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

I wholeheartedly oppose the use of administering a smallpox vaccine to small children in a randomized study. More controls need to be made to ensure the children’s safety in this situation, and there is too great of a potential to kill a child, or put one at risk of a terrible disease. I haven’t read that this drug has already been tested on healthy adults, or other animals/etc with no adverse side effects. I hope that this is the case before the FDA proceeds, but even if it is the case, this drug is too risky to use in a randomized study of children.

I will not vote for or support any candidate that will allow this remarkable misuse of humanity to occur. Our children should not be put at a great risk to find a vaccine that may or may not have a use.
Thank you for your time,
Ruth Ritter
American Citizen Research Associate

No way should we test a smallpox vaccine on children! If it did become a national crisis then we could use the diluted vaccine but not the full strength one. The risks are just too great to test on kids! I would never have my child be a test subject for something so dangerous and I have serious doubts about any parent who would. If the dilluted vaccine has shown to be effective in adults then I would say that a smaller amount of that in a true emergency would suffice. Better yet, find every stash of smallpox virus in the world and destroy it.
Ms. Kathleen O’Brien

That is absolutely insane! I am outraged that testing this vaccine on children is even being considered. It is woring to use children as test dummies, it is immoral!!!
Miss Kati Hamm

the vaccines should be tested mainly on adults who volinteer. after the side effects nolonger include possible fatal results then and only then should smaller doses be tested for children.
Miss jeanie summers

Putting children at risk, even for the benefit of the greater population, is unethical and something that, as a parent, I find horrific.
Mrs. Jennifer Quintana

Since there is no clear benefit to the children involved AND there is potential risk, this type of study should wait until there is an actual case of small pox. However, researchers should be prepared to act quickly should such an event occur.
Ms. Lois Furry

To whom it may concern: It has come to my attention -courtesy of the syndicated radio talk show host Michael Reagan (program from November 6, 2002)- that the FDA intends to conduct trial vaccinations for smallpox in a control group of 40 children, ages 2-5, in approximately a month?s time. At least my understanding is that the FDA is taking public comment on the issue between now and then and shortly thereafter a decision will be made as to whether or not to proceed with these trail vaccinations. I wish to weigh in on the issue. Simply put, it CANNOT be allowed to happen. Period. The reasons are many and varied, but all of them address the issue of the overall health and well-being of the children in question. To say nothing of the potential health risk for the rest of the public. First and foremost, we are talking about a live virus. All vaccines contain a severely weakened form -though still viable, and that is the key- of a virus, etc. that it is hoped the human immune system will be able to counteract and from there the individual should build up a long-term resistance (ranging anywhere from a matter of a few years to lifelong) to the viral agent in question. This alone is a potentially serious problem. The human immune system is simply not developed enough to cope with such extreme agents in early childhood (I.e.- the proposed 2-5 year olds). The risks of such a vaccination at that age range from minor infections in the area of the body where the injection is received to encephalopathy (sp-?) (where the brain experiences physical swelling and a subsequent and possibly permanent impairment of neurological functions) to death. There are certain ethnic groups (or anyone with similar lineage) who likely cannot genetically develop an immunity from a vaccination to smallpox. Particularly those of Native American decent. Anyone who has studied American history knows this is a factual statement. The next issue deals with the preparation of the vaccines themselves.

It is my firm understanding that today, vaccines are no longer prepared inside of monkey tissues as they were from the 1950s-1980s. However, I?m not certain of the validity of this. This opens up the possibility to contracting numerous strains of monkey viruses (particularly SV40, or Simian Virus #40) which was shown extensively to have carcinogenic properties in virtually every lab animal encountering it. Furthermore, it is known and documented by the CDC (Centers For Disease Control) in a classified document revealed during the hearings on Gulf War Syndrome that most, if not all, vaccines contain the element mercury. What?s more this element is present in a level that greatly exceeds the maximum human tolerance recommended by the EPA (Environmental Protection Agency).

Most vaccines also contain formaldehyde (used for embalming corpses) and a myriad of other delightful chemicals that the living human body can certainly live without. I cannot imagine for a moment that this latest version of smallpox vaccine would be any different in terms of the known harmful elements involved in its composition. Evidence to the contrary would be greatly appreciated. Additionally, the potential exists that the control group might expose others to smallpox, thereby setting off a chain reaction, the extent of which cannot be imagined or prepared adequately for. This reason alone is sufficient grounds not to conduct the trail vaccinations. Remember, as stated above, we are dealing with a LIVE AND VIABLE viral strain inside the vaccine itself (weakened or not). The risk of this getting out a result of these trails is a reality and should be taken into consideration. It is my honest OPINION that the decision has already been made to go ahead with the trial vaccinations of the children in question and that this campaign of accepting public comment is merely a formality designed to placate the public about the issue. I would certainly love to be proven wrong about this opinion. Sincerely, Jerod Stutsman, Concerned American citizen.
Mr. Jerod Stutsman

There is no need to isolate children vaccinated. One counts on the spread of the virus to extend immunity to those not formally vaccinated. Isolation is counterproductive. Society needs to be informed/cautioned re the mortality and morbidity of the vaccine itself as opposed to the m&m of the disease. Then do it.
Dr. William Corporon

Please don’t do this. Someone needs to start researching the real effects vaccines are having on our most precious asset – the victims – our children. Chronic illnesses, diseases, health problems and mental illnesses of every kind have skyrocketed right along with the development of vaccines…. the diseases were already at all time lows before the development of vaccines, but we’ve created a whole host of new diseases for our children while pushing diseases meant for children’s bodies and stimulating immune systems into older ages when peoples bodies are not meant to withstand the insult of disease.

Smallpox is one of the most damaging and worst vaccines ever developed and we are already at an all time high. Please save our children by not practicing on them. They have too much poison in their system now. Please don’t play into the fear factor by pushing the smallpox vaccine- the public does not need this. If the government really wanted to innoculate the entire US for smallpox…. they should check into the homeopathic method of innoculation for diseases- every household could do it instantaneously and safely – it’s likely to be just as effective and less expensive!. The gov’t would save millions (at least) doing it this way. There are many resources available for people interested in this: One resource is the Hahnemann College of Homeopathy. It would be informative to know how this type of plan might work and how it could be effective. This could be a beautiful chance to gain education on a safe, effective and cheap way of preventing and treating diseases. Please spare the little children any more harm from vaccines. If we go back in the history books, we find that homeopathy has been effective for hundreds of years. Thank you for the opportunity to respond to what’s on the docket.
Holly L. Kastl

A study of dryvax in Children should only be conducted once the drug has been thoroughly tested in adults and animals. While it is crucial to have a safe and effective drug to combat smallpox for children, it is not acceptable to put children at undue risk. Although this is a crisis matter, take the extra precautions.
Mrs. Julie Aguilar

10 Questions to the researchers, NIAID, NIH, and FDA

1. How can you ask American citizens, individuals and families whose health and well-being you are charged to protect, to assume a serious, or even deadly, risk for benefits that are highly speculative at best?
2. How would this vaccine protect your countrymen in the case of a mutated virus?
3. How can you in good conscience ask parents to volunteer their children for this experiment? (The word study seems inappropriately benign.) Would you place your *own* children/grandchildren/nieces and nephews at risk for such a highly questionable public good?
4. How can you ask the parents of the children being used as subjects to accept the risks associated with the vaccine *without at least* ensuring them that any required emergency medical care would be provided free of charge? (I just about dropped out of my chair when I read item #10 on the consent form. Does the PI know people–what motivates them, how to ensure good will, how to treat them ethically–at all?)
5. Why are you not concerned that requiring participants to make as many as 20 visits to the clinic will place at risk the dozens of people they will come in contact with on each of these trips (e.g., other passengers on the bus) as well as the clinic staff and patients? You seem to be placing a naive amount of faith in: a) the ability of a toddler to not rub a part of his/her body that hurts; b) the capacity of the same child to not then touch another body part–e.g., his/her eyes (think:serious corneal damage); c)the ability of a parent or caretaker to monitor such a child literally every moment for several weeks; d)the ability of a bandage to make concerns a-c irrelevant.
6. Why are you not concerned that the mothers of the children being used for the experiment may well be pregnant but not yet know it at the time the vaccine is administered?
7. What additives (e.g., mercury, thimerosol) would be injected along with the virus itself? If any would be used, why are they–and the potential risk associated with their use–not included on your disclosure form?
8. Can we, John/Joanne/Little Johnnie Q. Public, trust that our government (which *you*, dear reader, represent at this moment) is–concurrently with planning this experiment–also using every means at its disposal to diminish the risk of the danger that motivates your actions? If not, why should we trust you?
9. To the medical doctors among you: is this really what you went to medical school for? Does this experiment violate the non nocere (sp?) oath you took when graduating from medical school?
10. Why does your description of the experiment fail to name the pharmaceutical company that manufactures the vaccine? Full disclosure would seem to require this. I look forward to receiving a written response to my comments. Thank you for inviting the public to comment on this decision.
    Sincerely yours,
    Nancy B. Downes

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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