Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -4

Accepted - Volume 3

Comment Record
Commentor Dr. Bruce Bridgeman Date/Time 2002-10-31 13:41:56
Organization University of California
Category Academic

Comments for FDA General
1. General Comments Exposing children to a vaccine with a known complication rate with no possible benefit to either them or others borders on the criminal. There is no smallpox in nature, and the possibility that terrorists would obtain and use it is minimal - they know that once started, an epidemic is more likely to affect less economically developed areas. Any (very unlikely) outbreak would be localized, and would be treated in the same way as the last few cases of natural smallpox: Quarantine along with vaccination of all contacted persons. The perceived danger of a smallpox outbreak is largely the product of alarmist politicians supported unwittingly by sensationalist media. The problem is political, not medical, and should be dealt with politically. Putting children in harm's way for political ends is unethical by any standard.

EC -4