AAP strongly discourages off-label COVID-19 vaccine use


Today’s vaccine approval opens up the ability to administer it off-label to children aged younger than 11 years. A statement from the American Academy of Pediatrics (AAP) discourages doing so.

The news of today’s full approval from the US Food and Drug Administration (FDA) for the Pfizer-BioNTech vaccine in people aged 16 years and older is cause for celebration. It also means that clinicians could legally administer the vaccine off-label to children aged 11 years and younger who are currently ineligible for any approved or authorized COVID-19 vaccine. The American Academy of Pediatrics (AAP) has issued a statement saying that it strongly discourages doing so.1 In it, president Lee Savio Beers, MD, FAAP said, “we need to see the data from those studies before we give this vaccine to younger children. The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.”

The dose currently being tested in the trials for children aged younger than 12 years is much lower than the one in the adult vaccine. Yvonne Maldonado, MD, FAAP, chair of the AAP Committee on Infectious Diseases, added in the statement, “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… I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials.”

AAP also called on the FDA to work aggressively on authorization of a vaccine for children aged 11 and younger when one becomes available. The organization also urged for the vaccination of all eligible individuals.


1. American Academy of Pediatrics. American Academy of Pediatrics cautions against off-label use of COVID-19 vaccines in children under 12. Published August 23, 2021. Accessed August 23, 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/

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