The Code of Federal Regulations (45 CFR 46.407) requires that any experiment involving children which puts them at greater than minimal risk without a potential benefit to justify the risk, requires the Secretary of Health and Human Services to convene a panel of experts and afford the public an opportunity to review and comment. The proposed smallpox vaccine trial on 2 to 5 year old children is unapprovable under federal regulations.
Accordingly, an announcement in the Federal Register, Oct 30, 2002, sought public comment until Dec 2, 2002. By Nov 20, 2002, FDA posted 337 Public Comments on its website: http://www.fda.gov/ohrms/dockets/dockets/02n0466/02n0466.htm
The response from citizens across the country--including doctors and nurses--overwhelmingly opposed the proposed trial. There were only 9 in support out of 337 who expressed strong disapproval of the trial. FDA STOPPED POSTING PUBLIC COMMENTS RECEIVED BETWEEN NOV. 20 AND DEC. 2, 2002. WHY?
These public comments opposing the trial validate the position of The Alliance for Human Research Protection, which reflects the moral values of the people.
I've practiced family medicine
for 23 years. I am opposed to this vaccine study. These children's immune
systems are not yet fully mature and I feel their system is already
overwhelmed by the numerous vaccines we give. Why risk a live virus
vaccine in our country where no cases exist. I feel the threat is overblown.
Mobilize resources when the need is present. I cannot understand how
any parent could agree to their children receiving this vaccine if they
receive informed consent. This study, in my opinion, crosses the line
of proper medical ethics.
Dr. Kenneth Unice
The testing of the Dryvax
vaccine should not be done on Children. This is unethical because of
the known issues with the vaccine. An effort to create a safer vaccine
should be pursued before EVER using this on children. It is important
that the pharmaceutical industry focus on the safety of our children,
not profits. As someone who works in the pharma industry with Regulatory
submissions, I see the side effects and Adverse Events that occur because
of drugs. It is terrifying to think that we would put our children's
lives at risk because of a possible threat of bioterrism. Let's not
let fear dominate our lives and let's challenge the pharma industry
to research and develop SAFE vaccines. One death in 1 million may not
seem like much when looking at the statistics, but if it is your child
it will seem like EVERYTHING. Thank you,
Erin Northington
In about 1960 my sister,
age 3, received the smallpox vaccine. Although the details are somewhat
muddy, via my parents, my sister spiked a fever, and went into a coma
When she emerged from her coma a few days later, she had lost all motor
and vocal skills. She had to relearn to walk and talk. She still suffers
till this day. It has been an emotional and financial burden for my
parents. We have never received, nor did we ever ask for, any compensation.
We are Christian, of deep belief. I write only to suggets you be very
careful in any testing of smallpox vaccine. There is a great possibility
to destroy a child life. I fortunately did not suffer a simialar fate,
and became a dentist. My sister had such potiential, but it died with
the vaccination. You must also ask yourslef who would be responsible
for the potential lawsuits, which would follow, esp. with children envolved.
Warmest regards, bless you and your quest;
Gary McCready DDS
I am a pediatrician and am strongly opposed to testing the smallpox vaccine on children. First, the study will expose children to significant risks without any benefit to them. Young children are more likely to have eczema or an undiagnosed immune deficiency that increases their risk of a serious reaction. Children ages two to five do not keep bandages in place. Children do scratch freely when they have an itchy lesion, such as a smallpox vaccine site. They do not wash their hands well or practice good hygiene.
The 1:4,000 risk of disseminated smallpox rash following vaccination is probably an underestimate for this age group because of the above risk factors. The 1:150,000 risk of encephalitis and 1:200,000 risk of death is too high for vaccination, unless there is a smallpox outbreak. Second, the study will undermine public confidence in other vaccination programs. Anti-vaccine propaganda has many parents fearful of vaccines. As a pediatrician, I tell parents that no vaccine has been approved unless the risks from the disease are far greater than the tiny risks of the vaccines. Approval of this study would make it impossible to give parents this reassurance. Testing the smallpox vaccine on children would give anti-vaccine writers additional fuel to fan public paranoia. This will lower vaccine rates and put other children at risk.
Finally, most vaccinees
will undoubtedly be poor, minority children, thus raising other issues.
Please oppose testing of the smallpox vaccine on children. Thank you,
Margaret A. Kluthe, M.D., F.A.A.P ORMC Professional Building 425 E.
5350 South, Suite 355 Ogden, UT 84405-7408
No, this should NOT be tested
on our children. Our children are already pumped full of beneficial
medicines before they reach their first birthday, and then again before
they reach school-age. For many of these tested drugs, their side effects
are just now being discovered. These were deemed safe and necessary
by whatever agency paid the highest without regard to our children's
safety. Too many things are being forced on our society without our
consent, and often without our knowledge (gmo's, hormones, etc). This
is merely another vaccination that will be deemed necessary for the
safety of our children which will likely create a wonderful test-study
for some group of doctors and scientists to figure out what went wrong.
Mrs. Jonene Cook
This type of testing should
only be conducted on individuals who have reached the age of consent
and who have chosen to take part in this type of testing. Further, this
should only occur after thorough education has been provided regarding
the potential risks to the subjects who volunteer, and others who care
about them.
Ms. Cecile Childrose. Healthcare Professional
It is insane that you could
even consider giving such a dangerous toxin to children without knowing
the effects it will have. Do you realize that by introducing the vaccine
into the population once again, YOU will be re-introducing smallpox?
The terrorists won't even have to do it...you'll have taken care of
it for them. I am more scared of what our country is saying about this
vaccine than I am about the threat of smallpox! My son has never received
a vaccine. The only shot he has ever had was vitamin k at birth before
he was circumcised. Why don't you ask yourself this...would I trust
the vaccine in my own baby's body? What kind of compensation are you
planning on giving the families of those children considered when their
child is injured or killed? It would be on YOUR heads...not the terrorists.
Mrs. Dana Boyle
Your proposed study on young
children is sick and needs to stop. What is next - the effects of nerve
gas on infants?
Dr. Dave Bergman
I do not believe a small
pox vaccine should be tested on children.
Mrs. Stacey Zierak
Obviously, the gov. understands
the controversy in regards to testing any drug, let alone a drug know
to not only cause death but many known and unknown neurologic side effects
on children or you wouldn't be asking for the public's opinion. The
risks do not out weigh the benefits. Giving a healthy child a dose of
a drug that we know is very dangerous is crazy. If the researchers think
it's so safe, let them use their own children. Not really, I wouldn't
wont one child to receive neurologic damage or death just in the name
of science. Thank You.
Robert Cox MD
This is really a BAD idea.
Children are not lab rats. I can't even imagine what kind of parent
would allow their child to be a part of a study that could even POSSIBLY
cause him/her any harm. I understand the need, but look to history.
There are many human tests that years later turned out to be worse than
ever imagined. We're even still learning the side effects of the Anthrax
vaccine. Testing on children is unacceptable. In this day of modern
science, surely you can figure something else out.
Mrs. Melanie Reinke
I am absolutely oppose to
using 2-5 year old children for small pox vaccination research. It is
unethical and immoral to use children in this kind of research. The
fact that there is even the smallest chance of death seems to be a good
enough reason not to perform the research. There is also a huge risk
to thinking that a tighter band aid over the opening of the shot will
be the answer to the risk. As a doctor that is informed to the pros
and cons to vaccination, I encourage you to stop this test as the risk
of vaccination is too great. I do not want to see children used as lab
rats.
Dr. Jennifer Anacker, D.C.
This is an abomination.
I can't believe that it is even legal to pump our children full of poison.
Maybe if we're lucky, these 40 test children will make it past the clinical
trial, and hopefully anyone they come into contact with won't be affected
too poorly. DO NOT PERFORM THIS CLINICAL TRIAL ON OUR CHILDREN!!!
Dr. Jennifer Miano
I think it's awful and unethical
to give a Trial vaccine to children whose most serious question of the
day is what's for dinner. They are too young to understand why they
are being put though this trial, and the side effects are too serious
for them to have to deal with when the trial vaccine goes wrong. Any
adult in their right mind would not fathom to test any drug on such
small children!
Ms. Kristine Strauss
I would like to know why
it is you want to test a vaccine on our precious children that has a
potential for being deadly when you can try it out on adults that have
lived their lives and not on our children that are just starting out
in the world. When I first heard news about a nation wide vaccination
I was debating on taking my daughter to get the shot when it was time
to get it done and now after reading articles online and this one on
babycenter.com I absolutely will not have my daughter get the shot.
Why on earth would any mother put their childs life at risk for a measley
shot when you don't even know for sure that it will be necessary. I
propose to you that you test it on your own children first before you
ask us americans to endanger our children's lives. Thanks for listening.
One Disturbed Parent.
Ms. Sarah Knapp
I oppose the use or testing
of the Dryvax vaccine on children at this time. The vaccine is old enough
that I believe a full-scale retesting is in order, starting with non-human
trials. More appropriate would be the development of a new vaccine with
today's technology and testing. Risks and side effects that were acceptable
when the vaccine was first released well-outweighed the risks of smallpox.
At this time, we have no certain knowledge that smallpox exists at all
as a biological weapon. My personal feeling is that if they had it,
they would have used it by now. We are not dealing with individuals,
terrorists, or countries known for great self-restraint. Certainly now,
when we have identified the potential risk and have a plan to counter
it, would be a bad time for any use against us. The well-documented
risks of the vaccine, in my opinion, are NOT outweighed by a small (if
any) benefit to these children. I am a strong vaccine supporter in general,
but not on this issue. Thank you for letting me share my views.
Alan Grimes, MD
General Pediatrics Kansas City, MO
I ABSOLUTELY OBJECT to this
study. Why risk the lives of these 40 babies to test a vaccine we may
not even need to use?!?! It is irresponsible and dangerous!
Mrs. Alison Needham
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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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