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What to know about vaccines for kids under 6

Moderna seeks emergency use authorization from the FDA for its COVID vaccine for 6 months to 5 years
Moderna officially announced Thursday that it is seeking emergency use authorization from the Food and Drug Administration to give its vaccine to children from
Published: Apr. 28, 2022 at 3:07 PM EDT
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Moderna officially announced Thursday that it is seeking emergency use authorization from the Food and Drug Administration to give its vaccine to children from 6 months old to 5 years.

Children under 5 are the only group in the US ineligible to receive a COVID vaccine.

According to NBC News, Moderna’s vaccine for children 6 months to 5 years old is given as two 25-microgram doses four weeks apart. So, that dosage is a quarter of the dosage given to adults.

Last month, Moderna released results of a clinical trial that found two doses of its lesser dose shot provided about the same immunity levels for children as the full vaccine does for young adults.

The findings were based on 6,700 children under five. Moderna officials say the vaccines are safe and common reactions were minimal, including pain at the injection site.

There were no rare heart inflammation condition cases called myocarditis, which has been a particular sticking point for the FDA in Moderna’s vaccine application for kids ages 12 to 17, NBC News reports.

The FDA says it will inspect Moderna’s submission and meet with an advisory committee to discuss the issue.

“These are exciting results and important day for us,” Dr. Paul Burton, chief medical officer at Moderna, told NBC News. “When we looked at these children, and we had 7,000 of them in this study, first of all, we looked at safety. As a dad, as a physician, that is obviously what we want to look at first, particularly in this very young group. The safety was very reassuring, what we have seen in older kids, and other populations, some injection site pain, little bit of fever, but no excess risk of high fever. So that was really reassuring. And then when we look at antibody levels, we wanted to see levels that were similar to what we found in young adults, 18 to 24. It is - that’s exactly what we found. So overall, I think this is a very reassuring result and good news.”

Pfizer is also preparing to submit data to the FDA on a potential three-dose regimen of its vaccine for children under 5. If Pfizer submits its application soon, it’s unclear if the agency would authorize the Moderna and Pfizer vaccines one at a time, or hold off and authorize both at the same time.

Moderna also filed an application for two doses. Still, Burton says the company expects to seek authorization for a booster dose for the age group, which could be available in the fall.

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