The Food and Drug Administration has authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in kids aged 5 to 11, making it the first vaccine in the U.S. to be authorized for young children.

The agency decided the vaccine, which is given as one-third of the adult dose, is safe and effective in young children after reviewing the data, FDA acting commissioner Janet Woodcock said in a statement.

“As a mother and a physician, I know that parents, caregivers, school staff and children have been waiting for today’s authorization,” Woodcock said. “Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy.”

The authorization is the next step in getting 28 million more children vaccinated, especially as school is in session and the nation inches closer to winter. So far, some 8,300 children in that age group have been hospitalized with COVID-19, out of 3.2 million total hospitalizations in the U.S.

The Centers for Disease Control and Prevention (CDC) still needs to recommend the vaccine for children aged 5 to 11 before it’s more widely distributed. A panel of experts known as the Advisory Committee on Immunization Practices (ACIP) will meet on Nov. 2 to decide on a recommendation, after which CDC director Rochelle Walensky must approve it.

The Biden administration has pledged to prepare 15 million doses of the vaccine to immediately ship out to children’s hospitals, pediatrician offices and pharmacies once that recommendation is approved.