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
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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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