Moderna asks FDA to approve COVID-19 vaccine for kids under 6

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Moderna asks FDA to approve COVID-19 vaccine for kids under 6
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Moderna is asking U.S. regulators to approve its low-dose COVID-19 vaccine for children younger than 6, potentially opening shots for millions of tots by summer.

FILE IMAGE - A health worker draws the Moderna COVID-19 vaccine at a vaccination clinic. vaccine for children younger than 6, a long-awaited move toward potentially opening shots for millions of tots by summer.

Now, only children ages 5 or older can be vaccinated in the U.S., using rival Pfizer’s vaccine, leaving 18 million younger tots unprotected. While questions are swirling about what's taking so long, Marks pointedly told lawmakers this week that the FDA can't evaluate a product until a manufacturer completes its application. FDA will publicly debate the evidence with its scientific advisers before making a decision, and Marks said multiple meetings would be set to cover several expected applications.

The family continues to mask and take other precautions until it’s clear if the boys got real vaccine or dummy shots. If it turns out they weren't protected in the Pfizer study and Moderna's shots are cleared first, Dunphy-Daly said she'd seek them for her sons. But the vaccine proved between about 40% and 50% effective at preventing symptomatic COVID-19 during the trial. Burton blamed the omicron variant's ability to partially evade vaccine immunity, noting that unboosted adults showed similarly less effectiveness against milder omicron infections. While no children became severely ill during the study, he said high antibody levels are a proxy for protection against more serious illness — and the company will test a child booster dose.

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