FDA authorizes Pfizer’s vaccine for emergency use in kids ages 5 to 11

The U.S. is prepared to roll out doses to kids as soon as the CDC gives its final approval, which is expected to come early next week.

The U.S. Food and Drug Administration has granted emergency use authorization to Pfizer’s low dose COVID-19 vaccine for kids ages five to 11. The FDA’s announcement is a critical step in the process to begin rolling out the shots.

“Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” acting FDA commissioner Janet Woodcock said in the announcement. “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.”

Next, the U.S. Centers for Disease Control and Prevention will weigh in on who should receive the vaccine during a meeting scheduled for next week. Once the CDC makes its recommendation, the U.S. is prepared to begin distributing doses immediately. Last week, the Biden administration announced its plan to roll out the vaccine for kids by working with pediatricians, children’s hospitals, school clinics, and other health care centers.  

An FDA advisory committee had recommended emergency use authorization of the vaccine during a meeting held earlier this week. The New York Times reports that members of the FDA committee questioned whether the jabs are necessary for all children in the age group or if it should be limited to those with underlying conditions who are more at risk of severe COVID-19. However, they ultimately voted to authorize the vaccine because of their concern for the nearly two million children in that age group who have been infected.

Pfizer says its COVID-19 vaccine is 90.7 percent effective at preventing symptomatic disease in kids ages five to 11. An analysis of Pfizer’s clinical trials of 2,268 participants, released by the FDA on Friday, also showed that none of the participants reported cases of severe disease or the COVID-19-related multi-inflammatory syndrome that has been seen in children.

Stay up to date and read more on the latest vaccine developments here.

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