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News - October 29, 2021

FDA Authorizes Use Of Pfizer Vaccine For Children Ages 5 to 11


The U.S. Food and Drug Administration (FDA) expanded the emergency use of Pfizer’s COVID-19 vaccine to children ages 5 to 11 on Friday.

A “kid-size” dose of the vaccine may be given to children 5 to 11, and data presented to the FDA showed that the immune responses in that age group were similar to those in the 16 to 25 age group and was 90.7% effective in preventing COVID-19.

“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,” Acting FDA Commissioner Janet Woodcock said. “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.”

The Pfizer-BioNTech study was conducted on 4,700 children between 5 and 11, with 3,100 receiving the vaccine in a randomized placebo-controlled environment. In the study, no serious side effects were detected.

In the U.S., children between 5 and 11 make up 39% of positive COVID-19 cases under the age of 18, with 8,300 resulting in hospitalizations.

The emergency use authorization comes days after an FDA panel endorsed the use of the vaccine on that age group.

Receiving EUA is not the same as FDA approval, which at the moment has only been given to the Pfizer-BioNTech vaccine, for ages 16 and older.





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