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Dockets Management


C 31
Volume 144


Reference 1 - Centers for Disease Control and Prevention. Use of anthrax vaccine in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2000; 49 (No. RR-15): [39 pages]

Reference 2 - Brachman, P.S., H. Gold, S. Plotkin, F.R. Fekety, M. Werrin, and N.R. Ingraham. 1962. Field evaluation of a human anthrax vaccine. Am. J. Pub. Health, 52: 632-645. Published Material

Reference 3 - FDA. 1985. Biological Products: bacterial vaccines and toxoids: implementation of efficacy review. Proposed rule. Federal Register 50 (240): 51002-51117. Published Material

Reference 4 - Pittman PR, Hack D, Mangiafico J, Gibbs P, McKee KT Jr, Friedlander AM, Sjogren MH. Antibody response to a delayed booster dose of anthrax vaccine and botulinum toxoid. Vaccine. 2002 May 15; 20(16): 2107-15. Published Material

Reference 5 - Johnson-Winegar A. 1984. Comparison of enzyme-linked immunosorbent and indirect hemagglutination assays for determining anthrax antibodies. Journal of Clinical Microbiology 20(3): 357-361. Published Material

Reference 6 - Pittman PR. 2001. Anthrax vaccine: the Fort Bragg Booster Study. Presentation to the Institute of Medicine Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Meeting II, Washington, D.C.

Reference 7 - Pittman PR, Sjogren MH, Hack D, Franz D, Makuch RS, Arthur JS. 1997. Serologic response to anthrax and botulinum vaccines. Protocol No. FY92-5, M109, Log No. A5747. Final Report to the Food and Drug administration. Fort Detrick, Md.: U.S. Army Medical Research Institute of Infectious Diseases.

Reference 8 - Ivins BE, Fellows PF, Pitt MLM, Estep JE, Welkos SL, Worsham PL, Friedlander AM. 1996. Efficacy of a standard human anthrax vaccine against Bacillus anthracis aerosol spore challenge in rhesus monkeys. Salisbury Medical Bulletin 87(Suppl): 125-126.

Reference 9 - Pitt MLM, Ivins BE, Estep JE, Farchaus J, Friedlander AM. 1996. Comparison of the efficacy of purified protective antigen and MDPH to protect non-human primates from inhalation anthrax. Salisbury Medical Bulletin 87(Suppl): 130. Published Material

Reference 10 - Pitt MLM. 2001. Animal models for anthrax vaccine efficacy. Presentation to the Institute of Medicine Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Meeting III, Washington, D.C. Published Material

Reference 11 - Ivins BE, Pitt ML, Fellows PF, Farchaus JW, Benner GE, Waag DM, Little SF, Anderson GW Jr, Gibbs PH, Friedlander AM. 1998. Comparative efficacy of experimental anthrax vaccine candidates against inhalation anthrax in rhesus macaques. Vaccine 16( 1 l-l 2): 1141-1148. Published Material

Reference 12 - Fellows PF, Linscott MK, Ivins BE, Pitt ML, Rossi CA, Gibbs PH, Friedlander AM. 2001. Efficacy of a human anthrax vaccine in guinea pigs, rabbits, and rhesus macaques against challenge by Bacillus anthracis isolates of diverse geographical origin. Vaccine 19(23-24): 3241-3247. Published Material

Reference 13 - Lange, JL, Leskikar SE, Brundage JF, Rubertone MV. 2003. Comprehensive systematic surveillance for adverse effects of Anthrax Vaccine Adsorded, US Armed Forces, 1998-2000. Vaccine, 21: 1620-1628. Published Material

Reference 14 - Rehme PA, Williams, R, Grabenstein JD. 2002. Ambulatory medical visits among anthrax-vaccinated and unvaccinated personnel after return from southwest Asia. Military Medicine, 167: 205-210. Published Material

Reference 15 - Sato, PA, Reed RJ, Smith TC, Want L. 2002. Monitoring anthrax vaccine safety in US military service members on active duty: surveillance of 1998 hospitalizations in temporal association with anthrax immunization. Vaccine, 20: 2369-2374. Published Material

Reference 16 - Sever, JL, Brenner AI, Gale AD, Lyle JM, Moulton LH, West DJ, Anthrax Vaccine Expert
Committee. 2002. Safety of the anthrax vaccine: a review by the Anthrax Vaccine Expert Committee (AVEC) of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). Pharmacoepidemiology and Drug Safety, 11: 189-202. Published Material

Reference 17 - Sever, JL, Brenner, AI, Gale AD, Lyle JM, Moulton LH, Ward BJ, West DJ. 2004. Safety of anthrax vaccine: An expanded review and evaluation of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS). Pharmacoepidemiology and Drug Safety, 12: 825-40. Published Material

Reference 18 - Peeler RN, Cluff LE, Trever RW. 1958. Hyper-immunization of man. Bulletin of the Johns Hopkins Hospital, 103: 183-198.

Reference 19 - Peeler RN, Kadull PJ, Cluf LE. 1965. Intensive immunization of man: evaluation of possible adverse consequences. Ann. Intern. Med., 63: 44-57. Published Material

Reference 20 - White CS III, Adler WH, McGann VG. 1974. Repeated immunization: possible adverse effects-reevaluation of human subjects at 25 years. Ann. Intern. Med., 81: 594-600. Published Material

Reference 21 - Pittman, PR, Gibbs PH, Cannon TL, Friedlander AM. 2001. Anthrax vaccine: short-term safety experience in humans. Vaccine 20 (5-6): 972-978. Published Material

Reference 22 - Canadian Forces Medical Group. Letter from Assistant Chief of Staff Operations to Canadian Clinical Trials and Special Access Program. 15 October 1999.

Reference 23 - Wasserman, G, Grabenstein J, Pittman P, Rubertone M, Gibbs P, Wang L, Golder L. 2003. Analysis of adverse events after anthrax immunization in US Army medical personnel. J. Occupational and Environmental Med. 45: 22-33. Published Material

Reference 24 - Gunzenhauser, JD, Cook JE, Parker ME, Wright I. 2001. Acute side effects of anthrax vaccine in ROTC cadets participating in advanced camp, Fort Lewis, 2000. Med. Surv. Monthly Report, 7: 9-11. Published Material

Reference 25 - Wiesen, AR, Littell CT. 2002. Relationship between pregnancy anthrax vaccinations and pregnancy and birth outcomes amoung US Army women. J. Am. Med. Assoc. (JAMA), 287: 1556-1560. Published Material

Reference 26 - Catherino, WH, Levi A, Leondires M, et al. 2002 The anthrax vaccine does not affect semen parameters, embryo quality, or pregnancy outcomes in couples with a vaccinated male military service member. Fertility and Sterility, 78 (3), Suppl. 1 (abstract 0-285). Published Material

Reference 27 - Catherino, WH, Levi A, Kao TC, Leondires MP, McKeeby J, Segars JH. 2005. Anthrax vaccine does not affect semen parameters, embryo quality, or pregnancy outcome in couples with a vaccinated male military service member. Fertil Steril., 83 (2): 480-3. Published Material

Reference 28 - Sulsky, SI, Grabenstein JD, Delbos RG. 2004. Disability among US Army personnel vaccinated against anthrax. J. Occup. Environ. Med., 46(10): 1065-1075. Published Material

Reference 29 - Pittman, PR, Coonan KR, Gibbs PH, Scott HM, Cannon TL, McKee KT Jr. 2004. Longterm health effects of repeated exposure to multiple vaccines. Vaccine, 23 (4): 525-536. Published Material

Reference 30 - BioThrax AVA Product Insert January 31, 2002. Available online at http:\\www.bioport.com.

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