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FDA authorizes Pfizer COVID-19 vaccine for children 5-11

Enlarge (credit: Getty | Congressional Quarterly)

The Food and Drug Administration has issued an emergency authorization for the use of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11.

The FDA’s authorization follows the recommendation of its independent advisory committee, which earlier this week voted nearly unanimously in favor of authorizing the vaccine. The committee of 18 voting members voted 18 to 0 in favor, with one abstention.

In a day-long meeting Tuesday, advisors pored over data and analyses of the vaccine in the younger children, who will receive two shots of a 10-microgram dose—a third of the dosage used in people ages 12 years and up—three weeks apart. Data from clinical trials suggest that the smaller dose in children produces equally strong immune responses as those seen in older age groups while minimizing the risks of side effects.

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