October 26

Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children, Pg 4

More detailed comments


Children should not be tested for the Dryvax vaccine for the following reasons:

1) The original trials for the Dryvax vaccine already show that children respond similarly to adults when administered this substance. Since the effective dosage for adults has already been tested, it would be redundant to retest it on children. This is therefore not a valid reason for conducting the proposed trial in humans.

2) A terrorist attack is the only vehicle for exposure to smallpox, and, in the case of such an event, only a small geographic area is likely to be at risk for developing smallpox. Thus, the children tested with the vaccine are themselves unlikely to ever benefit from inclusion in the trial. This, according to standard federal guidelines for including children in clinical trials, is therefore not commendable research.

3) While the mortality rate following infection with smallpox is near 30%, the vaccine itself carries a mortality rate, which, while small, is much greater than the likelihood of a child included in the study both a) contracting the disease and b) subsequently dying from it.

4) A safer vaccine will soon be ready for testing, and as a terrorist attack with smallpox is very unlikely, there is no reason to test the DryVax vaccine on children only to conduct another efficacy trial on a new vaccine within a short period of time. For these reasons, I cannot recommend the FDA’s proposal to test the DryVax vaccine in children.            Ms. Karen LaFollette-Shumway. UT-Houston Medical School


To Whom This May Concern:

As a student at Hamden High School I am greatly concerned about the small pox

vaccination and whether its effects on children will be harmful or not. Forty children ranging from two to five years old will be given a weak dose of the small pox vaccine in order to discover if the vaccine will be helpful in the long run. Is it worth it to test healthy children when they probably will not benefit from the vaccine unless there is a bio terrorist attack? There has not been a small pox outbreak in the world since 1972 and I do not know why there is such a sudden need to put children at danger right now.

Forty children who have been inoculated are being placed in confinement without

even understanding why they cannot attend school for one month. .After the children are injected with the live virus called vaccinia how will they know not to touch the scab and then as young children tend to do, touch their eyes which could cause blindness.

Children would be fascinated by the big, sticky bandage on their arm and possibly play with it and then infect a loved one. Children who are two to five years old are being socially isolated from their playmates at school as well as missing school at a time which it is extremely important to their social and educational development. I would also be concerned as to who would care for these children while they are inoculated with the vaccine. Some parents of these children cannot afford to miss a whole month of work and risk the chance of infection.

I would like to know where the children are coming from: Whether they will be

only chosen from minority or poor families or whether they will be chosen from

extremely wealthy families. It is not fair to choose just one group of children to expose to this vaccine, but how will the Federal Drug Administration represent all of the different ethnicities and backgrounds in just forty children. I would like to know if there is a money incentive to families who volunteer their children for this study. If there is money involved, will that cause poor families to flock to the FDA to submit their children?

The Bush administration wants to make the vaccine available to health workers

first and then to the general public. I am not sure if I am ready to decide if I want to be injected with a virus that could possibly kill me. Fifteen out of every one million people vaccinated with the drug will suffer life-threatening reactions, while one or two of them will die. Many experts say that the research should be allowed because it could benefit society. The inoculation sites would be covered with a special bandage that Dr. Karen Midthun, the FDA’s head of vaccine research, said is, "very, very hard to get off."

In conclusion, I do not believe that this vaccine should be administered to children because of their lack of knowledge about what is happening to them. I think that if the FDA proceeds with this study that adults should be tested rather than children because adults have stronger immune systems and know not to touch an injection site. If a bio terrorist attack does not happen there is no way to know if the vaccine worked or not. I believe that a vaccine that has serious if not fatal side effects, with no medical benefit to the child is not worth risking their life.

Lauren Henderson


While reading the parental consent form for this study, a couple of major points jumped out at me. The first was under the benefits category, where the major point seems to be that this study is good for humanity, but for the individual children in the study these benefits may not occur and unexpected side effects may develop. Say what? Unexpected side effects?

Scrolling down towards the end of the form I came across a second MAJOR point in the lawyer-speak paragraph saying that, if your child is injured because of this research, emergency medical care will be available. The care will NOT necessarily be free of charge. Great. So the researchers are going to inject children with a substance that they know could have some bad side effects, then duck responsibility if something goes wrong and make the parents foot the medical costs? Do they think that the $10 a visit and the gift certificate are going to cover that?

After reading this I went over to the CDC web site (www.cdc.gov) to find out just what side effects were possible from this vaccine, and there is some NASTY stuff there. No way I would willingly put any child through some of that stuff even if someone was paying for their medical care. Finally, even if everything went well with the vaccine, anyone who has been around little kids knows that keeping them cooped up for 30 days away from their friends like the experiment requires is near impossible and may even be traumatic for the child. Basically I don’t think that this study should be done, and I certainly wouldn’t put any child I know in it. Mr. John Bisges. Truman State University


December 1, 2002

Dr. Leslie Ball
Office of Human Research Protections

Dr. David Lepay
Food and Drug Administration

Re: FDA Docket Number 02N-0466, Study of Dryvax Administered to Children 2 to 5 Years of Age

I have studied the protocol, informed consent, and comments from the ten panelists asked to review this trial. After careful consideration, I have concluded that the trial does not meet the requirements of 45 CFR 46.407 in the form in which it is currently being proposed. The following are my reasons for this conclusion.

(1) Although I support the pediatric testing of drugs and biologics, both ethically and medically it is advisable to begin testing with older children before extending testing to 2 to 5 year olds. While many argue that older children are more likely to respond the same as adults, this hypothesis should be tested before involving preschool age children. Moreover, experts such as panelist Neil Halsey state that "there is no biologically plausible reason to expect children 2-5 years of age to respond less well than adults," the same claim that is made regarding older children. Why then should younger children be tested first?

(2) Older children have the ability to decide whether to assent to the risks and discomforts of this trial. If experience with an older age group, say 10 to 17 year olds, showed these children to be reluctant to participate in such a trial, that would indicate that extreme caution is warranted regarding 2 to 5 year olds.

(3) The argument for choosing preschool children because of concerns about the school attendance of older children is unpersuasive. If this trial is of crucial importance for the health and welfare of children, then surely it would justify keeping 40 school-age children out of school for 30 days. There are many ways to enable these children to continue their educations at home. (In the 1930s and 1940s we were frequently quarantined at home, thus missing school, because someone in the family had a communicable disease.)

(4) Both the letter to parents and the informed consent suggest to parents that their child may benefit from participation in the trial. In reality, even if there is a smallpox outbreak in the U.S., the probability that any of these 40 children would be among those exposed is virtually zero.

(5) Immunization against smallpox was stopped in 1971 in the U.S. even though cases of smallpox were still occurring throughout the world. The risks of the immunization itself were considered greater than the small risk of contracting smallpox in the U.S. Unless our government has information about the current smallpox threat that we citizens do not have, the situation today seems comparable to that in 1971.

(6) One of the panelists and a number of parents (in the public comments) have said that they approved of the trial, but would not themselves be willing to enter their patients (in the case of the panelist) or their own children (the parents) into such a trial. These views offer a strong ethical argument against testing on 2 to 5 year olds. If the trial is too risky for your own children, then it is too risky for anyone’s children.

(7) Since we have adequate information about the efficacy and safety of the undiluted vaccine, I do not see any value in having a control group receive the undiluted form. Whatever age group is used in the trial, there is no need to give children the undiluted form of the vaccine. I agree with panelist Neil Halsey that by eliminating this aspect of the trial, the number of children involved could be reduced.

(8) The sample size is too small to give any valid information about safety. The term "safety" should be removed from the title and descriptions of the trial.

(9) Before making a final determination on the need for this trial (in children of any age), authorities must have good factual information about the timeline for trials and availability of the new generation of safer vaccines. If these vaccines will be ready for trials at about the same time as the proposed Dryvax study is conducted, then the Dryvax study would be endangering children for essentially no purpose.

The panelists who were asked to evaluate this trial provided excellent criticisms and suggestions. I believe that the arguments, taken as a whole, lead to the conclusion that the trial of Dryvax in 2 to 5 year olds does not meet accepted standards for pediatric testing, and in particular, does not satisfy 45 CFR 46.407. It could possibly be revised as to age group, undiluted control group, information to parents, etc., so as to satisfy 46.407.

Carol A. Tauer, Ph.D.
Emeritus Professor of Philosophy, College of St. Catherine
Visiting Scholar, Center for Bioethics, University of Minnesota

Read more comments
Comments by Dr. William J. Bicknell, Professor of International Health, Boston University
Comments by Dr. Nelson and Dr. Offit, U of Pennsylvania
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Comments Page 7 (Comments in Support)
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Comments Page 10 (Detailed Comments)
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