Comments re: Smallpox Vaccine Trial on 2-5 year old children

Mon, 2 Dec 2002

Recent public and professional debate about a smallpox vaccine trial and its risks provides the framework for evaluating the ethical justification for conducting clinical trials on children.

The Alliance for Human Research Protection has submitted documented comments (8 pages) to the Food and Drug Administration regarding the proposed smallpox vaccine trial on 2 to 5 year old children.

We note the overwhelming objection by the public to this unethical trial: more than 350 citizens who (so far) have submitted their comments to the FDA: http://www.fda.gov/ohrms/dockets/dockets/02n0466/02n0466.htm

Below are some of the concerns raised by AHRP about the trial and the false claims made in the informed consent documents.

1. There is no imminent risk of smallpox exposure for the children.

2. The risks of the vaccine are significant and, for some, they can lead to disability and even, death.

3. Stockpiles of the vaccine (Dryvax)to be used in the experiment have deteriorated.

4. Another vaccine using a purer laboratory grown vaccinia virus not the impure method that was used to create Dryvax (harvesting the virus from infected calves) is under development.

5. According to leading experts, smallpox vaccine can be administered 3-4 days AFTER exposure to the smallpox virus.

6. Plans are underway by every state for providing rapid response clinics to vaccinate the public should a smallpox infection occur in the U.S.

7. Leading experts have stated publicly they would not give the vaccine to their own children.

8. The proposed trial is not designed to shed any light on the “safety” of the vaccine or provide any information that is not known or not procurable by other means–a requirement under The Nuremberg Code.

9. Vaccinated children can transmit the virus and pose a high risk to others who have not been vaccinated. The risk is both to healthy adults and children as well as those with eczema or a compromised immune system.

10. The informed consent documents make false claims about a potential benefit to the children. Such claims are false and intended to mislead parents.

11. If the informed consent document is inaccurate, the research is unapprovable.

12. Serious questions are raised about whether the vaccine would protect from a bioterrorist attack. It is more than likely that terrorists would not use a pathogen for which the targeted population has vaccine capability.

Anyone can submit comments until 4:30 today: http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm