1. The current anthrax vaccine was licensed base on data from a different vaccine.
See anthrax vaccine chronology on House Government Reform web site at http://www.house.gov/reform

2. There are no studies of human safety and efficacy regarding this vaccine. The only study which can be quoted, known as the Brachmann Study, was actually done on the original vaccine, not the re-configured vaccine which has been used by the military on its troops. Other studies quoted by BioPort, the vaccine's manufacturer, have not been peer-reviewed or published.
See anthrax vaccine chronology on House Government Reform web site at http://www.house.gov/reform

3. BioPort, the current manufacturer of the vaccine, has a long and troubled history with the manufacture of the product, including:
· Producing contaminated batches - and using them
· Producing non-sterile product - and using it
· Switching labels on batches of the vaccine to reveal false expiration dates
See anthrax vaccine chronology on House Government Reform web site at http://www.house.gov/reform for these three bullets

· Changing the fermenting and filtering equipment used to make the vaccine in 1990, without notifying the FDA - resulting in a 100-fold increase in the potency of the vaccine.
· Using equipment for other vaccines besides the anthrax vaccine, in direct violation of FDA rules
· Failing to have a written protocol to maintain consistency between batches and lots
See the FDA Citizen Petition at http://www.anthraxvaccine.net for these three bullets

2. There was never any rationale for the six-shot protocol used with the vaccine. The original protocol was for three shots, and the change was made without study or scientific backing.
See anthrax vaccine chronology on House Government Reform web site at http://www.house.gov/reform

3. The vaccine has always been known to be highly reactogenic, and the new label on the vaccine admits as much.
Where the old label claimed an adverse reaction rate of just 0.2%, the new label says adverse reactions may be as high as 35%.
Where the old label admitted to no fatalities, the new label describes the six deaths related to the vaccine.
The new label also details a far stronger list of adverse reactions than did the old label.
See http://www.fda.gov/cber/label/biopava0131022LB.pdf

6. After last fall's anthrax attacks via the U.S. Mail, civilians were offered the anthrax vaccine in combination with antibiotic drugs known to be effective against anthrax, such as Cipro and Doxycycline. They were offered informed consent documents, as required by law, since the anthrax vaccine has for years been on file with the FDA as an Investigational New Drug. However, no member of the U.S. military has ever been offered informed consent documents. The Centers for Disease Control (CDC) claims that civilians were offered informed consent documents because the vaccine was given post-exposure, rather than pre-exposure. However, this explanation circumvents the fact that the vaccine is still on IND status with the FDA, and the FDA has never issued a final ruling on that status. See http://www.anthraxvaccine.net/CDCdocs.shtml

7. BioPort was suddenly cleared by the FDA to start manufacturing the vaccine again after last fall's anthrax attacks, after many years of failing FDA inspections. If they are manufacturing according to the old formula, then we can still expect a high adverse reaction rate with more permanent illnesses and more fatalities. If they have once again re-configured the vaccine without notifying the FDA or other authorities, then the vaccine is once again - still - an Investigational New Drug, and constitutes medical experimentation on the troops. In the brief eight or nine months since BioPort's clearance to resume the manufacturing process, there certainly has not been enough time to develop and test a new drug. In fact, recent news of a second generation anthrax vaccine clearly states that it may take until 2009 for such a drug to be developed, tested and licensed, unless it is offered earlier as an Investigational New Drug. See http://ebird.dtic.mil/Aug2002/s20020808dod.htm

8. The Department of Defense announced in early July, 2002, that it would resume the Anthrax Vaccine Immunization Program within the military, but only for those in undefined "high risk areas," who were deployed there more than 15 days, and only in complete secrecy. The original announcement included the fact that no troop who received the vaccine would be allowed to talk about it, leading one to wonder what those troops are expected to do when they become ill from the vaccine, as some of them certainly will. Prohibiting any talk of the vaccine also leads the Department of Defense to be able to deny a connection between the vaccine and a subsequent illness, or cluster of illnesses - as has already happened with Gulf War veterans, whose shots were never entered into their medical records.

In the same announcement, the Department of Defense announced with it was withholding half of its stockpiled vaccine - and by "stockpiled," one has to ask whether this is the vaccine that was quarantined at BioPort as being unfit for use - for civilian use. They want to share this vaccine with the civilian population. See http://story.news.yahoo.com/news?tmpl=story&u=/ap/20020517/ap_wo_en_ge/us_anthrax_vaccine_3

The headline on the above article reads, "Military wants to limit troops' anthrax vaccinations; question of civilian needs unanswered," which leads us to the next point:

9. Wisconsin is among those states which have now passed a law declaring that in time of national emergency, taking vaccines such as the anthrax vaccine will be mandatory. Under the Homeland Security Act, various states are joining Wisconsin in considering mandatory bioterrorism vaccines for the general public. These include (but are not limited to): Maine ("Two homeland security bills sent to governor -House clarifies bioterror attack powers," By PATRICK JACKSON - Dover Bureau reporter, The News Journal, 06/27/2002), Georgia (Story last updated at 2:28 p.m. on Sunday, January 20, 2002, "Online Athens," "Terror attacks spur new security laws" By Brian Basinger, Morris News Service), and Oklahoma ("Public health, eavesdropping top lists as states craft anti-terror policies" By the Associated Press, Aug. 13, 2002, in "Shawnee Online.")

Meanwhile, we have veterans in their 20's walking with canes, crippled with arthritic conditions since taking the anthrax vaccine; we had tough former Marines and Army Special Forces who have grand mal seizures, blackouts, and severe memory loss since taking the vaccine; women who are unable to conceive, and hemorrhage constantly; men whose bodies will no longer produce testosterone; troops who have lost vision in one eye, or peripheral vision; who have blood clots, brain tumors, cysts on internal organs, severe skin rashes and infections, short-term memory loss, depression and dementia, and diagnosed autoimmune illnesses - all since taking the vaccine. Nearly every person who has reported becoming ill since the vaccine expresses complete mystification and dismay that they have changed so completely from being physically fit, athletic, and active, to a person whose disabilities prevent any kind of a normal life.

The Veterans Administration, in July of 2002, issued a precedent-setting ruling recognizing a disability specifically related to the anthrax vaccine, the same week the Department of Defense announced a resumption of the shots. See http://www.va.gov/ogc/docs/PREC_4-2002.doc This is a major step forward, because since the shots were first given (as far back as the 1970's), troops have been repeatedly told there is no connection to their illnesses and the anthrax vaccine; and if they can prove there is at all, they most often fight one-to-two years to obtain even partial VA benefits. One result is that they often go bankrupt in the process as they face the dual stress of mounting medical bills while they are no longer able to earn a living. Many of our veterans - our nation's finest, in their healthier days - have become homeless, and have had to move back in with family members or friends.

The Department of Defense has long stated that some 16 bioterrorism vaccines are in the pipeline, and has many times expressed concern that an AIDS vaccine be developed. An AIDS vaccine is now being tested in Thailand, for that matter. It is of some note that the adjuvant squalene, used in several experimental vaccines and found by the FDA to be present in various lots of the anthrax vaccine, is also an adjuvant considered for the AIDS vaccine. Recent research out of Tulane University points to squalene antibodies present in those who have received the anthrax vaccine, and points to a definitive link between the anthrax vaccine and the cluster of conditions and illnesses known as Gulf War Syndrome. See http://www.autoimmune.com/NewsRel15July02.html, and
http://www.autoimmune.com/GWSGen.html

In addition, a recent study by Kansas State University found, among other things, that "Declines in long-term subjective health were associated with receipt of anthrax vaccine by Gulf War veterans but not for those who did not deploy to the Gulf, although few of the latter received anthrax vaccine." (cover page), and that "While the U.S. military maintains that 'There have been no long-term side effects from the vaccine,' (footnote, page 8) our research and Unwin, et al's (footnote, page 36) suggest to the contrary that anthrax vaccination might have direct and indirect long-term side effects on health, most notably for those individuals who have the most severe reactions to the vaccinations initially." (page 651)
Contact head researcher: Dr. W. R. Schummm, School of Family Studies and Human Services, Justin Hall, Kansas State University, 1700 Anderson Ave.,Manhattan, KS 66506-1403, or e-mail to: Schumm@humec.ksu.edu