June 9

Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children, Pg 6

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

Please do not place young children in jeopardy by testing this vaccine on them. Children’s bodies and minds are still fragile and growing, and a vaccine that has so far caused many adverse reactions in adults can kill a small child. As far as keeping them out of school or daycare during their active period, that only holds true for those outside the family. Many of these small children have brothers and sisters at home which makes it impossible to aviod. If you must test this on live humans, at least make the subjects be adult and informed.
Mrs. Dorothy Dankanyin

I think it is barbaric to test this vaccine on children that young. Surely some parents will risk their child’s health to test this for the good of the masses, those parents should be made aware of the rest of us parents who wouldnt give this vaccine to our children anyway, no matter what they risked for science. Given the nature of the vaccina vaccine, it would be too easy for a small child to spread it over their entire body putting their entire health status at risk. No, I cannot see us risking the life of any child at this point to test some vaccine for smallpox. If smallpox appears on the face of the earth again in the populus, the risk benefit equation would change and we would basically all be guinea pigs. For now, dont risk the children please! It is a sad testament to the world today that it has come to this. (side note.) ~A concerned parent of a 4 yo
Dr. Lynn Doria

It is my understanding from what I have read that although you are already running trials on adults, the Dryvax being used has been in storage a long time and is old, of limited quantity, of questionable effectiveness, prepared by methods not allowed today, with known potential serious side effects and unknown effectiveness. Preparations for producing newer, more controlled and effective vaccine must be underway to adequately prepare for any real need for the vaccine that should arise. What is the purpose of testing this old vaccine brought out of storage that is so questionable and in short supply on children aged 2-5? Any potential benefit from this can hardly outweigh the risks involved.
Ms. Aileen Veitch

The question I would ask is where do you get such children? I can only assume that thet must be orphans as no parent would be stupid enough to take such a risk! I think that the diluted vaccine should be tested and then the results carefully evaluated before considering the full vaccine.
Mr. Darren Adams

I do not feel that children should be used in a trial of vaccines as sensitive as this.
Mrs. Jeannie Julian.
Healthcare Prof

I do not believe we should experiment on our children for any reason. It took many years before the non-live virus of polio was administered here in this country. When in Europe they advised the U.S. that it was unsafe, and there were risks. As the mother of two children, I would not subject them to such terror. My children are healthy and have not had any illnesses growing up. I am opposed to mandatory immunization of any kind, and know it is unconstitutional. As the parent I have a right and obligation to protect my children from such unnatural, unsafe practices. Just as Hospitals’ decide upon admission that you have now just signed your rights away, and that the hospital and/or doctor has the ability to decide what is in the patients best interest.
Ms. Heidi Cohen

Please do not experiment on the children of this nation (or anywhere else in the world) with a small pox vaccine. I cannot put into words just how sad this would be for the humankind.
Mrs. Michelle Pinkowski

am outraged at the idea of using children as guinea pigs to test, of all things, the smallpox vaccine!! Vaccine safety in this country is questionable to begin with, and now the federal government wants to test perhaps the most experimental and dangerous vaccine on our nation’s children?? I can’t believe that anyone would even suggest this!! In the Journal of the American Medical Association (June 9, 1999, Vol. 281, No.22, p.2132), it is stated For each million people vaccinated with the smallpox vaccine, as many as 250 could die. Without knowing virtually anything about the consequences of a mass smallpox vaccination policy in this country, how could the FDA want to test it on children?? I urge you with all my heart and soul to NOT go ahead with this testing. If you do decide to go ahead with this clinical trial, I do have one question — will you allow your own children to participate in it??
Miss Naomi Pestana

Children should not be used in medical experiments (nor should any other persons) – Please refer to the Neurenberg Trials after Nazi Germany.
Ms. Marguerite Willner.

I’d like to register an opinion AGAINST proceeding with a smallpox vaccine trial on children age 5 and under. I think we should extrapolate the adult information to kids rather than put them through a clinical trial at this point.
Moira Ratchford

I believe you will end up with some dead children if you administer the smallpox vaccination as is. Time, effort and $$$ need to be invested to optimize the vaccine itself so the risk is drastically reduced.
Clifford Joseph Piel Jr.

I do not support the small pox vaccination study Docket No. o2N-0466
Carol Boczarski

I am totally against the smallpox vaccination and refuse to have it administered to any member of my family. My daughter has eczema which can have major side affects from the vaccine. If you attempt to vaccinate the U.S. population you are going to open up a can of whoop as you will not be able to close. God help you in your decision.
Mr. Michael Sanders

It is absolutely unthinkable that the United States Government would allow or propose exposure of CHILDREN to an experimental vaccine. People are not animals to be used and discarded at will.
Ms. Kim Liberty.

I will make this short. I am opposed to this study on children. I do not want any type of experimentation done on my child or any one else’s. We the people can make an educated decision and we don’t need ‘you’ to do it for us. We refuse to be guinea pigs for your profit or pleasure.
Mrs. Debra Lamb

I will make this short. I am opposed to this study on children. I do not want any type of experimentation done on my child or any one else’s. We the people can make an education decision and we don’t need ‘you’ to do it for us. We refuse to be guinea pigs for your profit or pleasure.
Mrs. Debra Lamb

I object to the experimentation on small children with the Dryvax vaccine. Parents of these children may not be in the best position to understand the risks. I recommend extrapolating the results from the adult testing to the children. What are the ingredients in the vaccine in addition to the live virus, i.e. Mercury, etc. Also, children that are subjected to the vaccination need to be healthy and free of infection and allergies. It is important to investigate vaccines possible connection to autism, ear infections and Hyperactivity.
Mrs. Lee Osborne

I had a vaccine when I was a child. How does the side effects compare to that one? (I was born in 1969) I would not want my children to be a guinea pig for these trials, and I wouldn’t be the first in line to get the vaccine either. I do make sure that they are up to date on their current vaccines, so I am not against the idea of them. If after the trials are over, and they are fairly successful, would the smallpox vaccine be required, or only administered in the event of a biological attack. This question raises so many other questions and concerns that need to be addressed.
Mrs. Sheila Robles

Based on the results of our research (ref 1), we believe that natural rubber latex proteins can be eluted from natural rubber stoppers into aqueous solutions in pharmaceutical vials during storage or the process of puncturing.

It is our believe that natural rubber containing closures should not be used vials containing vaccine to minimize the prospect of exposure of any latex allergic child or adult to rubber allergen exposure. Alternative synthetic closures are widely available and effective.

Ref 1: Primeau M, Adkinson NF, Hamilton RG. Natural rubber pharmaceutical vial closures release latex allergens that produce skin reactions. J Allergy Clin. Immunol 107:958-962, 2001.
Sincerely yours,
Robert G. Hamilton, Ph.D.
Professor of Medicine and Pathology
Johns Hopkins University School of Medicine

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 6
Comments Page 7 (Comments in Support)
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Comments Page 9
Comments Page 10 (Detailed Comments)
Comments Page 11 (Detailed Comments)

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