Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -38

Accepted - Volume 3

Comment Record
Commentor Mr. John Kotick Date/Time 2002-11-01 13:37:21
Organization Center for Health Care Rights
Category Consumer Group

Comments for FDA General
1. General Comments I have noted in the materials describing this test that the authors make the following statement, ...For these reasons, it seems appropriate to limit the study to children ages 2-5 years of age. Observations in children of this age should be relevant to children of any age... This assumption that the results of this study would be relevant to children of any age seems to ignore all previous experiences with medications in young children versus adolescents. We know that medications interact differently with children of different ages. Therefore, I would like the investigators in the study to address the issues posed by vaccination of young children versus children in older age coherts.

EC -38