The US Centers for Disease Control and Prevention still needs to advise on how the shot should be administered, which will be decided after a group of outside advisers discuss the plan on Tuesday.
Only a few other countries, including China, Cuba and the United Arab Emirates, have so far cleared COVID-19 vaccines for children in this age group and younger.
The regulator said on Friday that known and potential benefits of the Pfizer vaccine in individuals aged between 5 and 11 outweigh the risks. "We certainly hope that as people see children getting vaccinated, and being protected and being able to participate in activities without concern, that more people will get their kids vaccinated," Acting FDA Commissioner Dr. Janet Woodcock said at a press conference.Pfizer and BioNTech said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
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