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WHAT EVERYONE NEEDS TO KNOW ABOUT THE ANTHRAX VACCINE
1 May 2000.


Anthrax is a highly lethal biological weapon.

For more information on the Anthrax Vaccine Immunization Program, Call toll free 1-877-GET-VACC (1-877-438-8222) http://www.anthrax.osd.mil/


WHAT IS THE THREAT?

Biological weapons are maintained by several countries around the world, including some of our potential adversaries. Use of these weapons could cause widespread illness among unprotected U.S. forces. Anthrax is the biological weapon most likely to be encountered because it is:


WHAT IS ANTHRAX?

Anthrax is a disease normally associated with plant-eating animals (sheep, goats, cattle, and swine). It is caused by the bacteria Bacillus anthracis. Once common where livestock were raised, it is now controlled through animal vaccination programs. Anthrax still occurs in countries where animals are not vaccinated, mainly in Africa and Asia. It occurs infrequently in many countries, including the United States.

Human infection with anthrax usually results from direct contact with infected animals, or animal products such as wool, meat or hides. However, when anthrax is used as a biological weapon, people become infected by breathing anthrax that is released into the air. Inhalational anthrax is the disease that results from breathing in anthrax spores. Under expected battlefield conditions, experts believe you can inhale enough anthrax spores to kill you in one deep breath. Symptoms of inhalational anthrax can begin as early as 24 hours after breathing the spores. Initial symptoms include fever, cough, and weakness. These ultimately progress to breathing problems, shock, and death.


WHY VACCINATE?

Vaccines prevent illness by stimulating the body's natural disease-fighting abilities. They are among the most powerful tools developed by modern medicine to keep people healthy. Vaccines are used routinely in the United States to protect against diseases like tetanus, mumps, measles, whooping cough, and polio. Vaccines also help protect against biological weapons like anthrax.

As part of Force Health Protection, Department of Defense (DoD) and U.S. Coast Guard (USCG) personnel are given additional vaccines to provide maximum protection against naturally occurring diseases encountered when deploying overseas, such as typhoid, hepatitis A, and yellow fever. The DoD has established a vaccination program to protect DoD and USCG personnel against anthrax.


WHAT IS THE ANTHRAX VACCINE?

Anthrax vaccine is a sterile product made from a strain (type) of the anthrax organism that does not cause disease. The vaccine contains no living or dead anthrax organisms. Vaccination produces antibodies that neutralize the disease-causing protein common to every strain of anthrax. The anthrax vaccine is not new. Human anthrax vaccines were developed in England and the U.S. in the 1950s and early 1960s. The anthrax vaccine you will receive was licensed in 1970 by the Food and Drug Administration (FDA) and is manufactured by BioPort Corporation (Lansing, Michigan) under License No. 1290, formerly the Michigan Biologic Products Institute under License No. 99.

It has been safely and routinely administered in the United States to at--risk veterinarians, laboratory workers, and livestock handlers since 1970.


COMMONLY ASKED QUESTIONS & ANSWERS

Q: Why are we getting this vaccine?
A: Anthrax is a lethal biological weapon we may encounter. Vaccination before exposure is critical to protect us against this weapon.

Q: Is the vaccine all I need to protect against inhalational anthrax?
A: Vaccination is a vital component of Force Health Protection. Being fully vaccinated greatly increases your chances of surviving an exposure to anthrax. Force Health Protection is further enhanced through early warning and detection systems, health surveillance, and the proper wear of the protective mask and over-garments. Antibiotics play a limited role, but vaccination is essential.

Q: Is this an experimental vaccine?
A: No. The anthrax vaccine has been FDA-licensed since 1970.

Q: Is this vaccine safe?
A: Yes. This vaccine has been safely administered in the U.S. since 1970. However, as with other vaccines, minor reactions are common. Serious adverse events occur rarely after any vaccination.

Q: What are the side effects?
A: Like all vaccines, anthrax vaccine may cause soreness, redness, itching, and swelling at the injection site. Up to 30% of men and 60% of women report mild local reactions, but these reactions usually last only a few days. For both genders, between 1% and 5% report reactions of 1 to 5 inches in diameter. Larger reactions occur about once per hundred vaccines or less. A lump at the site occurs commonly, usually lasting for a few weeks, before going away on its own, if left alone.

Beyond the injection site, from 5% to 35% will notice muscle aches, joint aches, headaches, malaise, rashes, chills, low-grade fever, nausea, or related symptoms. These symptoms usually go away in less than a week.

Any vaccine can cause serious reactions, such as those requiring hospitalization. For anthrax vaccine, they happen less than once per 200,000 doses. Severe allergic reactions occur less than once per 100,000 doses.

Discuss with a health-care provider whether antihistamines or pain relievers before or after vaccination can help reduce bothersome symptoms. Report adverse events after vaccination to a health-care provider promptly, before receiving additional vaccinations.

Q: What about long-term side effects?
A:
At Fort Detrick, MD, 1,500 laboratory workers have been followed up to 10 to 20 years or more after anthrax vaccination. 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.

Q: What if I am pregnant or breast-feeding?
A:
Anthrax vaccine, like other non-living vaccines, is not expected to cause fetal harm. No evidence exists to indicate adverse reproductive effects occur after vaccination, including infertility. Prudent medical practice is to defer vaccination during pregnancy unless clearly needed. Therefore, pregnant women should not receive the anthrax vaccine, unless anthrax exposure occurs or is imminent. 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.

The Centers for Disease Control and Prevention (CDC) reports that vaccines are safe for breast-feeding women, causing no harm to children who breast-feed.

Q: What if I'm planning on having children?
A:
The vaccine contains no infectious substance. Therefore, there is no reason to delay child bearing. This applies to both men and women who are vaccinated.

Q: Anthrax vaccine was administered to personnel deployed in the Persian Gulf War. Has the anthrax vaccine been linked to illnesses among Gulf War veterans?
A:
No. Several renowned scientific groups, including the National Academy of Sciences, have addressed this issue and found no evidence to link the FDA-licensed anthrax vaccine with illnesses among Gulf War veterans.

Q: What other medical conditions should I inform the medical staff about?
A:
If you have an active illness, a chronic illness under medical treatment, or take medication that suppresses the immune system, inform the medical staff before taking any vaccine.

Q: If I feel I'm having a health problem related to vaccination, what should I do?
A:
If an adverse event occurs, seek medical care as appropriate. At a minimum, any adverse event that results in 24 hours or more time lost from duty, or hospitalization, must be reported by your health-care provider using the Vaccine Adverse Events Reporting System (VAERS). Anyone may report a vaccine-associated adverse event of any severity through VAERS. For blank forms, go to: www.anthrax.osd.mil/vaers/vaers.htm or contact VAERS by calling 1-800-822-7967. Please see a health-care provider for help with filling out the form.

Q: I'm a Reservist/Guard member. If I have an adverse reaction, can I go to a military (DoD or Coast Guard) hospital or clinic?
A:
Adverse events after DoD- or USCG-directed vaccinations are line-of-duty illnesses. There-fore, a member of the Reserve Component may seek initial treatment and evaluation at any military treatment facility after vaccination during a period of duty. The member will be examined and provided necessary medical care. Once treatment is rendered or the individual's emergent condition is stabilized, a Line of Duty and/or Notice of Eligibility status will be determined by the member's unit, as required. No treatment beyond that justified to stabilize the condition or emergency is authorized until Service connection is validated. Evaluation does not require being in a duty status, nor DEERS enrollment. For more information, contact your unit representative.

Q: How many shots will I have to take?
A:
Six shots, with the first three given 2 weeks apart. The next three are given at intervals of 5 months, 6 months, and 6 months after the date of the previous dose. After the sixth dose, booster doses are given every 12 months to maintain immunity. This is the anthrax vaccine schedule licensed by the FDA and used by the DoD.

Q: What happens if I am late for a shot?
A:
All reasonable steps should be taken to receive each vaccination on or as close as possible to the approved schedule. Do not get vaccinated early. If you are late for a vaccination, get it as soon as possible. There is no increase in side effects from late vaccinations. Getting vaccinated late does not reduce the protection you ultimately develop. But you may not be optimally protected during the interval when your shot is overdue.

Q: Am I required to take the vaccine?
A:
Yes. This vaccine, like every other required vaccination, is necessary to prepare you for deployment. Medical exemptions can be granted, if medically appropriate.

Call toll free 1-877-GET-VACC Go to http://www.anthrax.osd.mil/

Dr. Sue Bailey
Assistant Secretary of Defense
for Health Affairs and
The Service Surgeons General


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