Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -239

Accepted - Volume 3

Comment Record
Commentor Ms. Larry Sundberg Date/Time 2002-11-12 11:01:38
Organization St. Louis County Public Health Department
Category Individual

Comments for FDA General
Questions
1. General Comments It is difficult to imagine how this study can proceed since with current available information there is no way to judge or estimate the potential benefits to the subjects or other children. It is said that this trial was developed in the context of the potential risk of smallpox being used as a weapon of bioterrorism. However, at least based on information provided to the public, this risk is entirely theoretical or conjectural. There is a risk only if a supply of smallpox virus has gotten into the hands of someone who would consider using it as a biological weapon. The government has not provided information on whether or not it either definitely knows such a party has the smallpox virus or, if this is not definitely known, the extent/certainity it has reason to believe such a party has obtained smallpox virus. To date the government's statements on the level of risk fall into the realm of Could be, You never know, You can't say it couldn't happen. Such estimates of the risk the children in this study may be exposed to smallpox, and thereby the estimate of the potential benefit of the vaccine to them, are not sufficently tangible to provide a counter balance to the much more substantially calculated risk of permanent disability or death from an adverse reaction to the vaccine. The basic question then is what possible statement of benefit to the child could be made to the parents to justify the risk of harm from the vaccine. And if the researchers cannot provide some means by which parents can reasonably estimate the potential benefit to their children then it does not seem study would meet the requirements for use of human subjects in research




EC -239