Pfizer's vaccine for younger children is one-third the dose (10 micrograms) given to people ages 12 and up, and it comes in a two-dose series given three weeks apart. When authorized, it could affect more than 28 million children, according to The New York Times.
"As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today's authorization," acting FDA Commissioner Janet Woodcock said in a release. "Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy."
The FDA also stressed that the vaccine is safe and effective in younger kids, saying no serious side effects have been detected in the 3,100 children ages 5 through 11 who received the vaccine as part of an ongoing study.
"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," Woodcock said.
The Pfizer-BioNTech vaccine was fully approved by the FDA for people 16 and older in August, but is still under emergency use authorization for kids 12 through 15. Pfizer remains the only vaccine authorized in US for kids as young as 12.
Children are at lower risk of severe COVID-19 illness and death compared with the adult population, but they can still experience complications. About 8,300 COVID-19 cases in children 5 through 11 years of age have led to hospitalization, according to the FDA release. As of Oct. 17, 146 deaths from COVID-19 have been reported in the US in children ages 5 through 11.
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The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.