The U.S. agency granting use of the shot in adolescents will also accelerate the nation's efforts to drive down infections, public health officials and infectious disease experts say.
The two-dose vaccine is already authorized for use in people 16 and older. The Centers for Disease Control and Prevention's vaccine advisory committee has scheduled a meeting Wednesday to review the shots for kids. If approved by the CDC as expected, it could be distributed to adolescents as soon as this week.
Acting FDA Commissioner Dr. Janet Woodcock said the decision brings "us closer to returning to a sense of normalcy and to ending the pandemic." She assured parents that the agency "undertook a rigorous and thorough review of all available data" before clearing it for use in the teens.
The companies said in late March that the vaccine was found to be 100% effective in a clinical trial of more than 2,000 adolescents. They also said the vaccine elicited a "robust" antibody response in the children, exceeding those in an earlier trial of older teens and young adults. Side effects were generally consistent with those seen in adults, they added.