Absence of Mycoplasma Contamination in the Anthrax Vaccine

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´╗┐Absence of Mycoplasma Contamination in the Anthrax Vaccine
Mycoplasma contamination of the licensed anthrax vaccine administered to military personnel has been suggested as a possible cause of Persian Gulf illness. Vaccine samples tested by nonmilitary laboratories were negative for viable mycoplasma and mycoplasma DNA and did not support its survival. Mycoplasma contamination of anthrax vaccine should not be considered a possible cause of illness.

Anthrax Vaccine Adsorbed (AVA, BioPort Corporation, Lansing, MI) is a licensed vaccine for anthrax that was administered to approximately 150,000 U.S. military personnel during the Persian Gulf War. It was used more recently as part of a comprehensive vaccination policy for Department of Defense (DOD) service members. The vaccine, which is administered subcutaneously over an 18-month schedule, is derived from sterile, acellular filtrates of microaerophilic cultures of the avirulent, nonencapsulated V770-NP1-R strain of Bacillus anthracis. The cultures are grown in a sterile synthetic liquid medium devoid of enriched supplements such as serum. The filtrates predominantly contain the protective antigen of anthrax. The final vaccine formulation contains protective antigen adsorbed to aluminum hydroxide (<2.4 mg/0.5 mL) as an adjuvant. Formaldehyde (<0.02%) is added as a stabilizer and benzethonium chloride (0.0025%) as a preservative. The final product is checked for potency and safety according to U.S. Food and Drug Administration (FDA) regulations.

Approximately 1.9 million doses of AVA were administered in the United States from January 1990 through August 2000, with 1,544 adverse reactions (0.08% of all injections) reported through the Vaccine Adverse Event Reporting System. Most of these adverse reactions were limited to the injection site; local hypersensitivity, edema, and pain were the most commonly reported, although 76 (4.9%) of the adverse reactions were classified as serious.

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