Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -342

Accepted - Volume 3

Comment Record
Commentor Mr. John Buder Date/Time 2002-11-20 11:09:17
Organization International Network for History of Public Health
Category Individual

Comments for FDA General
1. General Comments The recent finding that targeted vaccinations may be sufficient (Halloran et al., 'Containing Bioterrorist Smallpox,' SCIENCE, Nov. 15, 2002) assumes the traditional single initial infective person (Table 2, p. 1430), a historic fatality rate average of 30 percent in the unvaccinated majority (ibid.), and ordinary transmission by personal contact. These assumptions are flawed. The Tennessee Health Commissioner, Dr Fredia Wadley, recently said (emphasis added) that 'When you have someone TRYING to transmit [smallpox] in an ABNORMAL way, then that sort of changes the picture...instead of one case you might have a thousand cases' (end quote). We need a study that postulates a targeted population of confined susceptibles, efficient transmission by weaponized aerosols, massive initial cases, a high proportion of deadly hemorrhagic infections, and a fatality rate approaching 100 percent. --John Buder

EC -342