While the Food and Drug Administration (FDA) granted full licensure to the Pfizer-BioNTech COVID-19 vaccine Monday, the AAP and FDA are discouraging clinicians from administering the vaccine in an off-label use to children under 12 years.

“The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children,” AAP President Lee Savio Beers, M.D., FAAP, said in a statement. “The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 (years) until authorized by the FDA.”

AAP: Don’t use COVID-19 vaccine off-label for children | American Academy of Pediatrics (aappublications.org)