ANTHRAX AND THE VACCINE

October 1999
		Which is worse -- a deadly disease, or the vaccine that guards against it? Experts answer your questions.

Forum Introduction. Who in the military must take the vaccine? Is Anthrax a national health problem? What are the side effects? Who is at risk for side effects? What company makes the vaccine? Is the vaccine approved by the FDA? Is there a medical resource on the topic?     Oct. 21, 1999: The growing controversy over the Anthrax vaccine. Jan. 7, 1997: Gulf War Syndrome Update. Nov. 7, 1996: Chemical weapons debate. Sept. 11, 1996: Chemical weapons vote. Browse the NewsHour's coverage of defense and health.       Anthrax, from the Secretary of Defense Anthrax Vaccine Web site Centers for Disease Control and Prevention American Gulf War Veterans Association Arnot Ogden Medical Center Anthrax Links and Information: Created by opponents of the vaccine	Perry Hookman M.D. of Potomac, MD asks: I'm getting a lot of questions from patients who want to know if the vaccination is safe. Is there one inclusive medical article, summary or medical symposium publication I can refer to? Lt. Col. Randy Randolf responds: In addition to the Department of Defense, other agencies and groups advocate or support the use of the anthrax vaccine. In 1970, the anthrax vaccine was licensed by the National Institutes of Health's Division of Biologics Standards (who had licensing responsibilities in the US prior to the Food and Drug Administration; responsibility for vaccine regulation was transferred from NIH to the FDA in 1972). The Centers for Disease Control & Prevention, the World Health Organization, the Armed Forces Epidemiological Board, and many other respected public health organizations support use for people at risk or exposed to Bacillus anthracis. Information about the Anthrax Vaccine Immunization Program (AVIP) is available on the Internet (a variety of DoD Web sites as well as the Center for Disease Control & Prevention and the Food & Drug Administration Web sites) which include facts about the anthrax vaccine, history, side effects, purpose for immunizations and more. Evidence for the efficacy of the anthrax vaccine is sufficient for it to be included in standard medical reference books in the United States and around the world. These references include: * Control of Communicable Diseases Manual, 16th ed. Abram S. Benenson, ed. "An official report of the American Public Health Association," Washington, DC, 1995. * Guide for Adult Immunization, Philadelphia: American College of Physicians, 1994 edition. * Immunisation Against Infectious Disease. Her Majesty's Stationery Office, London: British Joint Committee on Vaccination and Immunisation, 1996. * Report of the Committee on Infectious Diseases, 24th edition, Elk Grove Village, IL: American Academy of Pediatrics, 1997. * ImmunoFacts: Vaccines & Immunologic Drugs. Saint Louis: Facts and Comparisons, Inc., November 1999. * Merck Manual on Drugs & Therapeutics. West Point, PA: Merck and Company, 1999. Anthrax vaccine is a prominent part of the World Health Organization's 1998 Guidelines for the Surveillance and Control of Anthrax in Humans and Animals (http://www.who.int/emc-documents/zoonoses/whoemczdi986c.html. Similarly, anthrax vaccination is specifically endorsed in the Working Group on Civilian Biodefense position paper on preparedness against anthrax (Inglesby, et al. Anthrax as a biological weapon. Journal of the American Medical Association (JAMA) 1999;281:1735-45; http://jama.ama-assn.org/issues/v281n22/full/jst90000.html). Officials at the CDC confirmed the validity of the vaccination guidelines in the Inglesby paper (MMWR 1999;48(Feb 5):69-74). ftp://ftp.cdc.gov/pub/Publications/mmwr/wk/mm4804.pdf The U.S. Department of Agriculture lists anthrax vaccine as a condition of employment for personnel of the Animal & Plant Health Inspection Service (APHIS), if potentially exposed on the job. The anthrax vaccine has been reviewed by civilian medical review boards at least three times. A civilian medical advisory panel to the Food & Drug Administration reviewed all bacterial vaccines in the early 1980s, revoking a few licenses for lack of evidence of safety or efficacy. When that panel considered anthrax vaccine, they reaffirmed all previous NIH and FDA decisions about the vaccine. The report can be found in the 1985 edition of the Federal Register, volume 50, pages 51002-117. Second, the Armed Forces Epidemiological Board (AFEB), a civilian body of scientists and physicians, provides recommendations regarding vaccination use and other medical issues to the Assistant Secretary of Defense for Health Affairs (ASD(HA)). AFEB has specific responsibilities in DoD Directive 6205.3, Immunization Program for Biological Warfare Defense. The AFEB assists in providing recommendations on vaccines and immunization protocols necessary to enhance protection against validated BW threats. The external Department of Defense Anthrax Vaccine Adverse Event Task Force reviewed adverse events on 3 August 1998 and provided a report on 10 August 1998. The Task Force recommended further reviews of adverse event reports received as a result of the anthrax immunization program be completed at 3 to 6 month intervals. Based on review of the adverse events reported to the date and the apparent safety of the anthrax vaccine, the Task Force recommended no other change in the current DoD Anthrax Vaccine Immunization Program. They also recommended a review of Vaccine Adverse Event Reporting System (VAERS) reports at service level for completeness. AFEB also suggested a small prospective study--"a small records review study" to record all reactions. This led to the survey at Tripler Army Medical Center of 603 medics to collect data on symptoms, side effects and reactions subsequent to vaccination. Third, the Anthrax Vaccine Expert Committee (AVEC) is a panel of civilian physicians convened by the Health Resources & Services Administration of the Department of Health & Human Services to review all form VAERS-1 reports submitted to the FDA relating to the anthrax vaccine . This independent external review panel meets every 6 weeks or so. To date, the committee has identified no unexpected events after anthrax vaccination. Today, there is a broad consensus that the FDA-licensed anthrax vaccine is safe and effective for people at high risk of exposure. Recent publications of the CDC [ftp://ftp.cdc.gov/pub/ Publications/mmwr/wk/mm4804.pdf] and the Johns Hopkins Center for Civilian Biodefense Studies [http://www.ama-assn.org/sci-pubs/journals/archive/jama/vol_281/no_18/jst800 27.htm] recognize the anthrax vaccine as part of the national preparedness against biological terrorism. Dr. Meryl Nass responds: Unfortunately not. There is not a single published study of the efficacy or safety of the current vaccine in humans. There are a number of unpublished studies which give short-term systemic reaction rates of 20% to 50%, but no long-term rates. The best one can do is review the article by Unwin C et al in the Jan 16, 1999 Lancet. This describes a large study of UK servicemembers, some of whom developed a syndrome fitting the Gulf War Illness definition. It was found that those who had received anthrax vaccine had a statistically significant increased risk of developing Gulf War Illness. The risk was increased even more for Bosnia vets who had received anthrax vaccine. The British Ministry of Defense has not said officially how much anthrax vaccine used by their troops came from the US, but some appears to have originated here, and some was made in the UK. My article in the March 1999 Infectious Disease Clinics of North America, pages 187-208, "Anthrax vaccine, model of a response to the biologic warfare threat" reviews the published literature and includes sections on quality control problems at the manufacturer, and the ethical issues involved. To view the FDA inspection report of the vaccine manufacturer from February 1998, go to http://www.anthraxvaccine.org/Inspect.htm The big question is why, when $140 million dollars is being spent on research into Gulf War illnesses, has not a single study examined the relationship between anthrax vaccine and subsequent illness in US servicemembers? DOD says they have lost the vaccination records from the Gulf War; but anti-anthrax antibody titres, routinely done at Fort Detrick, could identify those who were vaccinated. Such a study needs to be done immediately to shed more light on what can be expected from anthrax vaccine over the long term. No vaccinations should be given until this information is collected and reviewed.