In addition to updating routine vaccinations in need of a booster—as with tetanus-diphtheria and oral poliovirus vaccines—the guidance from CENTCOM in August 1990 recommended additional countermeasures for personnel deploying to Southwest Asia that included meningococcal, typhoid, and yellow fever vaccines, and immune globulin to protect against hepatitis A. Smallpox, plague, cholera, and rabies vaccines were not recommended in this guidance.^[24] The services sometimes modified these recommendations as indicated in the discussion of specific vaccines below. The biological warfare vaccines, anthrax and botulinum toxoid, are discussed in a following subsection.

Meningococcal Vaccine (groups A, C, Y, and W-135). This vaccine was routinely given to military recruits for protection against meningococcal disease during initial training. (See previous subsection.) Meningococcal infections usually begin with growth of the bacteria in the respiratory tract. Serious meningococcal diseases can spread to the lining of the brain and spinal cord (meningitis) or to the bloodstream (meningococcemia), and without rapid treatment are often fatal. The vaccine is considered 85 to 95 percent effective in preventing meningococcal disease associated with four of the five common strains of these bacteria (namely, groups A, C, Y, and W-135; there is no licensed vaccine for group B strains).^[25] Meningococcal disease had been reported in Saudi Arabia, especially at the times of annual religious pilgrimages.^[26]

During Operation Desert Shield, CENTCOM recommended meningococcal vaccine for personnel deploying to the Gulf who had not had it within five years and who would be expected to have prolonged close contact with local nationals, especially children, but not for those who would have only occasional casual contact.^[27] The Army recommended it for all personnel, especially for those with the contacts mentioned above (civil affairs and medical personnel were given as examples), but indicated that solders could deploy without it.^[28] The Navy, Air Force, and Marine Corps essentially reiterated the original CENTCOM guidance for this vaccine.^[29] Later guidance reinforced the need for this vaccine, restated the position that it was not necessary for all personnel, and suggested that there might have been shortages, requiring some servicemembers to receive the vaccine after arriving in the Gulf.^[30] There were reports of meningococcal disease in two American servicemembers during the Gulf War, one of whom died of meningococcal meningitis.^[31] Given the scope of this paper, we do not know whether these individuals had received the vaccine.

Typhoid Vaccine. Typhoid fever is a bacterial infection characterized by prolonged fever, which is usually acquired from contaminated food or water. It is debilitating and can be life threatening. Of the typhoid vaccines available at the time of the Gulf War, the military generally used the more effective acetone-inactivated vaccine. This vaccine’s effectiveness ranged between 75 percent to 94 percent; other typhoid vaccines were somewhat less effective.^[32] CENTCOM recommended typhoid vaccine for all deploying personnel who had not had it within three years.^[33] The Army required this vaccine; the Navy, Air Force, and Marine Corps essentially reiterated the original CENTCOM guidance.^[34] No confirmed cases of typhoid fever were reported among US personnel deployed to the Gulf.^[35]

Yellow Fever Vaccine. The Navy and Marine Corps used this vaccine for all active duty and reserve forces; the Army and Air Force used it only for personnel deployed to areas with high risk of contracting this disease. Yellow fever, usually acquired from a mosquito bite, is a potentially serious viral disease that can affect the liver and kidneys, and that can be life threatening. An available vaccine is highly effective in preventing this disease. While the initial CENTCOM guidance recommended yellow fever vaccine for deployment to Southwest Asia, the Army specifically noted it was not required.^[36] The Navy, Air Force, and Marine Corps reiterated the CENTCOM guidance.^[37] Yellow fever is not generally present in Southwest Asia, and we are not aware of any reports of servicemembers who acquired this disease during the Gulf War.^[38]

Immune Globulin. Immune globulin is not a vaccine, but it protected servicemembers against hepatitis A in a similar way.^[39] Hepatitis A is a disease of the liver that can be debilitating, although full recovery is the rule. It is spread by direct contact with infected individuals, or by food or water contaminated with the virus, and is common in Southwest Asia.^[40] Immune globulin—also known as immune serum globulin, gamma globulin, and immune globulin intramuscular—is 80 to 95 percent effective in preventing hepatitis A disease. During Operation Desert Shield, CENTCOM recommended the use of immune globulin as an injection of either 2.0 cc if servicemembers were only to be in the areas of exposure for three months or less, or a larger amount of 5.0 cc if they were to stay longer.^[41] The Army required the larger amount for all individuals.^[42] The Navy, Air Force, and Marine Corps reiterated the original CENTCOM guidance.^[43] Shortages of this product caused the military to seek additional sources. Immune globulin from a second source was approved by the FDA, but was not administered to US servicemembers.^[44] The shortages of immune globulin may have limited the size of the initial dose in some cases and this, along with extensions of the deployment, required that some servicemembers be given additional doses in theater. Only a few cases of hepatitis A were reported among deployed US personnel, reflecting the effectiveness of immune globulin along with other preventive medicine measures.^[45] A vaccine against Hepatitis A is now available and is used by the military to prevent this disease.^[46]

These deployment vaccinations (along with updating of the more routine vaccinations) were generally carried out at the home stations or at the mobilization stations. Some were also given in theater due to initial shortages, as was the case with meningococcal vaccine and immune globulin, or because the requirement for a particular vaccine was seasonal, as with influenza vaccine.^[47]

Casualties from infectious diseases during Operations Desert Shield and Desert Storm were extremely low, reflecting at least in part an extensive preventive medicine program.^[48] From available records, it appears that few servicemembers required medical evacuation for diseases that were potentially vaccine-preventable.^[49] The death from meningococcal meningitis was the only reported death from an infectious disease.^[50]

From the onset of Operation Desert Shield, the military was concerned that Iraq might use biological weapons. In August 1990, the Central Intelligence Agency believed Iraq possessed two biological warfare agents, botulinum toxin and Bacillus anthracis (the bacterium that causes anthrax).^[51] The Armed Forces Epidemiological Board reviewed intelligence data to determine the need for biological agent vaccines against anthrax and botulism, and in August 1990 recommended that immunization of forces at risk begin as soon as possible.^[52]

Anthrax Vaccine. Anthrax is a bacterial disease that ordinarily occurs through contact with infected animals or contaminated animal products, or by ingestion or inhalation of infected dust from hides, wool, or similar substances. Naturally occurring anthrax affects small numbers of people who often work in environments with occupational exposure to the anthrax spores (one form of the bacterium). The spores are quite hardy, can be produced in large quantities, and can be spread by aerosols, making anthrax useful as a biological warfare agent. Anthrax infection acquired through inhalation generally starts within a few days with symptoms of fatigue, fever, and cough, and progresses to severe breathing difficulty and shock. At this point the mortality is very high.^[53] Even less seriously ill servicemembers would substantially weaken the military force. While protective masks provide a barrier against this infection, and antibiotics given early in the infection can be useful, adequate warning of an attack would be unlikely, so a vaccine would clearly offer the best pre-combat protection for military personnel.

After the testing and review process, the Food and Drug Administration licensed an anthrax vaccine in 1970.^[54] In field trials with textile workers prior to licensure, vaccinated workers did not develop inhalational anthrax, while some unvaccinated workers did; however, the total number of individuals studied was small.^[55] At the time of the Gulf War, the anthrax vaccine, which was slightly different from the earlier tested version, contained aluminum hydroxide as an adjuvant. (See also Vaccine Adjuvants, section V.) The recommended schedule was a series of six injections over 18 months, followed by yearly booster injections to maintain protection.^[56] The vaccine was produced by the Michigan Department of Public Health (MDPH). In the 20 years preceding the Gulf War, the MDPH had distributed more than 70,000 doses of the vaccine, which had been given to more than 10,000 veterinarians, laboratory workers, workers in the hide and wool industries, and others who were most likely to come in contact with anthrax spores.^[57] Adverse reactions were generally tolerable and limited. (See also Adverse Reactions, section V.) During the early period of the Gulf War deployment, additional animal studies were done to further support the vaccine’s effectiveness against inhalational anthrax.^[58]

Botulinum Toxoid Vaccine. Botulism is a disease caused by toxins produced by the bacterium, Clostridium botulinum. The bacteria are commonly found in soil, and natural disease can occur from ingestion of toxin-containing food or direct contamination of a wound. Though contamination of food sources was possible, the military was most concerned that botulinum toxin could be aerosolized as a biological warfare agent and inhaled by military personnel. Within a day or so of exposure, sometimes longer, the toxins cause progressive muscle weakness with difficulty swallowing, speaking, and breathing, and finally respiratory paralysis. While prompt administration of prepared anti-toxins can neutralize botulinum toxins, and intensive respiratory support can be life saving, the effects on the military force could be incapacitating. The military viewed vaccination as the best available pre-combat protection for the forces.

A botulinum toxoid vaccine was available as an investigational product at the time of the Gulf War. (See also Investigational Vaccines, section V.) According to data collected by the CDC, the vaccine had been used since 1970 to protect high-risk laboratory workers against botulism. The vaccine contained aluminum phosphate as an adjuvant.^[59] (See also Vaccine Adjuvants, section V.) Vaccine recipients developed levels of antibody considered protective when compared to studies in animals, but protection in humans was more difficult to demonstrate since botulism from any cause is a rare disease. The vaccine required a series of three injections over 12 weeks, with subsequent booster injections to maintain antibody levels. Between 1970 and the Gulf War, over 10,000 injections of the vaccine had been given, mostly to volunteers and laboratory workers. Adverse reactions were generally tolerable and limited. (See also Adverse Reactions, section V.)

Availability of Biological Warfare Vaccines. The peacetime demand for anthrax and botulinum toxoid vaccines was not large. The Michigan Department of Public Health was the sole producer of both vaccines. In October 1990, in an effort to expand the industrial base for biological vaccine production, the Secretary of Defense directed the Assistant Secretary of Defense for Health Affairs to acquire a second source for these biological vaccines.^[60] In response, the Assistant Secretary established a tri-service vaccine task force, subsequently named "Project Badger." Project Badger reviewed the MDPH capabilities and the probable vaccine delivery timelines based upon the projected needs for the Gulf War. The task force also conducted a survey to find out if other manufacturers (including manufacturers of veterinary vaccines) could produce anthrax and botulinum toxoid vaccines. The feasibility of purchasing vaccines from a foreign source and producing the vaccines at Fort Detrick, Maryland and other Army facilities was also explored. ^[61]

The search for alternative sources was not successful. The MDPH had suspended further production of botulinum toxoid vaccine in order to produce the anthrax vaccine.^[62] Veterinary vaccine manufacturers used processes different from those used to produce human vaccines.^[63] One potential manufacturer would not have been able to deliver any vaccine until April 1991.^[64] Only one foreign manufacturer was identified.^[65] Production of botulinum toxoid vaccine at Fort Detrick was feasible, but would require substantial renovation and equipment purchases.^[66] Production at Army facilities other than Fort Detrick was not feasible.^[67] In the end, only anthrax and botulinum toxoid vaccines produced by the MDPH were used by US forces during the Gulf War deployment.^[68]

Since supplies of the two biological warfare vaccines were limited, the DoD allocated the vaccines only to personnel they believed to be at greatest risk of exposure to these biological warfare agents.^[69] Vaccine shortages were likely responsible for reducing the anthrax vaccine doses required to two, with the knowledge that two doses would provide at least partial protection to most individuals, and for reducing the botulinum toxoid vaccine to three doses, as recommended by an earlier working group. Shortages may also have led to holding some anthrax vaccine in reserve to use along with antibiotics for unprotected servicemembers who may be exposed, and to acquiring botulinum anti-toxin for use under similar conditions.^[70] Most servicemembers who received the biological warfare vaccines received them in the Gulf during early 1991, but at least some special forces personnel received them stateside during the latter part of 1990.^[71] The initial shipment of the anthrax and botulinum toxoid vaccines was flown from the US to the Gulf accompanied by members of a tri-service vaccination team. This team helped ensure safe transport of the vaccines and assisted with finalization of the plan to distribute the vaccines in theater.^[72]

Biological Warfare Vaccine Use in the Gulf. In late December 1990, following discussions with the Joint Staff, the US Central Command (CENTCOM) established immunization priorities for the use of biological warfare vaccines.^[73] CENTCOM messages in January 1991 initiated the anthrax and botulinum toxoid vaccination programs.^[74]

The anthrax vaccination guidelines directed that only personnel assigned to fixed units within the areas designated by CENTCOM were to be vaccinated at that time. No transient or shipboard personnel were to be vaccinated. Exceptions were pathologists and medical laboratory personnel. The guidelines indicated that sufficient quantities of anthrax vaccine would be available by May 1991 to vaccinate all personnel in the area of responsibility. It was anticipated that the relatively long period between exposure and onset of illness (when compared to botulism) would make anthrax an agent more likely to be used against fixed and rearward units. The guidance called for two doses of vaccine approximately 14 days apart.^[75] CENTCOM directed that personnel in the following areas and units would be vaccinated: Riyadh, Dhahran-Damman, King Khalid Military City (KKMC), Logistics Bases A/B/C/D/E, Headquarters VII Corps and XVIII Airborne Corps, 1^st Cavalry Division, and Bahrain.^[76] Available records indicate that anthrax vaccine from (at least) lot numbers 19, FAV002, FAV003, FAV004, FAV005, and FAV006 was distributed in theater.^[77]

The botulinum toxoid vaccination guidelines specified that only personnel in units prioritized by CENTCOM, namely the Army VII Corps and the 1^st Marine Expeditionary Force, were to be vaccinated at that time, and that limited additional quantities of botulinum toxoid vaccine would be available in February and March 1991 to vaccinate additional designated personnel in the area of responsibility. It was anticipated that the relatively brief period between exposure and onset of illness (when compared to anthrax) would make botulinum toxin an agent likely to be used against forward units. The guidance called for two doses of vaccine approximately two weeks apart, followed by a third dose 10 weeks after the second dose.^[78] Available records indicate that botulinum toxoid vaccine from (at least) lot number PBP001 was distributed in theater.^[79]

Although informed consent was not required for either the anthrax or the botulinum toxoid vaccines, in practice both were administered as voluntary to some extent. A post-conflict status report indicates that anthrax vaccinations were not portrayed as mandatory, but as highly recommended.^[80] This is substantiated by an affidavit documenting the voluntary refusal of a servicemember to take the anthrax shot.^[81] Subsequent testimony by the CENTCOM Surgeon indicated that the botulinum toxoid vaccine was also voluntary: "And, again I mention, there wasn't enough vaccine for everybody. And it seemed reasonable enough to give them the choice, based upon the fact that you gave them the information upon which to base a choice."^[82] Reports indicate that the botulinum toxoid vaccine was likely declined by several thousand servicemembers.^[83]

A CENTCOM message in March 1991 terminated the biological warfare vaccine programs and instructed any personnel who began the series that they need not complete the immunization programs.^[84] At the end of hostilities, personnel from the US Army Medical Research Institute of Infectious Diseases traveled to Saudi Arabia to recover remaining stocks of anthrax and botulinum toxoid vaccines, which were stored at the 47^th Medical Supply, Optical, and Maintenance facility in Dhahran.^[85] The team reported that there were two refrigeration malfunctions in April and May 1991 that may have affected the quality of the vaccines. The team recommended disposal of the anthrax vaccine and re-testing of the botulinum toxoid vaccine.^[86]

There is no accurate count of how many servicemembers received these vaccines. The DoD estimated that 150,000 servicemembers received at least one immunization against anthrax and that 8,000 servicemembers received at least one immunization of botulinum toxoid.^[87] A recent survey of Gulf War veterans suggests the numbers of servicemembers who received these vaccines may be higher.^[88]

The Office of the Special Assistant now holds a collection of rosters showing biological warfare vaccines administered to individual servicemembers, but this collection is incomplete. The information included in many of these rosters is insufficient and difficult to interpret. Some of the rosters appear original, others apparently were created in response to a post-war call for this information. (See also Vaccine Record Keeping, section V.)

After the war, Iraq acknowledged that it had conducted research into the offensive use of biological warfare agents, including anthrax and botulinum toxin. During the Gulf War, Iraq had filled some weapons with these two biological warfare agents (and also with aflatoxin, a toxin for which there is no vaccine), but did not use them.^[89] A report by the Central Intelligence Agency also concluded that Iraq did not use biological warfare agents during the Gulf War.^[90] The best evidence available to the Presidential Advisory Committee on Gulf War Veterans’ Illnesses indicated that US personnel were not exposed to biological warfare agents during the Gulf War.^[91]

Because anthrax remains a biological warfare threat, the Department of Defense has decided to vaccinate the total military force against this disease.^[92] The DoD’s Anthrax Vaccine Immunization Program office manages this effort and regularly provides updated information on its web site.^[93] The military also continues an active research program to develop new and better vaccines against a variety of biological warfare agents.

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