Anthrax Vaccine License opened for 90-day public comment period: We need your help now!

Newsflash
Anthrax Vaccine License opened for 90-day public comment period: We need your help now! Click on http://www.fda.gov/cber/rules/bvactox.pdf

Click here to submit your comments: http://www.regulations.gov/AGCY_FOODANDDRUGADMINISTRATION.cfm
Comments accepted until March 29, 2005:

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend the biologics regulations in response to the report and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel). The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids
with standards of potency, bacterial antitoxins, and immune globulins. On the basis of the Panel’s findings and recommendations, FDA is proposing to classify these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness). On December 13, 1985, FDA proposed to amend the biologics regulations and proposed to classify the bacterial vaccines and toxoids. After reviewing the Panel’s report and comments on the proposal, FDA published a final rule and
final order on January 5, 2004. FDA is issuing this proposed rule and proposed order again to provide notice and to give interested persons an opportunity to comment.

Instructions: All submissions received must include the agency name and Docket No. for this proposal. All comments received will be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided.

DATES: Submit written or electronic comments on the proposed rule and proposed order by [insert 90 days after date of publication in the Federal Register]. Publication date expected to be Dec. 29, 2004 - Editor's note.

ADDRESSES: You may submit comments, identified by Docket No. 1980N–0208, by any of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

• Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site.


• E-mail: fdadockets@oc.fda.gov. Include Docket No. in the subject line of your e-mail message.


• FAX: 301–827–6870.


• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]:
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.


Instructions: All submissions received must include the agency name and Docket No. for this proposal. All comments received will be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any
personal information provided.

For detailed instructions on submitting comments and additional information on the process, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm and
insert the docket number found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.




The Military Vaccine Action Committee MVAC-PAC CALLS LATEST PUSH TO FORCE ANTHRAX VACCINE IRRESPONSIBLE


Friday, 17 December 2004

FOR IMMEDIATE RELEASE: DEC. 17, 2004



CONTACT: KATHRYN HUBBELL, PRESIDENT (406) 531-9355 or contact@mvacpac.org



MVAC-PAC CALLS LATEST PUSH TO FORCE ANTHRAX VACCINE IRRESPONSIBLE

ABUSE OF POWER BY THE DOD



MISSOULA, MT: Responding to last week’s request by Deputy Secretary of Defense Paul Wolfowitz that HHS Secretary Tommy Thompson declare a state of emergency in order to justified renewed use of the anthrax vaccine, MVAC-PAC President Kathryn Hubbell has called the latest move by the Dept. of Defense “another irresponsible abuse of power.” Federal Judge Emmett Sullivan declared the military’s anthrax vaccine immunization program illegal on Oct. 27th of this year.

The Judge’s ruling is not the only factor to consider. If there is a genuine anthrax threat , the DOD knows that soldiers can still get the anthrax vaccine. The DOD can provide troops with consent forms. That’s all that has ever been required.

In addition, more published reports indicate that vaccines are not the most effective way to treat anthrax. Antibiotics are a far more efficient, life-saving method, according to a Dec. 16 article in Forbes. And this article isn’t the first to come to such a conclusion.

Karl Rove, senior advisor to the President, described the anthrax vaccine as a “political problem” in a 2001 memo to Wolfowitz (see at http://www.milvacs.org/rovememo.pdf ). The Bush administration has clearly known for several years of the numerous problems associated with this vaccine.

Continually attempting to force the anthrax vaccine on the men and women of our armed services constitutes deliberate medical experimentation with an unproven, unsafe drug. Rather than protecting the troops, the DOD seems intent on using its strong-arm, bullying tactics to get its own way, even bending the law to attempt to achieve its objectives. These unconscionable acts of cowardice toward the troops who are already putting their lives on the line to defend the United States must stop. With proven, more effective, and less dangerous ways to protect our troops, DOD must at last take responsibility and face up to its own documented illegal conduct. It must compensate those who are ill, clear the names of those who rightly refused this illegal vaccine, and use better ways to protect our troops. Now.

For more information about the Military Vaccine Action Committee, L.L.C, go to www.mvacpac.org.

###



Military Vaccine Action Committee, L.L.C.

P.O. Box 8168 – Missoula, MT 59807

PH: (406) 531-9355 - e-mail: contact@mvacpac.org

Last Updated ( Friday, 17 December 2004 )
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MVACPAC.ORG Joins In Support Of Senator Bingaman's Letter To Rumsfeld For VHC Funding
Written by Administrator

Wednesday, 12 February 2003
The Military Vaccine Action Committee is pleased to be a signatory on this letter, and we encourage you to endorse it as well. Please contact Bruce Lesley in Senator Bingaman’s office at Bruce_Lesley@bingaman.senate.gov to sign on directly, or write to your Congressional delegation to endorse this funding. Thank you! VACPAC.ORG Forums Board Now Open.
Last Updated ( Thursday, 09 December 2004 )

Defense Department Embarks On Disinformation Campaign Concerning Anthrax Vaccination Program
Written by Administrator

Saturday, 12 April 2003

Involuntary Vaccinations Must Stop For A Minimum Of Three To Four Months In Order For The Government To Comply With Court Order

WASHINGTON, D.C. -- On October 27, 2004, the Honorable Emmet Sullivan of the U.S. District Court for the District of Columbia vacated an Order issued by the Food & Drug Administration and imposed a permanent injunction prohibiting the Department of Defense from administering the anthrax vaccine without informed consent or a presidential waiver. This second injunction followed Judge Sullivan's earlier decision of December 22, 2003, that the anthrax vaccine was investigational and unlicensed for its intended purpose to protect against inhalation exposure.

Since the imposition of a permanent injunction the Department of Defense has led a disinformation campaign to downplay the significance of the Court's decision, particularly regarding the length of time the injunction will remain in place. These efforts, which are made amidst convenient FDA silence, do a great disservice to the loyal men and women who are attempting to protect the United States of American in military and civilian positions. "DoD is trying to equate Judge Sullivan's granting a permanent injunction with his earlier decision granting a preliminary injunction, but that's simply wishful thinking," said Mark S. Zaid, Esq. of the Washington, D.C. Law Firm of Krieger & Zaid, PLLC, one of two lawyers who brought the lawsuit on behalf of the plaintiffs. "In fact, given the state of the medical and scientific evidence, it will be extremely difficult for FDA to make a proper case that the vaccine has any effectiveness against inhalation anthrax. That means the vaccine stays an investigational drug and it cannot be used by the military without informed consent or a presidential waiver," Zaid added.

Last Updated ( Thursday, 09 December 2004 )
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