Before U.S. troops deployed to the Gulf region, they received a standard series of inoculations against infectious diseases-e.g., cholera, typhoid, tetanus, diphtheria, polio, and measles-that might be given to any U.S. citizen traveling to these regions. After arriving in the Gulf War region, some U.S. service members received two additional vaccines for protection against the BW agents anthrax and botulinum toxin.

Although active long-term safety surveillance is not generally part of the FDA vaccine licensing process, the FDA encourages U.S. health care providers and the law requires manufacturers to report serious adverse reactions for all licensed vaccines.305 FDA has not received data that raise concerns about the safety of the anthrax vaccine.

Historical data for short-term health effects of the anthrax vaccine indicate up to six percent of recipients experience mild discomfort, including tenderness, redness, swelling or itching at the inoculation site for up to 72 hours. Fewer than one percent experience a more severe local reaction that potentially limits the use of the arm for one to two days. Systemic reactions, e.g., fever, malaise, are uncommon (about 0.1 percent).102,103

According to DOD, medical monitoring and surveillance conducted during the Gulf War found the expected short-term side effects of anthrax vaccines occurring at approximately the historical rates.53 A single hospitalization for a vaccination site infection was reported. DOD points out that precise information about all possible short-term side effects is unknown, however, because of difficulties in collecting such data during and after the Gulf War.

Since 1970, as part of the IND evaluation, FDA has reviewed information from CDC about the cumulative safety record for BT vaccine. Records of more than 10,000 administered vaccine doses (including approximately 2,200 in the five years before the Gulf War) indicate that treated individuals experience only local side effects often associated with many types of vaccinations. These effects, primarily at the injection site, include local pain, tenderness, swelling, redness, and itching. Systemic reactions such as temporary fever, tiredness, headache, or muscle pain also can occur. Rarely, reactions include soreness of the arm sufficient to leave individuals unable to perform duties for a day or two or development of a lump at the injection site that generally resolves within several weeks. Such adverse reactions also are observed with other licensed toxoid vaccines, such as diphtheria and tetanus toxoids.53,102

The U.S. Army examined the frequency of side effects of BT vaccinations seen in some U.S. service members. In one report of 237 Gulf War veterans who had received BT vaccine, 2.5 percent had systemic reactions. This rate parallels that recorded by the U.S. Army and CDC prior to the Gulf War.127

• formaldehyde (anthrax and BT vaccines),
• benzethonium chloride (anthrax vaccine only),
• isotonic saline solution (BT vaccine only), and
• Thimerosal (BT vaccine only).

The Committee concludes it is unlikely that Mycoplasma organisms contaminated anthrax vaccine or BT vaccine.

The Committee concludes it is unlikely that health effects reported by Gulf War veterans today are the result of exposures to the BT or anthrax vaccines, used alone or in combination.