Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -259

Accepted - Volume 3

Comment Record
Commentor Mrs. Karen Jackson Date/Time 2002-11-13 20:39:20
Organization Medshares Home Care of Stateline, KY
Category Individual

Comments for FDA General
1. General Comments I am an RN with ER and ICU experience with pediatrics and adults. I have been a member of APIC. I am currently the administrator of a home health agency. I support the randomized study. I believe it is important to have some idea how pediatric populations will respond to the vaccine. 40 children is probably not a large enough study. My children are older than that or I would be offering to have them included in the study. I'm still willing to have them vaccinated and studied, but they are 12 and 13. Sure there are risks. But a terrorist-induced epidemic would result in far more deaths or complications. And our children will be exposed if/when we vaccinate adults. Let's not fly blind; let's get some information on the vaccine response in children.

EC -259