Tourists spend time on the National Mall in Washington D.C., the United States on Oct. 30, 2021. The U.S. Food and Drug Administration (FDA) on Friday authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine in children 5 through 11 years of age. (Photo by Ting Shen/Xinhua)
WASHINGTON, Oct. 29 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Friday authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine in children 5 through 11 years of age.
The authorization was based on the FDA's thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group, said the agency in a statement.
The Pfizer-BioNTech vaccine for children ages 5 to 11 is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).
It is the first COVID-19 vaccine approved for emergency use in the United States for children ages 5 to 11.
The decision came following an FDA advisors' meeting held earlier this week which recommended authorizing the vaccine for children ages 5 to 11. The advisors believed the benefits of the Pfizer-BioNTech vaccine outweigh its risks for use in this younger group.
Data show immune responses of children ages 5 to 11 were comparable to those of individuals ages 16 to 25. In that study, the vaccine was 90.7 percent effective in preventing COVID-19 in children 5 through 11, according to the FDA.
The vaccine's safety was studied in approximately 3,100 children ages 5 to 11 who received the vaccine and no serious side effects have been detected in the ongoing study, said the FDA.
The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.
"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," she said.
COVID-19 cases in children 5 through 11 years of age make up 39 percent of cases in individuals younger than 18 years of age, according to the CDC. Approximately 8,300 COVID-19 cases in children ages 5 to 11 resulted in hospitalization.
As of Oct. 17, 691 deaths from COVID-19 have been reported in the United States in individuals less than 18 years of age, with 146 deaths in the 5 to 11 years age group. Enditem
Tourists spend time on the National Mall in Washington D.C., the United States on Oct. 30, 2021. The U.S. Food and Drug Administration (FDA) on Friday authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine in children 5 through 11 years of age. (Photo by Ting Shen/Xinhua)
Tourists spend time on the National Mall in Washington D.C., the United States on Oct. 30, 2021. The U.S. Food and Drug Administration (FDA) on Friday authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine in children 5 through 11 years of age. (Photo by Ting Shen/Xinhua)
