AAP strongly discourages off-label COVID-19 vaccine use

The news of today’s full approval from the US Food and Drug Administration (FDA) for the Pfizer-BioNTech vaccine in people aged 16 and older is cause for celebration. It also means clinicians can legally administer the vaccine off-label to children 11 and under who are not currently eligible for an approved or authorized COVID-19 vaccine. The American Academy of Pediatrics (AAP) released a statement saying it strongly discourages this.1 In it, FAAP President Lee Savio Beers, MD, said, “We need to see the data from those studies before we give this vaccine to younger children. The dosage may be different for younger ages.The AAP recommends not giving the vaccine to children under 12 until it is approved by the FDA.

The dose currently being tested in the studies for children under 12 years of age is much lower than that 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 calculate doses and dosing schedules one at a time for younger children based on vaccine experience in older patients. …I know that parents are eager to protect their children, but we want to ensure that children can take full advantage of ongoing clinical trials.”

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


1. American Academy of Pediatrics. American Academy of Pediatrics warns against off-label use of COVID-19 vaccines in children under 12 years old. 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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