October 26

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

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

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

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 7 (Comments in Support)
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Comments Page 10 (Detailed Comments)
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