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FDA advisers recommend authorization for Moderna’s COVID shot in kids 5 and under

(The Hill) — An outside Food and Drug Administration (FDA) advisory panel on Wednesday unanimously recommended the agency grant emergency use authorization to Moderna’s COVID-19 vaccine for children between the ages of 6 months and 5 years.

The agency’s vaccine advisers voted 21-0 to recommend the agency authorize the vaccine.

An advisory panel for the Centers for Disease Control and Prevention will meet this weekend to issue its own recommendation. If the panel votes in the affirmative and the CDC director signs off, children could start to get vaccinated next week.

Moderna’s two-dose mRNA vaccine is intended to be administered four weeks apart, and is one quarter the strength of an adult dose.

The FDA previously said the vaccines are safe and effective, though the vaccine did not perform very well in preventing symptomatic disease, mainly against the omicron variant. 

Moderna found its vaccine was 51 percent effective in preventing symptomatic infection in children 6 months to 2 years old, and 37 percent effective in children 2 through 5. 

The panel will vote on recommending Pfizer’s vaccine later this afternoon.

— Developing

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