Testing Anthrax vaccine on children

Someone explain to me how you test the ‘Anthrax vaccine’. Would you not have to expose people who were given the anthrax vaccine to ‘ANTHRAX’? You know, to see if the vaccine works.

This from wikipedia [link below]: "While effective in protecting against anthrax, the licensed vaccine schedule is not very efficient, involving a cumbersome six dose injection series. Typically, six injections are given over a period of 18 months in order to induce a protective immune system response."

So unless we know 18 months in advance …..

"The shelf-life of BioThrax is reported to be three years, the Strategic National Stockpile retains a current unexpired inventory of 60 million doses of BioThrax. The US GAO reports that 4 million doses of the inventory will expire every year, requiring vaccine destruction services."

You know we cant let the stockpile go to waste. I wonder what the cost will be to a regular Joe and how much profit someone will make. Think H1N1 swine flu.

[Bold text below added]

via The Washington Post

The Obama administration is wrestling with the thorny question of whether scientists should inject healthy children with the anthrax vaccine to see whether the shots would safely protect them against a bioterrorism attack.

The other option is to wait until an attack happens and then try to gather data from children whose parents agree to inoculate them in the face of an actual threat.

and….

The vaccine has been tested extensively in adults and has been administered to more than 2.6 million people in the military. But the shots have never been tested on or given to children, leaving it uncertain how well the vaccine works in younger people and at what dose, and whether it is safe. Unlike with measles, mumps and other diseases, the chance that children will be exposed to anthrax is theoretical, making the risk-benefit calculus of testing a vaccine on them much more questionable.

“It’s hard to believe that it’s something that makes a great deal of sense,” said Joel Frader, a pediatrician and bioethicist at Northwestern University’s Feinberg School of Medicine. “It would be difficult to justify testing it on kids simply on the hypothetical possibility that there might be an attack.”

and …

The federal government has spent $1.1 billion to stockpile the vaccine to protect Americans in the event of an attack.

and…

“With this, you’re putting children at risk for no clear scientific or medical benefit,” said Meryl Nass, a doctor in Bangor, Maine, who is one of the most outspoken critics of testing the vaccine in children. Nass and others maintain that there are serious questions about the vaccine’s effectiveness in adults as well as concerns about sometimes serious complications among those vaccinated in the military. A variety of complications have been reported, including nervous system and autoimmune disorders, Nass said.

and last but not least…

After sifting through the scientific, social and ethical conundrums raised by this question, the eight-member working group concluded that it would be ethically justifiable to conduct a study, which would provide crucial information, such as whether the vaccine is safe and how many doses would be needed.

see related:

Next 9-11 attack flagged in Nicolas Cage movie “Trespass”?? : ‘Wall Street, Anthrax … and who knows what else.’

ELEven NINe : an extinction level event set to happen on 11/9 (or “Extinction Level Event Notable Impact November“)

More info via http://en.wikipedia.org/wiki/Anthrax_vaccines

Vaccination schedule

Vaccination with Emergent BioSolutions BioThrax AVA and BioThrax IM intramuscular injections in the deltoid is given at 0 and 4 weeks, with three vaccinations at 6, 12, and 18 months, followed by annual boosters.

As of December 2008, the new BioThrax IM for intramuscular injections in the deltoid was approved by the US FDA which changes the immunity initialization sequence from 6 to 5 shots given at 0 and 4 weeks and then at 6, 12, and 18 months, followed by annual boosters. This prolonged initialization sequence is required with annual booster shots, because the anthrax vaccine’s primary ingredient, the Anthrax Protective Antigen, can impair the life-cycle of the human immune system’s memory B-Cells and memory T-cells, through inducing the production of immunoglobulin G (IgG) which sequesters furin.

The loss of memory B-Cells leads to declining concentrations of IgG which can sequester APA, and therefore declining tolerance to the presence of anthrax bacteria. There is the potential that other memory B-Cell populations will be adversely affected as well.

Furin is the protein activator for pro-parathyroid hormone, transforming growth factor beta 1, von Willebrand factor, pro-albumin, pro-beta-secretase, membrane type-1 matrix metalloproteinase, gonadotropin, and nerve growth factor. Furin is also essential to maintain peripheral immune tolerance by creating memory T-cells and suppressor T-cells.[8]

Because IgG will cross the maternal fetoplacental blood-barrier, Furin-sequestering IgG can cause severe congenital birth defects during pregnancy.[9]

The approved US FDA package insert for Anthrax Vaccine Adsorbed contains the following notice:

Pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus.[10]

Contraindications

The approved US FDA] package insert for Anthrax Vaccine Adsorbed contains the following notice:

* Severe allergic reaction (e.g., anaphylaxis) after a previous dose of BioThrax&trade.

* Administer with caution to patients with a possible history of latex sensitivity because the vial stopper contains dry natural rubber and may cause allergic reactions.[10]

Adverse reactions

The approved US FDA package insert for Anthrax Vaccine Adsorbed contains the following notice:

The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema and arm motion limitation. The most common (>5%) systemic adverse reactions were muscle aches, fatigue and headache.

Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax™.[10]

Drug interactions

The approved US FDA package insert for Anthrax Vaccine Adsorbed contains the following notice:

Immunosuppressive therapies may diminish the immune response to BioThrax.[10]

Adjuvant

The Anthrax Vaccine Adsorbed contains aluminium hydroxide as an adjuvant.[3] Each dose of the vaccine contains no more than 0.83 mg aluminum per 0.5 mL dose. This is near the allowed upper limit of 0.85 mg/dose.[11] The BioPort anthrax vaccine also contains 0.0025% benzethonium chloride as a preservative, and 0.0037% formaldehyde as a stabilizer.[3]

In 2007, tests with mice of the anthrax vaccine using aluminum hydroxide adjuvant were reported as resulting in adverse neuropathy symptoms.[12]

Concern has been raised that the Pentagon did not inform the United States Congress about more than 20,000 hospitalizations involving troops who had received the anthrax vaccine, because “hospitalizations merely followed vaccinations in time, without documented proof of a cause-and-effect relationship.”[15] Independent researchers, David and Mark Geier, published “Anthrax vaccination and joint related adverse reactions in light of biological warfare scenarios” in Clinical and Experimental Rheumatology in 2002 vol. 20 page 119. They also published “Gastrointestinal adverse reactions following anthrax vaccination” in Hepatogastroenterology in 2004 vol. 51 page 762. The Geiers found a very large and statistically significant increase in joint symptoms and gastrointestinal problems following vaccination with anthrax vaccine. These authors concluded that due to the extreme reactogenicity of anthrax vaccine, its general use in the civilian population is undesirable. The safety of the U.S. anthrax vaccine continues to be an active area of study for both government and non-government personnel, but to date no data have been found that have caused the FDA to declare the vaccine anything other than safe and effective.[6]

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One thought on “Testing Anthrax vaccine on children

  1. Ive always wondered about the troop who came back from derest storm #1. They have all kinds of health problem. Yes Im sure the oil fileds burning wasnt good on them amonst other things that happened there. Then there are the vaccines. As any of you who know anything about the military, the inject you with all kinds of shit and you really dont know what they inject.

    Injecting Kids? Thats just nuts to me. Hey, I got an Idea. Lets stop pissing other countries off so we DONT HAVE TO WORRY ABOUT GETTING ATTACK!….as much anyway.

    By the way ,Thanks for the add B,man. I’ll see about an introductory post tomorrow!

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