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Sign your child up FAST! Swine flu trials commencing soon.

snickelfritz
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snickelfritz

snickelfritz

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It's really hard for me to imagine putting my kids into a clinical trial for this.

 

For a condition which the child has been diagnosed with and doesn't have a cure and is otherwise fatal or has severe results (cancer? Parkinsons? Alzheimers?), maybe. Just depends on what the exact circumstances are.

 

But, this? And I find it interesting that they are approved to test on kids but not adults. That's not the way I would enroll my family in a trial. I would do me first, IF I was even going to do it....which I'm not.

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snickelfritz

snickelfritz

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You had me going there for a few seconds too!

 

However...based on this WHO report, 40% over two years and 90,000 mortality (worst case) is pretty sobering.

 

http://news.yahoo.com/s/ap/20090724/..._med_swine_flu

 

Call me paranoid, but I am not letting down my vigilance and guard on this one yet.

 

 

I'm against doing a TRIAL for a vaccine.

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lionfamily1999

lionfamily1999

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It's really hard for me to imagine putting my kids into a clinical trial for this.

 

For a condition which the child has been diagnosed with and doesn't have a cure and is otherwise fatal or has severe results (cancer? Parkinsons? Alzheimers?), maybe. Just depends on what the exact circumstances are.

 

But, this? And I find it interesting that they are approved to test on kids but not adults. That's not the way I would enroll my family in a trial. I would do me first, IF I was even going to do it....which I'm not.

I'm very leery of things that are "okay" for my kids, but dangerous for me :glare:

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snickelfritz

snickelfritz

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What is a Clinical Trial?

 

 

 

A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

 

 

From : http://health.ucsd.edu/clinicaltrials/faq.htm

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Julie in Austin

Julie in Austin

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I'm against doing a TRIAL for a vaccine.

 

How do you think we would end up with vaccines if there were no trials?

 

I find this quite the moral dilemma because I can't honestly imagine signing my children up for a trial . . . but at the same time, I'm more than relieved that my kids can get vaccines (although we do skip/delay some) . . . which were tried on other people's kids.

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snickelfritz

snickelfritz

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.

I find this quite the moral dilemma because I can't honestly imagine signing my children up for a trial . . . but at the same time, I'm more than relieved that my kids can get vaccines (although we do skip/delay some) . . . which were tried on other people's kids.

 

 

I just know that I'm not signing MY child up for a trial, before it has even been done on adults (and it didn't mention if animal testing has been done????). Especially not for a flu, which has thus far, manifested itself in mild cases.

 

ETA: I'm reminded of the scene in "John Adams" where Abigail has the children vaccinated against....Small Pox? She didn't know if the vaccination would work or would kill them. But, she knew that small pox would very likely kill them. That's a whole different situation than this flu....for now. Few decisions are all-encompassing and applicable to every situation. It's a matter of weighing the risks.

Edited by snickelfritz
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mommaduck

mommaduck

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Oh my, I thought you had lost your mind for a moment!

 

 

On the vaccine issue...it is not uncommon for a vaccine to be put out there and the common populace IS the trial (just advertise it and they will not only volunteer, but pay for it! Think Gardisil!) Sorry, but after nearly losing one of my daughters, my kids will not be ANYONE's guinea pigs.

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Perry

Perry

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They are testing different age groups at different sites. Testing will begin in adults first, and if no safety issues are identified, will then start in children.

 

Animal studies have already been done.

 

Source

 

The objectives of the trials are 3-fold:

 

 

  • To assess vaccine safety in healthy people of various ages, including children, once safety in adults is established;

  • To assess the size and number of doses needed to induce a protective immune response; and

  • To assess whether a 2009 H1N1 influenza vaccine can be safely administered at the same time as the seasonal flu vaccine.

 

"These data will be factored into the decision about how and if to implement a 2009 H1N1 flu immunization program this fall," announced NIAID Director Anthony S. Fauci, MD, in a press release.

The 5 trials are:

 

 

  • A comparison of 15 vs 30 mg and 1 vs 2 doses of the Sanofi Pasteur H1N1 vaccine in healthy adults aged 18 years and older;

  • A comparison of 15 vs 30 mg and 1 vs 2 doses of the CSL Biotherapies H1N1 vaccine in healthy adults aged 18 years and older;

  • A comparison of 15 vs 30 mg of the Sanofi Pasteur H1N1 vaccine in healthy children aged 6 months to 17 years, if safety in healthy adults is established;

  • A comparison of simultaneous vs sequential administration of the seasonal flu vaccine and the Sanofi Pasteur H1N1 vaccine in healthy adults; and

  • A comparison of simultaneous vs sequential administration of the seasonal flu vaccine and the Sanofi Pasteur H1N1 vaccine in primed children (children who have received 2 doses of seasonal vaccine in 1 year or who are older than 9 years).

 

 

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snickelfritz

snickelfritz

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because I can't log into the site that you referenced. Or maybe I could, if I signed up?

 

But, my newspaper article said that they are starting the sign up to test children on August 17. Now, I reread and it did say that the particular COMPANY will find out soon if they will test on adults....so maybe other companies are testing on adults?

 

But, if children will be tested as soon as August or September....I don't think that's enough time to really tell if the adults will have an adverse reaction?

 

Again, it's not a dispute, more of a question of clarification because I couldn't read the source that you linked to.

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Liz CA

Liz CA

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They need 200 children between the ages of 3 and 8 from my state and 12,000 nationwide. They're still determining if they want to do adult testing.

 

My 2 children will be first in line to determine if there are any ill effects or long term damage.....um...not.

 

http://www.newson6.com/global/story.asp?s=10783632

 

Testing for side effects of the vaccine? What are these people thinking? We volunteer our children for guinea pigs?

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mommaduck

mommaduck

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Testing for side effects of the vaccine? What are these people thinking? We volunteer our children for guinea pigs?

Not unusual at all. In fact, you would be disgusted if you read about medical experimentation over the past 100yrs in the US alone. And the typical guinea pigs were children (both the general school population as well as those placed in institutions for anything from disability to poverty), the mentally handicapped, and the disabled.

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Danestress

Danestress

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I went to see Bruno. With my 70 year old mother. Who laughed enthusiastically.

 

And so now that I know there are real life women who would have LIPOSUCTION performed on their toddler daughters, I guess I am not surprised that there are willing participants in the "does this vaccine cause hideous side effects" study. But it's hard to imagine!

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mommaduck

mommaduck

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I went to see Bruno. With my 70 year old mother. Who laughed enthusiastically.

 

And so now that I know there are real life women who would have LIPOSUCTION performed on their toddler daughters, I guess I am not surprised that there are willing participants in the "does this vaccine cause hideous side effects" study. But it's hard to imagine!

 

:eek::thumbdown::banghead::glare:

 

That should be akin to child abuse.

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Peela

Peela

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I tell you I am so heartened to read this thread and that obviously so many people are against the rushing in of this vaccine.

I am not even a strongly anti vaccine person but I wouldnt go near the swine flu vaccine with a 10 foot pole.

Something smells fishy about the whole swine flu thing. With a death rate about 10% of the normal flu, I just dont get it and I hope the general public just dont get it too. I dont like being treated like an idiot.

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hillfarm

hillfarm

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I, too, have a serious aversion to vaccinations. However, IMO, this one could possibly be a real help and at the worst will be an insurance policy for the government. The WHO predictions say that if no vaccine is produced and if the flu stays on its current track, "up to 40 percent of Americans could get swine flu this year and next and several hundred thousand could die without a successful vaccine campaign and other measures."

 

Unfortunately they are dealing with a very short timeline for testing a vaccine and have no guarantee that the strain they put into production will still be effective against the vaccine that continues to mutate every hour. They may be fighting a losing battle, but they have no better alternative.

 

The government has to do something. If everything that can go wrong with this flu does, then after hundreds of thousands of deaths, you had better believe the citizens will be screaming to know why a vaccine was not created. By getting one available, no matter whether corners are cut or not, the PTB can say they did what they could.

 

All that said, they're not getting my child as a Guinea pig! When the vaccine is done, at that time I will have to assess the risks of the vaccine versus the risk of contracting the flu and the possible outcomes of each. This is how we did each of the childhood vaccines--I looked at the risk of catching the disease, the likely severity of it, and the risk associated with the vaccine.

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Donna T.

Donna T.

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I always assumed trials were done on animals first, then men, or at least adults? This vaccine is being rushed way too fast. I am confused, but I read that the vaccine maker is protected from lawsuits should people suffer adverse side effects from this particular vaccine.

 

Yes, the trials will take six to eight weeks and require children because baby boomers have some natural immunity already. And, yes, the vaccine makers are fully protected from lawsuits.

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Donna T.

Donna T.

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They are testing different age groups at different sites. Testing will begin in adults first, and if no safety issues are identified, will then start in children.

 

Animal studies have already been done.

 

I'd love to see that info. I've been reading about the trials alot and my understanding is that that is not the case. But, there's so much to read, I'd love to know more about that :001_smile:. I'm finding that the articles sometime contain so much misinformation, it's really hard to find out what exactly is occurring. And, they very often contradict one another.

Edited by Donna T.
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hornblower

hornblower

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I'm not wading into the vax or no vax, test or no test debate but I do want to say this:

 

-this disease is not always presenting as mild

 

-this disease is not targeting the 'normal' population which is affected by the seasonal flu - ie. the elderly, severly immuno compromised/cancer/HIV etc or premature infants: people who were at high risk of death

 

-it is often targeting the young and previously healthy or people with such underlying conditions as:

-pregnancy

-asthma

-copd

-diabetes

-overweight

 

How many people do you know with these conditions? When these people get this flu, many end up on ventilators in ICU.

 

In Canada, our aboriginal population has been extremely hard hit.

 

There are also a number of very troubling cases of previously healthy children who are dying within a day or two of symptom onset. This is not how normal seasonal flu presents. This is a virus for which a certain population has no immunity and which in some cases attacks deep in the lungs fast.

 

This is one of the reasons why the vax is being rolled out for children & prob pregnant women first.

 

 

I'm one of the moderators on the flutrackers site. We try to track cases & news stories. You can check out the death toll for the US

http://www.flutrackers.com/forum/showthread.php?t=115485&page=8

 

Canada's:

http://www.flutrackers.com/forum/showthread.php?p=271315#post271315

 

We are tracking as many countries as we can. Argentina is getting hard to count.

 

Stay healthy ~

 

~hornblower

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Donna T.

Donna T.

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I tell you I am so heartened to read this thread and that obviously so many people are against the rushing in of this vaccine.

I am not even a strongly anti vaccine person but I wouldnt go near the swine flu vaccine with a 10 foot pole.

Something smells fishy about the whole swine flu thing. With a death rate about 10% of the normal flu, I just dont get it and I hope the general public just dont get it too. I dont like being treated like an idiot.

 

I agree.

Edited by Donna T.
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Perry

Perry

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I'd love to see that info. I've been reading about the trials alot and my understanding is that that is not the case. But, there's so much to read, I'd love to know more about that :001_smile:. I'm finding that the articles sometime contain so much misinformation, it's really hard to find out what exactly is occurring. And, they very often contradict one another.

 

 

NIAID

 

NIAID Set to Launch Clinical Trials to Test 2009 H1N1 Influenza Vaccine Candidates

 

Scientists in a network of medical research institutions across the United States are set to begin a series of clinical trials to gather critical data about influenza vaccines, including two candidate H1N1 flu vaccines. The research will be under the direction of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

“With the emergence of the 2009 H1N1 influenza virus, we have undertaken a collaborative and efficient process of vaccine development that is proceeding in stepwise fashion,” says NIAID Director Anthony S. Fauci, M.D.

After the isolation and characterization of the virus, the U. S. Centers for Disease Control and Prevention generated and distributed a 2009 H1N1 seed virus to vaccine manufacturers for the development of vaccine pilot lots for testing in clinical trials.

“Now, NIAID will use our longstanding vaccine clinical trials infrastructure—the Vaccine and Treatment Evaluation Units—to help quickly evaluate these pilot lots to determine whether the vaccines are safe and to assess their ability to induce protective immune responses,” says Dr. Fauci. “These data will be factored into the decision about how and if to implement a 2009 H1N1 flu immunization program this fall.”

Initial studies will look at whether one or two 15 microgram doses of H1N1 vaccine are needed to induce a potentially protective immune response in healthy adult volunteers (aged 18 to 64 years old) and elderly people (aged 65 and older). Researchers also will assess whether one or two 30 microgram doses are needed. The doses will be given 21 days apart, testing two manufacturers’ vaccines (Sanofi Pasteur and CSL Biotherapies). If early information from those trials indicates that these vaccines are safe, similar trials in healthy children (aged 6 months to 17 years old) will begin.

A concurrent set of trials will look at the safety and immune response in healthy adult and elderly volunteers who are given the seasonal flu vaccine along with a 15 microgram dose of 2009 H1N1 vaccine. The H1N1 vaccine would be given to different sets of volunteers either before, after, or at the same time as the seasonal flu vaccine. If early information from those studies indicates that these vaccines are safe, similar trials in healthy children (aged 6 months to 17 years old) will start.

A panel of outside experts will conduct a close review of the safety data from these trials to spot any safety concerns in real time. Information from these studies in healthy people will help public health officials develop recommendations for immunization schedules, including the optimal dosage and number of doses for multiple age groups, including adults, the elderly, and children. Data may also be used to support decisions about the best recommendations for people in high risk groups, including pregnant women and people whose immune systems are weakened or otherwise compromised.

The trials are being conducted in a compressed timeframe in a race against the possible autumn resurgence of 2009 H1N1 flu infections that may occur at the same time as seasonal influenza virus strains begin to circulate widely in the Northern Hemisphere.

Close collaboration among NIAID, the U.S. Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (a component of the Department of Health and Human Services) was key to launching the trials quickly while ensuring high standards. Following initial discussions between the agencies on trial design, NIAID prepared the protocols and submitted them to the FDA for review. FDA rapidly completed the necessary reviews and approved the trial protocols.

Since 1962, NIAID’s Vaccine and Treatment Evaluation Units (VTEUs) have been intensively involved in the successful development and clinical testing of vaccines and treatments against many pathogens that threaten the health of people in the United States and around the world. Among the vaccines tested have been those that prevent seasonal influenza, H5N1 avian influenza and pneumococcal pneumonia.

The VTEU network consists of eight university research hospitals and medical organizations across the United States that provide a ready resource for conducting clinical trials that evaluate vaccines and treatments for a wide array of infectious diseases.

An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into trials and to immunize the volunteers in a safe, effective and efficient manner. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns. Results are expected to be available weeks after the trials begin.

NIAID’s Vaccine and Treatment Evaluation Units include the following:

 

 

  • Baylor College of Medicine, Houston

  • Children’s Hospital Medical Center, Cincinnati

  • Emory University, Atlanta

  • Group Health Cooperative, Seattle

  • Saint Louis University, St. Louis

  • University of Iowa, Iowa City

  • University of Maryland School of Medicine, Baltimore

  • Vanderbilt University, Nashville, Tenn.

 

Further information about the five trials can be found at ClinicalTrials.gov at the following links:

 

 

  • 09-0053 Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine Given at Two Dose Levels to Healthy Adult and Elderly Populations

     

     

    [*]09-0043 Unadjuvanted CSL H1N1 Influenza Vaccine Given at Two Dose Levels to Healthy Adult and Elderly Populations

     

     

     

    [*]09-0039 Licensed Seasonal Flu Vaccine Given Together or Sequentially with Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine in Healthy Adult and Elderly Populations

     

     

     

    [*]09-0054 Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine Administered at Two Dose Levels to Children

     

     

     

    [*]09-0047 Licensed Seasonal Flu Vaccine Given Together or Sequentially with Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine in Previously Primed Children

     

     

     

     

 

For more information about the 2009 H1N1 clinical trials, see Questions and Answers: Clinical Trials of 2009 H1N1 Influenza Vaccines Conducted by the NIAID-Supported Vaccine and Treatment Evaluation Units.

For more information on influenza, visit www.flu.gov for one-stop access to U.S. government information on avian and pandemic influenza. Also, see http://www3.niaid.nih.gov/topics/Flu/.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

 

###

 

 

 

Edited by Perry
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