The Food and Drug Administration (FDA) gave emergency use authorization to the Pfizer/BioNTech coronavirus vaccine for children ages 5 to 11, paving the way toward making the vaccine available to millions of children.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said acting FDA Commissioner Janet Woodcock. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

For the vaccine to become widely available, it will also need a recommendation from the Centers for Disease Control and Prevention (CDC). The Advisory Committee on Immunization Practices (ACIP) is scheduled to meet on November 2.

The Pfizer/BioNTech vaccine for children should be administered as two doses three weeks apart, just like the other versions, but uses a lower 10-microgram dose.

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FDA authorizes Pfizer Covid-19 vaccine for children aged 5 to 11