Dockets:

1980N-0208
BKG 6
Volume 225

Reference 1 - Brachman, P. S.; H. Gold; S. A. Plotkin; F. R. Fekety; M. Werrin; and N. R. Ingraham, “Field Evaluation of a Human Anthrax Vaccine,” American Journal of Public Health, 52: 632-645, 1962. Published Material

Reference 2 - Institute of Medicine. “The Anthrax Vaccine. Is It Safe? Does It Work?” Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-Up Agency. Washington, DC: National Academy Press, 2002. Published Material

Reference 3 - Fellows, P. F.; M. K. Linscott; B. E. Ivins; M. L. M. Pitt; C. A. Rossi; P. H. Gibbs and A. M. Friedlander, “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, 2001. Published Material

Reference 4 - Ivins, B. E.; P. F. Fellows; M. L. M. Pitt; J. E. Estep; S. L. Welkos; P. L.Worsham and A. M. Friedlander, “Efficacy of a Standard Human Anthrax Vaccine Against Bacillus Anthracis Aerosol Spore Challenge in Rhesus Monkeys,” Salisbury Medical Bulletin 87(Suppl.): 125-126, 1996. Published Material

Reference 5 - Ivins, B. E.; M. L. M. Pitt; P. F. Fellows; J. W. Farchaus; G. E. Benner; D. M. Waag; S. F. Little; G. W. Anderson, Jr.; P. H. Gibbs; and A. M. Friedlander, “Comparative Efficacy of Experimental Anthrax Vaccine Candidates Against Inhalation Anthrax in Rhesus Macaques,” Vaccine, 16(11/12): 1141-1148, 1998. Published Material

Reference 6 - Anthrax Vaccine Adsorbed (BIOTHRAX) Package Insert (January 31, 2002).

Reference 7 - Wright, G. G.; T. W. Green; and R.G. Kanode, Jr., “Studies on Immunity in Anthrax: V. Immunizing Activity of Alum-Precipitated Protective Antigen,” Journal of Immunologv, 73: 387-391, 1954.

Reference 8 - “FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products,” April 1996.

Reference 9 - “Revocation of Certain Regulations; Biological Products,” Final Rule; 61 FR 40153, August 1, 1996.

Reference 10 - “International Conference on Harmonisation; Guidance on Statistical Principles for Clinical Trials,” Notice of Availability; 63 FR 49583, September 16, 1998.

Reference 11 - Plotkin, S. A., P.S. Brachman, M. Utell, F. H. Bumford, and M. M. Atchinson, “An Epidemic of Inhalation Anthrax, the First in the Twentieth Century, I. Clinical Features.” American Journal of Medicine, 29: 992-1001, 1960. Published Material

Reference 12 - Brachman, P.S., S. A. Plotkin, F. H. Bumford, and M. M. Atchinson, “An Epidemic of Inhalation Anthrax: The First in the Twentieth Century, II. Epidemiology.” American Journal of Hygiene; 72: 6-23, 1960. Published Material

Reference 13 - Pittman, P. R.., G. Kim-Ahn, D. Y. Pifat, K. Coonan, P. Gibbs, S. Little, J. G. Pace-Templeton, R. Myers, G. W. Parker, and A. M. Friedlander, “Anthrax Vaccine: Immunogenicity and Safety of a Dose-Reduction, Route-Change Comparison Study in Humans,” Vaccine; 20(9-10): 1412-1420, 2002. Published Material

Reference 14 - “Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment,” March 2005.

Reference 15 - Institute of Medicine. “Adverse Effects of Pertussis and Rubella Vaccines.” A Report of the Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines. Washington, DC: National Academy Press, 1991. Published Material

Reference 16 - Institute of Medicine. “Immunization Safety Review.” http://www.iom.edu/project.asp?id=4705 Published Material

Reference 17 - Review of VAERS Anthrax Vaccine Reports Received Through 8/15/05, and Adverse Event Reports Submitted to Docket No. 1980N-0208; dated December 2005.

Reference 18 - Puziss, M., L. C. Manning, J. W. Lynch, E. Barclay, I. Abelow, and G. G. Wright, “Large-Scale Production of Protective Antigen of Bacillus anthracis in Anaerobic Cultures.” Applied Microbiology, 11(4): 330-334, 1963. Published Material

Reference 19 - Wright, G. G.., M. Puziss, and W. B. Neely, “Studies on Immunity in Anthrax, IX. Effect of Variations in Cultural Conditions on Elaboration of Protective Antigen by Strains of Bacillus anthracis.” Journal of Bacteriology, 83: 515-522, 1962. Published Material

Reference 20 - Nikkila K., K. Hiickerstedt, and T. A. Miettinen, “Serum and Hepatic Cholestanol, Squalene and Noncholesterol Sterols in Man: A Study on Liver Transplantation,” Hepatoloay, 15: 863-70, 1992. Published Material

Reference 21 - Matyas, G. F:., M. Rao, P. R. Pittman, R. Burge, I. E. Robbins, N. M. Wassef, B. Thivierge, and C. R. Alving, “Detection of Antibodies to Squalene III. Naturally Occurring Antibodies to Squalene in Humans and Mice,” Journal of Immunological Methods, 286: 47-67, 2004. Published Material

Reference 22 - Jernigan, J. A., et al., “Bioterrorism-Related Inhalational Anthrax: The First 10 Cases Reported in the United States,” Emerging Infectious Diseases, 7(6):933-944, 2001. Published Material

Reference 23 - Barakat, L. A., et al., “Fatal Inhalational Anthrax in a 94-Year-Old Connecticut Woman,” Journal of the American Medical Association, 287(7): 863-868, 2002. Published Material