Being proactive is generally
a good idea. But in the absence of a definitive outbreak it is difficult
to justify exposing pediatric patients to potential risks such as neurologic
complications which may not show up for years. On a more practical level,
working parents cannot afford to have their children out of school or
daycare for 30 days.Even mothers at home commonly leave their children
in mothers' morning out programs or church daycare on Sunday potentially
exposing a much greater number of individuals. I would not allow my
children to participate nor would I encourage my patients to be involved.
Dr. Marie Trenga
I do not think this vaccine
should be tested on children, I think the majority of the vaccines we
use currently have way too many health risks and the studies are not
done to prove results for long term, or even neurological reactions,
also 40 seems like too small of a population.
Mrs. C Jones
I am opposed to the testing
of any vaccine on anyone not of age to give informed consent. It is
a gross violation of the Nuremburg Code. Most especially because it
involves children should it not be done. I don't need to explain all
the medical reasons why this testing should not be done. The people
involved know all that. I suggest they focus on the moral and ethical
reasons it should not be done.
Mrs. Lisa Jillani.
People Advocating Vaccine Education
Even though you may argue
that the proposed benefits vs risk warrants their use, until it is proven
without a doubt that any vaccine is 100% safe, I and many other parents
would prefer not to risk the health or lives of our children with this
vaccine study. They are not guinea pigs! Therefore, we are strongly
against Vaccine Study Docket No. 02N-0466. Thank you for your consideration.
Samantha McTighe
Carlsbad, CA
Instead of risking children,
why not vaccinate healthy senior citizens who have already been immunized
when they were children. If the vaccine didn't harm them when they were
young, odds are it won't now. If this worked, then all the people who
have previously been vaccinated could be revaccinated with no risk.
That would remove a large group of people needing vaccine in the event
of an emergency. It would also cover most of the leaders of the country,
industry, etc. as they are probably older than 35, the age innoculations
stopped.
Mrs. Eileen Lenney
The recent finding that
targeted vaccinations may be sufficient (Halloran et al., 'Containing
Bioterrorist Smallpox,' SCIENCE, Nov. 15, 2002) assumes the traditional
single initial infective person (Table 2, p. 1430), a historic fatality
rate average of 30 percent in the unvaccinated majority (ibid.), and
ordinary transmission by personal contact. These assumptions are flawed.
The Tennessee Health Commissioner, Dr Fredia Wadley, recently said (emphasis
added) that 'When you have someone TRYING to transmit [smallpox] in
an ABNORMAL way, then that sort of changes the picture...instead of
one case you might have a thousand cases' (end quote). We need a study
that postulates a targeted population of confined susceptibles, efficient
transmission by weaponized aerosols, massive initial cases, a high proportion
of deadly hemorrhagic infections, and a fatality rate approaching 100
percent.
--John Buder
No childrun should be used
to test small pox Dryvax. This is a particularly dangerous and just
plain 'nuts' suggestion. Anyone who supports this ought to have their
own childrun at the head of the line. Perhaps if the Reality were not
'other people's childrun' but 'my own', this would not have even been
suggested. I absolutely object to this 'study'.
Dr. Demelza Costa
I think it would be a horrific
violation of children's rights to allow such testing to be done. It's
appalling that this question is even an issue in this day and age. Ms.
Kim McCarthy I am very disturbed by the possibility of testing this
vaccine in young children. We know that it causes side effects; those
can be serious in adults. Why risk our children at this point? And if
I understand correctly, there is some risk that the virus itself may
be passed to other people--so if one child at daycare or a school participates
in the test, other children may be exposed without parental knowledge
or consent.
Ms. Nicole Discenza
There is absolutely NO REASON
to potentially KILL or DAMAGE our children. If an outbreak occurs let
the parents decide at that time. Why would you people even consider
using this nations children as lab rats?
Mrs. Amy Tuttle
I can't imagine any parent
volunteering their child for this study. By the time a child is 5 years
old, he/she has already been so bombarded with toxins in the form of
inoculations, I think it would be absolutely criminal to subject these
little ones to this study. These are little children, our future; not
sacrificial lambs. I doubt there would be any children who would choose
to participate in such a potentially dangerous endeavor. Why would any
intelligent loving adult put them at such risk? And what happened to,
"First, do no harm"? Do NOT go on with the proposed study!
Mrs. Kathryn Snyder
Gelbmann Wolfgang [Wolfgang.Gelbmann@bifa.bmsg.gv.at]
Sent: Friday, November 08, 2002 11:20 AM To: 'fdadockets@oc.fda.gov'
Subject: clinical trial with smallpox vaccine Dryvax Dear Sirs! I would
like comment on that. Is more information available about the background
(aim) of this study anywhere on the HP of the FDA ? The ratio benefit
(information?) in correlation to the risk for these children is not
acceptable - in the current situation (to my knowledge). I agree that
further dose response studies with the old smallpox vaccine stocks could
be of high value (also for Europe, where some countries have large stocks
of the old vaccine). But I do not understand why children should take
part in this planned study.
Best regards,
Wolfgang Gelbmann
Dr. Wolfgang Gelbmann,
Assessor, Division Biomedical Assessment
Federal Institute for Medicines,
Possingergasse 38, A-1169 Vienna Tel: 0043 1 4920070 150, Fax: 0043
1 4920291
I feel that Dryvax should NOT be tested on children ages 2 to 5. First, according to the package insert, Dryvax has already been used in children under 5. So it appears to me that all the proposed research study would really do is determine if a watered-down version of Dryvax would be as effective as the full-strength version. If I am not mistaken, 680 adults have already participated in such a study, and this study showed the watered-down version to be 99.1% effective. Therefore, I feel that the proposed research study is unnecessary. It certainly does not justify putting these children in harms way. Second, children this young are apt to remove their bandages. I have a 2 year old child, and she will not leave any of her bandages alone. No amount of persuasion will sway her determination to pull one off. Once she has pulled it off, she will then proceed to pick at her hurt spot with her fingers. One time, she even managed to put the pulled-off bandage in her mouth before I could get it away from her (I was driving and she was in her car seat). If that particular bandage had had vaccinia virus residue on it, wouldn't it have caused her to develop lesions (or worse) in her mouth or wherever else the bandage touched her body? Third, the parental consent form states that participating children should not attend day care or school for 30 days after vaccination. Shouldn't they also be isolated from churches, grocery stores, playgrounds, neighbors, friends, relatives, baby-sitters, etc.? What about contact with their UNvaccinated parents and siblings? Is that safe?
How can you guarantee that they will not accidentally transfer the vaccinia virus to other children or adults, especially those who have scratches or cuts, are pregnant, or who suffer from eczema, dermatitis, cancer, AIDS, and other immune system problems, all of which are known contraindications to vaccinia and smallpox? And if that exposure caused damage to those people, who would pay for their care and recovery?
Fourth, the consent form
states that if a participating child is injured because of this research
study, medical care would be available, but would (and I quote) not
necessarily be free of charge. Why not? It should be. I am not aware
of any health insurance company that will cover the costs of complications
resulting from experimental research. Fifth, the consent form states
that, other than the small amount of money received for participating
in the research study ($120-$160), financial compensation would not
be available for an injured child. What if that child needed life-time
medical care, or (God forbid) died, because of this research study?
Compensation should definitely be available for any children that are
damaged or killed by this proposed study. Thank you for allowing me
to express my opinions.
Mrs. J. Jones
I am writing you to protest the use of smallpox vaccinations. I am 32 years old, a US Citizen and the daughter of a retired/deceased Senior Chief Petty Officer in the US Navy who was stationed in Japan during the Vietnam War. In 1972, while living in Japan, I was vaccinated against smallpox. The smallpox vaccine caused me to be infected with smallpox. I am alive today, as is my sister who contracted the disease from me, but this is not the case for everyone who contracted the smallpox virus.
My concern is that as this
is a live vaccine, like the oral polio vaccine, many people will become
infected who may not survive: HIV/AIDS patients, cancer patients and
others who are immunocompromised. I am a practicing pharmacist and am
well aware of how important vaccinations are to the well-being of children,
but I also am fully informed of how dangerous live vaccines are to the
receiving them and to those who are in direct contact with the receiver.
I know that smallpox is on the mind of every US Citizen but until we
know that the benefit of the vaccination out-weighs the deaths that
will result I must insist upon the FDA not approving any trials or programs,
which vaccinate children against the smallpox virus.
Thank you for your consideration,
Traci Mitchell, Pharm.D.
I am strongly opposed to
using children to test the weakened smallpox vaccine. If this is the
same as the dryvac, I apologize for voicing my opposition at this site.
The current supply should only be tested on a fully informed, carefully
screened adult population given the potential for adverse side effects
and spread of the smallpox lesion through improper care to the original
inoculated site. I am a retired public health nurse and would hate to
think that the Bush Adm. would be willing to take minority children
and use them for guinea pigs in a "war on terrorism."
Shirley B.
I am appaled that the United
States of America with all it's wealth, knowledge would ever consider
using innocent children to see if Dryvax, which has been kept in a freeze
dried state since the 1960's, works against a threat of small pox. As
Vera Sharav, president of the Alliance for Human Research Protection
said it is a CONTROVERSIAL VACCINE and is unconscionable!!!!! Nothing,
nothing CONTROVERSIAL should ever, ever been give to CHILDREN!!!! Yes,
we need to protect them, but my GOD find another way. Mr. Jenner who
discovered the vaccine in the 1600's by seeing young girls milking cows,
who had coxpox, would if he could, get up from his grave and say, AMERICA,
what has happened to our country that you would ever consider putting
our CHILDREN at risk without the data to make sure they are SAFE!!!!!!
In addition to the risk to children, what is this nonsense about a band-aid
- if it came off the CHILDREN the virus could be lethal if spread to
people who are immune compromised. Wake up AMERICA, HUMAN BEINGS are
PRECIOUS, LIFE is PRECIOUS, please, please, please find another way
to test 1960's DRYVAX in order to protect our CHILDREN and our Adults.
Thank You,
Karen Podesta
This email is to advise
you that I DO NOT support the smallpox vaccine study, Docket No. 02N-0466.
I believe that the risks far outweigh any potential benefits. Thank
you for your time and consideration.
Sincerely,
Jane A. Sherwin, RN
I believe that this study
is dangerous, and that we should avoid exposure to small pox as long
as we can, and it would be very unwise to reintroduce exposure to an
eradicated virus. I also am firmly opposed to mandatory vaccination
with this vaccine, if the issue arises.
Mr. Christopher Masterjohn
I say NO to the smallpox
vaccine.How dare you put children at risk as experiments in a clinical
trail.
Ms. Carol Caputo
I am opposed to testing
on small children until a safer vaccine from a dead virus is developed.
Ms. Debra Adler
I DO NOT support the smallpox
vaccine study,
Ms. Glory Leavins
I do not support the proposed
trials on children for Docket No. 02N-0466.
Edith Martin
I do not support the smallpox vaccine study, Docket# 02N-0466.Ray Gallup Lake Hiawatha, NJ
I DO NOT support the smallpox
vaccine study, Docket No. 02N-0466
Mrs. Sheila Ealey
I just wanted to let you
know that I don't think it is a good idea to use our precious children
as guinea pigs for the smallpox vaccine. At this point, I don't think
the benefits of the study outweigh the risks. Thanks for your time.
Sincerely,
April Yeager
Before I even thought of
having my child take the MILDER dose I would want to know ALL the side
effects that the adults who took it had. And what risk there was to
my child. As a parent, my children are PRECIOUS to me, a gift from God.
I would want to protect them and would protect them at all costs. But
I also would not want to expose them to something that could kill them
if it didn't help them. So, before we expose our children to this, we
really need to find out all we can and then decide.
Mrs. Lenora Day
All of this talk about forced
immunization against smallpox makes me angry and afraid. Why are we
talking about innoculating people with a dangerous vaccine just in case
it is unleashed into our society? I think the government is overreacting
to all of this. I am completely against ANY FORCED vaccination. I am
angry about all of the vaccinations my child must have now before he
can go to school. While I agree that vaccinations are basically a good
thing, I don't think we've given enough thought or study time to the
long term effects of pumping our kids up with nearly 20 vaccines before
the age of two. What does it do to their immune systems? The smallpox
vaccine is known to have bad side effects and still these guys in the
government are talking about forcing people to be vaccinated. It makes
me angry. Many in the medical community have made the point that we
can wait until we actually do come across smallpox before we vaccinate.
. . Anyway, to answer your question specifically, I am against testing
the vaccination on toddlers. I think that companies and the govt ought
to put their heads together to make a safe smallpox vaccine first and
then test it in other ways. Sorry for the diatribe but I needed to get
my opinion in there.
Ms. Mary Ellen Hegedus
I read an article in the
Atlanta Journal Constitution on October 1, 2002 regarding a vaccine
study planned for Children's Hospital in Cincinnati and in LA. As a
parent of a child injured by a live virus in a DPT shot in 1975 (Paul
lived brain damaged and died at age four in 1979), I am very upset that
children would be used in such a study. Ironically, I am from Cincinnati
and my son died on June 2, 1979 at Children's Hospital in Cincinnati.)
The risks are too high to test such a vaccine on young children. There
has to be another way to develop a safe vaccine for smallpox.
Susan Rogers McCreary
Atlanta, GA
I DO NOT support the smallpox
vaccine study, Docket No. 02N-0466.
Joanna Jaicks
Charleston, SC
I am a concerned citizen
and am horrified as the prospect of the government performing "research"
on our children using the small pox vaccination. I believe that this
proposed research is dangerous not only to the children, but to anyone
who comes into contact with them as the test will be performed with
a live virus. With the lack of proven effectiveness of other vaccinations
(as submission of any damaging effects is severely under-reported) I
strongly oppose this experimentation and feel that our children would
be better off developing an innate immunity. The potential danger of
permanent neurological and physical damage is far to great for the possible
'benefit' that may never be tested.
Sincerely,
Nitha M. White
D.C.
I understand there is a
consideration to allow toddlers and preschool children to be used experimentally
with smallpox vaccinations. This would be a deplorable action and should
not be done. The children have no voice in the matter and what kind
of parents would even allow this to happen. Please do not do this.
Theresa Davidsen
Being one of the people
who is at risk of contracting and dying from smallpox, if exposed, I
am highly opposed to any smallpox vaccination being carried out just
in case we have a terrorist attack some day. From what I have read,
the vaccine is effective AFTER smallpox is contracted so why administer
this at all and risk the population-at-large until it becomes absolutely,
definitively necessary? And why experiment on children?
Mrs. Kelly Ford
I do not believe that Dryvax
should be tested on children at all! If the Smallpox vaccine is offered
to the public, only those who are 18+ should be allowed to receive it.
I cannot be exposed to Dryvax because I have Eczema. It could kill me.
The last thing I want is a bunch of children putting my life at risk!
This is an issue of the responsibility level. Children are not always
that responsible and they will be more likely to not keep the bandage
on at all times for two weeks. They could put other lives at risk, especially
at school and in daycare. Granted, I am not around small children very
much, but I do not want to be worried about keeping my distance in public
(for example, the subway). Also, I do not see myself saying, Get away
from me, I cannot be exposed to the Smallpox vaccine, to every single
child that comes within a couple of feet of me.
Ms. Katherine Owens
Although I understand the
fear behind the testing, I would not want this experiment to be performed
on my kids! Isn't there a better solution? Why isn't the jet injector
being used in this study? The previous study showed less scarring, better
results and no complications. How about a nonlive vaccine? This sure
is an awful lot of pain and confusion to inflict on our young ones because
of a bunch of what ifs.
Mrs. Brandi Blaesing
This is a terrible idea.
With all of the side effects that are already part of existing vaccines,
and with the side effects that have been shown to come from the existing
small pox vaccines, how anyone can ever consider injecting this material
into young babies? The theory that vaccination is based on is flawed,
and there is no point in exposing young children to these risks. This
is a horrible idea. How can the people behind this sleep at night? This
project is not worth the risk.
Mrs. Lindsay Wolsey
I have no intention of allowing
my child to participate in such a trial. I feel that is irresponsible
to even suggest it. From my research, I do not feel this vaccine is
safe, and I completely disagree with offering it to small children without
a threat being present. Perhaps the FDA, Senate or Congress members
would be willing to offer it to their own children??
Mrs. Jessica Smith
I had to re-read the news
article to make sure I was not mistaken. You plan to test a live and
admittedly dangerous vaccine on BABIES! Whose children? What parent
would allow this abuse of their child? One pictures you tapping a source
of unwanted children; Where would your 'subject' toddlers come from?
The article has not stated if you have tested this dangerous dose on
adults, if you have, has the wound site and/or the vaccine itself adversely
or benificially impacted the adult test subjects. I think you should
cease and desist this instant, you cannot ethically test this dose on
little children!!!
Mrs. Kathryn Bush
I would not knowingly submit
my own child to a clinical trial involving aged vaccine stock. This
is especially true because there has not been enough research done that
will explain the effect the vaccine has in causing or exacerbating autoimmune
responses. In addition, it seems to be entirely plausible to attempt
to design and manufacture a dead virus vaccine which would make it more
palitable to the general public.
Ms. Christine Palermo
As a mother, I would never
allow my children to be an actual part of a life-threatening study of
this serious magnitude. Each person is given a small dosage of the disease
in each vaccination. You could be the percentage that dies from the
disease. I would never take that chance. I think immunization should
be done away with due to many reports of children dying from polio after
getting the polio vaccination.
Mrs. Melanie Coopeer
Your proposal to test the
smallpox vaccine on children aged 2 to 5, reflects the ethics of Nazi
concentration camp experimentation. I am strongly opposed to your intended
testing.
Sincerely,
Diane A. Ricucci
Comments: It is my understanding
that the Food and Drug Administration wants public comments on testing
the small pox vaccine on toddlers and pre-schoolers. I feel this is
a mistake, everything I have read about this vaccine points out all
the possible risk and side effects involved. If this vaccine is going
to be tested on humans I feel the first test subjects should be the
public health officials who support this plan. . If more test are needed
after that test it on the officials family members.
Butler, Jennie C
I oppose testing the smallpox vaccine on young children -- or on anybody. I believe the risks outweigh the gains. In fact, I think blanket vaccination of the public is a crime.
Why not educate the public?
Smallpox is not as contagious as most peole fears. You have to be in
close contact with someone for many hours. That means that anyone with
a real risk of smallpox will know it and can get the vaccine afterwards.
Thank you.
Amy L. Lansky, Ph.D.
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
Comments Page 1
Comments Page 2
Comments Page 3
Comments Page 4
Comments Page 5
Comments Page 6
Comments Page 7 (Comments in Support)
Comments Page 8
Comments Page
9
Comments Page 10 (Detailed Comments)
Comments Page 11
(Detailed Comments)