Posted on 10/31/2011 8:29:24 PM PDT by neverdem
An advisory board to the U.S. Department of Health and Human Services this afternoon urged the U.S. government to launch a controversial trial of the anthrax vaccine in children. The 12-1 vote backs a September recommendation from a working group that spent about 3 months weighing the pros and cons of such a study and came out in favor of it.
Today's recommendation, by the National Biodefense Science Board (NBSB), isn't binding, and even if a study goes forward it will have to jump through many hoops before it can get up and running. That's because a trial like this one is almost without precedent in modern medical research: It involves giving children a vaccine that is almost certain not to benefit them, and that might harm them, all to protect other children from an unlikely scenario—a large-scale anthrax attack.
That said, "the science is clear that we need to do this," says Daniel Fagbuyi, the medical director of disaster preparedness and emergency management at Children's National Medical Center in Washington, D.C. Fagbuyi chaired the NBSB Anthrax Vaccine Working Group with seven voting members, all of whom are also part of the NBSB. The lone dissenter on the vote was Patricia Quinlisk, state epidemiologist and medical director of the Iowa Department of Public Health. Quinlisk chairs the NBSB and also sat on the working group, but said without elaborating that she could not support the recommendation.
The working group began considering a pediatric anthrax trial back in the spring at the government's request. The concern was that researchers have tested other vaccines given to children beforehand, to ensure that they're both safe and effective, but the anthrax vaccine never has been given to children. In a real disaster, medical personnel would be making decisions on the fly, uncertain whether children would react as adults do to the vaccine dose. For some vaccines, like tetanus, "the same dose is given to a 2-month-old infant and an NFL football player," says John Grabenstein, senior medical director for adult vaccines at Merck, who also sat on the working group and voted in favor of the recommendation this afternoon. Other vaccines, like hepatitis B and flu, are dosed differently in kids.
"For me, this decision comes down to, would I rather the first exposures [in children] occur before mass exposures or not, and I would," said Grabenstein during a conference call this afternoon prior to the vote. "I'd rather know what the response to the vaccine is before offering it to many, many, many thousands of children."
In adults, studies have suggested that the anthrax vaccine is quite safe; it's made with inactivated protein from the anthrax bacteria, much like vaccines that protect against diptheria and tetanus. Generally, however, studies in children must meet a higher standard than adult trials in protecting children from risk, particularly if the treatment has little chance of providing benefit. And that's where some worry that the proposed anthrax trial fails to meet ethical standards.
"I don't see how you can ethically do a study on a child where there is no chance the child benefits from that study," says Paul Offit, an infectious disease specialist at the Children's Hospital of Philadelphia in Pennsylvania, who often speaks out in favor of childhood vaccination. Offit attended one of the meetings of the working group and spoke out against a study. "I didn't prevail," he says.
Another big question is who would enroll their children in a clinical trial like this one. Fagbuyi, who served in Iraq as a U.S. Army Major and received the anthrax vaccine himself, says that some military members, first responders, and scientists working with anthrax—many of whom get the vaccine now—have expressed interest in having their children vaccinated, too. They may be comfortable volunteering them for an anthrax study, if it gets off the ground.
I say you ask for volunteers and do the study.
If we get hit with Anthrax, you may not be able to vaccinate enough people in time to prevent death.
Were I President, I’d vaccinate my children and allow a third party agency verify that my kids were carrying the antibodies.
A vaccine against Anthrax is a big, big deal. I’m very glad there are efforts within government to protect against weapons like this.
A mandate is only a short step away, especially for an administration which thinks it can Constitutionally require you to purchase health insurance (not "care").
Close, test it on the children of these board members, their siblings children, and any one else that is in their family, test all of THEIR children first.
Then test it on all the children in the federal government, including the White Huts two girls.
THEN, they can see if it is safe, then the general population can take it, IF they want to.
My husband is a tough as nails soldier.
I’ve seen him come down with the flu once in 22 years. Other than a mild case of the ‘sniffles’ once a winter, he’s never sick.
The anthrax shot turns him inside out. He’s sick for a week after. It’s the only thing that we *know* will bring him to his knees and he’s had it three or four times. (I’ve lost count, but you can believe that *he* hasn’t!)
Everything that we do medically to our children involves a risk/benefit analysis. There is no way I’d subject my kids to this shot without a good reason.
As another poster pointed out, the odds are that an anthrax attack wouldn’t be a wide-spread crisis. It would be a localized problem.
AT THAT TIME, we break up the already exposed kids into two groups - one that gets the higher dose and kids that get the lower dose. Exposed children would be at risk and it would be ethical to give them the shot. It is not ethical to give a healthy child a vaccination that may harm them when their risk of exposure to the pathogen is nearly zero.
I recall the broadcast, and the word was that what the Ford family received on TV was not the vaccine, but sterile normal saline solution.
There had been many claims of problems with the vaccine (which is why the publicity stunt). Would you risk the life of the POTUS, (recall, this was 1976) or his effectiveness over a shot when you can screen persons in contact with him?
In the end, the vaccine is credited with more deaths than the disease.
The trouble with that approach is that it usually takes a few weeks to generate an immune response as measured by specific antibodies for anthrax, IMHO.
I believe you are correct, but darn, I just don’t see giving this to kids.
That’s because a trial like this one is almost without precedent in modern medical research: It involves giving children a vaccine that is almost certain not to benefit them, and that might harm them,
///
the United Nations, and the New York Times,
wants to give ALL children in the world,
the Gardasil vaccine.
...which ONLY prevents 4 HPV viruses of 126,
and ONLY helps if the child is sexually active.
and then possibly only for 5 years.
at the low cots of $360 for the 3 shots?
A Vaccine May Shield Boys Too (Gardasil )
New York Times ^
UN Wants Billions for STD Vaccination Scheme
http://www.freerepublic.com/focus/f-bloggers/2795479/posts?page=13#13
I suggest we try it on their kids first.
They can take their vaccine a shove it.
Our children aren’t lab rats.
‘I wouldn’t allow my child 3,000 yards of that “vaccine”.’
Let’s try the vaccine on Obama.
“Our children aren’t lab rats.”
No they are not, and even our soldiers have been harmed by taking the vaccice:
” In this case, “protecting” means injecting children who will probably face no threat of being exposed to anthrax with a vaccine that has caused the most fit Americans, its servicemen, such severe reactions as heart problems and diabetes.”
“The Government Accountability Office (GAO) reported in June 2007 that “some servicemembers who received the anthrax and smallpox vaccines” experienced “severe reactions such as migraines, heart problems, and the onset of diseases including diabetes and multiple sclerosis.”’
And since there’s such a small chance that our children won’t be exposed to anthrax, imo, and the opinion of experts, it’s not worth the risk.
I think that is the sum of it. The risk outweighs the benefit.
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