Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -41

Accepted - Volume 3

Comment Record
Commentor Dr. Christopher Broder Date/Time 2002-11-01 14:03:43
Organization Uniformed Services University
Category Academic

Comments for FDA General
1. General Comments I have recently attended the DoD smallpox preparedness conference and have the concerns and suggestions which I put on the table here. I do not understand why (other than political and/or availability issues) DoD or HHS cannot pursue the opportunity here (under IND) that since there appears to be 1000's to 10's of 1000's of potential vaccination candidates (first responders) whom are naive, to vaccinate first with the attenuated vaccinia strain MVA and then boost with the current vaccinia NY (wildtype) strain. Such a procedure would in my view (as well as others in the field) virtually eliminate post-vaccination adverse events to the vaccinee and dramatically reduce the number of inadvertent vaccine infections to secondary individuals, including those to which vaccination is contraindicated, because of the shortened period and level of virus shedding. This would take smallpox 'off the table' of biodefense concern, not only for the military but the civilian population as well. I would NOT start re-vaccination of children with the diluted wild-type vaccine in the absence of a documented smallpox case or release.

EC -41