Docket Management
Docket: 02N-0466 - Randomized Dose Response Study of Dryvax in Children Ages 2 to 5
Comment Number: EC -128

Accepted - Volume 3

Comment Record
Commentor Mr. Bill Sardi Date/Time 2002-11-04 00:09:07
Organization Knowledge of Health, Inc.
Category Media

Comments for FDA General
1. General Comments November 4, 2002 Knowledge of Health, Inc. 457 West Allen Avenue #117 San Dimas, California 91773 Phone: 909 596-9507 Fax: 909 596-9189 Office of Public Health and Science and Food & Drug Administration Re: Dryvax smallpox vaccination to small children age 2-5 years of age I object to the experimentation on small children with the Dryvax vaccine on the following grounds: 1. The FDA and the OPH are asking for comment on experimental smallpox vaccination on small children without divulging the details of the study. 2. Are candidates for the vaccination going to be recruited from lesser-educated or minority groups? Parents of these children may not be in the best position to understand the risks posed to their small children. No mention is made whether financial incentives will be offered to attract parents into vaccinating their children. You get into a situation where poor families may wish for a complication and a financial reward. 3. There is a likelihood of cross-vaccination to the mother of the vaccinated child who may be pregnant. This poses risks beyond what may be explained to the parents. 4. There is no current threat of smallpox, an eradicated disease, and there is little chance that the vaccine would not be available in time should exposure to smallpox virus take place. The immediate reasons for the study are not clear. 5. The scientific community already knows the side effects of smallpox vaccine. While this is a new vaccine, the study would likely only tabulate numbers rather than uncover any new side effects. The data may not be not valuable enough to pose known risks of side effects to these children. 6. Is there a measurable end point to the trial? There is no absolute way of knowing if the children are protected from smallpox virus unless there is a variola outbreak. The study would only tabulate side effects. If antibody response can be measured and it is inadequate with this diluted vaccine, then only side effects would be possible and no health benefits. 7. No mention is made whether all the ingredients in the vaccine will be disclosed to the parents. Are there adjuvants such as squalene or alum, or nutrients to keep the virus alive such as glutamic acid (MSG)? These additives need to be disclosed to the parents along with the information concerning the concentration of vaccinia. 8. Who will pay for treatments should side effects occur? The US government or the company that produces Dryvax? 9. Is sufficient immune globulin available for this vaccine? If not, how will side effects be treated? 10. How will informed consent be performed? The consent form should be read aloud to every parent of a prospective child. 11. No mention is made as to who are acceptable candidates for the vaccine? Healthy children free of recent infection or other disease? How can the American people make adequate comment on this issue without the details? Bill Sardi President

EC -128