Reconsidering Off-Label Pediatric COVID-19 Vaccination

Authors

Elizabeth Lanphier, University of Cincinnati College of MedicineFollow
Shannon Fyfe, Washington and Lee University School of LawFollow

Document Type

Essay

Publication Title

JAMA Pediatrics

Publication Date

9-29-2025

DOI

https://doi.org/10.1001/jamapediatrics.2025.3462

Abstract

Off-label vaccination is not a widespread public health strategy. Structural responses are also necessary, like the American Academy of Pediatrics publishing its own vaccine schedule and filing a lawsuit against HHS challenging the legality of the Secretary’s decision to remove healthy children and pregnant people from the CDC immunization schedules. However, vaccinating children off-label is an ethically and legally supportable tool at a time when other tools are being removed from the toolkit. It is a decision between parents and trusted pediatricians that may also be involved for other vaccines as the regulatory and public health administrative landscape evolves and until policy priorities from federal health care agency leaders return to evidence-based public health.

Recommended Citation

Elizabeth Lanphier & Shannon Fyfe, Reconsidering Off-Label Pediatric COVID-19 Vaccination, JAMA Pediatrics New Online, Sept. 29, 2025, https://doi.org/10.1001/jamapediatrics.2025.3462.