key: cord-0690584-h6hnvcsg
authors: Anderson, Evan J; Kamidani, Satoshi; Orenstein, Walt; Campbell, James D
title: COVID-19 Vaccines Have Moved Out of Neutral, but Still Gearing Up in Children
date: 2021-05-05
journal: Clin Infect Dis
DOI: 10.1093/cid/ciab400
sha: 6055a21f3b2d31cff5f7e081272f7991a68faa5a
doc_id: 690584
cord_uid: h6hnvcsg

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We agree that optimal drug doses in those ≥12 years of age have been similar to those identified for adults. [1, 2] Neither of our articles addressed the complexity of pediatric drug development. [3, 4] Importantly, the bar for vaccine licensure in healthy children is different from that for administration of a potentially lifesaving therapeutic. Additionally, classic pharmacokinetic data (e.g., clearance, volume of distribution) do not exist for locally administered vaccines. As such, we need to determine the vaccine dose and schedule from clinical trial data. While we can utilize "our present understanding of the developing human body" [2] as a starting point for rational clinical trials, we owe our children data on which to base vaccine licensure. Children change dramatically during adolescence. For example, the median boy undergoes puberty between 12 -17 years of age and has a >60% increase in weight (median of ~40kg to ~65 kg). [5] Data support 2 doses of HPV vaccine in younger children, but 3 in those ≥16 years of age. [6] Data about the dosing of COVID-19 vaccines in children (including those 12 -17 years of age) are needed and required by the US Food and Drug Administration (FDA) before vaccine approval. The FDA has noted that the "epidemiology and pathogenesis of COVID-19, and the safety and effectiveness of COVID-19 vaccines, may be different in children compared with adults" and such studies will help ensure compliance with the Pediatric Research Equity Act. [7] Recently, Pfizer-BioNTech announced preliminary data that antibody levels 

Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of

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Development and Licensure of Vaccines to Prevent COVID-19. Guidance for Industry

CDC. lnfluenza-Associated Pediatric Mortality

A c c e p t e d M a n u s c r i p t