Alarmed by indications that the FDA could constrain future approval of COVID-19 vaccines for children1 and the CDC could remove them from the pediatric vaccine schedule.2 a medical ethicist and a legal scholar are calling on practitioners to consider off-label vaccinations.3
"Vaccinating children off-label is an ethically and legally supportable tool at a time when other tools are being removed from the toolkit," declare Elizabeth Lanphier, PhD, MS, Ethics Center, Cincinnati Children's Hospital Medical Center, and Departments of Pediatrics and of Philosophy, University of Cincinnati, Cincinnati, Ohio, and Shannon Fyfe, PhD, JD, School of Law and Department of Philosophy, Washington & Lee University, Lexington, Virginia.
Lanphier and Fyfe contrast the current "foreboding moves on the part of the administrative state" to previous expansion of FDA approval of pediatric COVID-19 vaccines.On the other hand, they are critical of the earlier position taken by the American Academy of Pediatrics against off-label COVID-19 vaccination for children younger than 12 years to coincide with emergency use authorization at the time, and of the CDC for excluding it from vaccine provider agreements.
"These prohibitions departed from typical ethical and legal norms guiding off-label use as a matter of clinical evidence and judgment," Lanphier and Fyfe remark.
What You Need to Know
Ethicists argue that off-label COVID-19 vaccination for children is ethically and legally supportable, particularly as potential FDA and CDC policy shifts could limit future pediatric vaccine access.
Evidence continues to show strong safety and effectiveness of pediatric COVID-19 vaccines, while hospitalization rates and risks such as long COVID highlight the ongoing need for protection in young children.
Off-label vaccination is not a complete solution, and the authors call for broader structural responses—such as independent pediatric vaccine schedules and continued advocacy—to ensure evidence-based public health guidance for children.
They point to growing evidence of the safety and effectiveness of COVID-19 vaccination in children.They also relate data that indicate infants and children aged 0 to 4 years are hospitalized for COVID-19 at the highest rates after adults older than 65 years. In addition, they cite studies that increase understanding of long COVID, and reveal that this outcome, which can be averted with vaccination, can affect persons without the established risk factors for COVID-19 complications.
Given evidence of vaccine safety and effectiveness amidst an uncertain public health and regulatory environment, Lanphier and Fyfe call on pediatricians and their professional organization to "continue to make decision to best serve the interest of their patients and the pediatric population that are informed by available medical evidence."
Although they acknowledge that off-label prescribing is most common in treating medical conditions, off-label vaccination has been recommended by pediatricians, albeit with CDC guidance, such as for measles vaccination for children younger than 12 months traveling to, or residing in regions with outbreaks.
Lanphier and Fyfe recognize several obstacles to providing safe and effective off-label vaccination.Among these is increased cost related to lack of insurance coverage of off-label treatments.In addition, FDA-approved pediatric formulations could become unavailable, or not updated to meet currently circulating strains.Manufacturers may not continue trials for pediatric COVID-19 vaccines, they suggest, if they cannot anticipate regulatory approval after their research investment.
They also recognize that off-label vaccination is not an adequate response to the current public health environment, and call for "structural responses" such as the American Academy of Pediatrics publishing its own vaccine schedule.They applaud the Academy for filing a lawsuit4 against the HHS and challenging the legality of the Secretary's decision to remove healthy children and pregnant people from the CDC immunization schedules.
Lanphier and Fyfe suggest that the decision for off-label vaccination lies between parents and their pediatrician, and should be considered, "until policy priorities from federal health care agency leaders return to evidence-based public health."
References
1. Prasad V, Makary MA. An evidence-based approach to COVID-19 vaccination. N Engl J Med. 2025;392(24):2484-2486.
2. Gostin LO, Reiss D, Offit PA. Changed recommendations for COVID-19 vaccines for children and pregnant women: a failure of process, policy, and science. JAMA. 2025. Published online June 13, 2025. doi:10.1001/jama.2025.10658.
3. Lanphier E, Fyfe S. Reconsidering off-label pediatric COVID-19 vaccination. JAMA Pedatr. 2025;179(12):1253-1254.
