The Food and Drug Administration on Friday authorized Pfizer-BioNTech’s COVID-19 vaccine for emergency use in children ages five to eleven.
Pending CDC approval, children could start receiving the shots as soon as Wednesday, according to the New York Times.
Children will receive one-third of the adult dose, with two injections three weeks apart.
The authorization, which makes some 28 million children eligible to receive the shots, comes several days after a key FDA advisory committee voted 17-0, with one abstention, in favor of recommending the vaccine.
The panel concluded that the benefits of vaccination outweigh its risks after committee members review data on efficacy of the vaccine and the potential risk for side effects.
Pfizer and BioNTech reported that their vaccine was 90.7 percent effective at preventing symptomatic COVID-19 in children ages 5-11. No participant in the companies’ study of children developed myocarditis, a heart-inflammation condition seen in rare instances in young men who received the vaccine.
Committee member Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan said during the panel’s discussions that the benefits of the vaccine “far outweigh the known risks.”
“We certainly cannot anticipate all the risk ahead, but we know we have systems in place that can help us do that,” Fuller said, according to NBC News. “So, I think we have to take a step and say we want to make this option available for what it might do to help the children, as well as others in this pandemic.”
The Pfizer vaccine is fully approved for teens and adults 16 and older and has been given emergency use authorization for children and teens 12 to 15.
More than 243 million doses of the Pfizer vaccine have been administered in the U.S. as of Tuesday, according to the CDC.