| News... |
The Anthrax Vaccine: A Dilemma for Homeland Security
by Lt. Col. Thomas Rempfer, USAF -
The Journal of the Naval Postgraduate School Center for Homeland Defense and Security - Wednesday June 17, 2009
***Story published in May, 2009 edition of Journal:
Past problems with the Department of Defense anthrax vaccine currently impact Department of Homeland Security and the Department of Health and Human Services policy. Following the 2001 anthrax letter attacks, those departments included the old anthrax vaccine in the Strategic National Stockpile. This article explores the Department of Defenses experience with the vaccine, enumerating past safety, efficacy, regulatory, and legal problems. Public health policy alternative courses of action are suggested, including use of antibiotics and development of a new vaccine.
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Research narrows cause of Gulf War Syndrome
by Kyle Hodges | Army News Service -
Fort Leavenworth Lamp - Tuesday June 16, 2009
Story first published May 28, 2009:
WASHINGTON, D. C. - Research completed and analyzed over the past year has narrowed the underlying causes of Gulf War Syndrome to three factors.
For 18 years, researchers struggled to pinpoint the causes of Gulf War Syndrome and its wide-ranging symptoms. Then last year, a group of researchers under the U.S. Army Medical Research and Materiel Command and the Congressionally Directed Medical Research Program narrowed the primary causes to three: chemical nerve agents, pesticides and the use of pyridostigmine bromide pills.
Commentary:
Uh-huh. Remember those little PB bills you were all forced to take? Another investigational new drug - another medical experiment. And you had no choice. In addition, there were years of denials that you were ever exposed to sarin gas. So, Pentagon, you finally going to release funds to get our veterans the health care they need and deserve? Or is it still all in their heads?
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Emergent BioSolutions Meets With FDA To Review Regulatory Strategy For Recombinant Anthrax Vaccine
Medical News Today - Sunday June 14, 2009
Emergent BioSolutions Inc. (NYSE:EBS) announced that it has met with the U.S. Food and Drug Administration (FDA) to review Emergent's regulatory strategy for the development of its recombinant anthrax (rPA) vaccine. Emergent recently submitted to FDA, among other documents, its rPA Development Plan in response to the Department of Health and Human Services' (HHS) amendment to its request for proposal (RFP) to develop and deliver up to 25 million doses of an rPA vaccine for the Strategic National Stockpile. In amending the RFP, HHS required that all bidders deemed to be in the competitive range submit to FDA a comprehensive plan outlining the regulatory strategy for their rPA vaccine. Emergent completed that submission on May 12, 2009 ahead of the June 15, 2009 submission deadline.
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Emergent biosolutions receives FDA approval extending shelf life of biothrax (Anthrax Vaccine Adsorbed) to 4 years
Welt Online - Wednesday June 10, 2009
"Emergent BioSolutions Inc. [...] announced today that [...], BioThrax [...] has been granted a shelf life extension from 3 to 4 years by the U.S. Food and Drug Administration (FDA). [&] Emergent continues to research additional enhancements to BioThrax such as a possible further reduction in the vaccination regimen and a potential label expansion to include use as a post-exposure prophylaxis. To date, Emergent has supplied over 33 million doses of BioThrax to the U.S. government, with additional deliveries to the [Strategic National Stockpile] SNS scheduled through the third quarter of 2011. [&] BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection [sic]. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax [spores]. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. Since 1998, the U.S. government has procured nearly 33.5 million doses of BioThrax. During tha...
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| Press
Room... |
New Disability Review Process
Friday February 06, 2009
To all:
Recently, the DOD has come out and said that anyone who left the military for medical reasons, but received a disability rating of 20%...
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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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| 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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