October 26

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

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

Personally, I think it’s a bad idea to test the smallpox vaccine on children. Especially because of side effects. I can’t imagine anyone I know who has a child between theses agea allowing their child to be a test study. Ms. Lanell Bridenbaugh I support the study. Although I would never volunteer my child , parents who do will be protecting the rest of us. I might question the judgement of a parent who subjected their child to such a risk, but I do not see the study as infringing on my rights or privileges.
Mr. Justin Grenier

I believe this smallpox vaccine should not be tested on children because it carries a risk of fatal or serious side effects. This is very unethical. Children should not be experimented on in this way.
Mrs. M.I.H. Gelder *

This was discussed in my online TXSAHM group. Most of the moms who expressed an opinion wouldn’t let their kids be tested, and some thought having the test done was unnecessary. I disagree. Doing a cursory test is IMHO prudent and warranted. My daughter’s pedi said I was probably one of the last people on the planet to get vaccinated for small pox. My vaccination scar is visible on my upper arm. I remember having to wear a clear dome of sorts with holes in it over the vaccination area so it could get air and heal. I think I was like 4 at the time. The point about younger children picking at the vaccination area is a valid one though. The child needs to have the self control not to do that. That’s not a reasonable expectation for infants or toddlers so I would imagine some sort of adequate deterrant device, like an updated better version of the dome with holes I had 30 years ago adapted for babies/toddlers, would certainly be necessary. So, knowing it’s a diluted version of the same vaccine, and knowing the miniscule risk of complication, I would have no problem having my healthy child(ren) participate in a trial.
Ms. Carla Chiang

Why would we test these things on our children? Becuase they cannot stand up and say no? If you want to test something test it on an adult with a developed immune system!
Mr. Andrew Yeager

I think that conducting these tests on children would be highly immoral. Children have no right to consent or refuse, and no idea how dangerous this test is. Most parents are very uninformed about the dangers of vaccines, expecting that our doctor wouldn’t do anything to harm us. Those parents who are fully informed of the risks would never submit their child to testing a vaccine. Leave the testing to consenting, informed adults if they want to increase the U.S. vaccine supply.
Thank you.
Leslie Warren

I think that conducting these tests on children would be highly immoral. Children have no right to consent or refuse, and no idea how dangerous this test is. Most parents are very uninformed about the dangers of vaccines, expecting that our doctor wouldn’t do anything to harm us. Those parents who are fully informed of the risks would never submit their child to testing a vaccine. Leave the testing to consenting, informed adults if they want to increase the U.S. vaccine supply.
Mrs. Laurie Morgan

Who would sign up thier child for a test that could result in serious side effects or death, and why? I would question the motives of the guardian. I’m sure there is always someone who will sign up their child, but perhaps we should question whether participating in this test could be in any child’s best interest, even if it is for the greater good of the community. Only the participant should have the right to choose such risk and potential sacrifice, and a child can’t make that choice. I can’t see a selfless reason why any responsible parent would include their child in this test.
Ms. Elizabeth Tierney
SAVVI, Crisis Center

I can’t imagine anyone willing to take that risk with their child, this should be tested and approved before it is allowed to be given to a child. A child’s resistance and tolerence to a drug is different than an adults. If the measels vaccine can give small cases of the measels, imagine what the small pox can do. I would never take that risk with my child!
Mrs. Michelle Novotny

This study has numerous problems, not the least of which are ethical issues related to the use of children where known risk factors have been quantified. Additionally, how will children be isolated so they do not pose a threat to other children or adults who may not have been vaccinated? This study should be kept on the shelf.
Mr. Lynn H. Ehrle
freelance medical writer

I do not believe that the vaccine should be tested on children because it is not safe, nor is it warrented for the small chance of exposure. Like the recommended vaccines for babies and toddlers, I think that it automatically subjects them to preservatives and chemicals in the vaccine, not to mention live doses, when the chances of them getting the actual disease are minimal.
Mrs. Erin McSparron

At this time, I do not believe the Small Pox vaccine should be giving to children. I am usually a proactive person; however due to the the fatal risks involved, I am going to have to be more reactive in this case. We should only use the vaccine if the United States becomes involved in a biological warfare.
Mrs. Judy Dietrich

I will not take the risk of ‘testing’ the vaccination on my child. It might be worth it for most parents, but not for the ones who’s children suffer from side effects or even death. Mrs. Michelle Sanders

I strongly disagree with testing Dryvax in Children 2-5 yrs. old!!!!! Please reconsider this study for the sake of the innocent!!!!!!!
Janet Altum

Based on the information the government has released via the media, I am sufficiently convinced that the terrorist threat of smallpox germ warfare is likely to occur. Therefore, I believe that we, in the United States, should test varying strengths of the smallpox vaccine on our children for the good of all children. Maybe the risks of the vaccine are unknown, but the certainty of the symptoms of smallpox is known. As a parent of a two year old, if there were to be a smallpox outbreak, then I would have my child definitely take whatever vaccine is available in whatever dosage. Thus, if we can test now with a small group, then we will provide for the safest and most efficient dosage of vaccine when and if needed.
Mr. Rob Sedgwick

Routine smallpox vaccination in the US ended in 1972. Officials are hesitant to resume the immunizations because the vaccine is the most reactive of all and has been linked to serious side effects, including death. –Reuters, Nov. 29, 2001. Also, The new smallpox vaccine will be genetically engineered. Many scientists believe that genetically engineered vaccines may be respoinsible for the global epidemic of auto-immune disease and neuroloical dysfunction. –American College of Rheumatology, annual meeting, Nov. 8-12, 1998. With this in mind, how can we offer up our children (who would have no understanding or say in the matter) to test these drugs that could cause them lifetime disabilities or death.
Mrs. Barbara Farmer

I absolutely do not think a new smallpox vaccine should be tested on children under five years old or any child. Isn’t it enough that our children are subject to multiple vaccines already? Isn’t it enough that the required vaccines already cause serious side effects that the FDA and the medical and pharmaceutical industries won’t admit to? Stop using our children as guinnea pigs!!!
Mrs. Melissa Tumminello

It is unconscienable to pursue a wag the dog for profit war that you know will endanger the lives of over half the world’s population with smallpox and anthrax.Smallpox is an eradicated disease,those who choose to use it to make billions from the plagues for profit should have it tried on their babies first. Only fitting , why have other babies die in a rushed ,exceedingly dangerous clinical trial. Try it on Tommy Thompson’s,Charles Fisher,Tom Ridge and Aventis/Pasteur,Baxter/Acambis children and grandchildren and we will see if it works.
Ms. Margo Reid,
healthcare professional

As horrible as it seems to subject 40 innocent children to drug testing, how much more horrible it would be to discover in the midst of a major biological incident that a diluted vaccine offers no smallpox protection for those five and under.
Mrs. Laurie Mulert.
Healthcare professional

I am in favor of the trial as long as the health of the children remaines a focus. I believe they should be provided free long term health care as part of the study and education benefits through the undergraduate level as compensation for assuming the risk.
Mr. Michael Dorsey.
Healthcare prof

It is difficult to imagine how this study can proceed since with current available information there is no way to judge or estimate the potential benefits to the subjects or other children. It is said that this trial was developed in the context of the potential risk of smallpox being used as a weapon of bioterrorism. However, at least based on information provided to the public, this risk is entirely theoretical or conjectural. There is a risk only if a supply of smallpox virus has gotten into the hands of someone who would consider using it as a biological weapon. The government has not provided information on whether or not it either definitely knows such a party has the smallpox virus or, if this is not definitely known, the extent/certainity it has reason to believe such a party has obtained smallpox virus. To date the government’s statements on the level of risk fall into the realm of Could be, You never know, You can’t say it couldn’t happen.

Such estimates of the risk the children in this study may be exposed to smallpox, and thereby the estimate of the potential benefit of the vaccine to them, are not sufficently tangible to provide a counter balance to the much more substantially calculated risk of permanent disability or death from an adverse reaction to the vaccine. The basic question then is what possible statement of benefit to the child could be made to the parents to justify the risk of harm from the vaccine. And if the researchers cannot provide some means by which parents can reasonably estimate the potential benefit to their children then it does not seem study would meet the requirements for use of human subjects in research.
Ms. Larry Sundberg.
St. Louis County Public Health Department

Because the possibility of nationwide vaccination in the event of a bioterrorism episode is prominent in the minds of our government and leadership, this would obviously involve children as well as adult recipients. To fail to test a vaccine in children would be unethical. Even though this vaccine, or one very similar to it, was administered routinely to children prior to 1971 in this country, the rejuvenated material may have different reactogenicity and immunogenicity. The studies in adults are reassuring but demonstrate a significant degree of reactivity. In order to anticipate and prepare for this in children, only a research protocol trial would provide appropriate information. Indeed, it might eventually be necessary to extend this to an even younger age group down to age 1-year rather than stopping at age 2. When vaccine was routinely administered to youngsters in this country, it was given shortly after the first birthday. Once the new tissue culture grown vaccine (Acambis) becomes available, this too should be tested in children as well as adults. Would it not be required by The Pediatric Rule (Dept. of HHS, FDA, Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients; final rule. Fed Regist 1998; 63(231): 66632-72.) to perform such studies?
Dr. Samuel Katz.
Duke University Medical Center

What loving parent would sacrifice their precious child for a study like this? I am shocked to hear that our government would conduct a study using the most vulnerable of our population knowing full well the risks to these children and anyone that may come into contact with them. The perceived benefit is certainly not worth the risk. Please do not make this fatal mistake!
Mrs. Amy Todisco

experimentation on children?! whether chemical or biological, even consideration of such an act is ethically reprehensible and appalling to me. Smallpox was officially erradicated in 1980. No Smallpox vaccine has been given since 1971. Giving even ONE vaccine will begin the re-exposure process to our culture. This is not only absurd but reckless. It’s only a humble opinion but mine is that there’s been no smallpox exposure since 1971 and it should stay that way!!! While I would certainly understand some uninformed people wanting to receive a smallpox vaccine in the case of an outbreak, we should all be given the choice as to whether we deem that appropriate, especially since we run the risk of either ruining our lives or dying from the vaccine which is fully acknowledged by the administrators and manufacturers of the vaccine.
Ms. SarahAnne Schapiro

A child’s immune system should not be attacked at the age of 2 with the smallpox vaccine. If there are side effects, children should not receive vaccinations until they are older. It should also be up to the parent if they want their children to receive the smallpox vaccine. It should not be federally or state mandated.
Mrs. Norma Schwanse

I strongly oppose using young children to test Dryvax as it IS such a risky measure. To think that they want to try something so risky on our children is crazy. This is something they want to try just incase there is a biochemical war. Why not just have it all on hand incase we truelly need it. Why put our childrens lives in danger when we don’t even know if anything is going to happen, but yet we do know that this test could kill our children. I am a mom of a 5 year old and have a baby on the way, there is no way I would ever let something like this be TESTED on my child like they are some kind of LAB RAT.
Mrs. Kim Maldonado

What are the potential benefits of the research, if any, to the subjects and to the children in general? There are no benefits to this type of experimentation on children 2 to 5 years of age. Smallpox has been eradicated from earth since 1979, to reintroduce it into a population for the purpose of research to find out the safe dosage on children because of the theoretical risk of biological warfare is immoral and unethical. We do not have a smallpox epidemic right now. To introduce smallpox vaccine on children, a population that could not speak, is abusive to the children. How are you getting your research subjects, are you giving monetary incentives to parents to seduce them to use their children as subjects? The old live vaccine from the 1970s has been prepared from the vesicle fluid taken from live calves deliberately infected with vaccinia virus.

In June 22, 2001 MMWR, the CDC confirmed that the previous methods of vaccine production using calves are no longer being used and that the new production through a different cell substrate must be approved by FDA. What is going on, why are you considering using this old live vaccine that the method of production has strong possible contamination – cows now have mad cow disease, how do you know that those cow tissues are not contaminated? (2) What are the types and degrees of risk this research presents to the subjects? The method of vaccination is to punch a forked needle 15 times into the upper arm of the children and apply bandages to prevent it from spreading.

Children 2-5 years of age will not be able to keep their bandages on. Therefore, the children will spread the virus to their entire bodies. Besides being cruel and inflicting pain on children, the smallpox virus will affect people surrounding them. Passing it to other children or their parents, how do you propose to quarantine these children? Basically, these children whom you’ve selected for research purposes are perfect guinea pigs. They are like mice or monkeys because they cannot speak when they are in pain. (3) Are the risks to the subjects reasonable in relation to the anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result?

The risks outweigh the benefits. The smallpox vaccine reaction rate is high. Bacterial infections in children will be high since they will be manipulating the vaccinated sites the most. Also, there are many children with asthma, eczema, and other autoimmune diseases. They may be transmitted the smallpox virus from the research subjects. More importantly, how are you selecting subjects for this clinical trial? Do you account for children who have preexisting conditions who when receiving the vaccine will be susceptible to more reactions? Testing this vaccine on the healthy population will not give you evidence that the dosage level will work for every child. Every child is an individual.

Everyone’s immune system works differently. You cannot conduct research on the healthy individuals and expect the outcome to be the same for everyone. (4) Does the research present a reasonable opportunity to further the understanding, prevention or alleviation of a serious problem affecting the health or welfare of children? Smallpox has been eradicated from earth since 1979, to reintroduce it into a population for the purpose of research to find out the safe dosage on children because of the theoretical risk of biological warfare is immoral and unethical. Smallpox is not a serious problem right now affecting the health or welfare of ch.
Ms. M Young,
Concerned Citizen of the U.S.

TO: Dockets Management Branch (HFA-305), Docket Number 02N-0466, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. FM: Dewey Ross Duffel, 841 Blue Slide Rd. Thompson Falls, MT 59873-9410 1-406-827-4451 email: duffel@blackfoot.net Organization: Self. Category: Individual. Reference: Docket Number 02N-0466 A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Responses of Dryvax Administered to Children 2 to 5 Years of Age Reference, the four questions you wish comments on: (1) What are the potential benefits of the research, if any, to the subjects and to children in general; (2) what are the types and degrees of risk that this research presents to the subjects; (3) are the risks to the subjects reasonable in relation to the anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result; and (4) does the research present a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children?

Comment on question 1: Little benefits are expected for the study subjects. However, the potential benefits for children in general can be obtained only by proving or disproving one or more of the assumptions which underlie the study. The following assumptions are widely believed, but have never been proven by double blind, placebo controlled studies.

There is considerable evidence to call each one of these assumptions into doubt. Assumption: vaccine is the primary, if not the only, protection against smallpox. Assumption: milkmaids were protected from smallpox by exposure to cows sick with cowpox. Assumption: smallpox is a random striking disease caused by a virus. Assumption: smallpox is a highly contagious disease. Assumption: smallpox is a highly dangerous/severe disease. Assumption: ‘scarification’ following vaccination is an adequate guide to smallpox immunity. Assumption: antibody count following vaccination is an adequate guide to smallpox immunity. Assumption: smallpox would make a nearly ideal bioterrorist weapon. Assumption: the population of the USA has little or no current immunity to smallpox.

In response to these assumptions, consider the following: A. The near disappearance of smallpox incidence, occurred simultaneously with several co-factors: sanitary and water purity reforms, improvements in nutritional factors, reforms in hygiene, improved transportation, moving from animal power to mechanical power, medical reforms, and of course vaccination. B. In 1800, when Jennier introduced the vaccination procedure, milkmaids were said to be largely immune to smallpox. At what age did milkmaids become employed? What protected the milk maids before exposure to diseased cows? What really protected the milk maids after exposure to diseased cows? It should be remembered that smallpox was not a random disease but occurred with the highest rates in those who lived in slums where poverty, filth, malnutrition and overcrowding were greatest. Medium smallpox rates occurred in the greater metropolitan areas. The least numbers of people affected by smallpox were dwellers in rural countryside and small villages. These low rates were probably due to relatively less polluted water, greater home to waste seperation, quicker transportation of vegetables, fruit, meat and dairy products from farm to rural table versus the long transit time from farm to city tables. So it was not only dairy maids who enjoyed low smallpox rates but most individuals who lived in rural and small town environments. The primary cause of smallpox is not virus but filth.

The severity of smallpox is related to three primary factors: the amount of toxicity within the body, the nutritional status of the body and the treatment given the patient. Under conditions of sanitation and nutrition such as enjoyed today, smallpox would be mild in most of the rare cases of development. C. Large smallpox epidemics occurred in highly vaccinated populations.

No large smallpox epidemics have occurred in highly sanitary populations which have good nutrition. D. Less than 10 percent of children in developing countries were vaccinated in the WHO smallpox eradication campaign. E. Records do exist of smallpox scabs covering smallpox vaccine scars to the point where it was impossible to determine if an individual had been vaccinated. No study ever proved that ‘antibodies’ correspond to long term smallpox immunity. F. When both sanitation and nutrition are common, all contagious diseases, including smallpox, become less frequent and more mild.

Given the facts listed above, the protocol of any smallpox study needs to give scientific answers to the following questions: Was smallpox vaccine a significant factor in the control of smallpox? Did smallpox vaccine produce a significant increase in immunity versus the immunity conferred by sanitation, nutrition and hygiene? Was scarrification and/or smallpox ‘antibodies’ adequate indications of smallpox immunity? In a modern society, is smallpox either highly contagious or a severe disease? Does smallpox truly provide a near ideal bioterrorist weapon or is it only a weapon of terror not destruction? Is immunity to smallpox in the general population of the USA low or actually quite high? There is sufficient information to justify stating that vaccine had little or no impact on the declining incidence of smallpox. Smallpox is not highly contagious, or greatly severe (in a society with adequate sanitation and nutrition) and would make an extremely poor biowarfare weapon. The US population currently has an extremely high percentage of individuals who are immune to smallpox.

The Dryvax vaccine has been classified as a IND, Investigational New Drug. This classification needs to taken very seriously, literally and the study protocol should be based on the concept that we need adequate, valid and scientific procedures to answer the basic questions outlined above. The current protocol will not answer any of the above questions. Further, the testing protocol relies on assumptions which have been brought into serious doubt. Many of the statements made in both the application and ‘informed consent form’ for parents makes statements which are ‘sales concepts’ but have no place in a scientific document.

Comment on question 2: Potential side effects include those in the Dryvax Package Insert. And also include potential weakening of the immune system as well as adding a burden to the total body health which will increase chronic diseases. Long term adverse effects can range from an increase in cancers and chronic fatigue to a host of other known and unknown side effects. Comment on question 3: If there is no smallpox disease, either natural or due to biowarfare, then the vaccine cannot be of benefit. If the smallpox vaccine does little or nothing to immunize against smallpox then the adverse side effects will greatly outweigh the questionable benefits even if there is an attempt to reintroduce smallpox. If we take the attitude that sanitation, nutrition and hygiene are the key factors to immunity to smallpox, the vaccine is unnecessary even in the event of an attempted bioterrist attack using smallpox or similar virus. A large amount of data on historical smallpox incidence and the failure of vaccine to prevent epidemics proves there is NO justification for any large scale vaccination campaign.

Given these facts, it is certain that the vaccine will prove to be a detriment to individuals and to public health in any modern setting. comment on question 4: The protocol of the present study is designed to answer only the questions of scarification, antibody production, and superficial ‘safety’ in a small and healthy population. Clinical effectiveness will be impossible to test much less prove. Serious underlying flaws in the study protocol allow assumptions to go untested and even unquestioned. It is likely that this small number of healthy children will be used to create a smokescreen of seeming positive results for both effectiveness and safety, neither of which will be adequately tested. The reality is that this vaccine is not needed, is not effective and can not be anything approaching safe. Since the study is not designed to either prove or disprove the above contention or any of the underlying assumptions, it is clearly unethical and unscientific to conduct the study as outlined in the protocol.
Sincerely yours;
Dewey Ross Duffel

I think the only way to do a truly valid trial is to have the children and grandchildren of the drug company CEO’s and some from the FDA officials who will making the final decisions be the subjects of this ‘trial’. With these children being the test subjects all the families involved will be able to more clearly and objectivley evaluate the results of any short-term or long-term damage caused by the vaccine, as the families will have to live everyday with their own results. If the CEO’s of the drug companies and the FDA officials are not willing to put their own children on the line for the trials then do not ask anyone else to do so.
Ms. Cyndi Ringoen

I believe that it is important to test products for their efficacy and safety. However, I think that it is a bit reckless to start testing these products on children that have niether a say in the decision nor any knowledge of the risk that may be involved. In short I think it is a bad idea!
Mr. Jeremy Beireis

Please do not use our children as test rats. This vaccines is known to have serious side effects. To test it on children is not wise. Todays children are already bombarded by an array of harmful chemicals. The last thing they need is another dose.
Mr. Marcus Kerske

I do not agree with this. When giving a child vaccines, the benefits should outweigh the risk. In this case it does not.
Mrs. Martha Begly

As a parent I do not want toddlers or prescoolers to be used as guinea pigs for the new vaccine. The old vaccines have enough side effects. The dangerous risks of testing the new vaccine is far more dangerous and the possibility of children getting small pox. please do not go foward with testing the new vaccine.
Ms. Stephanie Jones

I agree with Dr. Paul A. Offit, chief of infectious diseases at Children’s Hospital of Philadelphia, who believes the benefits of testing the vaccine do not outweigh the risks. Noting that the vaccine offers protection when given up to four days after exposure, Dr. Offit said he believed testing in children was ethical only after an actual case of smallpox had been reported.
Mr. Ronald Myers

What are you guys smoking? Not innoculating the general population is just copying the French policy paralysis during the Sitzkrieg, which failed to either prepare for civilian evacuation from the German border, or to move the army to forward positions in preparation for invasion. Saddam, as he amply demonstrated when he torched Kuwait’s oil fields after the Gulf war was clearly lost, is capable of absolutely wanton and senseless actions. He was innoculating his army against smallpox in 1990 before invading Kuwait. Let’s get on with it before he kills 30% of the world population by dispersing small pox. Unlike our policy experts who have read too much Dr. Spock, I’m willing to wager he’ll do things that horrible before he discovers the lost, hurt child hidden in his psyche.
Mr. Daryl Suzukawa

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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