The Food and Drug Administration has approved Pfizer-BioNTech’s COVID-19 shot for children ages 5 to 11, paving the way for 28 million children to get vaccinated in the U.S.
The federal agency announced its approval on an emergency use basis on Friday. The Centers for Disease Control and Prevention’s vaccine advisory committee will next meet to review the FDA’s decision on Nov. 2-3. It’s expected to recommend it shortly after.
The FDA’s decision comes after an advisory panel for the agency decided unanimously that the vaccine’s benefits for children outweigh any potential risks.
“Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said acting FDA Commissioner Janet Woodcock in a press release. “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.”