Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -140

Accepted - Volume 3

Comment Record
Commentor Dr. Florence Rollwagen Date/Time 2002-11-04 13:03:12
Organization None
Category Individual

Comments for FDA General
Questions
1. General Comments I am an immunologist AND a liver transplant recipient, and am increasingly concerned about the news that mass vaccinations against smallpox may be carried out in the near future. The population of the US contains hundreds of thousands of at risk persons, including organ transplant recipients, chemotherapy patients and HIV/AIDS infected persons. Even though these persons will not be vaccinated, significant risks of infection can still occur. For example: · Poxviruses are stable when dried onto surfaces – what is the risk of accidental contact, say from someone scratching their vaccine site then touching an elevator button or doorknob? The at-risk person then comes along and is infected passively by touch. · Vaccinia can also be transmitted by aerosols. How will transmission to at-risk persons be controlled? · The population contains a high percentage of at-risk individuals. This is a different spectrum when compared to the 1950s and ‘60s, when most studies on contact vaccinia were carried out, and this old data cannot be extrapolated to the current population. · The New York Times mentioned involuntary isolation of at-risk persons, a decision that makes perfect medical sense, but has implications for jobs, childcare, and other necessary functions. · I know that there are no clear answers to these questions, but I would like to be certain that the decision makers are aware of these potential problems, and that knowledgeable (insofar as is possible) physicians and scientists can influence effectively those in charge. These comments apply even more so to children. While I understand the driving force to protect our kids, this vaccine is far too dangerous for the recipients as well as the [passive] public. Thank you for this chance to comment




EC -140