<<Anthrax is a bacterium. You cannot "vaccinate" until exposure has been confirmed.>>
source: US Army
The Vaccine
We routinely receive vaccines to protect us against tetanus, influenza and many other dangerous diseases. The anthrax vaccine will protect us from another disease - a killing disease that can be used as a weapon.
What it is:
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The vaccine is a cell-free filtrate, produced from a strain of anthrax that does not cause disease. The vaccine contains no whole bacteria, dead or alive.
The vaccine was developed in the United States during the 1950s and 1960s for humans and was licensed by the FDA in 1970.
Since 1970, it has been safely and routinely administered to at-risk wool mill workers, veterinarians, laboratory workers, livestock handlers and Service Members in the United States.
The vaccine is manufactured by one company, the BioPort Corporation, formerly known as the Michigan Biologic Products Institute (MBPI).
An independent civilian advisory panel reaffirmed the evidence for the safety and efficacy in a report published in 1985.
What it does:
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The vaccine helps your immune system to prevent the anthrax bacteria from growing and producing toxins that lead to disease and death.
Possible side effects (% of people vaccinated):
Mild local reactions, about 30% of men and 60% of women (less than 1" of redness, swelling, tenderness at the site of injection -- not unlike other vaccine shots)
Moderate local reaction (1" to 5"), 1% to 5% (redness, minor swelling, tenderness at the site of injection)
Large local reactions, about 1% (redness greater than 5", swelling at the site of injection and forearm)
Beyond the injection site, from 5% up to 35% of people 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.
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.
There have been no patterns of long-term side effects from the vaccine, neither persistent side effects, nor delayed side effects.
Effectiveness:
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For obvious reasons, anthrax vaccines cannot be tested by inhalational challenge in humans.
Rhesus monkeys are the best animal model used to test the effectiveness of anthrax vaccine, monkey tests produced compelling evidence that the vaccine series will be effective at preventing disease after you are exposed to airborne spores (inhalational anthrax).
25 monkeys vaccinated with 2 doses.
Challenged with anthrax aerosol 8-38 weeks later
All Survived
10 monkeys vaccinated at 0 & 2 weeks
Challenged with anthrax aerosol 2 years later
9 Survived
10 monkeys vaccinated only one time
Challenged with anthrax aerosol 6 weeks later
All Survived
20 monkeys vaccinated at 0 and 4 weeks
Challenged with anthrax aerosol 10 to 20 weeks later
18 survived
The Schedule:
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May 18, 1998: Secretary of Defense William Cohen approved the vaccination plan based on the successful completion of all testing and operational criteria.
Between now and about 2005, the entire force, including all new Service Member will begin receiving the six-shot series of the anthrax vaccination in a phased immunization program:
Phase 1: Forces assigned now or rotating to high threat areas in Southwest Asia and Korea
Phase 2: Early deploying forces into high threat areas
Phase 3: Remainder of the force and new accessions
The first three shots are given in two-week intervals. The following three shots are administered at 5 to 6 months after the previous dose. Annual boosters are given for prolonged protection.
IMMUNIZATION SERIES
plus annual booster
Who will be immunized:
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United States military service members between the ages of 18 and 65
Emergency essential DoD employees and contractors assigned to a high threat area
Disqualification criteria:
Permanent deferral
Persons with a history of severe reaction to anthrax vaccination.
Disqualification criteria:
Temporary deferral
Persons with acute respiratory disease or active infection.
Persons with depressed immune response.
Persons younger than 18 and older than 65.
Pregnant women.
NOTE: Like all other vaccines in the U.S., the anthrax vaccine has not been formally studied for effects on the reproductive system. Therefore, vaccinations should be deferred during pregnancy unless clearly indicated. Women will be questioned about the possibility of pregnancy. If a vaccine is inadvertently given to a pregnant woman, no adverse pregnancy outcome or fetal harm is expected because of the vaccine's inactive state.
Data Sources:
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Food & Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review. Federal Register 1985;50:51002-117
Chin J, ed. Control of Communicable iseases Manual, 17th ed. Washington, DC: American Public Health Association, 2000
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., Gibba 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 (not available online)
Advisory Committee on Immunization Practices. General recommendations on immunization. MMWR—Morbidity & Mortality Weekly Report 1994;43(RR-1):1-38.
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