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Anthrax - The Anthrax Vaccine
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Independent Scientific Reviews of the Anthrax Vaccine

Questions
Answers
  1. Have any independent scientific panels outside the Department of Defense rendered opinions about anthrax vaccine?

    Yes, since 1978, seven independent civilian panels affirmed the safety and efficacy of anthrax vaccine. These include (each discussed in detail below):

    Panel on Review of Bacterial Vaccines & Toxoids
    Armed Forces Epidemiology Board (AFEB); Now named the Defense Health Board (DHB)
    Advisory Committee on Immunization Practices (ACIP)
    Cochrane Collaboration
    Working Group on Civilian Bio-defense
    Anthrax Vaccine Expert Committee (AVEC)
    National Academy of Sciences - Institute of Medicine

  2. Why has anthrax vaccine been subjected to so many independent reviews? Is this the normal process for a licensed vaccine?
    All vaccines used in the United States are subjected to independent scientific review before and after licensing. The same is true for anthrax vaccine. Because the Anthrax Vaccine Immunization Program (AVIP) is actively opposed by small vocal groups of people, additional scientific panels have evaluated anthrax vaccine. Although anthrax vaccine critics are committed and dedicated; they base their opposition largely on emotion and assumption. To determine the truth based in science about anthrax vaccine, the Department of Health & Human Services (DHHS) and the Department of Defense (DoD) turn to America's senior vaccine experts for objective findings and advice. The DoD uses facts determined by these scientific bodies for the messages and education material DoD distributes to Service members, their families, and the public.

  3. What is the National Academy of Sciences Institute of Medicine (IOM) Committee on the Safety and Efficacy of Anthrax Vaccine, and what did they do?

    The IOM committee reached two major conclusions: that anthrax vaccine works and that anthrax vaccine is as safe as other vaccines. Regarding effectiveness:

    "The committee finds that the available evidence from studies with humans and animals, coupled with reasonable assumptions of analogy, shows that AVA as licensed is an effective vaccine for the protection of humans against anthrax, including inhalational anthrax, caused by all known or plausible engineered strains of B. anthracis." [Pages 7 and 58].

    The whole report is available at the website of the National Academy Press: Joellenbeck LM, Zwanziger L, Durch JS, Strom BL, editors. The Anthrax Vaccine: Is it Safe? Does it Work? Washington, DC: National Academy Press, March 2002, 235 pages. http://www.nap.edu/catalog/10310.html



  4. What was the Panel on Review of Bacterial Vaccines & Toxoids, and what did they find?

    When responsibility for vaccine regulation shifted from the National Institutes of Health (NIH) to the Food & Drug Administration (FDA) in 1972, FDA convened a series of civilian advisory panels.

    The FDA commissioned these panels to determine whether sufficient evidence of safety and effectiveness existed for vaccine licenses to be continued. These panels considered every vaccine used in America at that time, including such "old" vaccines as polio vaccine, tetanus toxoid, measles vaccine, and many others. The Panel on Review of Bacterial Vaccines & Toxoids met first in 1978 and published their report in 1985 in the Federal Register (1985; 50:51002-117).

    The panel consisted of prominent infectious disease experts and other physicians and scientists with expertise in pharmaceutical manufacturing quality. The panel recommended that the federal licenses for each bacterial vaccine be continued, but the panel recommended that several other product licenses be terminated. In the case of anthrax vaccine, this civilian panel concluded: "The Panel recommends that this product be placed in Category I and that the appropriate license(s) be continued because there is substantial evidence of safety and effectiveness for this product." The FDA accepted this recommendation completely. FDA revoked the licenses for the other products, following the recommendations of the civilian panel.



  5. What is the Advisory Committee on Immunization Practices (ACIP), and what did they find?

    The Advisory Committee on Immunization Practices (ACIP) consists of America's preeminent vaccine scientists, civilian physicians who advise the Centers for Disease Control & Prevention (CDC) (http://www.cdc.gov/nip/publications/ACIP-list.htm). The ACIP sets national standards for vaccine delivery. ACIP guidelines for the nation are published in the CDC's weekly journal, the Morbidity & Mortality Weekly Report (MMWR).

    Between fall 1999 and June 2000, an ACIP working group reviewed published and unpublished information about anthrax vaccine adsorbed (AVA). In June 2000, the ACIP unanimously adopted a report finding anthrax vaccine effective and safe for the prevention of anthrax. The report notes that: "The efficacy of AVA is based on several studies in animals, one controlled vaccine trial in humans, and immunogenic data for both humans and lower mammalian species. ...Routine vaccination with AVA is indicated for persons engaged in work involving production quantities or concentrations of B. anthracis cultures and in activities with a high potential for aerosol production."

    The ACIP recognizes that it is the role of the Defense Health Board (DHB) to advise the military Surgeons General on vaccination policies for military personnel. Nonetheless, the ACIP noted that "For the military and other select populations or for groups for which a calculable risk can be assessed, pre-exposure vaccination may be indicated." Advisory Committee on Immunization Practices. Use of anthrax vaccine in the United States MMWR-Morbidity & Mortality Weekly Report 2000; 49(RR-15):1-20. http://www.cdc.gov/mmwr/PDF/rr/rr4915.pdf



  6. What is the Cochrane Collaboration, and what did they find?
    The Cochrane Collaboration is an internationally respected group of scientists who apply principles called evidence-based medicine to discern the most objective use of medications. The Cochrane Collaboration is based in Oxford, England (http://www.cochrane.org).

    In 1998, the Cochrane Infectious Diseases Group reviewed the evidence for effectiveness and safety of two anthrax vaccines, manufactured in the United States and the former Soviet Union. "Trial quality assessment and data extraction was conducted independently by the six authors."

    This international group of scientists found that "Killed anthrax vaccines appear to be effective in reducing the risk of contracting anthrax with a relatively low rate of adverse effects. Further research should be restricted to testing new vaccines only." (http://www.cochrane.org/cochrane/revabstr/ab000975.htm) This review was later published in the peer-reviewed medical journal Vaccine: Demicheli V, Rivetti D, Deeks JJ, Jefferson T, Pratt M. The effectiveness and safety of vaccines against human anthrax: A systematic review. Vaccine 1998;16:880-4. http://www.vaccines.mil/documents/library/Demicheli%201998%20Vaccine%20p.%20880.pdf

  7. What is the Working Group on Civilian Biodefense, and what did they find?

    The Working Group on Civilian Bio-defense included 23 representatives from staff of major academic medical centers and research, government, military, public health, and emergency management institutions and agencies. The original consensus statement of 1999 resulted from a synthesis of published information and the revision of three drafts. Members of the working group reviewed anthrax literature again in January 2002, with special attention to articles following the anthrax attacks of 2001. Members commented on a revised document with proposed revisions being incorporated in the final product put out by The Center for Civilian Bio-defense Strategies (http://www.hopkins-biodefense.org/). The working group concurred with the findings of the March 2002 IOM report on the safety and efficacy of AVA, that AVA is effective against inhalational anthrax and concluded that if given with appropriate antibiotic therapy, it may help prevent the development of disease after exposure. The working group also found that: "Pre-exposure vaccination of some persons deemed to be in high-risk groups should be considered when substantial supplies of vaccine become available."

    The working group also addressed the use of anthrax vaccine in children: "The U.S. anthrax vaccine is licensed for use only in persons aged 18 to 65 years because studies to date have been conducted exclusively in this group. No data exist for children, but based on experience with other inactivated vaccines, it is likely that the vaccine would be safe and effective." Inglesby TV, O'Toole T, Henderson DA, Bartlett JG, Ascher MS, Eitzen E, Friedlander AM, Gerberding J, Hauer J, Hughes J, McDade J, Osterholm MT, , Parker G, Perl TM, Russell PK, Tonat K, Working Group on Civilian Bio-defense. Anthrax as a biological weapon, 2002: Updated recommendations for management. Journal of the American Medical Association 2002; 287:2236- 52. http://jama.ama-assn.org/cgi/content/short/287/17/2236



  8. What is the Anthrax Vaccine Expert Committee (AVEC), and what did they find?
    In October 1998, DoD requested that the U.S. Department of Health and Human Services (DHHS) establish an Anthrax Vaccine Expert Committee (AVEC) to review reports to the Vaccine Adverse Events Reporting System (VAERS) involving anthrax vaccine. A distinguished university professor chaired this review committee of civilian physicians with expertise in immunology, internal medicine, neurology, rheumatology, and microbiology. The AVEC independently reviewed all anthrax vaccine-related reports. The Committee met every 3 to 6 weeks, along with nonvoting representatives of DoD, CDC, FDA, and DHHS. The AVEC reviewed the quality of the submitted information, evaluated the reported event in the context of expected and unexpected adverse events to vaccines, and assessed the cause-and-effect relationship of the event with anthrax vaccine. The Committee also looked for any significant patterns in the aggregate data. The review performed by the AVEC is unprecedented for a licensed vaccine. To date, the AVEC reports it found no unexpected patterns in the side-effect profile of anthrax vaccine.

  9. Besides the six scientific panels described in detail above, have any other independent scientific individuals or groups rendered opinions about anthrax vaccine?
    Gerald R. Burrow, MD, reviewed the health and medical aspects of the Anthrax Vaccine Immunization Program (AVIP) in 1998 before the program began. This is also discussed below. The Society of Medical Consultants to the Armed Forces (SMCAF) endorsed the anthrax vaccination program in September 1999.

  10. Who is Gerald Burrow, MD, and what did he find?
    On December 15, 1997, Secretary of Defense William Cohen approved the plan to immunize the Total Force against anthrax, contingent on four conditions: (1) supplemental testing for potency, purity, sterility, and general safety; (2) plans for execution and communication; (3) a system for fully tracking anthrax vaccinations; and (4) review of the health and medical aspects of the program by an independent expert. To achieve condition (4), Secretary Cohen asked Gerald R. Burrow, MD, to make the review. Dr. Burrow served as dean of medicine at the University of California at San Diego and dean of medicine and special assistant to the president of Yale University. Dr. Burrow was one of a few physicians elected as a member of the prestigious National Academy of Sciences, one of the nation's most prestigious scientific honors.

    On February 19, 1998, Dr. Burrow reported: "I have made several visits to the Pentagon, have had a number of telephone conferences and have consulted extensively with experts in allergy, immunology and infectious disease." Based on his review, Dr. Burrow concluded: "The anthrax vaccine appears to be safe and offers the best available protection against wild-type anthrax as a biological warfare agent. Steps have been taken to ensure the safety and quality of the department's vaccine stockpile." (http://www.defenselink.mil/other_info/burrows.html)

  11. What is the Society of Medical Consultants to the Armed Forces (SMCAF), and what did they say?
    The Society of Medical Consultants to the Armed Forces was formed in 1946 to disseminate the knowledge of military medicine gained in both armed conflict and peacetime practice and research, and to respond promptly to the call of the Surgeons General for advice on issues of professional importance in the Armed Forces (http://www.smcaf.org).

    In September 1999, the Society expressed its support of the Anthrax Vaccine Immunization Program of the Department of Defense. In letters to the Secretary of Defense and the Surgeons General, President Nicholas Rock, MD, furnished documentary evidence of the need for and the safety of the Immunization Program, and declared that "The Society of Medical Consultants to the Armed Forces endorses the decision of the Surgeons General to proceed with priority attention, to provide protection against anthrax for our military forces."

  12. What is the Defense Health Board (DHB), and what did they find?

    The Defense Health Board (DHB), formerly known as Armed Forces Epidemiological Board (AFEB), has a proud 60-year heritage of protecting the health of America's Armed Forces. The DHB consists of civilian physicians and scientists selected to advise the Surgeons General of the Armed Services (http://www.ha.osd.mil/DHB/default.cfm).

    From its first reviews of anthrax vaccine under DoD Directive 6205.3, the DHB has affirmed the value of this vaccine. In August 1994, the DHB concluded: "The licensed anthrax vaccine is suitable for use in personnel assigned, pre-designated or scheduled for deployment to areas with a validated higher threat under its approved indications." In November 1996, the Defense Health Board reported that it "endorses the proposed DoD anthrax vaccine implementation plan under the current vaccine protocol [i.e., dosing schedule]."

    The DHB reaffirmed its recommendations to use anthrax vaccine for bio-defense of military personnel in 1999 and 2000. A March 25, 1999, report states "The DHB continues to strongly endorse the current DoD Anthrax Vaccine Immunization Program."

    On March 29, 2000, the DHB reported: "...we are (DHB) concerned and somewhat surprised at the criticism surrounding the program given the high level of professionalism that had characterized this effort... Anthrax vaccine is a fully licensed FDA vaccine.

    The vaccine does cause local side effects, but has an excellent safety profile. The Anthrax Vaccine Immunization Program has carefully tabulated person-specific immunization data and has assiduously investigated reported complications associated with receipt of anthrax vaccine. These data have been regularly reviewed by the board and attest to the safety of the vaccine." http://www.anthrax.mil/resource/library/afeb.asp

    The DHB continues to receive regular updates regarding implementation of the Anthrax Vaccine Immunization Program and the variety of safety surveillance methods used by the Department of Defense to monitor the vaccine's use.



  13. Where can I find supporting scientific information about the safety and effectiveness of anthrax vaccination? What about more information regarding the military vaccination program?
    Additional information concerning the scientific data that supports the safety and efficacy of the anthrax vaccine can be found at the following locations: