What’s in the News: AAP Cautions Against Off-label Use of COVID-19 Vaccines in Children Under 12

The American Academy of Pediatrics (AAP) recently cautioned against off-label use of COVID-19 vaccines in children younger than 12 years old. In an Aug. 23 statement, the organization recommended against giving the vaccine to children under 12 until authorized by the Food and Drug Administration (FDA) for this age group and noted that clinical trials are underway. The dose of the adult vaccine is much higher than the doses being tested in children younger than 12, according to AAP’s announcement. The statement followed FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine for those 16 and older. The vaccine remains available for children ages 12 through 15 under an emergency use authorization.

“We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients,” Yvonne Maldonado, MD, chair of AAP’s Committee on Infectious Diseases, said in AAP’s statement. “We should do this based on all of the evidence for each age group, and for that we need the trials to be completed. I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials.”

Media coverage of AAP’s statement included articles by STAT, CNBC, and MedPage Today.

Improving the health of children worldwide through philanthropic support of scientific and educational programs.