Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -320

Accepted - Volume 3

Comment Record
Commentor Mrs. Marlene Tessler Date/Time 2002-11-19 08:49:37
Organization Emory University Student Health Service
Category Health Professional

Comments for FDA General
Questions
1. General Comments I see no need to take even a small chance of side effects with this age group unless there is a true risk. We have enough data on possible side effects from all the years the vaccine was given before 1972. Why risk even minor side effects when there is no information to be gained that cannot be obtained by testing the vaccine on older people who are less likely to spread the organism to eyes or skin?




EC -320