Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -364

Accepted - Volume 4

Comment Record
Commentor Ms. Karen LaFollette-Shumway Date/Time 2002-11-23 00:44:43
Organization UT-Houston Medical School
Category Individual

Comments for FDA General
Questions
1. General Comments Children should not be tested for the Dryvax vaccine for the following reasons: 1)The original trials for the Dryvax vaccine already show that children respond similarly to adults when administered this substance. Since the effective dosage for adults has already been tested, it would be redundant to retest it on children. This is therefore not a valid reason for conducting the proposed trial in humans. 2)A terrorist attack is the only vehicle for exposure to smallpox, and, in the case of such an event, only a small geographic area is likely to be at risk for developing smallpox. Thus, the children tested with the vaccine are themselves unlikely to ever benefit from inclusion in the trial. This, according to standard federal guidelines for including children in clinical trials, is therefore not commendable research. 3)While the mortality rate following infection with smallpox is near 30%, the vaccine itself carries a mortality rate, which, while small, is much greater than the likelihood of a child included in the study both a) contracting the disease and b) subsequently dying from it. 4) A safer vaccine will soon be ready for testing, and as a terrorist attack with smallpox is very unlikely, there is no reason to test the DryVax vaccine on children only to conduct another efficacy trial on a new vaccine within a short period of time. For these reasons, I cannot recommend the FDA's proposal to test the DryVax vaccine in children.




EC -364