Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -238

Accepted - Volume 3

Comment Record
Commentor Dr. Samuel Katz Date/Time 2002-11-12 10:07:06
Organization Duke University Medical Center
Category Health Professional

Comments for FDA General
1. General Comments Because the possibility of nationwide vaccination in the event of a bioterrorism episode is prominent in the minds of our government and leadership, this would obviously involve children as well as adult recipients. To fail to test a vaccine in children would be unethical. Even though this vaccine, or one very similar to it, was administered routinely to children prior to 1971 in this country, the rejuvenated material may have different reactogenicity and immunogenicity. The studies in adults are reassuring but demonstrate a significant degree of reactivity. In order to anticipate and prepare for this in children, only a research protocol trial would provide appropriate information. Indeed, it might eventually be necessary to extend this to an even younger age group down to age 1-year rather than stopping at age 2. When vaccine was routinely administered to youngsters in this country, it was given shortly after the first birthday. Once the new tissue culture grown vaccine (Acambis) becomes available, this too should be tested in children as well as adults. Would it not be required by The Pediatric Rule (Dept. of HHS, FDA, Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients; final rule. Fed Regist 1998; 63(231): 66632-72.) to perform such studies?

EC -238