The Food and Drug Administration (FDA)-approved COVID-19 vaccine from Pfizer and BioNTech should not be prescribed off-label for children under 12, as no data exists on proper dosing or safety in youth, an FDA official said on Monday.
Acting FDA Commissioner Dr. Janet Woodcock told reporters that the federal agency does not believe it would be appropriate for children under age 12 to get the vaccine, saying it “would be a great concern if people vaccinate children because we don’t have the proper data.”
