Another 2,500 children ages six months to two years were also given two doses 28 days apart.

"We're very excited that the results dictated that we may have a vaccine available for this age group," said Hartman.

Results of the Moderna trial show no substantial adverse effects on the thousands of kids in it.

"The most common side effect was a fever that occurred after the second dose but this was a transient fever that usually went away with treatment with Tylenol," said Hartman.

"Do some get fevers? Yeah. But do any kids get myocarditis, inflammation of the heart? Not a single one out of thousands of kids studied," said Ben Weston, Milwaukee County Chief Health Policy Advisor.

Parents outside a West Allis daycare had mixed reactions about whether they'd let their little ones get the shot.

"You always want to do everything to protect them so unfortunately, I'm still not 100 percent, neither is mom so we're both on the same page," said Augustin Lopez, parent of a three-year-old.

"I think they should take it because a lot of parents are missing work because you know, you have to deal with COVID and everything you know. You have to pay bills somehow. So you know I think they should get it," said Herman James, parents of a toddler.

For anyone concerned about long-term side effects:

"These vaccines do their work and then they're gone, but the protection lasts, but the side effects that the vaccine may cause are really short lived and noted right up front. I think form the initial data we can be pretty comfortable that this is going to be a safe vaccine," said Dr. Weston.

Moderna's efficiency for kids six and under is said to be around 40% in fighting Omicron. The trial will continue for another year.

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