1. American Academy of Pediatrics “American Academy of Pediatrics Cautions against Off‐Label Use of COVID‐19 Vaccines in Children under 12 ” news release August 23 2021 https://www.aap.org/en/news-room/news-releases/aap/2021/american-academy-of-pediatrics-cautions-against-off-label-use-of-covid-19-vaccines-in-children-under-12/.
2. At the time of writing Pfizer and BioNTech had submitted their clinical trial data to the FDA and requested review for emergency‐use authorization of their vaccine at a 10‐microgram dose in children ages five to eleven. Shortly before publication of this essay theFDA authorized emergency use for this age group.
3. The Law and Practice of Off‐Label Prescribing and Physician Promotion;Syed S.;Journal of the American Academy of Psychiatry and the Law,2021
4. Controlling Off-Label Medication Use
5. 45 C.F.R. § 46(2018).