Questions & Answers
Anthrax - The Anthrax Vaccine
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Overview

Questions
  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?
Answers
  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.