November 12

Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children, Pg 7

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

The following comments supported the smallpox vaccine trial:

I believe this is a necessary and very much needed trial. What if tomorrow smallpox was to become a problem? Since children are more susecptible to it, I am sure many would die. Thsi test might save, in the long run, hundreds of lives if it where implemented.
Mrs. Kristin Price

Yes, I would like to see clinical testing performed on children under 5.
Mrs. Carolyn Kuti, RN
Allentown Health Bureau

I completely support vaccination of the entire US population against variola (smallpox). Any steps towards attaining this goal as quickly as possible should be taken immediately. Smallpox epidemic by release by terrorists is a clear and present danger to our society.
Thank you.
Mr. Paul Durieux

I am an RN with ER and ICU experience with pediatrics and adults. I have been a member of APIC. I am currently the administrator of a home health agency. I support the randomized study. I believe it is important to have some idea how pediatric populations will respond to the vaccine. 40 children is probably not a large enough study. My children are older than that or I would be offering to have them included in the study. I’m still willing to have them vaccinated and studied, but they are 12 and 13. Sure there are risks. But a terrorist-induced epidemic would result in far more deaths or complications. And our children will be exposed if/when we vaccinate adults. Let’s not fly blind; let’s get some information on the vaccine response in children.
Mrs. Karen Jackson

I believe that all children, and adults, should be vaccinated against small-pox. We did this routinely when I was a child, and my four children all were vaccinated against this terrible disease. Done correctly, there should be no greater risk than any other vaccination. I’m sure that if any of these people who are against vaccination were ever to witness first hand just how horrible the disease is, they would be first in line to receive the vaccine. There is a small time period of generally feeling ill, but it goes away and DOES NOT LEAVE POX SCARS (except at the vaccination site) which can be extremely disfiguring. Also, people do die from contracting Small pox. I would never want to expose my children or grandchildren to the dangers of suffering through Small pox. Not being vaccinated if a vaccine is available is the height of criminal foolishness!
Frisco, TX

We are faced with the real possibility of attack with biological weapons, and have drawn up plans to innoculate the entire unvaccinated segment of this country in a 10-day period. And someone has ethical qualms about running a clinical trial to test the efficacy of a dilute vaccine in children. I note that the article soliciting comments in the Washington Post of November 12, 2002 does not include any critical evaluation of the trial protocol, but instead questions the ethical rational for doing a trial itself, based on the assumption that an attack will never happen. We cannot afford to make that assumption, because if we do, we encourage an attack to take place. Assume the worst: Assume that some of these proposed 40 children ARE vulnerable to some aspect of the vaccine. Would it be better for these children to be part of a clinical trial where they are watched closely by highly trained researchers, or part of a massive vaccine effort? Further, if there is a problem with the dilute vaccine, wouldn’t it be better to know about it, and possibly find ways to mitigate it, or detect the markers of a likely bad reaction, before we are put in the unlovely position of vaccinating all our scoolchildren at once? If we are attacked, and if the d ilute vaccine has not been tested, the only alternative will be to use the higher doses. And the vast majority of people who will be vaccinated will be children. Let’s also not be too impressed with the numbers. The smallpox vaccine is not ideal, but it has been used in an enormous number of people without bad side effects. There will be no shortage of volunteer parents who want this protection for their children now, before an attack can take place. I am one of them. I have a little scar on my arm, and two sons who could die in pain because some people think they can hide their heads in the sand instead of facing the real dangers we have. The better plan is to go forward with this clinical trial, as well as further research to identify 1) who should NOT be vaccinated, and 2) whether any of the new antiviral drugs might be used to treat the disease. If we identify who should NOT be vaccinated, we can still use this imperfect vaccine to protect all our people, including those with impaired immune systems. That is what vaccines are for. The clinical trial should go forward, and plans should be made to begin voluntary vaccination of our population. A very real prospect is that the voluntary program could take an attack via smallpox off the table. Obviously, the terrorists would be able to turn to something else. But if we deny them at least a few of their weapons, we may buy enough time to catch them before they have a real effect.
Valerie E. Looper. Law Offices of

I do not understand the current furor regarding the smallpox vaccination and the testing on children thereof. The innoculation was given to billions of people throughout the world, adult and children alike, for decades until the early 1970’s, and the vast majority of those who are alive (many having deceased due to natural causes unlinked to the vaccination) have never had a problem, lingering or otherwise, related to said smallpox virus. What is it that now makes the serum so dangerous? Has there been a measurable change in the type of virus used? Why is it that this generation is so molly-coddled that useful treatment/preventation from the past is questionable now? There are consequential possibilities related to every single thing that occurs in the life of a human being, and if the narrow margin of problem affects so few then let us think of the majority. I am dismayed to read that the field will so narrowed–years ago the only persons not given the virus were those allergic to eggs. I, myself, have a child who had an averse reaction to the vaccination; however, if I had it to do again I would do so. For once, let us think of the majority and stop cow-towing to special interest minority objection. With men like Sadaam Hussein inhabiting the earth we need to leave no stone unturned to protect our country and her people.
M. Geldmacher,
Yuma, AZ

It seems clear that, if information released by the media regarding the possibility of a smallpox outbreak anywhere in the world is accurate, vaccinating all U.S. citizens will become a reality. Any medical action carries risk; if the clinical trial truly is the only way of evaluating the vaccine, then I support proceeding with the study.
Ms. Laila Barker

Any assessment of risk to children from a smallpox bioattack, for the purpose of justifying vaccine trials, must consider not only the likelihood of an attack per se but also the likely pediatric fatality rate were exposure to occur. That smallpox historically killed typically 30 percent of its victims in naturally occurring outbreaks is a dangerously misleading statistic within the context of bioterror risk assessment. In a naturally occurring outbreak, infections sufficiently massive to result in the commonly fatal flat and hemorrhagic forms of the disease – collectively known as black pox – are relatively rare. In the event of a deliberate smallpox bioattack using concentrated aerosols released clandestinely in closed, poorly ventilated spaces occupied by large numbers of children, however, our risk assessment should be anticipating a far higher incidence of the usually fatal forms, certainly among those born after 1972 who have no immunity. A 1924 Canadian outbreak killed 50 percent of those infected, and no one was even trying to kill anyone. Weaponized variola, the virus that causes smallpox, could possibly wipe out a generation. The potential for catastrophic consequences from a threat of unknowable credibility surely justifies these vaccine trials.
–John Buder

Government should proceed with these tests. Smallpox vaccines should be made available to everyone. Each person should have the right to wigh the risks of vaccine against the risks of bio-terror.
Ms. Alice Kimble

It was foolish of our government to ever assume that this disease had truly been eradicated. It is in the best interest of all of us (parents, citizens, humans) to innoculate everyone to remove the smallpox threat. This testing needs to move forward.
Ms. Lynda Johnson

I support the clinical trial.

This vaccine in its original dose was used for decades. It is an effective vaccine. The 1:5 dilution has already been tested in younger people (20-32) earlier this year and it was proven to be effective with no severe side effects. This vaccine has also has been tested recently in another country with no serious side effects. When the vaccine was used previously it was common to vaccinate around the age of one year. These children will be monitored closely and they will be screened appropriately. Every thing must be done now to prepare for the possibility that we may need to vaccinate large amounts of people in a very short time period. Those parents who want their children vaccinated as well as the parents themselves who may or may not have been vaccinated in the past should have the vaccine available to them after being screened for risks. I would have my children vaccinated as well as getting a booster for myself.

Mr. John Howell

I am an RN but am also a mother and grandmother. I believe the children as well as all US citizens should begin to get the smallpox vacinne as we used to years ago. I feel biological warfare using the smallpox virus is not that unrealistic. We all are aware of the possibility esp. after the Anthrax scare. Now is the time. Voluntarily of course.

Alison Cowen

From: Swider, Marlene (CBER)

If smallpox vaccine research takes place: 1) parents consenting participation of their children should be fully informed and understanding of all known risks involved should be shared with them; 2) the usage of the special bandage (very hard to get off — especially by the children) should be a must.

Thanks, Marlene Garcia-Swider
(mother of two and vaccine’s manufacturing investigator)
Scientist Reviewer, Division of Manufacturing and Product Quality, CBER, FDA

I believe that this research trial should go forward as soon as possible, especially given the possibility of the U.S. going to war against Iraq. As of now the children of the United States are completely without any pre-vaccination defense against smallpox. We need this and other trials so that we have as much information as possible about the effectiveness (as well as the risks) of smallpox vaccination. I also hope that in the near future all Americans will have the choice to vaccinate themselves and their families.

Mr. William Tell

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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