While the Food and Drug Administration (FDA) has granted full approval of the Pfizer-BioNTech COVID-19 vaccine (marketed as Comirnaty) for individuals 16 years of age and older on Monday, the American Academy of Pediatrics (AAP) is strongly discouraging the administration of the vaccine for off-label use in children 11 years of age and younger. 

According to the FDA, health care professionals may legally prescribe a drug, biologic, or medical device for an off-label use when it is judged to be medically appropriate for a patient. However, given that the adult and adolescent dose of the Pfizer-BioNTech COVID-19 vaccine is much higher than the doses being investigated in children younger than 12 years of age, the AAP advises against this practice for younger children.

“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,” said Yvonne Maldonado, MD, FAAP, chair of the AAP Committee on Infectious Diseases. “We should do this based on all of the evidence for each age group, and for that we need the trials to be completed.”

Trial results from the Pfizer pediatric studies are expected as soon as September for children 5 to 11 years of age. Results in children 2 to 5 years and those 6 months to 2 years are anticipated in October or November. Under the current Emergency Use Authorization, the vaccine is authorized for administration in individuals 12 to 15 years of age.

In a media briefing, acting FDA commissioner Janet Woodcock, MD stated that the Agency does not recommend that children younger than age 12 be vaccinated with the current vaccine as it would not be appropriate to administer an adult dose to this patient population. “Ordinarily, as you know, when a medical product is approved, physicians often do use off-label prescribing, however, this is a different situation,” said Woodcock. “The vaccine is being distributed under a provider agreement by the US government through the CDC and there are many considerations that would pertain to off-label prescribing.”

The CDC’s Advisory Committee on Immunization Practices will be meeting on August 30th to discuss its updated recommendations for the Pfizer-BioNTech COVID-19 vaccine.


American Academy of Pediatrics cautions against off-label use of COVID-19 vaccines in children under 12. News release. American Academy of Pediatrics. Accessed August 24, 2021. https://www.aap.org/en/news-room/news-releases/aap/2021/american-academy-of-pediatrics-cautions-against-off-label-use-of-covid-19-vaccines-in-children-under-12/