The U.S. Food and Drug Administration approved the emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for children aged 5-11.
The FDA announced the approval on Friday, adding that an FDA study showed comparable results in the effectiveness of the vaccine for these children compared to the 90.7% effectiveness results for people aged 16-25.
According to an FDA news release, the safety of the vaccine for children aged 5-11 was studied in approximately 3,100 children who received the vaccine with "no serious side effects."
The vaccine will be administered as a two-dose primary series, three weeks apart in a lower 10 microgram dose versus the 30 microgram dose given to children 12 years old and older.
According to the Tennessee Health Department, 188,000 known people aged 11-20 have contracted COVID-19 since the beginning of the ongoing pandemic, with that number standing at 99,000 for children five and under.
The FDA reports that 39% of COVID-19 cases involving people under 18 years old are children aged 5-11, with approximately 8,300 cases in that age range having resulted in hospitalization and 146 deaths nationally.
“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 in the news release. “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.”
More information about the COVID-19 vaccine can be found here.