The Department of Defense is implementing a vaccination program, against the biological warfare agent anthrax, which will be administered to all active duty and reserve personnel.

The vaccination program will consist of a series of six inoculations over an 18 month period, with initial emphasis on those service members deployed to high biological warfare threat areas in Southwest and Northeast Asia and service members within 35 days of deployment to those areas. The vaccine is FDA-licensed and exhibits few side-effects.

Q1. Why did DoD accelerate the anthrax vaccination for personnel in Southwest Asia?

A1. We are taking prudent measures to protect our forces and continue to assess the situation in Southwest Asia. As a result of that assessment, the Commander-in-Chief of U.S. Central Command, Gen. Anthony C. Zinni, requested acceleration of the anthrax vaccination program for forces in his area of responsibility. Secretary of Defense William Cohen approved the request upon the recommendation of the Chairman of the Joint Chiefs of Staff, Gen. Henry H. Shelton. Since the Gulf War, the Department of Defense has increased the level of attention given to biological warfare defense and other force protection measures. The current world threat environment and the unpredictable nature of terrorism make it prudent to include biological warfare defense as part of our force protection planning. Anthrax is 99 percent lethal to unprotected individuals exposed to battlefield concentrations of the agent.

Q2. When will inoculations begin?

A2. Inoculations of personnel in threat areas will begin this month with general vaccination of the force to follow. Michigan Biologic Products Institute (MBPI), under contract to the Department of the Army, has produced and stockpiled the vaccine to support inoculation of the force.

Q3. Is the anthrax vaccine available in the Central Command area of responsibility?

A3. Yes.

Q4. Is the anthrax vaccination program a result of lessons we learned from the 1991 Gulf War?

A4. Yes, we found a significant deficiency in our ability to protect U.S. forces from a biological attack during the Gulf War. The current world threat environment and the unpredictable nature of terrorism make it prudent to include biological warfare defense in all of our force protection planning. As a result, we have produced and stockpiled a safe and effective vaccine to protect our forces against anthrax, the greatest biological threat agent as validated by the Chairman of the Joint Chiefs of Staff.

Q5. What about coalition partners? Will you give them the anthrax vaccine?

A5. We routinely consult with our allies and coalition partners concerning individual and combined requirements.

Q6. What about vaccinations for U.S. citizens in the Southwest Asia region?

A6. The current DoD vaccination plan includes immunization of mission-essential non-military DoD employees in the threat area. For questions on other categories of U.S. citizens, contact the State Department.

Q7. In overseas areas where military family members are present, will family members be vaccinated also?

A7. Military family members will generally not be vaccinated. If the threat warrants, the first option is to withdraw them from the area.

Q8. Will service members have a choice in receiving the anthrax vaccine?

A8. No. This series of immunizations will be treated the same as other vaccinations required for service members to be deployed. All service members will be required to take the vaccinations, unless medically deferred, according to the DoD directive for the purpose of protecting our forces.

Q9. Who is medically deferred from taking the anthrax shot?

A9. Pregnant women and immunodeficient individuals (such as HIV positive) should not receive the vaccine unless anthrax exposure occurs or is imminent. Service members should inform the health care provider of such conditions. Even if women who subsequently become pregnant have begun the vaccinations, the vaccination schedule will be deferred until the pregnancy is completed. Anthrax vaccine, like other vaccines in the U.S., is classified as "Pregnancy Category C," which means that animal reproduction studies have not been conducted with anthrax vaccine. Therefore, prudent medical practice dictates that all vaccinations, including anthrax, should be routinely deferred during pregnancy unless clearly needed. Every woman will be questioned about the possibility of pregnancy.

Q10. In light of the recent arrest by the FBI of two persons in possession of an anthrax agent, what is being done to protect the U.S. civilian population?

A10. As President Clinton stated in December 1997, there is no expert opinion that says that the U.S. civilian population should be vaccinated; there's no evidence to support that kind of recommendation.

Q11. Is anthrax vaccine available to the civilian population?

A11. Small quantities are made available as needed to civilians who are exposed to anthrax hazards in their work environment such as veterinarians, lab workers and others. Anthrax vaccine is produced exclusively by the Michigan Biologic Products Institute under contract to the Defense Department. Virtually all vaccine produced is earmarked for military use in recognition of the documented threat to military personnel.

Q12. Who approved this vaccination program? On what authority?

A12. The final decision to vaccinate was made by the Secretary of Defense in accordance with the procedures prescribed in DoDD 6205.3. The vaccine implementation plan was developed with the full cooperation of the services and the Joint Chiefs of Staff and coordinated with the Armed Forces Epidemiological Board and appropriate medical agencies.

Q13. How is the policy applied?

A13. In November 1993, DoD established the policy, responsibilities and procedures for stockpiling biological agent vaccines and determined which personnel should be immunized and when the vaccines should be administered. The policy, Department of Defense Directive 6205.3, specifically states that personnel assigned to threat areas and those pre-designated for immediate contingency deployment to these areas (such as personnel in units with deployment dates up to 30 days after mobilization) should be vaccinated in sufficient time to develop immunity prior to deployment.

Q14. What is anthrax?

A14. Anthrax is an infectious disease that normally afflicts animals, especially cattle and sheep. Anthrax spores can be produced in a dry form which may be stored and ground into particles. When inhaled by humans, these particles cause respiratory failure and death within a week.

Q15. Has any country ever used it as a weapon?

A15. No, but several countries are believed to have weaponized anthrax as a biological warfare agent.

Q16. Has the threat of biological warfare changed?

A16. The threat of biological warfare presents a constant risk to U.S. forces. DoD analysts maintain an updated evaluation of the level of threat, adjusting the information as necessary to reflect the risk to U.S. operations.

Q17. How real is the threat?

A17. Our assessments of the potential offensive biological threat facing American service men and women indicates it is prudent to have a robust biological defense program today.

Q18. Who is the executive agent for the biological immunization effort?

A18. DoDD 6205.3 designates the Secretary of the Army as the executive agent for the DoD immunization program for biological warfare defense.

Q19. How will the program be implemented?

A19. Each service participated in the development of the armed forces immunization plan. The vaccine will be centrally procured but the task of immunizing will be decentralized.

Q20. How many military members will be vaccinated?

A20. In the near term, all military members in the threat area will be vaccinated. This total would be approximately 40,000.

Q21. Why immunize at all? Why not treat with antibiotics after exposure?

A21. Immunization is the safest, most practical way to protect military forces against anthrax.

Q22. What vaccine will military members be given?

A22. Military members will receive "anthrax vaccine adsorbed (injected)." It is a sterile commercial product manufactured by the Michigan Biologic Products Institute, Lansing, Michigan. It is fully licensed (U.S. License No. 99, 1970) by the U.S. Food and Drug Administration (FDA) for human use and has had an excellent safety record.

Q23. How does the vaccine work?

A23. The vaccine promotes increased resistance to anthrax by active immunization. The recipient develops protection by means of antibodies and other immune mechanisms to the bacterium following immunization.

Q24. What is the protocol for this vaccine? How many shots does it take?

A24. Immunization consists of three subcutaneous injections, 0.5ml each, given 2 weeks apart followed by three additional subcutaneous injections, 0.5ml each, given at 6, 12, and 18 months.

Q25. What will happen if personnel are exposed to anthrax before they gain immunity through vaccination?

A25. Antibiotics, particularly ciprofloxacin and doxycycline, are known to be effective in treating animals, including primates, exposed to inhalation anthrax, if started before symptoms develop. This would usually mean starting them in the first 24 hours after exposure.

Q26. Once immunity is achieved, is the protection complete?

A26. Protection may not be complete for personnel who are exposed to very large doses of anthrax, such as those very near the point of release. Antibiotics for such individuals will offer additional protection.

Q27. How long does the vaccine remain effective, once administered? Does it require a booster of any kind?

A27. If immunity is to be maintained, subsequent booster injections of the vaccine at one year intervals are recommended.

Q28. Who developed the vaccine?

A28. The product was developed and is manufactured by the Michigan Biologic Products Institute, Lansing, Michigan. It is fully licensed (U.S. License No. 99, 1970) by the U.S. Food and Drug Administration (FDA) for human use.

Q29. Who is producing the vaccine for DoD?

A29. The Michigan Biologic Products Institute.

Q30. Has this vaccine been used in the past? How many times? By the military?

A30. Yes, the vaccine has been routinely administered to populations at risk (veterinarians, laboratory works, civilians working with live stock) for several years. The Michigan Biologic Products Institute estimates private sector usage at between 400 to 500 doses per year. This vaccine has been purchased by the Army since 1970 for use by at-risk laboratory workers (estimated at between 500 to 1000 total recipients), and it was used during the Gulf War (approximately 150,000 recipients) to immunize U.S. Forces against Iraq's weaponization of b. anthracis.

Q31. Was it FDA-licensed at the time it was given?

A31. Yes. It was licensed by the FDA in 1970.

Q32. How safe is the vaccine?

A32. The vaccine is safe. There is no evidence from records at the Michigan Biologic Products Institute that anthrax vaccine absorbed (injected) is associated with chronic or permanent local or systemic effects.

Q33. What are some of the side effects from taking this vaccine?

A33. Reported side effects to the vaccine are mostly limited to local reactions. Minimal local reactions, such as redness and swelling, are seen in up to 30 percent of recipients. Moderate reactions are seen in up to 4 percent of recipients. Severe local reactions, which include edema that may extend to the elbow or forearm, are very rare (less than 1 percent). Some recipients may develop a non-tender, subcutaneous nodule that can last up to 2 months, but which resolves without treatment. Systemic reactions, such as fever, malaise and headache, are extremely rare (less than 0.2 percent or less than 2 per 1,000) with this vaccine. There have been no long term side effects from the vaccine.

Q34. Is there a requirement for long-term follow-up after this vaccine is administered?

A34. No. This is an FDA-licensed product and does not require patient monitoring beyond the normal patient care immediately following the injection.

Q35. How much does each dose of the vaccine cost? What is the cost of the program?

A35. The current cost of a single dose at the manufacturer level is approximately $3.50. A troop equivalent dose (TED), consisting of the full six dose regimen, costs approximately $21. When all associated costs (transportation, storage, administration, etc.) are included, the cost to immunize an estimated 2.4 million personnel (over a six-year period) is approximately $130 million.

Q36. What about the threat of agents other than anthrax? Are vaccines being developed for other biological agents?

A36. As potential biological warfare threats are identified, we are working with the FDA to determine appropriate protection mechanisms. Vaccines are being developed, whenever appropriate, for all validated biological threat agents. Certain biological agents, such as physiologically active compounds, may not be effectively contravened using a vaccine.

Q37. What about botulinum toxoid? Will a similar program be developed for protection of U.S. forces against that threat?

A37. A botulinum vaccine is available for use as an investigational new drug (IND). That means it is not yet FDA-licensed and must be administered only under special medical protocols. DoD is working with the FDA to license a botulinum vaccine for use as a force protection measure.

Q38. Who is at greater risk from a biological attack? Soldiers? Sailors? Air Force? Marines? Front line? Rear area? Logistical units?

A38. Anthrax in a weaponized form has the potential to cover significant areas of a battlefield. It's difficult to determine who would be at greatest risk from a biological threat.

Q39. Will those refusing to be vaccinated be court-martialed? Discharged?

A39. Each case will have to be determined on its own merits but in general, persons refusing to comply will face disciplinary action.

Q40. Will military members be asked to sign a consent form before being given the vaccine?

A40. The vaccine is fully licensed by the FDA, and does not require signed consent. Vaccine recipients will be provided with appropriate information on the vaccine at the time of immunization, or upon request at any other period.

Q41. Will the military members receive any kind of education about the vaccine?

A41. Yes, service members will be educated as a matter of routine prior to immunization.

Q42. Were soldiers given any biological vaccines during the Gulf War?

A42. Yes. During the Gulf War approximately 150,000 service members received at least one dose to immunize U.S. forces against Iraq's weaponization of b. anthracis. Approximately 8,000 doses of botulinum toxoid were also administered during the Gulf War.

Q43. Have the biological agent vaccines administered during the Gulf War been linked to Gulf War Illness?

A43. No. Several scientific bodies have addressed this issue and to date there is no scientific information to that effect.

Q44. What are biological agents?

A44. Viruses, bacteria, and toxins that can be used against U.S. interests.

Q45. How are biological agents deployed?

A45. Biological agents can be deployed in numerous ways from simple spray devices to ballistic missiles. The agents are often difficult to detect, symptoms are delayed, and without preventive medical efforts, such as vaccination, the results can be devastating and wide spread.

Q46. Are biological agents detected differently from chemical agents?

A46. It's important to clearly distinguish the difference between the biological and chemical agents. The science and technology required to detect biological versus chemical agents is vastly different.

Q47. What was the U.S. Biological Offensive Program?

A47. The Biological Research and Development Program was a classified program conducted from 1942-1969. It was responsible for large scale research and development programs in biological warfare agents (BW), BW intelligence, and BW defense. It was ended by executive order on November 25, 1969. Since then, the Department of Defense has engaged only in research and development of defense materials to protect U.S. forces from the threat of biological warfare.

Q48. Why was the Biological Research and Development Program developed?

A48. In 1941, a National Academy of Sciences committee surveyed the world's BW situation. This committee concluded that BW weapons were feasible and urged President Roosevelt to take steps to reduce U.S. vulnerability to BW attack.

Q49. Where was the Biological Research and Development Program located?

A49. Camp Detrick, Maryland (now Fort Detrick) was the home of the Biological Research and Development Program from 1943 to 1969. Since 1969, the Medical Biological Defense Program has operated at Fort Detrick.

Q50. Why was the program continued after WWII?

A50. The program continued in response to concerns about the continued vulnerability of the United States to covert biological weapons attack.

Q51. What was U.S. policy regarding the use of biological weapons during the cold war?

A51. The U.S. policy regarding biological warfare between 1941 and 1969 was to first deter its use against the U.S. and its forces, and secondly to retaliate if deterrence failed.

Q52. Does the U.S. still have an offensive biological program?

A52. No. In an executive order issued on November 25, 1969, President Nixon discontinued all U.S. activities that supported the offensive focus of the Biological Research and Development Program. The army continued a defensive biological research program to include vaccine research. U.S. BW weapon stocks were destroyed by 1973.

Q53. Did the U.S. ever produce infectious biological agents for retaliatory use?

A53. During WWII, a plant was constructed in Indiana to provide retaliatory BW capability using aerial bombs; however, it ceased operation before infectious BW agent production began. From the end of WWII until 1950, no production was carried out for purpose of operational readiness, and no facilities were available. The first limited BW retaliatory capability was achieved in 1951 when an anti-crop bomb was developed. By 1954, a BW antipersonnel agent was being produced. Production of BW anti-crop and antipersonnel agents continued throughout the 1960s. In August 1969, President Nixon directed an immediate end to all BW production. DoD antipersonnel BW stocks and munitions were destroyed between May 1971 and May 1972. Anti-crop agents were destroyed between April 1971 and February 1973.

Q54. Does the U.S. have a biological research program today?

A54. Yes. Since the inception of the Biological Research and Development Program in 1942, the U.S. has conducted research and development into defensive measures against biological warfare. That defensive program, known today as the Biological Defense Research Program, continues in accordance with the 1969 presidential policy statement. The Biological Defense Research Program seeks to develop effective warning and detection devices, protective clothing and equipment, and continues to assess the vulnerability of the U.S. and its forces to enemy BW attack.

Q55. Does the U.S. still have live biological agents?

A55. Yes, U.S. military laboratories maintain limited archives of the microorganisms and toxins associated with BW efforts in order to develop vaccines, drugs and other therapeutics needed to protect our personnel. It does not maintain agents for any offensive biological weapons purposes.

Q56. When was the U.S. Biological Warfare Program first made public?

A56. The Congress and American public were initially made aware of tests conducted as part of the Biological Research and Development Program in 1977 when the report, "U.S. Army Activity in the U.S. Biological Warfare Programs," was released.