Moderna Inc said on Sunday it has been told that the U.S. Food and Drug Administration will require additional time to complete its assessment of the company's COVID-19 vaccine for use in adolescents aged 12 to 17 years.
An employee shows the Moderna COVID-19 vaccine at Northwell Health's Long Island Jewish Valley Stream hospital in New York, U.S., December 21, 2020. REUTERS/Eduardo Munoz/File Photoon Sunday it has been told that the U.S. Food and Drug Administration will require additional time to complete its assessment of the company's COVID-19 vaccine for use in adolescents aged 12 to 17 years.
The FDA informed Moderna that the review may not be completed before January 2022, the company said in a statement, dealing a potential setback to the timing of an emergency use authorization for that age group.