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FDA approves shortened anthrax-vaccine course
by Lisa Schnirring Staff Writer -
CIDRAP - Monday December 22, 2008
The US Food and Drug Administration (FDA) recently approved a new version of BioThraxthe nation's only licensed anthrax vaccinethat requires fewer doses and changes the injection route.
Emergent BioSolutions, maker of BioThrax, said in a Dec 19 press release that the FDA's approval of the company's supplemental biologics license application for its anthrax vaccine adsorbed (AVA) allows a new schedule for the vaccine: five intramuscular (IM) doses compared with the previous regimen of six subcutaneous doses.
The vaccine is required for US military members who are deployed to the Middle East, but some have objected to the vaccine because of side effects.
The FDA's approval is based on early findings from a large multicenter trial that was initiated by the US Centers for Disease Control and Prevention (CDC) in 2002, according to the statement from Emergent. The goal of the study is to evaluate if as few as three doses of the vaccine administered over 6 months with booster do...
Commentary:
Pardon the sarcasm but oh, big fat discovery. The original protocol when this vaccine was first developed was only for 3 doses; there was never any research to back up the change to 6 doses; and on top of that, the label was changed to reflect the practice of 6 doses, not to dictate the accepted protocol of 3 doses. Now they're claiming they've done some research and made the discovery that just 3 doses were needed all along. Any sacrifice of our service members in order to save face, is that it?
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Self (inflicted) defense can up risk
by http://www.gao.gov/products/GAO-08-108T -
Baltimore Examiner - Sunday November 23, 2008
Two clear facts shine from the clouded mystery of anthrax attacks on America and our governments tenuous claim seven years later of closing the case with the suicide of a suspect.
Fact No. 1: Government warnings about anthrax being a weapon of mass destruction were false. Somebody dispersed the most lethal strain our tax dollars can produce weapons-grade or near enough via the U.S. Postal Service, exposing tens of millions of people, yet managed to infect 22. Five died. But from anthrax vaccination, at least 21 died and thousands reported a wide range of illnesses.
Fact No. 2: If FBI accusations against their prime suspect in the 2001 attack are true, it means billions of dollars taxpayers invested on the premise of prevention actually increased the risk.
When senior biodefense researcher Bruce Ivins died from an overdose of Tylenol 3 after being identified as sole suspect, our central
government declared the crime solved.
However, co-workers at the U....
Commentary:
Link to GAO reports
High-Containment Biosafety Laboratories
http://www.gao.gov/products/GAO-08-108T
Issues Associated with Expansion
http://www.gao.gov/products/GAO-07-333R
Read the vaccine series:
Scientific impossibility
Sickening results
Costly program
Pentagon responds
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Costly Program with a Shady Past
by Deborah Rudacille -
Baltimore Examiner - Thursday November 20, 2008
The Food and Drug Administration licensed Anthrax Vaccine Adsorbed in 1970, based on a 1950s study of textile mill workers who processed imported goat hair. Each year, several mill workers contracted anthrax, a disease that humans get by touching, breathing or ingesting the pathogen bacillus anthracis from infected animals.
Of the 400 vaccinated workers, three contracted anthrax, and all of them developed cutaneous anthrax, a skin infection that is rarely fatal if treated with antibiotics. The FDA then approved AVA as safe and effective against cutaneous anthrax.
When anthrax is inhaled, however, its spores germinate in the lungs, releasing toxins that cause internal bleeding and death.
For nearly two decades, scientists studying B. anthracis in biodefense programs like the one at Fort Detrick in Frederick received the vaccine that the Michigan State Department of Public Health produced under contract to the Pentagon.
During the first Gul...
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The Pentagon Responds to Anthrax Articles
by Eileen M. Lainez, Pentagon spokeswoman -
Baltimore Examiner - Thursday November 20, 2008
We vaccinate our service members to protect them against deadly diseases, both natural and those potentially spread by terrorists or enemy forces. We take very seriously the potential use of weapons of mass destruction by terrorists. Anthrax is a deadly infection, and this vaccine is a [protective] measure to combat it.
The Food and Drug Administration has repeatedly found, and independent medical experts have confirmed, that the anthrax vaccine is safe and effective. Mandatory vaccinations are designated for uniformed personnel assigned to Central Command [in the Middle East] and Korea areas of operation for 15 or more consecutive days.
Vaccinations are also extended to emergency-essential and equivalent [Department of Defense] civilian and contractor personnel carrying out mission-essential services serving in the Central Command and Korea areas of operation for 15 or more consecutive days.
To date, with vaccines we have protected almost 2.1 million s...
Commentary:
Ms. Lainez, surely you can quote chapter and verse on peer-reviewed, published research to support your "safe and effective" claims?
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| Press
Room... |
7-year anthrax emergency declared along with vaccine/remedy immunity
Monday October 20, 2008
But Sen. Edward Kennedy, D-Mass., and some other Democrats, along with consumer groups such as Public Citizen, derided the liability provision as a g...
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"All the Way Home" move trailer; movie to be shown in Congress Wednesday, July 23
Monday July 21, 2008
"All the Way Home," a movie featuring our own Vance Wasden, long disabled from the anthrax vaccine, and other disabled vets on the outdoor experience of a lifetime, will be shown in Congress this Wednesday, July 23, and later to the VA with future distribution via cable channels. Stay tuned, and enjoy the trailer!! You can also order the full DVD from this site.
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Bill in Congress Needs Leaders, Support, to overcome Feres Doctrine
Monday June 09, 2008
5/20/2008--Introduced.
Carmelo Rodriguez Military Medical Accountability Act of 2008 - Amends the Federal Tort
Claims Act to allow claims...
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| Anthrax
Vaccine Fast Facts ... |
Federal
Court Ruling: "The involuntary anthrax vaccination program,
as applied to all persons, is rendered illegal absent informed
consent or a Presidential waiver." Click
here for Judge Emmet Sullivan's decision.
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Congressional
General Accounting Office (GAO) Findings on the Safety and
Efficacy of the Anthrax Vaccine. NSIAD-00-54R
-- Abstract
-- "The long-term safety of the vaccine has not been studied"
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GAO
-- Medical Readiness: Safety and Efficacy of the Anthrax
Vaccine. T-NSIAD-99-148
-- Abstract
-- "The nature and magnitude of the military threat of biological
warfare (BW) has not changed since 1990"
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Hypersensitivity
Pneumonitis Following Anthrax Vaccination by LT Suzanne
J. Timmer, MD, MC,USNR; CAPT Dennis E. - Chest Online by
American College of Chest Physicians
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Anthrax
Vaccine: GAO's Survey of Guard and Reserve Pilots and Aircrew.
GAO-02-445
-- Abstract
-- "systemic reaction rate reported through the survey represents
a level more than a hundred times higher than the 0.2 percent
published in the product insert."
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| Leaders
Speak Out ... |
Presidential
Candidate George W. Bush, US Medicine. Sep. 2000:
"The Defense Department's Anthrax Immunization Program
has raised numerous health concerns and caused fear among
the individuals whose lives it touches. I don't feel the
[Clinton] administration's anthrax immunization program
has taken into account the effect of this program on the
soldiers in our military and their families. Under my administration,
soldiers and their families will be taken into consideration."
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Presidential
Candidate Sen. John McCain, San Diego Union Tribune. Feb.
26, 2000:
"I think that there should be a pause. I think that
they have not done the job in educating the members of the
military, and I would pause and I would get the best scientific
and medical people together and make a better argument than
they've made ... I'm not saying that I know enough to say
that it should never be, but right now members of the armed
services, the Guard and reserves are not accepting it."
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Defense
Secretary Rumsfeld, Pentagon News Briefings, Oct. 18, 2001:
"We're going to try and save it. There have been other
efforts that have failed over a period of years. And it
may or may not be savable ... it's not very well underway,
as you point out ... they have not been approved by the
FDA, as I understand it. They do not have what looks to
be -- well, I shouldn't be characterizing a private entity
that way, but things have not been going swimmingly for
them ..."
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Defense
Secretary Rumsfeld, Pentagon News Briefings, October 25,
2001:
Q: Are you taking the anthrax vaccine, Mr. Secretary?
Secretary Rumsfeld: No.
Q: You're not being inoculated; you're not taking a series.
Secretary Rumsfeld: No. No.
Q: All right. No vaccine.
Secretary Rumsfeld: No, no, no.
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Defense
Secretary Rumsfeld, Pentagon News Briefings, October 28,
2001:
Q: Okay. Mr. Secretary, have you been vaccinated against
anthrax?
Secretary Rumsfeld: No. Have you?
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Sen.
Bill Frist, Senate Majority Leader, CNN. Dec. 18, 2001:
"The vaccine is a dated vaccine, it's an old vaccine.
There are very real and potentially serious side effects
from the vaccine and anyone who elects to receive the vaccine
needs to be made aware of that. I do not recommend widespread
inoculation for people with the vaccine in the Hart Building
...There are too many side effects and if there is limited
chance of exposure the side effects would far outweigh any
potential advantage."
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Al
Gore, Presidential Candidate, Apr. 11, 2000:
"I feel the concerns are genuine. I also know that
sometimes concerns of this sort are based on confusing data
that is hard to interpret. But based on the concerns I have
heard from military personnel directly, I think we are justified
in taking a closer look -- I think that some increased sensitivity
to the kinds of questions that are being raised is needed."
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