This is a prepublication version of an article that has undergone peer review and been accepted for publication but is not the final version of record. This paper may be cited using the DOI and date of access. This paper may contain information that has errors in facts, figures, and statements, and will be corrected in the final published version. The journal is providing an early version of this article to expedite access to this information. The American Academy of Pediatrics, the editors, and authors are not responsible for inaccurate information and data described in this version.
When the U.S. Food and Drug Administration fully approved the Pfizer‐BioNTech Covid‐19 vaccine for people sixteen and older, questions arose. Parents, pediatricians, and the media wondered whether Covid‐19 vaccines could be used off‐label—and whether they should be. The American Academy of Pediatrics cautioned against pediatric off‐label use of the vaccine, and the vaccine provider agreement from the Centers for Disease Control and Prevention appears to prohibit it. After briefly contextualizing ethical and legal precedents regarding off‐label use, we offer an analysis of the ethical permissibility of and considerations for pediatric off‐label Covid‐19 vaccination based on individual benefits, risks, and available alternatives. Our analysis challenges the ethics of a blanket prohibition on off‐label pediatric Covid‐19 vaccination, as it limits clinician ability to provide care they may determine to be clinically and ethically appropriate. At the same time, our analysis acknowledges that Covid‐19 creates population‐level ethical considerations that are at times in tension with individual health interests
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