Questions & Answers
Anthrax - The Anthrax Vaccine
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Questions

Independent Scientific Reviews of the Anthrax Vaccine

  1. Have any independent scientific panels outside the Department of Defense rendered opinions about anthrax vaccine?
  2. Why has anthrax vaccine been subjected to so many independent reviews? Is this the normal process for a licensed vaccine?
  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?
  4. What was the Panel on Review of Bacterial Vaccines & Toxoids, and what did they find?
  5. What is the Advisory Committee on Immunization Practices (ACIP), and what did they find?
  6. What is the Cochrane Collaboration, and what did they find?
  7. What is the Working Group on Civilian Biodefense, and what did they find?
  8. What is the Anthrax Vaccine Expert Committee (AVEC), and what did they find?
  9. Besides the six scientific panels described in detail above, have any other independent scientific individuals or groups rendered opinions about anthrax vaccine?
  10. Who is Gerald Burrow, MD, and what did he find?
  11. What is the Society of Medical Consultants to the Armed Forces (SMCAF), and what did they say?
  12. What is the Defense Health Board (DHB), and what did they find?
  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?

Overview

  1. What is anthrax vaccine?
  2. Isn't anthrax vaccine based on old (archaic) technology?
  3. Who licensed the availability of anthrax vaccine in the United States?
  4. What do I do if I am late for my next scheduled dose?
  5. What is the new standard dosing schedule for the anthrax vaccine?
  6. Can I get vaccinated ahead of schedule?
  7. What does the anthrax vaccine do to make a person immune?
  8. Do pilots who have received the anthrax vaccine have any troubles with FAA flight certification?
  9. Can people who have received the anthrax vaccine donate blood?
  10. After anthrax vaccination, is one able to donate a kidney or bone marrow?
  11. Has the anthrax vaccine ever been reviewed by any civilian medical review board?
  12. In some DoD documents it states that veterinarians have been "routinely administered" anthrax vaccinations. Why do some people dispute this statement?
  13. Which antibiotics does CDC recommend for prevention of inhalational anthrax?
  14. If an anthrax event occurs, should people buy and store antibiotics?
  15. What drugs are FDA-approved for treatment of anthrax?
  16. For More Information:
  17. What happens to those individuals who were court-martialed or given non-judicial punishment for refusing to take anthrax vaccine?
  18. How many DoD personnel have been vaccinated?
  19. When did the route of administration of anthrax vaccine change from subcutaneous to intramuscular and the number of doses in the initial series change from six to five doses?
  20. Why was the dosing schedule and route of administration for the anthrax vaccine changed?
  21. Will I receive the same level of protection from the five-shot anthrax vaccine series?
  22. If I have started my vaccination series while on the six-dose series, do I need to start my series over?

Anthrax Vaccine-Civilian Inquiries

  1. Can civilians get the anthrax vaccine?
  2. How would one respond to a bioterrorist attack involving anthrax?
  3. How will I know what to do, if there is a bioweapon attack near me?
  4. How can bioterrorist attacks be detected?
  5. What other reliable information is available from health authorities?

Anthrax Vaccine-Eligibility Criteria

  1. Who should not take the anthrax vaccine?
  2. Should people with lupus (SLE) get vaccinated?
  3. Why doesn't DoD policy include giving anthrax vaccine to people younger than 18 years or older than 65 years?
  4. Why aren't HIV-positive or immunodeficient people included in DoD's Anthrax Vaccine Immunization Program?
  5. For More Information:
  6. Is it true that I cannot receive anthrax vaccine because I am allergic to latex?

Anthrax Vaccine-Effectiveness

  1. Why do we think the anthrax vaccine will protect people if anthrax inhalation occurs? What scientific evidence do we have?
  2. I heard that the vaccine used in the 1962 Brachman study isn't the same as the vaccine used today. Is that true?
  3. What will happen if personnel are exposed to anthrax before they gain immunity through vaccination?
  4. If you receive all the shots, are you 100% protected?
  5. Does anthrax vaccine protect against disease if someone inhales anthrax spores?
  6. How long does it take after the first shot before protection begins?
  7. Will this anthrax vaccine protect soldiers from all forms of anthrax, including the ones reportedly developed in Russia?
  8. Is the anthrax vaccine licensed for use against biological agents?
  9. For More Information:
  10. What is FDA's position about the effectiveness of anthrax vaccine?

Anthrax Vaccine-Ingredients

  1. What are the ingredients of the anthrax vaccine?
  2. Why is aluminum in anthrax and other vaccines?
  3. What is benzethonium chloride?
  4. Does anthrax vaccine contain mercury?
  5. Formaldehyde is not approved for human consumption. Why is it used in the anthrax and other vaccines?
  6. Does the anthrax vaccine contain pork or egg products?
  7. Does the anthrax vaccine contain any fetal tissue?
  8. Does the anthrax vaccine contain squalene?
  9. Does the anthrax vaccine use squalene as an adjuvant?
  10. Is the Food & Drug Administration concerned about the quantity of squalene found in these vaccines?
  11. For More Information:

Safety

  1. Is the anthrax vaccine safe?
  2. What about long-term side effects?
  3. Is there a requirement for long-term follow-up after the anthrax vaccine is administered?
  4. Is this an experimental vaccine?
  5. What about sterility or impairment of fertility?
  6. Are there any other groups or agencies besides DoD that advocate the use of the anthrax vaccine?
  7. Is the Department of Defense continuing to research safety aspects of the anthrax vaccine?
  8. Is there any risk of cancer or mutagenesis (genetic mutations)?
  9. I don't have a spleen. Can I still get vaccinated?
  10. Should people with lupus (SLE) get vaccinated?
  11. For More Information:
  12. What information about potential risks of vaccination will DoD provide people who will be vaccinated against anthrax?
  13. How will the side effects of anthrax vaccinations be monitored?
  14. How will DoD track who receives anthrax vaccinations?
  15. What compensation is available for individuals who claim injury from anthrax vaccine?
  16. I was late getting a dose of anthrax vaccine. Do I have to start the anthrax vaccination series over again?
  17. Can I get the next dose of my anthrax vaccine early?
  18. A few days ago, I got a dose of anthrax vaccine. Now I have red lump on my arm. Is this normal?
  19. Every time I get an anthrax vaccination, the side effects get worse. Should I get any more doses?

Long Term Safety

  1. What do we know about the long-term safety of anthrax vaccine?
  2. When people talk about "long term," what do they mean?
  3. I have heard people say that "no data has been collected more than 48 hours after anthrax vaccination." Is that statement true?
  4. I have heard people say "there are no long-term safety studies of anthrax vaccine." Is that statement true?
  5. Laboratory workers at Fort Detrick, Maryland, have been vaccinated against anthrax since the 1940s. What do we know about the long-term health of those workers?

Mail Handling Safety

  1. How can mail get cross-contaminated with anthrax?
  2. When there is a known incident, how can I prevent anthrax exposure from cross-contaminated mail?
  3. What should people do when they get a letter or package with powder?
  4. What is the risk for getting anthrax from handling my own mail?
  5. When the possibility of cross-contamination of the mail exists, should I take antibiotics?
  6. What kinds of anthrax worker safety guidelines have been issued?

Vaccination and Reproductive Health

  1. Can the anthrax vaccine be taken by military members who are pregnant?
  2. What happens to vaccinated women who later get pregnant?
  3. What about men who get vaccinated? Should they delay fathering a child?
  4. What about a woman who is taking fertility-enhancing drugs in an effort to become pregnant?
  5. For More Information:
  6. Have any studies revealed birth defects among babies born to women who received anthrax vaccine during their pregnancy?
  7. Are the chances for birth defects increased if both parents have received anthrax vaccination?
  8. I don't have any children now, but hope to one day and I'm currently taking the anthrax vaccination. Will this vaccination cause birth defects in my future children?
  9. I'm scheduled to start/restart my anthrax vaccination series, but I want to start trying to get pregnant. Should I delay getting pregnant?
  10. Why is anthrax vaccine not contraindicated with breast-feeding?
  11. I got the anthrax vaccine and then found out that I am pregnant. What should I do?
  12. Will anthrax vaccine affect my ability to have children?

Anthrax and the Persian Gulf War

  1. Is the anthrax vaccination program a result of lessons we learned from the 1990-1991 Persian Gulf War?
  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?
  3. Was the anthrax vaccine FDA-licensed at the time it was given to Gulf War veterans?
  4. Has the anthrax vaccine been linked to illnesses among Persian Gulf War veterans?
  5. What did the Centers for Disease Control and Prevention find in their study?
  6. Where can I get more information about reputable studies of Gulf War illnesses?

Next Generation Anthrax Vaccine (NGAV)

  1. Is the Department of Defense (DoD) pursuing an improved anthrax vaccine?
  2. Why is DoD pursuing another anthrax vaccine? Doesn't the one you have now work?
  3. Then why are you pursuing a next-generation anthrax vaccine?
  4. What efforts does DoD have underway? Who are DoD's partners?
  5. What advantages could an NGAV offer?
  6. How will this new anthrax vaccine be produced?
  7. Will a next-generation anthrax vaccine protect as well as the current anthrax vaccine?
  8. What has to be done before we can use an NGAV?
  9. When will human clinical trials of next-generation anthrax vaccines (NGAV) begin?
Answers

Independent Scientific Reviews of the Anthrax Vaccine

  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:



Overview

  1. What is anthrax vaccine?
    Anthrax vaccine is known officially to the FDA as "Anthrax Vaccine Adsorbed." It is abbreviated AVA. It is also referred to by its trade name "BioThrax". This vaccine is a sterile product, made from filtrates of microaerophilic cultures of an avirulent nonencapsulated strain of Bacillus anthracis. This means that the vaccine is the solution that results after filtration of a culture of anthrax bacteria. If you've ever seen percolated coffee, you know that liquid coffee is the filtrate and the coffee grounds are what are left in the filter. These bacteria are grown with very little oxygen (microaerophilic conditions). The bacteria cannot cause disease themselves (they are avirulent). They are from a strain of anthrax that does not have a capsule around the bacterial cells (they are nonencapsulated). The master seed used for vaccine manufacturing was transferred from Fort Detrick to Lansing in 1970 and is identified as Bacillus anthracis strain V-770-NPI-R1. Adsorbed refers to the fact that the vaccine is deposited on the surface of ("adsorbed to") a chemical called aluminum hydroxide. Aluminum hydroxide is added to the vaccine to increase the amount of antibodies that the body makes in response to vaccination. Aluminum hydroxide is called a vaccine adjuvant. Adjuvant comes from the Latin word meaning "to help." Anthrax vaccine is a cell-free filtrate vaccine, which means that it contains no whole bacteria, neither live nor dead. The vaccine is manufactured and distributed by BioPort Corporation (formerly the Michigan Biologic Products Institute), in Lansing, Michigan.

  2. Isn't anthrax vaccine based on old (archaic) technology?
    Anthrax vaccine was invented using mid-century technology that also led to highly successful vaccines against tetanus, diphtheria, and other infectious diseases. Today's manufacturing of anthrax vaccine by BioPort meets all current Food and Drug Administration standards of production.

  3. Who licensed the availability of anthrax vaccine in the United States?
    The vaccine was developed in the United States during the 1950s and 1960s for humans. The vaccine was licensed by the National Institutes of Health's Division of Biologics Standards for general use on November 4, 1970. In 1972, responsibility for vaccine regulation was transferred from NIH to the Food & Drug Administration (FDA). It is customary to refer to anthrax vaccine as "FDA-licensed." Since 1970, at-risk veterinarians, laboratory workers, and livestock handlers in the United States have used anthrax vaccine. FDA officials report that about 68,000 doses of anthrax vaccine were distributed in the United States between 1974 and 1989.

  4. What do I do if I am late for my next scheduled dose?

    The vaccine schedule should be followed as closely as possible. However, if a person is late for a dose, the next dose should simply be given as soon as possible. Then subsequent doses should be given according to the standard dosing intervals from the most recent dose. This applies to anthrax vaccine, as well as other vaccines, according to the Centers for Disease Control & Prevention. http://www.cdc.gov/mmwr/PDF/rr/rr4915.pdf

    If an annual booster has not been administered on time, administer the booster dose at the earliest possible date, adjusting the subsequent booster schedule accordingly. Once the primary series of five doses is complete, the primary series is never repeated.



  5. What is the new standard dosing schedule for the anthrax vaccine?

    The current FDA-licensed schedule calls for doses to be administered intramuscularly in the deltoid according to the following schedule (the first dose is considered "week 0"): 0, 4 weeks; 6 months, 12 months, and 18 months.

    Recipients receive the first shot, then the second shot four weeks later, and then the third shot five months after the second shot. Six months after the third shot, recipients receive the fourth shot. Six months after that, they receive the fifth shot. The entire primary series takes 18 months to complete. Annual booster doses of the vaccine are required for ongoing protection.



  6. Can I get vaccinated ahead of schedule?
    No. If you get vaccinated "too soon," the body's immune system might not have had enough time to prepare for the next dose, and you may not develop as good an antibody response as if you had complied with the standard schedule. Stay on schedule.

  7. What does the anthrax vaccine do to make a person immune?
    The anthrax vaccine, like other vaccines, stimulates your body to produce protective antibodies. These antibodies help your immune system to prevent the anthrax bacteria from producing toxins that could otherwise kill you, if you became infected with anthrax. Nearly everyone who receives two doses of anthrax vaccine has some antibody response. The full series plus annual booster doses provides maximum and on-going protection.

  8. Do pilots who have received the anthrax vaccine have any troubles with FAA flight certification?
    No, taking the anthrax vaccine has no effect on civilian or military aviation status. An excellent independent source for definitive information regarding aviation-related matters and the anthrax vaccine can be found at http://www.faa.gov/about/office_org/headquarters_offices/avs/offices/aam/. The Federal Aviation Administration reports that people vaccinated against anthrax are not disqualified from performing civilian airman duties.

  9. Can people who have received the anthrax vaccine donate blood?
    Yes, the American Association of Blood Banks (AABB) and the Food & Drug Administration allow blood donations following anthrax vaccination without any vaccine-related restrictions. For more information, see the Internet resources of the Armed Services Blood Program Office (http://www.militaryblood.dod.mil/). Sometimes people will not be allowed to donate blood for other reasons. For example, the Armed Services Blood Program has ordered Department of Defense blood banks to defer blood donations from all military personnel who were stationed in Saudi Arabia, Kuwait, Iraq, Bahrain, Qatar, the United Arab Emirates, Oman and Yemen at any time since August 1, 1990. This action was taken in response to a small number of diagnosed cases of leishmania infection -- a tropical disease -- among military personnel returning from that area. For more information regarding the temporary donor deferral related to Leishmaniasis http://www.fda.gov/bbs/topics/ANSWERS/ANS00360.html Data Source: The American Association of Blood Banks (http://www.AABB.org), 1801 Glenbrook Road, Bethesda, MD 20814-2749, 301-907-6977, Standards for Blood Bank and Transfusion Services, 19th ed., Standard B2.600.

  10. After anthrax vaccination, is one able to donate a kidney or bone marrow?
    Yes. Anthrax vaccine contains no live bacteria and poses no safety risk. There is no bar (contraindication) regarding donating organs or marrow after being vaccinated. In fact, your bone marrow might confer temporary immunity to the diseases to which you are immune to the marrow recipient. The immune response to anthrax vaccine would have no adverse effect on the internal organs of the kidney or marrow recipient. Anthrax vaccine is a sterile product made from filtrates of inactivated bacterial cultures. Sterile filtration during manufacturing yields a vaccine containing no whole organisms, thereby presenting no possibility of infection to the recipient, whether immunodeficient or not.

  11. Has the anthrax vaccine ever been reviewed by any civilian medical review board?
    Yes, seven times. See the separate Q&A page on Independent Scientific Reviews of Anthrax Vaccine for details.

    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 (http://www.cdc.gov/mmwr/PDF/rr/rr4915.pdf) and the Johns Hopkins Center for Civilian Bio-defense Studies (http://jama.ama-assn.org/cgi/content/short/287/17/2236) recognize the anthrax vaccine as part of the national preparedness against biological terrorism.

  12. In some DoD documents it states that veterinarians have been "routinely administered" anthrax vaccinations. Why do some people dispute this statement?
    Anthrax is not a widespread disease in the United States. Therefore, primarily at-risk veterinarians within the U.S. are vaccinated. "Routinely" was not intended to imply that veterinarians are universally vaccinated (i.e., that they are all vaccinated), but rather that if the person is potentially exposed to anthrax, vaccination is routine, a customary practice.

    Also, other at-risk workers such as laboratory personnel and livestock handlers are routinely vaccinated. Other non-military personnel have been vaccinated, including workers at an Alabama sweater factory from 1977-1996. The manufacturer and FDA report that about 68,000 doses of anthrax vaccine were distributed between 1974 and 1989.

    Anthrax vaccine is not experimental, not investigational, and does not require special authorization, nor informed consent. Anthrax vaccine was licensed for general use on November 4, 1970. It is a routine, common vaccination for people whose occupation places them at-risk for exposure to anthrax.

  13. Which antibiotics does CDC recommend for prevention of inhalational anthrax?
    In selecting an antibiotic, we will be guided by the organism's culture and sensitivity results, history of allergic reactions, age and health status factors and antibiotic availability. When no information is available about the antimicrobial susceptibility of the implicated strain of B. anthracis, initial therapy with ciprofloxacin or doxycycline is recommended for adults and children, or levofloxacin for adults.

  14. If an anthrax event occurs, should people buy and store antibiotics?
    There is no need to buy or store antibiotics, and indeed, it can be detrimental to both the individual and to the community. First, only people who are exposed to anthrax should take antibiotics, and health authorities must make that determination. Second, individuals may not stockpile or store the correct antibiotics. Third, under emergency plans, the federal government can ship appropriate antibiotics from its stockpile to wherever they are needed.

  15. What drugs are FDA-approved for treatment of anthrax?
    Ciprofloxacin, doxycycline and penicillin are FDA-approved for the treatment of anthrax in adults and children.

  16. For More Information:
    Advisory Committee on Immunization Practices. General recommendations on immunization. MMWR-Morbidity & Mortality Weekly Report 2002;51(RR-2):1-35 ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr5102.pdf

    Brachman PS, Friedlander AM. Anthrax. In: Plotkin SA, Orenstein WA, ed. Vaccines, 3rd ed. Philadelphia: W. B. Saunders, 1999.

    Brachman PS, Gold H, Plotkin SA, Fekety FR, Werrin M, Ingraham NR. Field evaluation of a human anthrax vaccine. American Journal of Public Health 1962; 52:432-45. http://www.vaccines.mil/documents/338field_eval.pdf

    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

    Food & Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review. Federal Register 1985; 50:51002-117. http://www.anthrax.mil/documents/library/bvactoxrevoke.pdf

    Franz DR, Jahrling PB, Friedlander AM, McClain DJ, Hoover DL, Bryne WR, Pavlin JA, Christopher GW, Eitzen EM Jr. Clinical recognition and management of patients exposed to biological warfare agents. Journal of the American Medical Association 1997; 278(Aug 6):399-411.

    Hambleton P, Carman JA, Melling J. Anthrax: The disease in relation to vaccines. Vaccine 1984; 2:125-32.

    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

    Sidell FR, Takafuji ET, Franz DR. Medical Aspects of Chemical & Biological Warfare. Washington, DC: Department of the Army, 1997. http://stinet.dtic.mil/oai/oai?&verb=getRecord&metadataPrefix=html&identifier=ADA398241

    Singleton JA, Lloyd JC, Mootrey GT, Salive ME, Chen RT, VAERS Working Group. An overview of the vaccine adverse event reported system (VAERS) as a surveillance system. Vaccine 1999;17:2908-17.

    Turnbull PCB. Guidelines for the Surveillance and Control of Anthrax in Humans and Animals, 3rd ed., WHO Report WHO/EMC/ZDI/98.6.

  17. What happens to those individuals who were court-martialed or given non-judicial punishment for refusing to take anthrax vaccine?
    This is a matter for long-established appeals processes and the Board for the Correction of Military Records.

  18. How many DoD personnel have been vaccinated?
    We have vaccinated over 1.5 million DoD personnel with over 5.9 million doses since the beginning of the AVIP in March 1998.

  19. When did the route of administration of anthrax vaccine change from subcutaneous to intramuscular and the number of doses in the initial series change from six to five doses?

    On 11 Dec 08, the Food and Drug Administration (FDA) approved two updates to the package insert for the anthrax vaccine. The route of administration was changed from a subcutaneous injection over the deltoid to an intramuscular injection in the deltoid. The FDA also approved a change in the vaccination series by removing the 2-week dose. The new schedule is now 0, 4 weeks, and 6 months, 12 months, 18 months, and annual boosters.

     



  20. Why was the dosing schedule and route of administration for the anthrax vaccine changed?
    The Centers for Disease Control and Prevention (CDC) conducted a randomized double-blind clinical trial investigating the safety and efficacy of a dose reduction and route change for the anthrax vaccine. The FDA has confirmed and approved the results of the clinical trial that Anthrax Vaccine Adsorbed (AVA) is safe and effective as a five-dose regimen for the primary series and administration of the vaccine is safe via the intramuscular route.

  21. Will I receive the same level of protection from the five-shot anthrax vaccine series?
    Yes. Researchers at the Centers for Disease Control and Prevention (CDC) conducted a randomized double-blinded study and found that dose reduction from 6 doses to 5 doses, over an 18 month period to include annual boosters, receive the same benefit of protection from anthrax vaccine.

  22. If I have started my vaccination series while on the six-dose series, do I need to start my series over?
    No. You will not start your primary anthrax series over. You will continue with your next scheduled dose in the series.

Anthrax Vaccine-Civilian Inquiries

  1. Can civilians get the anthrax vaccine?
    The vaccine's manufacturer, Emergent BioSolutions of Lansing, MI, offers anthrax vaccine for sale to licensed physicians in the United States. Emergent BioSolutions sells the vaccine, under the trade name BioThrax.

  2. How would one respond to a bioterrorist attack involving anthrax?
    The course of action for preventing anthrax after exposure in the civilian population would be with antibiotics, or a combination of anthrax vaccine and antibiotics.

  3. How will I know what to do, if there is a bioweapon attack near me?
    If there was an incident, people would be notified by the emergency public announcement system by federal, state, or local authorities about what to do or where to go to obtain treatment. The closest source of emergency assistance will come from your city, county, or state. Contact your state or local Health Department to find out procedures for handling possible bioterrorist incidents in your area.

  4. How can bioterrorist attacks be detected?
    The investigative skills, diagnostic techniques, and physical resources required to detect and diagnose a disease outbreak are the same ones required to identify and respond to a silent bioterrorist attack. A key component to success will continue to be the sharing of information among all components of the public health system so that early diagnosis and response can happen as quickly as possible.

  5. What other reliable information is available from health authorities?
    Advisory Committee on Immunization Practices. Use of anthrax vaccine in the United States. MMWR-Morbidity & Mortality Weekly Report 2000;49(RR-15, Dec 15):1-20. http://www.cdc.gov/mmwr/PDF/rr/rr4915.pdf l CDC BioTerrorism Preparedness and Response: www.bt.cdc.gov l CDC Public Inquiry line: 1-800-311-3435 l CDC National Immunization HOTLINE 1-800-232-2522 Civilian Panel on Review of Bacterial Vaccines & Toxoids, advising the FDA from 1978 to 1985. Federal Register 1985;50:51002-117. http://www.anthrax.mil/documents/205Fed_Reg.pdf Armed Forces Epidemiological Board (AFEB), civilian scientists advising the Surgeons General, from 1994 to present. Cochrane Collaboration, the international evidence-based medicine group from Oxford. 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 Anthrax Vaccine Expert Committee (AVEC), civilian physicians selected by the Department of Health & Human Services, who independently evaluate VAERS reports, 1998 to present: http://www.vaccines.mil/documents/library/AVEC_ms.pdf http://www.vaccines.mil/documents/library/SeverArticle.pdf

Anthrax Vaccine-Eligibility Criteria

  1. Who should not take the anthrax vaccine?
    Those with a true hypersensitivity reaction (serious allergic reaction) to a previous dose of the anthrax vaccine, people infected with HIV, people who have other kinds of immune suppression, pregnant women, and people under 18 and over 65 years of age. Other temporary reasons for deferring anthrax vaccination include an acute respiratory disease or active infection, and a temporary course of immune-suppressing drugs such as steroids (e.g., prednisone). Vaccinations should be resumed when these issues are resolved. If a person has an active infection or is taking a prescription medication that suppresses the immune system, a decision to give the anthrax vaccine will be made on a case-by-case basis.

  2. Should people with lupus (SLE) get vaccinated?
    People who have been diagnosed with lupus should talk with their physician about whether or not they should be vaccinated, considering the state of their disease, the medications they take, and their personal risk for specific infections. Several medical studies have shown that people with lupus can be safely and effectively vaccinated against influenza, hepatitis B, pneumococcal disease and other diseases that would pose a significant risk if they were infected. For military personnel with lupus, providers are authorized to grant medical exemptions according to the patient's specific situation. Medical specialists can advise how to get the best benefit from vaccination in such circumstances.

  3. Why doesn't DoD policy include giving anthrax vaccine to people younger than 18 years or older than 65 years?
    The FDA has only licensed the anthrax vaccine for use in people between ages 18 and 65. FDA does not perform its own clinical research; it reviews the quality of research performed by others. FDA can only determine the effectiveness of a vaccine in the same kind of population as the vaccine was tested in. No formal studies of children, adolescents, or the elderly have been performed to date. Once such studies are performed, FDA can determine if sufficient evidence is available. Individual physicians can treat individual people in ways that are outside the limitations of a package insert (these are called "off-label" uses of drugs). Indeed, DoD knows of no example of a vaccine that is effective among adults that is not also effective in the elderly or in adolescents. DoD policy is to abide by the age ranges in the FDA-approved labeling for its Anthrax Vaccine Immunization Program.

  4. Why aren't HIV-positive or immunodeficient people included in DoD's Anthrax Vaccine Immunization Program?
    Anthrax vaccine’s package insert says "anyone that is immunodeficient should not receive the vaccination." This precaution refers to the fact that the recipient, being immunodeficient, would be less likely to mount a full immune response to the vaccine, thus reducing the vaccine’s intended benefit. Inactivated vaccines are not considered to be harmful to immunodeficient people. HIV-positive and other immunodeficient people should receive the anthrax vaccine if exposure occurs or is imminent. These personnel should be counseled that the vaccine is not expected to harm them, but they may not mount as complete an immune response to protect against anthrax as other people do. Under these conditions, the adage "some protection is better than none" would apply.

  5. For More Information:
    Advisory Committee on Immunization Practices. General recommendations on immunization. MMWR-Morbidity & Mortality Weekly Report 2002;51(RR-2):1-35. http://www.cdc.gov/mmwr/pdf/rr/rr5102.pdf

  6. Is it true that I cannot receive anthrax vaccine because I am allergic to latex?
    Whether or not you can receive anthrax vaccine depends on the type of latex allergy you have. If you have a history of latex sensitivity or latex allergy, always inform the person who is vaccinating you before you are given a vaccine. The degree of your reaction to latex products in the past will guide your provider's decision as to whether or not you should receive the vaccine. In addition, your provider may recommend that you get further allergy testing before making a recommendation.

    A history of severe life-threatening anaphylactic reaction to latex is a contraindication to anthrax vaccination.

Anthrax Vaccine-Effectiveness

  1. Why do we think the anthrax vaccine will protect people if anthrax inhalation occurs? What scientific evidence do we have?
    This vaccine prevents anthrax regardless of route of exposure. Based on human and animal data, the National Academy of Sciences’ Institute of Medicine concluded in March 2002 that anthrax vaccine is “an effective vaccine for the protection of humans against anthrax, including inhalational anthrax, caused by all known or plausible engineered strains of Bacillus anthracis.” The original Brachman and CDC studies of anthrax vaccine in textile workers proved that the vaccine protected against anthrax. The calculations performed in that study combined the cutaneous (skin) and inhalational forms of anthrax infection that occurred. No inhalational anthrax occurred among the vaccinated workers, while five cases of inhalational anthrax occurred among workers who had not been vaccinated. The total number of inhalation cases was judged too few to show statistically conclusive proof of protection by itself. However, results from several animal studies provide additional evidence that the vaccine protects against anthrax challenge with hundreds of times the lethal dose of anthrax by inhalation. This information coupled with the encouraging results of the effectiveness and immune response in humans assures us that the vaccine will greatly increase the chances of soldiers surviving exposure to inhalational anthrax. When full immunization is combined with proper use of protective masks, detection devices, surveillance and post-exposure treatment with antibiotics, the threat is even further reduced.

  2. I heard that the vaccine used in the 1962 Brachman study isn't the same as the vaccine used today. Is that true?
    Yes, it is true that the current vaccine has more protective antigen (PA) in it than Brachman's vaccine formula, and also that the current vaccine is more highly purified than the vaccine used in the Brachman study. Between the time of the Brachman study and the licensing of the vaccine produced in Lansing, the conditions under which the anthrax bacteria were cultured were changed. These changes resulted in a purer, more potent vaccine. Government authorities were aware of and approved the changes at that time the license application was considered in 1970. The independent, civilian review panel advising the FDA was aware of the changes, and described them in its 1985 report. Both vaccine formulas are based on protective antigen (PA), the key protein common to all strains of anthrax.

  3. What will happen if personnel are exposed to anthrax before they gain immunity through vaccination?
    Personnel will be treated with antibiotics if there is a known exposure to anthrax before gaining immunity through vaccination. Antibiotics are effective in treating animals, including primates, exposed to inhalational anthrax, but only if started before symptoms develop. This would usually mean starting antibiotics in the first 24 hours after exposure. Unfortunately, servicemembers may not know they have been exposed until symptoms develop; by then, the infection is nearly always fatal within a few days, whether antibiotics are given or not. The best protection to counter inhalational anthrax is the use of the anthrax vaccine combined with the appropriate Mission Oriented Protective Posture (MOPP), including protective clothing and detection equipment.

  4. If you receive all the shots, are you 100% protected?
    No medication, no vaccine is 100% effecticve. The antibodies that result from any vaccine theoretically could be overwhelmed if one is exposed to extremely large doses of any pathogen. Even if vaccinated, one may not be completely safe if one is close to the point of release of the biologic agent. Antibiotics for such people will offer additional protection. That's why vaccination is only one part of force health protection efforts, which also includes protective gear and detection equipment. For continued protection, annual booster doses are required.

  5. Does anthrax vaccine protect against disease if someone inhales anthrax spores?
    The original studies of anthrax vaccine showed 93% fewer anthrax infections (combining both cutaneous and inhalational cases of anthrax) among vaccinated people, compared to unvaccinated people. In those original studies, no cases of inhaled (inhalation) anthrax occurred among vaccine recipients, while five cases of anthrax occurred among unvaccinated or incompletely vaccinated people. This difference involved too few people to be statistically conclusive, although the trend is obvious. It is unethical to intentionally expose human beings to inhaled anthrax to test the vaccine. Instead, anthrax vaccine was tested on rhesus monkeys. After 65 animals received one or two doses of vaccine, 95% survived aerosol challenge in full health. One animal died from anthrax exposure two years after the second dose of vaccine. This illustrates the importance of annual booster doses of anthrax vaccine. These data lead us to expect that anthrax vaccine would be quite effective in preventing inhaled anthrax.

  6. How long does it take after the first shot before protection begins?
    Antibodies begin to develop within a week or two after the first dose of vaccine. Protection levels increase as shots in the series are given, like walking up a set of stairs. The entire sixshot series is needed for full protection as licensed by the Food & Drug Administration.

  7. Will this anthrax vaccine protect soldiers from all forms of anthrax, including the ones reportedly developed in Russia?
    Every disease-causing strain of Bacillus anthracis causes anthrax disease via the same protein. The vaccine produces antibodies that neutralize that protein. The National Academy of Sciences’ Institute of Medicine concluded in March 2002 that “it is unlikely that either naturally occurring or anthrax strains with bioengineered protective antigen could both evade AVA [the U.S. anthrax vaccine] and cause the toxicity associated with anthrax.” DoD is aware of the Russian research effort recently reported in a British scientific journal. Russian scientists reported using technology to introduce two foreign genes into anthrax. The potential for a genetically altered virulent organism is of concern to us and we are anxious to learn more about this organism. Hamsters, vaccinated with the Russian live attenuated anthrax vaccine were not resistant to challenge with their engineered strain. There are substantive scientific questions about this report. First, the validity of the animal model that the Russians used needs to be addressed, because hamsters may not be predictive of results in other animals (including humans). Second, the strain produced may not be stable, a fact the Russians admit. An unstable organism would not be a candidate for weaponization. There have been ongoing efforts by OSD Cooperative Threat Reduction Program, the National Academy of Sciences, and the International Science and Technology Center to evaluate the possibility of a potential threat from genetically modified strains, and to ensure that our vaccine is effective against them. We believe that the current anthrax vaccine would be effective against altered genetic strains based on the biologic principles of the U.S. vaccine, which is different from the Russian vaccine.

  8. Is the anthrax vaccine licensed for use against biological agents?
    The anthrax vaccine is licensed for people at risk for exposure to anthrax spores. Biological weapons are designed to deliver aerosolized anthrax spores that will result in inhalational anthrax. The FDA concurs that the use of the anthrax vaccine to protect against inhalational anthrax is consistent with indications for use of the vaccine.

  9. For More Information:

    Brachman PS, Friedlander AM, Grabenstein JD. Anthrax. In: Plotkin SA, Orenstein WA, Vaccines, 4th ed. Philadelphia: W. B. Saunders, 2003.

    Brachman PS, Gold H, Plotkin SA, Fekety FR, Werrin M, Ingraham NR. Field evaluation of a human anthrax vaccine. American Journal of Public Health 1962;52:432-45. http://www.anthrax.mil/documents/338field_eval.pdf

    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

    Food & Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review. Federal Register 1985;50:51002-117. http://www.anthrax.mil/documents/338field_eval.pdf

    Franz DR, Jahrling PB, Friedlander AM, McClain DJ, Hoover DL, Bryne WR, Pavlin JA, Christopher GW, Eitzen EM Jr. Clinical recognition and management of patients exposed to biological warfare agents. Journal of the American Medical Association 1997;278(Aug 6):399-411. http://jama.ama-assn.org/cgi/content/short/278/5/399

    Hambleton P, Carman JA, Melling J. Anthrax: The disease in relation to vaccines. Vaccine 1984;2:125-32.

    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 Biodefense. 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

    Ivins BE, Fellows PF, Pitt MLM, Estep JE, Welkos SL, Worsham PL, Friedlander AM. Efficacy of a standard human anthrax vaccine against Bacillus anthracis aerosol spore challenge in rhesus monkeys. Salisbury Medical Bulletin 1996;87(Suppl): 125-6.

    Ivins BE, Pitt MLM, Fellows PF, Farchaus JW, Benner GE, Waag DM, Little SF, Anderson GW Jr., Gibbs PH, Friedlander AM. Comparative efficacy of experimental anthrax vaccine candidates against inhalation anthrax in rhesus macaques. Vaccine 1998;16:1141-8.

    Pitt MLM, Ivins BE, Estep JE, et al. Comparison of the efficacy of purified protective antigen and MDPH to protect non-human primates from inhalation anthrax. Salisbury Medical Bulletin. 1996;87:130.

    Sidell FR, Takafuji ET, Franz DR. Medical Aspects of Chemical & Biological Warfare. Washington, DC: Department of the Army, 1997.

    Turnbull PCB. Guidelines for the Surveillance and Control of Anthrax in Humans and Animals, 3rd ed., WHO Report WHO/EMC/ZDI/98.6.



  10. What is FDA's position about the effectiveness of anthrax vaccine?
    For years, FDA has held that anthrax vaccine prevents anthrax infection regardless of the route of exposure. On December 15, 2005, the Food and Drug Administration released a Final Rule and Final Order for anthrax vaccine. After reviewing extensive scientific evidence and carefully considering comments from the public, the FDA determined that anthrax vaccine is safe and effective in preventing anthrax disease regardless of route of exposure, including inhalation anthrax.

Anthrax Vaccine-Ingredients

  1. What are the ingredients of the anthrax vaccine?
    Anthrax vaccine is a sterile product made from filtrates of microaerophilic cultures of an avirulent nonencapsulated strain of Bacillus anthracis. These bacteria are grown with very little oxygen (microaerophilic conditions). The bacteria cannot cause disease themselves (they are avirulent). They are from a strain of anthrax that does not have a capsule around the bacterial cells (they are nonencapsulated). This means that the vaccine is the solution that results after filtration of a culture of anthrax bacteria. If you’ve ever seen percolated coffee, you know that liquid coffee is the filtrate and the coffee grounds are what are left in the filter. In this example, the vaccine is like the cup of coffee. Anthrax vaccine is known officially to the Food & Drug Administration (FDA) as "Anthrax Vaccine Adsorbed," generating its abbreviation "AVA." Adsorbed refers to the fact that the vaccine is deposited on the surface of ("adsorbed to") a chemical called aluminum hydroxide. Aluminum hydroxide is added as an adjuvant to the vaccine to increase the amount of antibodies that the body makes in response to vaccination. Anthrax vaccine is a cell-free filtrate vaccine, which means that it contains no whole bacteria, neither live nor dead. The bacteria used to make the vaccine cannot cause disease themselves. For these two reasons, it is impossible to contract the anthrax disease from the anthrax vaccine. The final product is formulated to contain 600 micrograms aluminum per 0.5ml, added as aluminum hydroxide in 0.85% sodium chloride. The product is formulated to contain 25 mg/mL benzethonium chloride and 100 mg/mL formaldehyde, added as preservatives.

  2. Why is aluminum in anthrax and other vaccines?
    Aluminum is an adjuvant. The word adjuvant comes from the Latin, meaning "to help." Adjuvants are added to vaccines to increase antibody responses to vaccination. Aluminum salts are the only kind of adjuvant so far licensed by the FDA and the only kind of adjuvant used in anthrax vaccines for humans in the United States. Anthrax vaccine contains aluminum hydroxide, as do FDA-licensed diphtheria, Haemophilus influenzae type b, hepatitis A, hepatitis B, Lyme disease, pertussis, and tetanus vaccines.

  3. What is benzethonium chloride?
    Benzethonium chloride is used as a preservative in the anthrax vaccine. It is also a common component in other injectable and nasal medications (such as thrombin, ketamine, orphenadrine [Norflex], and butorphanol [Stadol]). Benzethonium chloride is sometimes also called Phemerol, a trade name.

  4. Does anthrax vaccine contain mercury?
    No. The preservative of anthrax vaccine is benzethonium chloride.

  5. Formaldehyde is not approved for human consumption. Why is it used in the anthrax and other vaccines?
    Material Safety Data Sheets correctly warn people not to swallow formaldehyde. Small amounts of formaldehyde are approved by the FDA for use in manufacturing several vaccines, including vaccines against anthrax, diphtheria, hepatitis A, influenza, Japanese encephalitis, and tetanus. A small amount of formaldehyde, less than 2 parts per 10,000 (0.02%), is permitted by FDA to remain in the anthrax vaccine. Formaldehyde has been used in vaccine manufacturing since the 1960s, if not earlier. Literally billions of people around the world have been given tetanus toxoid processed with formaldehyde (as anthrax vaccine is), which is recognized as safe. FDA closely monitors all the ingredients and processing steps of all vaccines and other medications before they can be distributed for widespread use. Material Safety Data Sheets (MSDS) are a method to explain chemical hazards, according to OSHA standards (see http://www.osha-slc.gov/SLTC/smallbusiness/sec16.html). For any given chemical, health hazards vary by amount of chemical (concentration), duration of exposure (time), and route of exposure (skin, stomach, lungs, etc.). FDA's decision to permit formaldehyde to be present as residues in vaccines is based, in part, on the low concentrations and infrequent exposures involved. While it might not be prudent to have formaldehyde contact the skin every day at work, or to inhale formaldehyde fumes repeatedly, a few minute doses of formaldehyde in vaccines are recognized as safe.

  6. Does the anthrax vaccine contain pork or egg products?
    Anthrax vaccine adsorbed is a sterile, cell-free (filtered) bacterial vaccine that contains no live or dead organisms. It is not made from or with pork or egg products.

  7. Does the anthrax vaccine contain any fetal tissue?
    No human tissues of any kind are used in the process of making the anthrax vaccine.

  8. Does the anthrax vaccine contain squalene?
    In September 2000, DoD became aware of FDA test results finding trace amounts of squalene in three out of three US vaccines tested: anthrax, diphtheria, and tetanus. The level of squalene identified by the FDA test is so minute that it is likely the result of squalene in the oil of a fingerprint not cleaned from lab glassware. The trace level of squalene found by the FDA in anthrax vaccine is less than the concentration normally present in human blood (250 parts per billion).

  9. Does the anthrax vaccine use squalene as an adjuvant?
    No, the adjuvant in the anthrax vaccine is aluminum hydroxide.

  10. Is the Food & Drug Administration concerned about the quantity of squalene found in these vaccines?
    No. In Congressional testimony on 3 October 2000, FDA's Mark Elengold said that the trace quantities of squalene detected were "within the realm of both naturally occurring and safe."

  11. For More Information:

    Food & Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review. Federal Register 1985;50:51002-117. http://www.anthrax.mil/documents/205Fed_Reg.pdf

    Food & Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review. Federal Register 2004;29:78281-93. 
    http://www.anthrax.mil/documents/library/bvactox.pdf



Safety

  1. Is the anthrax vaccine safe?
    Yes, this vaccine has been safely administered in the U.S. to at-risk veterinary and laboratory workers, livestock handlers, and servicemembers since licensure by the Food & Drug Administration (FDA) in 1970. The FDA certifies the safety and efficacy of all pharmaceuticals (medications) used in the U.S. One of FDA’s primary missions is to ensure that pharmaceuticals released for use by the American public are tested for both safety and efficacy. Like all vaccines, anthrax vaccine may cause soreness, redness, itching, swelling, and lumps at the injection site. About 30% of men and 60% of women report these local reactions, but they usually last only a short while. Lumps can persist a few weeks, but eventually disappear. Injection-site problems occur about twice as often among women. For both genders, between 1% and 5% report reactions of 1 to 5 inches in diameter. Larger reactions occur in about one in a hundred vaccine recipients. Beyond the injection site, from 5% up to 35% will notice muscle aches, joint aches, headaches, rash, chills, fever, nausea, loss of appetite, malaise, or related symptoms. Again, these symptoms usually go away after a few days. Over-the-counter medications before or after the anthrax vaccine may help reduce bothersome symptoms. Like all vaccines, most adverse events are minor and temporary. Serious events, such as those requiring hospitalization, are rare. They happen about once per 200,000 doses. Severe allergic reactions can occur after any vaccination, less than once per 100,000 doses. Anthrax vaccine is as safe as other vaccines. Like other vaccines, deaths have been reported rarely after anthrax vaccination. Each of these cases is carefully reviewed by CDC, FDA, and DoD, to make vaccinations as safe as possible. For independent information about vaccines and vaccine safety see: Centers for Disease Control & Prevention's National Immunization Program: http://www.cdc.gov/nip

  2. What about long-term side effects?
    There are no known long-term side effects to anthrax vaccine. At Fort Detrick, more than 1,500 laboratory workers followed for up to 10 to 20 or more years after receiving anthrax vaccine. Most of these workers received 150 to 200 vaccinations and skin tests; some received more than 300 such injections during their tenure at Fort Detrick. The first report of this group of vaccine recipients was published in the Bulletin of the Johns Hopkins Hospital in 1958. Two follow-up reports were printed in the Annals of Internal Medicine in 1965 and 1974. An updated manuscript is currently being finalized. These employees have been followed annually. None developed unexplained symptoms due to repeated doses of this or other vaccines they received. From this and other monitoring, no patterns of delayed side effects to anthrax vaccine have been found. Monitoring continues. An extension of this long-term study is underway to determine, in even greater detail, whether people who received multiple vaccines, including anthrax vaccine, during their past employment at Fort Detrick demonstrated any adverse health effects over the long term. A total of 570 study and control volunteers have been enrolled in this case-control study begun in 1996. All volunteers signed an informed-consent document. The study methods include a 9-page health history questionnaire, extensive blood tests and urinalysis. The questionnaire queries mental and physical conditions of progeny as well as the health of volunteers. Study end points include symptoms, symptom complexes (including the complex of symptoms reported by veterans of the Persian Gulf War), diseases, and abnormal laboratory and urine tests. Study subjects will be compared to two to three race-, gender-, and age-matched control subjects to determine if any long-term medical effects exist among this unique group of study subjects. Analysis of the data from the extensive health history questionnaire and numerous laboratory tests is currently in progress. An October 2004 review of over 716,000 active-duty service members discharge rates shows anthrax vaccination does not increase risk of disability. Overall, the disability evaluation rate in the Army was very low for the 4.25 years covered by this study, and there appeared to be no effect of exposure to anthrax vaccine on the risk of disability evaluation.

  3. Is there a requirement for long-term follow-up after the anthrax vaccine is administered?
    No. Like other FDA-licensed products, the anthrax vaccine does not require follow-up monitoring of healthy vaccine recipients. Nonetheless, the DoD has already conducted such studies and is conducting more. No data collected to date shows any patterns of adverse events developing years after people have been vaccinated with anthrax vaccine or any other vaccine.

  4. Is this an experimental vaccine?
    No, the anthrax vaccine has been FDA licensed since 1970. License No. 99 was issued on November 4, 1970. It is neither "experimental" nor "investigational." Since 1970, this vaccine has been administered to people at risk for anthrax exposures including certain veterinary and laboratory workers and civilians who work with animal products. FDA officials reported that about 68,000 doses of anthrax vaccine were distributed in the United States between 1974 and 1989. Since licensure in 1970, the U.S. Army purchased this vaccine for use by at-risk laboratory workers, and it was used during the Gulf War (approximately 150,000 recipients) to vaccinate U.S. forces against Iraq's production of biological weapons. The military currently vaccinates people working in at-risk jobs and some 3,000 personnel assigned to special operations units, the Army Technical Escort Unit and the Marine Corps Chemical-Biological Incident Response Force (C-BIRF). The Centers for Disease Control and Prevention's offer of anthrax vaccine for Congressional and U.S. Postal Service workers used anthrax vaccine for "post-exposure treatment" in three doses. This is not a Food and Drug Administration-licensed use of the vaccine, although the vaccine itself was, and is, licensed. Therefore, in that case (post-exposure), the vaccine was administered under an "investigational new drug" protocol, with informed consent. The Department of Defense's use of anthrax vaccine in the Anthrax Vaccine Immunization Program for pre-exposure prevention is consistent with the Food and Drug Administration-licensed use of the vaccine. When Emergent BioSolutions bought the facilities of the Michigan Biologic Products Institute, License No. 1260 was substituted for License No. 99.

  5. What about sterility or impairment of fertility?

    In nearly 30 years of licensed use, there is no evidence of any sterility or fertility impairment from anthrax vaccine. Regarding reproductive health, the Center for Disease Control and Prevention's Advisory Committee on Immunization Practices states, "there is no convincing risk from vaccinating pregnant women with inactivated virus or bacterial toxoids."

    In the March 27, 2002, issue of the Journal of American Medical Association, two Army physicians published their peer-reviewed findings that women get pregnant at the same rate, whether anthrax-vaccinated or unvaccinated. These physicians from Fort Stewart, Georgia, also showed that women deliver offspring at the same rate, whether anthrax-vaccinated or unvaccinated. The Fort Stewart study found no difference in birth defect rates, but the study may have been too small to detect small differences. [Wiesen AR, Littell CT. Relationship between pre-pregnancy anthrax vaccination and pregnancy and birth outcomes among U.S. Army women. Journal of the American Medical Association (JAMA) 2002; 287:1556-60. http://jama.ama-assn.org/content/vol287/issue12/index.dtl.

    Preliminary data from the Naval Health Research Center raised a tentative signal that there may be an association with an increased rate of birth defects if vaccinated in the first trimester of pregnancy. This signal is being investigated thoroughly, to determine which of several explanations for the signal is most likely.

    Long-standing Defense policy is to defer routine vaccinations in women until after pregnancy. This policy has always applied to anthrax vaccine. Women are asked if they are pregnant before vaccination. Women who are not sure are offered pregnancy tests.

    Data about anthrax vaccination was obtained from men at time of oocyte and sperm retrieval. Researchers assessed characteristics of male gametes, including 254 vaccinated men and 791 unvaccinated men. The two groups were comparable for semen concentration (million sperm per milliliter), sperm motility (movement), sperm morphology (shape), need for intracytoplasmic sperm injection, and rate of fertilization of mature oocytes, embryo transfer, and clinical pregnancy. A diagnosis of male-factor infertility was less common in anthrax-vaccinated men than in unvaccinated men. The researchers concluded that anthrax vaccination of men did not impair semen parameters, fertilization rate, embryo quality, or clinical pregnancy rates.



  6. Are there any other groups or agencies besides DoD that advocate the use of the anthrax vaccine?

    In addition to the Department of Defense, other agencies and groups advocate or support the use of the anthrax vaccine. The Food & Drug Administration licensed the anthrax vaccine in 1970. The Centers for Disease Control & Prevention, the World Health Organization, the Defense Health Board, and many other respected public health organizations support use for people at risk or exposed to Bacillus anthracis. Information about the AVIP is available on the Internet (a variety of DoD web sites as well as the Centers for Disease Control & Prevention (www.cdc.gov) and the Food & Drug Administration web sites), which includes facts about the anthrax vaccine, history, side effects, purpose for immunizations and more. [See the Q&A page on independent scientific reviews.] 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, 17th ed. James Chin, ed. "An official report of the American Public Health Association," Washington, DC, 2000.

    Guide for Adult Immunization, 3rd ed, Philadelphia: American College of Physicians, 1994.

    Immunization Against Infectious Disease. Her Majesty's Stationery Office, London: British Joint Committee on Vaccination and Immunization, 1996. Report of the Committee on Infectious Diseases, 26th edition, Elk Grove Village, IL: American Academy of Pediatrics, 2003.

    ImmunoFacts: Vaccines & Immunologic Drugs. Saint Louis: Facts and Comparisons, Inc., 2006.

    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.

    Similarly, anthrax vaccination is specifically endorsed in the Working Group on Civilian Bio-defense position paper on preparedness against anthrax (Inglesby, et al. Anthrax as a Biological Weapon, 2002.
    Journal of the American Medical Association (JAMA) 2002;287:2236- 52).

    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.

  7. Is the Department of Defense continuing to research safety aspects of the anthrax vaccine?
    Thirty (30) years of experience with anthrax vaccine in the United States suggests it has a similar side effect profile compared to other commonly used vaccines. Nonetheless, the Department of Defense continues to monitor the safety of the anthrax vaccine during program execution. As the National Academy of Sciences pointed out, the most scientifically powerful way of assessing vaccine safety is by comparing and contrasting people vaccinated and unvaccinated against anthrax. In addition, DoD scientists are currently conducting more long-term research and designing yet more studies. In designing these studies, we will draw from the accumulated experience of some of the nation's best vaccine researchers at CDC and FDA. One of the methods used is a surveillance technique used by CDC in post-marketing studies: large, linked databases. DoD uses the large, linked database approach in its long-term research efforts through access to its immunization tracking programs database and though the medical databases maintained by the Defense Medical Surveillance System (DMSS).

  8. Is there any risk of cancer or mutagenesis (genetic mutations)?
    In nearly 30 years of use, there is no evidence that the anthrax vaccine causes cancer or mutagenesis. As with most other vaccines or other pharmaceuticals, studies regarding carcinogenesis or mutagenesis has not been performed with anthrax vaccine. Such studies have not been performed, in large part, because in over 200 years of administering vaccines to humans, no vaccine has ever been shown to cause cancer or genetic mutations.

  9. I don't have a spleen. Can I still get vaccinated?
    Yes, you may receive the anthrax vaccine if your spleen was removed in surgery or if your spleen no longer works properly. Several vaccines are specifically recommended for people without a spleen (asplenic people), to improve the body's defense against infections. In general, inactivated or killed vaccines (including anthrax vaccine) are recommended for people without spleens. In many cases, such vaccines may be life-saving by preventing overwhelming infection. The American College of Physicians (ACP) specifically names anthrax vaccine in its 1994 guidelines for people at risk of exposure to this bacterium. People without a spleen should get some live vaccines and avoid others. Spleens help people fight infections. People who do not have a spleen have a hard time protecting themselves against bacteria. Without a spleen, people are at risk of severe bacteremia (infection in the blood) from many types of bacteria. Some people lose their spleens during surgery to repair abdominal injuries suffered during accidents or their spleen is removed to help them respond to certain kinds of cancer. Certain diseases, especially sickle cell disease, destroy the spleen, while other people may be born without a spleen. According to the American College of Physicians (ACP), people without spleens or people whose spleens don't work properly should be vaccinated against the following diseases, if they are susceptible to them: Tetanus, diphtheria, pneumococcal, Haemophilus influenzae type b (Hib), meningococcal, and influenza. These people should be vaccinated against anthrax, cholera, hepatitis B, measles, mumps, plague, poliovirus (injectable vaccine), rabies, rubella, and typhoid fever (injectable vaccine), if these vaccines are needed. The ACP concludes by saying "In addition, the importance of anti-malarial prophylaxis must be emphasized for those planning foreign travel to areas where malaria occurs." (Guide for Adult Immunization, 3rd ed. Philadelphia: 1994) The American Academy of Pediatrics and the CDC's Advisory Committee on Immunization Practices provide similar recommendations on vaccines for persons with surgical or functional asplenia.

  10. Should people with lupus (SLE) get vaccinated?
    People who have been diagnosed with lupus should talk with their physician about whether or not they should be vaccinated, considering the state of their disease, the medications they take, and their personal risk for specific infections. Several medical studies have shown that people with lupus can be safely and effectively vaccinated against influenza, hepatitis B, pneumococcal disease and other diseases that would pose a significant risk if they were infected. For military personnel with lupus, providers are authorized to grant medical exemptions according to the patient's specific situation. Medical specialists can advise how to get the best benefit from vaccination in such circumstances.

  11. For More Information:

    Advisory Committee on Immunization Practices. General recommendations on immunization. MMWR-Morbidity & Mortality Weekly Report 2002;51(RR-2):1-35. ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr5102.pdf

    American College of Obstetricians & Gynecologists, Committee Opinion, Immunization During Pregnancy, 2003;282:1-6. http://www.acog.org/from_home/publications/misc/bco282.pdf

    Brachman PS, Friedlander AM, Grabenstein JD. Anthrax. In: Plotkin SA, Orenstein WA, ed. Vaccines, 3rd ed. Philadelphia: W. B. Saunders, 2003.

    Brachman PS, Gold H, Plotkin SA, Fekety FR, Werrin M, Ingraham NR. Field evaluation of a human anthrax vaccine. American Journal of Public Health 1962;52:432-45. http://www.anthrax.mil/documents/338field_eval.pdf

    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

    Catherino WH, Levi A, Leondires M, Segars JH, Alvero R, McKeeby J. Fertility & Sterility Abstracts Vol. 78, No. 3, Suppl. 1, September 2002, pages S108-S109. http://www.vaccines.mil/documents/library/Fertility&Sterility.pdf

    Christopher GW, Cieslak TJ, Pavlin JA, Eitzen EM Jr. Biological warfare: A historical perspective. Journal of the American Medical Association 1997;278(Aug 6):412-17. http://jama.amaassn.org/cgi/content/short/278/5/412

    Food & Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review. Federal Register 1985;50:51002-117. http://www.anthrax.mil/documents/205Fed_Reg.pdf

    Hambleton P, Carman JA, Melling J. Anthrax: The disease in relation to vaccines. Vaccine 1984;2:125-32.

    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 Biodefense. 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/reprint/287/17/2236.pdf

    Peeler RN, Cluff LE, Trever RW. Hyper-immunization of man. Bulletin of the Johns Hopkins Hospital 1958;103:183-98. Peeler RN, Kadull PJ, Cluff LE. Intensive immunization of man: Evaluation of possible adverse consequences. Annals of Internal Medicine 1965;63:44-57.

    Singleton JA, Lloyd JC, Mootrey GT, Salive ME, Chen RT, VAERS Working Group. An overview of the vaccine adverse event reported system (VAERS) as a surveillance system. Vaccine 1999;17:2908-17. Turnbull PCB. Guidelines for the Surveillance and Control of Anthrax in Humans and Animals, 3rd ed., WHO Report WHO/EMC/ZDI/98.6. http://www.who.int/emcdocuments/zoonoses/whoemczdi986c.html

    White CS III, Adler WH, McGann VG. Repeated immunization: Possible adverse effects: Reevaluation of human subjects at 25 years. Annals of Internal Medicine 1974;81:594 600. http://www.vaccines.mil/documents/library/Repeated.pdf



  12. What information about potential risks of vaccination will DoD provide people who will be vaccinated against anthrax?
    DoD will ensure potential vaccine recipients receive the most current educational trifold brochure available . An Individual's Briefing will be available at all immunization sites. Potential vaccine recipients will be educated about the threat of anthrax and the benefits and risks of vaccination.

  13. How will the side effects of anthrax vaccinations be monitored?
    DoD will continue its enhanced safety surveillance program, which features:
    • Encouraging healthcare workers and vaccine recipients to report adverse events to the Vaccine Adverse Events Reporting System (VAERS, www.vaers.hhs.gov)
    • Systematic monitoring of the health of recipients of anthrax vaccine adsorbed (e.g., cohort studies using the Defense Medical Surveillance System databases).


  14. How will DoD track who receives anthrax vaccinations?
    DoD will track anthrax vaccinations through Service-specific automated immunization tracking systems and the DEERS central repository. Where electronic immunization tracking is unavailable all vaccinations will be recorded in the individual health record and "yellow shot card" (PHS-731) (if provided).

  15. What compensation is available for individuals who claim injury from anthrax vaccine?
    Established military and civilian worker's programs provide compensation for injuries or illnesses resulting from military service or civilian job requirements.

  16. I was late getting a dose of anthrax vaccine. Do I have to start the anthrax vaccination series over again?
    No. The anthrax vaccine schedule should never be restarted. Rather, if you are late getting a dose, you should resume the normal anthrax vaccine schedule, beginning from where you left off. The current anthrax vaccine dose schedule is at 0, 4 weeks, 6 months, 12 months and 18 months, with annual boosters.

  17. Can I get the next dose of my anthrax vaccine early?
    It is not recommended to get any of the anthrax vaccine doses early. It is best to get your anthrax vaccine doses according to the vaccine manufacturer's recommended schedule and as approved by the Food and Drug Administration (FDA).

  18. A few days ago, I got a dose of anthrax vaccine. Now I have red lump on my arm. Is this normal?
    Yes, about 30% - 45% of all people who get anthrax vaccine develop a lump at the anthrax vaccination site. The lump usually lasts for several weeks, and then goes away on its own.

  19. Every time I get an anthrax vaccination, the side effects get worse. Should I get any more doses?
    If you have noticed side effects or a worsening of reactions after anthrax vaccination, you should have a medical evaluation before you receive any more anthrax vaccine doses. You may contact a IHB healthcare provider for more help.

Long Term Safety

  1. What do we know about the long-term safety of anthrax vaccine?
    Based on multiple objective sources of data, there are no known long-term side effects to anthrax vaccine.

  2. When people talk about "long term," what do they mean?
    There is no universal definition for "long term." When applied to vaccines, scientists may consider "long term" to be 6 months to 1 year or longer.

  3. I have heard people say that "no data has been collected more than 48 hours after anthrax vaccination." Is that statement true?
    No. Twenty safety studies of various types have been performed to assess anthrax vaccine. Several of these studies actively collected data for weeks or months after each vaccination:

    Brachman study: 24 and 48 hours after each dose

    Fort Bragg study: 1, 2, 3, 7, and 30 days after each dose

    Fort Detrick route-change study: 1, 2, 3, 7, and 30 days after each dose

    Tripler Army Medical Center study: 7 days or more after each dose

    Korea study: 2 weeks to 5 months after each dose

  4. I have heard people say "there are no long-term safety studies of anthrax vaccine." Is that statement true?
    No. Unlike the safety studies of single-dose vaccines, the 6-dose vaccination schedule for anthrax vaccine requires that individual vaccine recipients be observed for multiple months or years. Numerous studies have assessed the health of anthrax vaccine recipients over extended periods of time. The following list shows how much time elapsed after individual anthrax vaccine recipients received their first dose of anthrax vaccine:

    Vaccine Adverse Event Reporting System (VAERS) minutes to years

    Army Disability Discharge Study: 4.5 years

    Fort Detrick route-change study: 6 months

    Korea study: 6 months

    USAF vision study: at least 6 months

    Langley AFB study: at least 6 months

    Tripler Army Medical Center study: at least 1 year

    Brachman study: at least 1.5 years

    Inpatient/outpatient cohort study: at least 6 to 18 months

    Fort Detrick and US Army Medical Research Institute of Infectious Diseases (USAMRIID) 10 years or more

  5. Laboratory workers at Fort Detrick, Maryland, have been vaccinated against anthrax since the 1940s. What do we know about the long-term health of those workers?

    At Fort Detrick, Maryland, 99 laboratory workers were evaluated 10 to 20 years after receiving anthrax vaccine. Most of these workers received 150 to 200 doses of various vaccines (including anthrax vaccine); some received more than 300 such injections during their tenure at Fort Detrick. This study "failed to produce evidence that development of neoplasms, amyloidosis, or autoimmune diseases was associated with the vaccine dosages and frequencies used at Fort Detrick. The authors concluded "These data and the accompanying evaluation of an intensively immunized population provide evidence that no obvious adverse effects result from repeated immunization." The first report of this group of vaccine recipients was published in the Bulletin of the Johns Hopkins Hospital in 1958. Two follow-up reports were published in the Annals of Internal Medicine in 1965 and 1974.

    An extension of this long-term study is underway at the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID) to determine, in even greater detail, whether people who received multiple vaccines, including anthrax vaccine, during their past employment at Fort Detrick demonstrated any adverse health effects over the long term. More than 1,500 employees have been followed annually there. In a case-control study begun in 1996, vaccinated and unvaccinated volunteers have been enrolled. All volunteers signed an informed-consent document. The study methods include a 9-page health history questionnaire, extensive blood tests and urinalysis. The questionnaire queries mental and physical conditions of the volunteers, as well as the health of their offspring. Study end points include symptoms, symptom complexes (including symptoms reported by veterans of the Persian Gulf War), diseases, and abnormal laboratory and urine tests. Study subjects will be compared to two to three race-, gender-, and age-matched control subjects to determine if any long-term medical effects exist among this unique group of study subjects. Analysis of the data from the extensive health history questionnaire and numerous laboratory tests are currently in progress. No unexplained symptoms due to repeated doses of anthrax or other vaccines have been found. From this and other monitoring, no patterns of delayed side effects to anthrax vaccine have been found. Monitoring continues.

    White CS III, Adler WH, McGann VG. Repeated immunization: Possible adverse effects: Reevaluation of human subjects at 25 years. Annals of Internal Medicine 1974; 81:594-600.



Mail Handling Safety

  1. How can mail get cross-contaminated with anthrax?
    CDC does not have specific studies to address this, however, cross-contamination of the mail could occur during the processing, sorting, and delivery of mail when an envelope comes in contact with an envelope, piece of equipment (e.g., an electronic sorting machine), or other surface that is contaminated with Bacillus anthracis spores. In addition, airborne spores in contaminated postal facilities before they were cleaned might play a role.

  2. When there is a known incident, how can I prevent anthrax exposure from cross-contaminated mail?
    There are no scientifically proven recommendations for preventing exposure. However, there are some common-sense steps people can take:
    • Do not open suspicious mail
    • Keep mail away from your face when you open it
    • Do not blow or sniff mail or mail contents
    • Avoid vigorous handling of mail, such as tearing or shredding
    • Wash your hands after handling the mail
    • Discard envelopes after opening mail.


  3. What should people do when they get a letter or package with powder?
    Handling of Suspicious Packages or Envelopes:
    • Do not shake or empty the contents of any suspicious package or envelope.
    • Do not carry the package or envelope, show it to others or allow others to examine it.
    • Put the package or envelope down on a stable surface; do not sniff, touch, taste, or look closely at it or at any contents which may have spilled.
    • Alert others in the area about the suspicious package or envelope. Leave the area, close any doors, and take actions to prevent others from entering the area. If possible, shut off the ventilation system.
    • WASH hands with soap and water to prevent spreading potentially infectious material to face or skin. Seek additional instructions for exposed or potentially exposed persons.
    • If at work, notify a supervisor, a security officer, or a law enforcement official. If at home, contact the local law enforcement agency.
    • If possible, create a list of persons who were in the room or area when this suspicious letter or package was recognized and a list of persons who also may have handled this package or letter. Give this list to both the local public health authorities and law enforcement officials.
    These recommendations were published on October 26, 2001, in “Update: Investigation of bioterrorism-related anthrax and interim guidelines for exposure management and antimicrobial therapy” MMWR 2001; 50(42):909-919.

  4. What is the risk for getting anthrax from handling my own mail?
    If there is a risk for inhalational anthrax associated with exposure to cross-contaminated mail, it is very low. For example, about 85 million pieces of mail were processed on the few days in 2001 after envelopes containing Bacillus anthracis (addressed to two U.S. senators) passed through the New Jersey and District of Columbia sorting facilities until they were closed. Despite the fact that both of these facilities had evidence of widespread environmental contamination with B. anthracis spores and the fact that public health officials had been aggressively looking for anthrax cases, no new cases of anthrax were identified during that time.

  5. When the possibility of cross-contamination of the mail exists, should I take antibiotics?
    Preventive antibiotics are not recommended for persons who routinely open or handle mail, either at home or at the workplace. Antimicrobial prophylaxis is recommended only in certain specific situations such as for persons exposed to an air space known to be contaminated with aerosolized Bacillus anthracis or for persons in a postal sorting facility in which an envelope containing B. anthracis spores was processed. CDC's complete recommendations on antimicrobial prophylaxis are contained in the November 9, 2001 MMWR. Additional recommendations for use of vaccine as part of post-exposure prophylaxis are contained in the November 15, 2002 MMWR 51(45):1024-1026.

  6. What kinds of anthrax worker safety guidelines have been issued?
    The recommendations are divided into four categories. They are engineering controls, administrative controls, housekeeping controls, and personal protective equipment for workers. The guidelines describe measures that should be implemented in mail-handling/processing sites to prevent potential exposures to B. anthracis spores.

Vaccination and Reproductive Health

  1. Can the anthrax vaccine be taken by military members who are pregnant?
    It is DoD policy not to give anthrax vaccine to women who are pregnant or who think they may be pregnant. This is consistent with the general practice of withholding most medications from women who are pregnant. Most vaccinations are routinely deferred until after pregnancy, unless immunity is needed during pregnancy. Tetanus, meningococcal, hepatitis B, and influenza vaccines, for example, are specifically recommended for susceptible women during their pregnancy. As with other vaccines in the U.S., studies on possible reproductive side effects by intentionally giving anthrax vaccine to pregnant women have not been performed. However, there has been no confirmed evidence of infertility, miscarriages, or other reproductive problems with the use of inactivated vaccines. Because the anthrax vaccine is a sterile, cell-free (filtered) bacterial vaccine, it is non-infectious and is not expected to cause any harm to the fetus. If a pregnant woman is known to have been exposed to anthrax, she could be offered the vaccine as a potential life-saving measure. Women who believe that they may be pregnant should inform their health-care provider before vaccination. Once pregnancy is confirmed, anthrax vaccinations will be deferred until the woman is no longer pregnant. Once a woman is no longer pregnant, deferred anthrax vaccination will resume. A woman can safely become pregnant any time after vaccination that she wishes. Preliminary data from the Naval Health Research Center raised a tentative signal that there may be an association with an increased rate of birth defects. This signal is being investigated thoroughly, to determine which of several explanations for the signal is most likely.

  2. What happens to vaccinated women who later get pregnant?
    In the March 27, 2002, issue of the Journal of American Medical Associations, two Army physicians published findings that women get pregnant at the same rate, whether anthrax-vaccinated or unvaccinated. These physicians from Fort Stewart, Georgia, also showed that women deliver offspring at the same rate, whether anthrax-vaccinated or unvaccinated. The Fort Stewart study found no difference in birth defect rates, either, but the study may have been too small to detect small differences. Long-standing Department of Defense policy is to defer routine vaccinations in women until after pregnancy. This policy has always applied to anthrax vaccine. Women are asked if they are pregnant before vaccination. Women who are not sure are offered pregnancy tests.

  3. What about men who get vaccinated? Should they delay fathering a child?
    No. For all the same reasons mentioned above, there is no reason for a man to delay fathering a child after vaccination. A man can safely father a child any time after vaccination that he wishes. Data about anthrax vaccination was obtained from men at time of oocyte and sperm retrieval. Researchers assessed characteristics of male gametes, including 254 vaccinated men and 791 unvaccinated men. The two groups were comparable for semen concentration (million sperm per milliliter), sperm motility (movement), sperm morphology (shape), need for intracytoplasmic sperm injection, and rate of fertilization of mature oocytes, embryo transfer, and clinical pregnancy. A diagnosis of male-factor infertility was less common in anthrax-vaccinated men than in unvaccinated men. The researchers concluded that anthrax vaccination of men did not impair semen parameters, fertilization rate, embryo quality, or clinical pregnancy rates.

  4. What about a woman who is taking fertility-enhancing drugs in an effort to become pregnant?
    No drug interactions are known between fertility medications (such as clomiphene, Clomid) and any vaccination. Women on fertility-enhancing drugs receive all DoD vaccinations on schedule until they have a positive pregnancy test. At this point, further vaccinations are deferred as described above.

  5. For More Information:
    Advisory Committee on Immunization Practices. General recommendations on immunization. Morbidity & Mortality Weekly Report (MMWR) 2002; volume 51 (No. RR-2): pages 1-36; http://www.cdc.gov/mmwr/pdf/rr/rr5102.pdf)

    American College of Obstetricians & Gynecologists, Committee Opinion, Immunization During Pregnancy, 2003; 282:1-6. http://www.acog.org/from_home/publications/misc/bco282.pdf

    Brachman PS, Friedlander AM. Anthrax. In: Plotkin SA, Orenstein WA, ed. Vaccines, 3rd ed. Philadelphia: W. B. Saunders, 2003.

    Centers for Disease Control & Prevention. Status of U.S. Department of Defense preliminary evaluation of the association of anthrax vaccination and congenital anomalies. MMWR 2002; 51:127. http://www.cdc.gov/mmwr/PDF/wk/mm5106.pdf

    Catherino WH, Levi A, Leondires M, Segars JH, Alvero R, McKeeby J. Fertility & Sterility (Abstracts) Vol. 78, No. 3, Suppl. 1, September 2002, pages S108-S109. http://www.vaccines.mil/documents/library/Fertility&Sterility.pdf

    Food & Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review. Federal Register 1985; 50:51002-117.

    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/reprint/287/17/2236.pdf

    United States Army Regulation 40-562; Navy Bureau of Medicine & Surgery Instruction 6230.15; Air Force Joint Instruction 48-110; Coast Guard Commandant Instruction M6230.4E. Immunizations & Chemoprophylaxis. Washington, DC, 1 November 1995.

    Wiesen AR, Littell CT. Relationship between pre-pregnancy anthrax vaccination and pregnancy and birth outcomes among U.S. Army women. Journal of the American Medical Association (JAMA) 2002; 287:1556-60. http://jama.ama-assn.org/content/vol287/issue12/index.dtl

  6. Have any studies revealed birth defects among babies born to women who received anthrax vaccine during their pregnancy?

    A recent study by the Department of Defense (DoD) Center for Deployment Health Research with the Naval Health Research Center and the National Center for Birth Defects and developmental Disabilities indicated that women who received anthrax vaccinations during their first trimester of pregnancy could have a slightly higher risk of birth defects than women receiving anthrax vaccine at other times before or after the first trimester.  The study is still under review. Results are pending.



  7. Are the chances for birth defects increased if both parents have received anthrax vaccination?
    There is no evidence in the above mentioned study to indicate that anthrax vaccination in both parents increases the risk for birth defects in babies born to those parents.

  8. I don't have any children now, but hope to one day and I'm currently taking the anthrax vaccination. Will this vaccination cause birth defects in my future children?
    There is no increased risk of birth defects when receiving anthrax vaccination before becoming pregnant. If you are trying to become pregnant or think you may be pregnant, be sure to request a pregnancy test. Inactivated vaccines are generally considered safe in pregnancy.

  9. I'm scheduled to start/restart my anthrax vaccination series, but I want to start trying to get pregnant. Should I delay getting pregnant?
    There is no increased risk of birth defects when receiving anthrax vaccination before becoming pregnant. If you are trying to become pregnant or think you may be pregnant, be sure to request a pregnancy test. DoD policy is to temporarily exempt women who are pregnant.

  10. Why is anthrax vaccine not contraindicated with breast-feeding?
    Women who are breast-feeding may safely receive any vaccine. As an inactivated vaccine, anthrax vaccine contains no living or dead organisms and is non-infectious. No ill effects to the infant are anticipated through breast-feeding. As recommended by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC), there is no need to interrupt breast-feeding (lactation) for inactivated vaccines.

  11. I got the anthrax vaccine and then found out that I am pregnant. What should I do?
    You should discuss your anthrax vaccination with your healthcare provider and/or obstetrician. As with any pregnancy, you should receive regular prenatal care. the IHB is available to discuss the latest information about pregnancy and adverse events research. Please visit our pregnancy page or contact the IHB with further questions.

  12. Will anthrax vaccine affect my ability to have children?
    Current research shows that anthrax vaccine does not affect pregnancy rates. Please contact the IHB if you are interested in this research or if you would like to discuss this issue with one of our healthcare providers.

Anthrax and the Persian Gulf War

  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.



Next Generation Anthrax Vaccine (NGAV)

  1. Is the Department of Defense (DoD) pursuing an improved anthrax vaccine?
    Yes. DoD is actively pursuing a next-generation anthrax vaccine (NGAV) in cooperation with the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

  2. Why is DoD pursuing another anthrax vaccine? Doesn't the one you have now work?
    The National Academy of Sciences and its Institute of Medicine (IOM) stated in no uncertain terms that “AVA [the current FDA-licensed anthrax vaccine], as licensed, is an effective vaccine to protect humans against anthrax, including inhalational anthrax." This was in its March 2002 report, which can be found at: http://www.nap.edu/catalog/10310.html.

  3. Then why are you pursuing a next-generation anthrax vaccine?
    We want to explore whether a newer anthrax vaccine would be easier to produce and require fewer doses to achieve immunity. The IOM study also recognized the advantages of developing a next-generation anthrax vaccine when it said, "the production, testing, and licensure of a new vaccine requiring fewer doses and producing fewer local reactions are needed." Aviators consistently seek better airplanes. Similarly, we seek better vaccines.

  4. What efforts does DoD have underway? Who are DoD's partners?
    DoD and the National Institutes of Health (NIH) have been working on a next-generation anthrax vaccine (NGAV). Specifically, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Joint Vaccine Acquisition Program (JVAP) collaborated to develop an NGAV that uses state-of-the-art recombinant technology. The NIAID collaborates with this effort by preparing the NGAV product and sponsoring human clinical phase-1 trials. The NIAID is independently pursuing multiple “recombinant protective antigen” (rPA) candidate vaccines, to identify and develop the most promising next-generation vaccine as quickly as possible. This is a parallel effort from the DoD/NIAID cooperative effort on the DoD NGAV candidate.

  5. What advantages could an NGAV offer?
    NGAV is a much more highly defined product (a single highly purified protein). As a result, there should be more consistency from production lot to production lot, making release testing more predictable. Additionally, it might be possible to achieve immunity with fewer doses, because higher and more consistent doses of the protective-antigen protein may be administered. It might also be possible to use an intramuscular injection route, which may cause fewer adverse events after vaccination (i.e., be less reactogenic). However, this possibility won’t be known until human clinical trials of the vaccine are completed. Finally, the rPA is produced in non-sporeforming bacteria that permit the vaccine to be made in the same production facility as other vaccines, unlike anthrax vaccine adsorbed (AVA).

  6. How will this new anthrax vaccine be produced?
    The next-generation anthrax vaccine (NGAV) is based on a protein called “recombinant protective antigen” (rPA). rPA is a single purified protein that protects animals against aerosol exposure to deadly Bacillus anthracis spores. rPA can be produced in several genetically-engineered bacteria

  7. Will a next-generation anthrax vaccine protect as well as the current anthrax vaccine?
    That is our goal, yes. Until completion of human clinical trials, we do not know how much protective antibody human volunteers will produce. Preliminary data from non-human primates (rhesus monkeys) seems to indicate similar protection profiles compared to anthrax vaccine adsorbed (AVA).

  8. What has to be done before we can use an NGAV?
    NIH is in the beginning stages of clinical testing of an NGAV. Phase I tests in a few dozen people will study this new vaccine’s safety. Next, a preliminary Phase II test in a few hundred people will test antibody responses to the new vaccine. Expanded Phase III testing among thousands of volunteers will produce pivotal information about both safety and immune responsiveness required for product licensing. Advanced studies (post-clinical trials) will be conducted in animals to define the protective immune response induced by the NGAV candidate. Additionally, studies will be performed to optimize the vaccine’s formula and immunization schedule. In addition, results from the study of the current FDA-licensed anthrax vaccine, being conducted by the Centers for Disease Control & Prevention (CDC), will provide critical information on immune responses that will be required to license an NGAV. Finally, the FDA will study all of the data and eventually determine if the NGAV will become a licensed product.

  9. When will human clinical trials of next-generation anthrax vaccines (NGAV) begin?
    These clinical trials began in fall 2002.