Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -324

Accepted - Volume 3

Comment Record
Commentor Dr. Sarah Wilcox-Adelman Date/Time 2002-11-19 14:24:32
Organization CBRC/Mass General Hospital
Category Academic

Comments for FDA General
Questions
1. General Comments Knowing from recent data, concerning adult vaccination utilizing the small pox vaccine, that administration of a diluted sample is effective to promote immunization it seems unnecessary to sample a population of children for determination of the efficacy of the full strength virus given the potential deleterious side effect-




EC -324