Abstract

Can Covid-19 vaccines be used off-label? Should they be? These were questions on the minds of parents, pediatricians, and the media when the FDA fully approved the Pfizer-BioNTech Covid-19 vaccine for people aged 16 and up. Yet the American Academy of Pediatrics cautioned against pediatric off-label use of the vaccine, and the CDC Covid-19 Vaccine Provider Agreement 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.