Don’t Use Comirnaty Vaccine Off-Label For Children

When the US Food and Drug Administration (FDA) issued its Approval of the Comirnaty (Pfizer-BioNTech) COVID-19 vaccine for people ages 16 and older on August 23, 2021, the FDA also maintained this vaccine's Emergency Authorization for others. 

However, questions have arisen about the off-label administration of Comirnaty for children aged 11 and younger.

The American Academy of Pediatrics (AAP) issued a statement strongly discouraging that practice. 

“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,” stated AAP President Lee Savio Beers, M.D., FAAP, in a related press release.

“The (Comirnaty) vaccine dose may be different for younger ages."

"The AAP recommends against giving the vaccine to children under 12 until Authorized (or Approved) by the FDA.”

Previously, the AAP called on FDA to work aggressively to authorize a COVID-19 vaccine for ages 11 and younger.

The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists, and pediatric surgical specialists dedicated to the health, safety, and well-being of infants, children, adolescents, and young adults. For more information, visit www.aap.org.