The US Food and Drug Administration (FDA) on Monday authorized the use of the Pfizer-BioNTech Covid-19 vaccine on children aged 12 to 15 years old.
Acting FDA commissioner Janet Woodcock described the move as a "significant step in the fight against the Covid-19 pandemic."
"Today's action allows for a younger population to be protected from Covid-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic," Woodcock said in a statement.
"Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our Covid-19 vaccine emergency use authorizations," she added.
The FDA previously granted an emergency use authorization for the Pfizer-BioNTech vaccine to individuals aged 16 and older.
"Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the Covid-19 pandemic," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
The FDA said some 1.5 million Covid-19 cases in individuals aged 11 to 17 years old have been reported to the Centers for Disease Control and Prevention between March 1, 2020 through April 30, 2021.
The course of the disease is generally milder in children but they can pass it on to older, more vulnerable adults.