Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children, Pg 4

Anne, comments 1, 2, 3 are (more or less) short repeats… the others are more substantive so I separated them vera

Sent: Monday, December 02, 2002 6:07 AM
Subject: RE: Docket No. 02N–0466

I DO NOT support the smallpox vaccine  study, Docket No. 02N–0466. I oppose this study!!! Vaccines are proven more dangerous than effective. To test this known to be dangerous vaccine on children is a  crime.    

wisteria haines


From: carlo7
Sent: Monday, December 02, 2002 5:49 AM

I DO NOT support the smallpox vaccine study, Docket No. 02N–0466


Sent: Monday, December 02, 2002 5:31 AM

I DO NOT support the smallpox vaccine study, Docket No. 02N–0466.

Sheri Nakken, R.N., MA


Sent: Monday, December 02, 2002 4:47 AM

My name is Rene LeMay. I want to let you know that I am against your proposed smallpox vaccine study on children ages 2-5 years of age. The C.D.C has already stated that the very young, the elderly and those with weak immune systems are at risk of having adverse reactions to the smallpox vaccine. It is not wise to test it on children ages 2-5 years of age.

Sincerely,  Rene LeMay


Sent: Monday, December 02, 2002 1:34 AM

I DO NOT support the smallpox vaccine study on 2-5 year old children Docket No. 02N6.

Sincerely,  Kristie Richardson


From: William Bicknell
Sent: Monday, December 02, 2002 12:06 AM December 1, 2002

Dr. Leslie K. Ball
Office for Human Research Protection
The Tower Building
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
Re: Docket No. 02N–0466


Sent: Sunday, December 01, 2002 11:38 PM
Subject: small pox vaccine

I do not support the small pox vaccine being administrated to our troops. I would suggest that members of the Congress and Senate receive ALL vaccinations given to military personnel.

Robert Cliburn, Lawton, OK


From: Sue Graham
Sent: Sunday, December 01, 2002 10:05 PM

“Due to ongoing questions about the safety of the smallpox vaccine, I DO NOT support the smallpox vaccine study, Docket No. 02N-0466.”


From: Jay Einhorn
Sent: Sunday, December 01, 2002 9:38 PM

I DO NOT support the smallpox vaccine study on 2-5 year old children Docket No. 02N-0466


From: mpico
Sent: Sunday, December 01, 2002 9:24 PM

I am concerned regarding the future clinical investigation of the smallpox vaccine and children aged two to five.  This seems to be in violation of the two formost principles of the belmont report, in that you are dealing with an impaired or vulnerable population and that beneficeence( harm to benefit ratio) is not a favorable situation.

This infraction of deontology is compounded by the role of government agencies under the common rules A, B, and D.  If federal agencies will not hold to the highest standard how can we expect private research to be conducted responsibly?

MP


From: longtin
Sent: Sunday, December 01, 2002 7:37 PM

Docket No. 02N-0466/Smallpox Vaccine   TIMING IS RUNNING OUT!

“I DO NOT support the smallpox vaccine study,  Docket No. 02N-0466.”

VerDate 0ct<09>2002 14:59 Oct 30, 2002 Jkt 200001 PO 00000 Frm 00025 Fmt 47

Ginny Longtin    


From: Mcro99

Sent: Sunday, December 01, 2002 6:00 PM

I do NOT support the smallpox vaccine study, docket no# 02N-0466


From: Cynthia Hayes
Sent: Sunday, December 01, 2002 4:24 PM
Subject: Docket No. 02N-0466.

I DO NOT SUPPORT THIS! “Due to ongoing questions about the safety of the smallpox vaccine, I DO NOT support the smallpox vaccine study, Docket No. 02N-0466.”


Sent: Sunday, December 01, 2002 7:18 PM

FDA

Gentlepersons:

I would like to object to the propsed trial of Dryvax smallpox vaccine in children age 2 to 5 years old.

There is none or very marginal benefit to currently healthy children. A review of old newspaper reporting shows that smallpox was not nearly as easy to transmit as we are led to believe. and nobody knows if ever there will be an actual exposure. The severe adverse reactions, while rare are so life threatening and SEVERELY disabling that the risks faroutweigh the potential benefit.

Since the srain of any bio-engineered smallpox virus is now unknown it is an utter speculation to attempte to induce an immunity–already a chancy proposition without knowing what the bio-terrorist agent actually is going to be.

Sincerely,
Arnold Gore
Consumers Health Freedom Coalition


From: Geri Nehls
Sent: Sunday, December 01, 2002 4:09 PM
Subject: smallpox

I do not support smallpox vaccine study on children


From: Jerry Hurley
Sent: Friday, November 01, 2002 10:16 AM
To: HHS-Ball, Leslie (OS)
Subject: Correlation Search

Researcher:

It appears that HIV existed among primates all along. Why was it suddenly able to enter human cells? Is it true that the medical records of HIV Positives are sealed? Have there been correlation studies to see why some become HIV Positive while others do not?

What percent of the HIV Positives had received a smallpox vaccination? If they had received one, how long before they became HIV Positive? Or, were they Positive before they got their smallpox vaccination?

When one partner is HIV Positive and one isn’t, what is the difference? What about a correlation study of childhood diseases or, childhood vaccinations? Does the proposed smallpox vaccination program present a window of opportunity?

Yours, Jerry Hurley,


From: KillerBee
Sent: Friday, November 01, 2002 5:26 PM

I live in Iowa City and in our paper it was stated that you are taking opinions about doing research with the smallpox vaccination on 2-5 year olds.

It is unethical to do any kind of research on someone who is either to young, or mentally unable to comprehend exactly what is being done to them. In past history these type of things have been done and always a decade or so later it comes out and everybody says it was wrong and they are so sorry that it happenned. As a parent i cannot comprehend how anybody who loves a small helpless child would put that child in harms way. I can see this in a dictatorship, but here. You are absolutely crazy to consider it. Are these children going to by retarded or handicapped. Is that the criteria and therefore they are expendable. Why would you seriously risk the future health and maybe the like of someone who has no say so over the situation.


From: xxxxxxxxxxxxxxxxxxx
Sent: Friday, November 01, 2002 1:49 PM
To: OHRP
Subject: RE: Small Pox vaccine for children

Just read that the government wants to do a study group on children with the Small pox vaccine (toddlers and preschoolers). In my opinion it would be a bad idea. How many incidents of small pox do we have now anyway? It is not a common disease that we have concern about. The risks are very high of spreading the virus itself, it is very insane to think of doing it.

I am really concerned about the vaccinations we are giving at birth as it is. We have an increase in ADHD, Autism, Aspbergers, and Crib Deaths. Other countries are giving these infant vaccinations at age two or four. What is the hurry on all of this.

Babies have a perfect immune system and we want to weaken it right away.  It makes no sense to me. I am concerned about about this, and hope that my concerns are heard and considered.  Thank you. 

Mary Tiernan


Please consider that for PREVENTIVE medicine, using a live virus that kills some people is unacceptable. Please consider developing a dead virus vaccine. I posted an article with 4 congressmen calling for this last year.

Sincerely, Dr Peter Rickards, Twin Falls , Idaho

From Thursday, December 6, 2001 issue.

Smallpox I: Lawmakers Advocate Dead-Virus Vaccine Four members of the U.S. House of Representatives have signed a letter asking Congress and health officials to pursue a safer form of smallpox vaccine. The four representatives are expected to hold a briefing on the subject today. Representative Curt Weldon (R-Pa.) called for the briefing after meeting with representatives of the Maryland-based biotech firm Novavax, which has been working to develop a smallpox vaccine using a dead virus, rather than a weakened live one that previous and current vaccines use. The letter, signed by Weldon, Joseph Hoeffel (D-Pa.), Connie Morella (R-Md.) and Roscoe Bartlett (R-Md.), followed a decision by the U.S. Health and Human Services Department last week to award a second contract to the British firm Acambis to produce more smallpox vaccine using the live virus (see GSN, Nov. 29). The Acambis vaccine could have serious side effects for some people, and 20 percent of the U.S. population could not receive the vaccine safely, said the letter from the representatives. People at high risk for negative side effects would include young children, the elderly, people with eczema, pregnant women and anyone with weakened immune systems, such as those with HIV (see GSN, Nov. 21). Health officials have said that due to negative side effects, they have no plans to mass-vaccinate Americans against smallpox (see GSN, Nov. 30). They currently plan to vaccinate only people who are directly at risk when an outbreak occurs. The United States needs a vaccine that could be administered to the population before a smallpox outbreak occurs, so a safer vaccine is necessary, the representatives said. Novavax said its dead virus vaccine might fill that need, but some experts question the vaccine’s effectiveness. Novavax said it planned to begin producing the vaccine early next year but would need months or years to test it. The firm has asked for U.S. funding assistance. "If they need a billion dollars to do this [develop a safer vaccine], add $4 to everyone’s tax bill. "If we had a good, safe vaccine, we would revaccinate the U.S.," said Roger Pomerantz of the Center for Human Virology at Thomas Jefferson University in Philadelphia (Julie Appleby, USA Today, Dec. 6).

Dr. Peter Rickards


I believe the FDA’s proposal to inoculate children in efforts to research for a smallpox vaccine is insane. Why are you testing this product on children? You are willing to risk the health of the general public and these small precious lives just because there might be biological warfare. The American public thinks you are crazy. You are way out of line here.

Mrs. Kelly Vetter


I just wanted to go on the record as being against testing smallpox on children. This live vaccine comes with too many risks. Mass vaccination would potentially harm more people than a terrorist attack.

Dr. Brian Lieberman


Depending on the maximum contact that the children at hand will have with society (due to the possible spreading of the virus) the vaccination should be given if the children will be observed constantly and lead normal lives. If such a situation is not possible, then the conditions and procedures of this test must be re-evaluated.

Thank you.

Mr. Abram Lot


Please do not give these doses of Dryvax to children ages 2 to 5. Please test this on other than human beings to BE SURE it is safe to use on our children.

Mrs. Sarah Peterson


I think its completely unethical to administer such an unsafe vaccine to young children. What kind of person would offer their child as such a guinea pig to what is already being called a risky vaccine?

Ms. Kelly Kondrup


I am absolutely opposed to giving vaccinations to children, ages 2-5, or even giving the vaccination to adults. Vaccinia is very dangerous. The basic health of people of this country has deteriorated damatically over the last 50 years. There is a much greater incidence of all kinds of diseases and disorders that reflect a compromised immune system. Subjecting people to vaccinia, those who are actually vaccinated and those who will be exposed to it through being around those who are vaccinated, is too great a risk for the possible benefit.

Mrs. Susan Carfagno


I believe this study should not be done, because of the risk involved for the children and for the people that may come in contact with them. I think the vaccine should be made available only if and when needed. Being that a great number of people are not vaccinated against smallpox currently increases the danger of this kind of test causing problems. I am very uncomfortable with it. One of the factors that increases the danger of side effects is skin diseases such as eczema. Eczema is a very common skin disease that may not be evident yet in these children that are being tested or people they may come in contact with. How about a smallpox vaccine with a non-live virus like the one made for polio. Doctors have now stopped using the live-polio vaccine because of the dangers of getting the disease, couldn’t more study be done to come up with a safer smallpox vaccine that is not so risky?

Mrs. Carrie Baert


it is absurd to do such a thing.these children are the parents responsibility not the government,or FDA who are constantly clearing food and drugs that have been harmfull to many people.there is no smallpox outbreak,but you never know what UNCLE SAM would do to create such a thing.Save our children from such genocide.

Mr. joseph frazee. American Citizen. Health Professional.


Based on studies from the 1960s, 15 of every 1 million people vaccinated will suffer life-threatening reactions, and one or two of them will die. I don’t believe it is ethical to test healthy children with a vaccine that could cause a life-threatening reaction. Especially since the only benifit would be IF a bioterrorist should attack with smallpox. It is entirely possible that any bioterorist attack would be using a technologically altered strain of smallpox, making vaccinating with the original smallpox vaccine ineffective. I understand the vaccine is made of a live virus or vaccinia. Until the injection site heals, the children could scratch the site & transfer the active infection to their eyes, other areas of their body or to their family members. I recommend more undercover work to identify the exact threat before vaccinating our general population with something that could unleash the original smallpox disease in our country.

Dr. Karen Hammel


From: Onstad Dianne
Sent: Monday, December 02, 2002 12:02 PM

I DO NOT support the smallpox vaccine study, Docket No. 02N–0466.


Sent: Monday, December 02, 2002 11:51 AM

I do not support the smallpox vaccine study, docket no. 02N-0466—  

Thank you  

Marion Weis


Sent: Monday, December 02, 2002 11:36 AM

Message:  I DO NOT support the smallpox vaccine study, Docket No. 02N-0466

Barbara Powell


Sent: Monday, December 02, 2002 11:34 AM

I  do not support the smallpox vaccine.

Debbie Milligan, Director of Research
Headache Care Center 1230 E. Kingsley St. Springfield, MO  65804


From: Beth Mortl
Sent: Monday, December 02, 2002 12:05 PM

I DO NOT support the smallpox vaccine study, Docket No. 02N-0466


From: chandramathi vemuri Sent: Monday, December 02, 2002 11:19 AM

I am the mother of an autistic 3 year old child and I  do not support this smallpox trial study.

Sincerely, Chandramathi Vemuri


From: SHAREBRADENTON

Sent: Monday, December 02, 2002 11:16 AM

To: fdadockets@oc.fda.gov

Cc: president@whitehouse.gov

Subject: DO NOT support the vaccine study, Docket #02N-0466


December 2, 2002

TO:  FDA RE: Docket No. 02N-0466

Message: I DO NOT support the smallpox vaccine study, Docket No. 02N-0466

PLEASE do not harm these little children (ages 2-4)…. this vaccine can be deadly!

Sincerely,

Mr. & Mrs. Emmett Dykes
2616 27th Ave Dr W
Bradenton, FL 34205


Sent: Monday, December 02, 2002 11:00 AM

I DO NOT support the smallpox vaccine study, Docket No. 02N-0466.

Sharyn Cerniglia


Sent: Monday, December 02, 2002 10:55 AM

I DO NOT support the smallpox vaccine study, Docket No. 02N-0466

Cindy Stolten


Sent: Monday, December 02, 2002 10:31 AM

Do not attempt clinical trials of small pox vaccine that could hurt children.

Jennifer


From: masktharrett

Sent: Monday, December 02, 2002 10:25 AM

I do NOT Support smallpox vaccine testing,  docket number 02N-0466.


From: RICHARD SHUSTER

Sent: Monday, December 02, 2002 12:13 PM

Subject: “I DO NOT support the smallpox vaccine study, Docket No. 02N0466.”


Sent: Monday, December 02, 2002 11:27 AM

As a health care worker and a parent of a vaccine injured child, I urge you to avoid this vaccine study. Too many of our children have already been damaged.

Mary Brookhart, 1227 Sheridan Ave., Iowa City, Iowa 52240


“I DO NOT support the smallpox vaccine study, Docket No. 02N–0466.” Broad use of un-necessary inoculation with the smallpox vaccine will create unacceptable illness and death to countless numbers, especially children, and to those who are designated as first responders and front line military, medical and emergency personnel.

Richard G. Shuster
7062 Cinnamon Drive
Sparks, NV  89436


I DO NOT support the smallpox vaccine study, Docket # 02N-0466.

Penny Ray
Detroit Michigan


From: FuchsiaStars

I oppose the testing of the Smallpox vaccination on young children.

Lorraine, NJ


From: BAMAFANB4u
Sent: Sunday, November 24, 2002 11:06 AM
Subject: RE: Docket No. 02N–0466

“I DO NOT support the smallpox vaccine study, Docket No. 02N–0466.”


 

Sent: Sunday, November 24, 2002 9:05 AM
Subject: Docket No.02N-0466

Due to ongoing questions about the safety of the smallpox vaccine, I DO NOT support the smallpox vaccine study, Docket  no. 02N-0466.

Fran and Ed Marcyjanik


From: gwen
Sent: Sunday, November 24, 2002 8:21 AM
Subject: Docket #02N-0466

I DO NOT support the smallpox vaccine study, Docket No. 02N-0466.”


Sent: Sunday, November 24, 2002 5:06 AM
Subject: Vaccinations-Small Pox etc.

I am protesting any vaccinations that are mandated by our Government. We have a freedom of choice and I don’t need the government telling me what to do.

Phyllis Miller


“I DO NOT support the smallpox vaccine study,  Docket No. 02N–0466.”

Candice Hughes


I STRONGLY OPPOSE the smallpox vaccine study, Docket No. 02N-0466.”

Barbara Gaines NYC


I am writing to support the effort to eliminate natural rubberstoppers from aqueous solutions in pharmaceutical vials. I am an individual with latex allergy and have experienced allergic responses from latex contaminated vaccines.  I support the following statement by Dr Robert HAmilton on this matter.

Sincerely,

Amy Romanczuk RN MSN


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
Johns Hopkins Asthma and Allergy Center
Room 1A20
5501 Hopkins Bayview Circle
Baltimore, MD 21224 USA


Read more comments
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Comments by Dr. Nelson and Dr. Offit, U of Pennsylvania
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