Pediatric infectious disease experts have cautioned that the Pfizer COVID-19 vaccine, which has now been fully approved by the U.S. FDA, should not be used off-label in children below 12 years of age.

A full approval provides physicians with legal grounds to use the vaccine off-label. However, experts have stated that the doses being evaluated in younger children are much lower than those being given to adults. Additionally, there is no published data about use of the vaccine in children below 12. Pediatric infectious disease expert, David Kimberlin, from the University of Alabama at Birmingham, stated that the dose authorized for use among individuals aged 12 and above is 30 mcg, while that being studied in children aged 5 to 11 years 10 mcg. Furthermore, the dose being studied for children below 5 is 3 mcg. FDA Acting Commissioner Janet Woodcock also warned against the off-label use of the vaccine in younger children… (Medpage Today)