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Anthrax - The Anthrax Vaccine
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Anthrax and the Persian Gulf War

Questions
Answers
  1. Is the anthrax vaccination program a result of lessons we learned from the 1990-1991 Persian Gulf War?
    Yes. Building upon the lessons of past wars and leveraging superior technologies available today and in the future, the AVIP is one of the cornerstones of Force Health Protection. Additionally, the current world threat environment and the unpredictable nature of terrorism make it prudent to include biological warfare defense in all our force protection planning. We also learned that we need to put more effort into documentation of vaccinations in Service Members' medical records. This is the reason for the new immunization tracking systems operated by each of the military services.

  2. Anthrax vaccine was administered to personnel deployed in the Persian Gulf War. How many Service Members received vaccines against biological weapons during the Gulf War?
    During the Persian Gulf War approximately 150,000 Service Members (about 1 in 5 of the people who served in the operation) received at least one dose of anthrax vaccine to vaccinate U.S. forces against Iraq’s weaponization of Bacillus anthracis. Approximately 8,000 doses of botulism vaccine were also administered during the Gulf War.

  3. Was the anthrax vaccine FDA-licensed at the time it was given to Gulf War veterans?
    Yes. The FDA licensed the anthrax vaccine in 1970. All of the anthrax vaccine administered during the Persian Gulf War was produced at the Lansing facility and release according to the lot-release test criteria for potency, purity, safety, and sterility.

  4. Has the anthrax vaccine been linked to illnesses among Persian Gulf War veterans?
    No. Several independent nationally renowned scientific groups have addressed this issue and have found no evidence to link anthrax vaccine with illnesses among Gulf War veterans. Symptoms have been reported both by Gulf War veterans who were vaccinated and those who were not. The Institute of Medicine, the Presidential Advisory Committee on Gulf War Veterans' Illnesses, National Institute of Health, and the Defense Science Board have reviewed the correlation and concluded that the anthrax vaccine does not explain the reported chronic effects associated with illnesses among Gulf War veterans. There have been several unsubstantiated allegations in the media and elsewhere about experimental vaccines that may have contained non-FDA-licensed substances. Only the FDAlicensed anthrax vaccine was used then or now.

  5. What did the Centers for Disease Control and Prevention find in their study?
    One study of the health of Gulf War veterans was coordinated by scientists at the CDC. The clinical evaluation portion of their study assess 158 Gulf War veterans from one Air Force unit, regardless of health status. Portions of their research report is reprinted verbatim here: METHODS: "...To screen for exposure (either by vaccination or in combat) to 2 widely discussed putative biologic warfare agents, we tested serum samples for antibodies to toxin produced by Clostridium botulinum and Bacillus anthracis. Serum samples were screened at the Division of Bacterial and Mycotic Diseases, CDC, for antibodies to type A botulinum toxin. Serum samples were assayed at the US Army Medical Research Institute of Infectious Diseass, Washington, DC [sic], for antibodies against anthrax protective antigen and lethal factor...." RESULTS: "...There was no association between seropositivity to various infectious agents and chronic multisymptom cases. ... Ten subjects reacted to botulina [sic] toxin and 14 to anthrax protective antigen, but there were no differences between cases and noncases...." COMMENT: "We tested participants for exposure to several infectious agents that are important health problems in the Gulf region, that may have been used in vaccines, and that might be associated with a chronic illness. ... Similarly, we found no association between illness and antibody against the other viruses, rickettsiae, parasites or bacteria for which we assayed...." CITATION: Fukuda K, Nisenbaum R, Stewart G. Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisystem illness affecting Air Force veterans of the Gulf War. Journal of the American Medical Association (JAMA) 1998;280:981-8.

  6. Where can I get more information about reputable studies of Gulf War illnesses?

    The Special Assistant for Gulf War Illnesses, Dr. Bernard Rosker, published an info paper entitled "Vaccine Use During the Gulf War" (http://www.gulflink.osd.mil/va/). When Persian Gulf War veterans returned and started reporting symptoms, some people asked if vaccines administered during the Gulf War might have caused the symptoms. Several independent expert panels addressed this and related questions head-on. These panels consisted of Veterans, civilian academic experts, scientists, health-care professionals, and policy specialists. Each of these panels included some of the nation's best scientists, who spent months or even years listening to veterans, reviewing the evidence, and deliberating the issues.

    In each case, the independent expert panels found that there was no evidence of any link between any vaccine and any illness common to Gulf War veterans. These reports include:

    Presidential Advisory Committee on Gulf War Veterans' Illnesses: Final Report, December 1996. Pages of Interest: second page, Executive Summary, plus pages 112-114 of the original document (Chapter 4 in the web version).

    Institute of Medicine, Health Consequences of Service During the Persian Gulf War:

    Recommendations for Research & Information Systems, 1996. (http://books.nap.edu/books/0309055369/html/1.html)Pages of Interest: 49-52, 55, 100.

    National Institutes of Health, Technology Assessment Workshop: The Persian Gulf Experience and Health, 29 April 1994.

    Defense Science Board Task Force on Persian Gulf War Health Effects, June 1994. (http://www.gulflink.osd.mil/dsbrpt/index.html) See chapter VIII, section E.2.

    Three specific studies looking into the health of Gulf War veterans and their families were published in the New England Journal of Medicine. The postwar hospitalization experience of U.S. veterans of the Persian Gulf war. New England Journal of Medicine 1996; 335:1505-13. This study concluded that "During the two years after the Persian Gulf War, there was no excess of unexplained hospitalization among Americans who remained on active duty after serving in that conflict." The risk of birth defects among children of Persian Gulf war veterans. New England Journal of Medicine 1997; 336:1650-6. The authors concluded that "This analysis found no evidence of an increase in the risk of birth defects among the children of Gulf War veterans." Mortality among U.S. veterans of the Persian Gulf war. New England Journal of Medicine 1996; 335:1498-1504. The authors concluded: "Among veterans of the Persian Gulf War, there was a significantly higher mortality [death] rate than among veterans deployed elsewhere, but most of the increase was due to accidents rather than disease, a finding consistent with patterns of postwar mortality among veterans of previous wars."

    A DoD-funded British team at King's College, London, reported in the 20 May 00 issue of British Medical Journal that multiple vaccinations given in a theater of war, but not before deployment, were associated with multi-symptom illness, fatigue, psychological distress, health perception, and physical functioning. The analysis was limited to veterans who kept vaccination records.

    Exposures other than vaccination were not controlled for, except pesticide use. Anthrax vaccine was not analyzed independently. The lead author was Matthew Hotopf; the research team included Catherine Unwin. The authors recommend that Armed Forces be vaccinated before deployment: "It would be folly to allow Service personnel to be committed to a modern battlefield without all necessary means of protection against endemic infection and biological weapons." The accompanying editorial calls Hotopf's evidence "inconclusive," citing design limitations and contradictory findings.