Reply to Rose et al.

Abstract

TO THE EDITOR—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. In addition, classic pharmacokinetic data (eg, 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 use “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...