Pediatric Off-Label Use of Covid-19 Vaccines: Ethical and Legal Considerations.

ABSTRACT

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.