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Report on vaccines
PRESIDENTIAL ADVISORY COMMITTEE ON GULF WAR VETERANS' ILLNESSES: FINAL REPORT  [December 1996]
RE: ANTHRAX AND BOTULINUM TOXOID VACCINES

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.

 

Anthrax vaccine.
In 1970, FDA licensed anthrax vaccine to protect civilian workers against possible infection by anthrax bacteria. Since 1967 and before the Gulf War, more than 20,000 inoculations had been routinely administered to at-risk populations, including laboratory personnel who work with the bacteria that causes anthrax, persons in industries that work with animal hides and wool (which can be a source of anthrax infection), and veterinarians who come in contact with anthrax-infected animals.

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.

 

Botulinum toxoid vaccine.
Botulinum toxoid (BT) vaccine has been used for more than 25 years to protect industry and laboratory workers from occupational exposure to the extremely poisonous botulinum toxins. All civilian vaccinations have been administered under an investigational new drug (IND) application sponsored by CDC. For both civilian and military use, BT vaccine remains in "investigational" status-i.e., not yet licensed by FDA.

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

 

Precautions against contaminants.
The Committee examined the hypothesis that Gulf War veterans' illnesses could be the result of contamination of anthrax vaccine lots by Mycoplasma incognitus.182 Discussions with staff of FDA, Walter Reed Army Medical Center, U.S. Army Medical Research and Materiel Command, academic experts, and the manufacturer of the vaccines indicate that Mycoplasma could not survive in the anthrax and BT vaccines.136,138,168,303 Mycoplasma is difficult to grow, and the culture media used to produce Anthrax and BT vaccines do not contain serum, an essential ingredient for Mycoplasma growth. In addition, the vaccines are preserved and/or processed with other products that create a hostile environment for Mycoplasma, including:

  • 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.

 

Health effects of multiple vaccines.
The human immune system has evolved the capability to deal with thousands of foreign substances, to sort them out, and to regulate immune response. Humans live among a vast population of hostile microorganisms, and vaccinations-even multiple, contemporaneous vaccinations-are a small part of total immune stimulation. Individual vaccines can cause adverse effects, but several studies of the effects of giving multiple vaccinations at one time have found no adverse effects associated with the practice. Research on this issue continues, but based on available evidence, the Committee believes it is unlikely that multiple vaccines are responsible for illnesses reported today by Gulf War veterans.202,219,268

 

Conclusion
What do we conclude about the risks of vaccines to Gulf War veterans?

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.

 

 
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