FDA authorizes Pfizer's COVID-19 vaccine for kids ages 5 through 11
The CDC still needs to sign off on the vaccine before younger kids can get shots, but that could happen as soon as next week.
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The Pfizer vaccine already has emergency use authorization for kids ages 12 and up.
The US Food and Drug Administration on Friday gave emergency use authorization to Pfizer's COVID-19 vaccine for children ages 5 through 11. The decision comes after a panel of independent advisers to the FDA voted Tuesday to recommend the vaccine for younger kids.
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.
Before shots can be given to younger kids, the Centers for Disease Control and Prevention will also need to give its recommendation on the vaccine. An independent committee to the CDC is meeting next week and is expected to issue guidance on how shots roll out.
The White House has already shared a plan to get kids under 12 vaccinated against the coronavirus, saying it "will be ready to begin getting shots in arms in the days following a final CDC recommendation."
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.
