Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -204

Accepted - Volume 3

Comment Record
Commentor Dr. Alan Grimes Date/Time 2002-11-07 12:16:42
Organization Children's Mercy Hospital
Category Health Professional

Comments for FDA General
Questions
1. General Comments I oppose the use or testing of the Dryvax vaccine on children at this time. The vaccine is old enough that I believe a full-scale retesting is in order, starting with non-human trials. More appropriate would be the development of a new vaccine with today's technology and testing. Risks and side effects that were acceptable when the vaccine was first released well-outweighed the risks of smallpox. At this time, we have no certain knowledge that smallpox exists at all as a biological weapon. My personal feeling is that if they had it, they would have used it by now. We are not dealing with individuals, terrorists, or countries known for great self-restraint. Certainly now, when we have identified the potential risk and have a plan to counter it, would be a bad time for any use against us. The well-documented risks of the vaccine, in my opinion, are NOT outweighed by a small (if any) benefit to these children. I am a strong vaccine supporter in general, but not on this issue. Thank you for letting me share my views. Alan Grimes, MD General Pediatrics Kansas City, MO




EC -204