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The Anthrax Vaccine: Is it Safe? Does it Work? Appendix C Information-Gathering Meeting Agendas Meeting I October 3, 2000 The Foundry Building 1055 Thomas Jefferson Street, NW Washington, DC Agenda Tuesday, October 3rd Open Session 8:00 a.m. Introductory remarks and review of charge Dr. Brian Strom, Chair, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine 8:15 Introductions by committee members and meeting attendees 8:30 Sponsor presentation on the study charge Major General John Parker, Commander, U.S. Army Medical Research and Materiel Command

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The Anthrax Vaccine: Is it Safe? Does it Work?   Congressional comment on the study charge Mr. Robert Neal, Legislative Assistant, Office of Representative George Nethercutt, Jr. 9:15 Concerns Regarding the Safety or Efficacy of Anthrax Vaccine Dr. Meryl Nass Dr. George Robertson 10:00 Break 10:15 Anthrax the Disease, and Anthrax Vaccine Development and History LTC John D. Grabenstein, Deputy Director for Clinical Operations, Anthrax Vaccine Immunization Program LTC Mark G. Kortepeter, Chief, Education and Training, Operational Medicine Division, U.S. Army Medical Research Institute of Infectious Diseases 11:00 The DoD Anthrax Vaccine Immunization Program (AVIP) Status and Projected Future LTC John D. Grabenstein, Deputy Director for Clinical Operations, Anthrax Vaccine Immunization Program 11:45 Working lunch 12:30 p.m. How Are Safety and Efficacy Determined by FDA? Dr. Juli Clifford, Division of Vaccines and Related Products Applications, Center for Biologics Evaluation and Research, FDA Dr. Karen Midthun, Director, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA 1:15 The Vaccine Adverse Events Reporting System (VAERS) Dr. Gina Mootrey, VAERS Project Officer, National Immunization Program, CDC 2:00 The Anthrax Vaccine Expert Committee (AVEC) Dr. Vito Caserta, Health Resources and Services Administration, DHHS 2:30 Adjourn Open Session

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The Anthrax Vaccine: Is it Safe? Does it Work? Meeting II January 29–30, 2001 The Foundry Building 1055 Thomas Jefferson Street, NW Washington, DC Meeting Objectives Review several completed studies of anthrax vaccine safety and efficacy Evaluate knowledge of vaccine components Define needs for additional information gathering Plan future meetings Agenda Monday, January 29, 2001 12:00 p.m. Open Session A review of some of the studies of the anthrax vaccine 12:00 The CDC Observational Study Dr. Juli Clifford, Center for Biologics Evaluation and Research, FDA 12:30 Components of the Anthrax Vaccine Absorbed and Contrast with Merck Vaccine Dr. Robert Myers, BioPort Corporation 1:00 Working lunch 1:30 Field Evaluation of a Human Anthrax Vaccine Dr. Stanley Plotkin 2:00 Ft. Detrick Multi-Dose, Multi-Vaccine Safety Studies LTC Phillip Pittman, U.S. Army Medical Research Institute of Infectious Diseases 2:30 Ft. Detrick Special Immunization Program LTC Phillip Pittman

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The Anthrax Vaccine: Is it Safe? Does it Work? 3:00 Ft. Bragg Booster Study LTC Phillip Pittman 3:30 Break 3:45 Reduced Dose/Route of Administration Pilot LTC Phillip Pittman 4:15 Surveillance of Adverse Effects of Anthrax Vaccine Adsorbed Dr. Jeff Lange, U.S. Army Center for Health Promotion and Disease Prevention 4:45 Adjourn Open Session Tuesday, January 30, 2001 Open Session 8:00 a.m. Breakfast 8:30 U.S Forces in Korea Survey Dr. Ken Hoffman, Military and Veterans Health Coordinating Board Vaccine Research Portfolio LTC John Grabenstein, Anthrax Vaccine Immunization Program Agency 9:30 Adjourn Open Session

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The Anthrax Vaccine: Is it Safe? Does it Work? Meeting III April 17–18, 2001 The Cecil and Ida Green Building 2001 Wisconsin Avenue, NW Washington, DC Meeting Objectives Review information about anthrax pathology and anthrax vaccine efficacy in animal models Review information about variations in anthrax strains and discuss implications for vaccine efficacy Gather additional information regarding anthrax vaccine safety and efficacy from public input Agenda Tuesday April 17, 2001 Open Session 10:00 a.m. Anthrax Pathology in Humans Dr. David Walker, Professor and Chairman, Department of Pathology, University of Texas Medical Branch at Galveston Discussion 10:45 The Pathology of Experimental Anthrax in Rabbits and Nonhuman Primates LTC Gary Zaucha, Walter Reed Army Institute of Research Discussion 11:30 Animal Models for Anthrax Vaccine Efficacy Dr. Louise Pitt, U.S. Army Medical Research Institute of Infectious Diseases Discussion

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The Anthrax Vaccine: Is it Safe? Does it Work? 12:15 p.m. Working lunch 12:45 Group Discussion: What Outstanding Questions Remain About Animal Models for Vaccine Efficacy? Moderator, Dr. Dennis Kasper, Member, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine 1:15 Genetic Diversity in B. anthracis Dr. Paul Jackson, Environmental Molecular Biology Group, Los Alamos National Laboratory Discussion 2:00 Break 2:15 Efficacy of AVA in Different Animal Models Against Challenge by B. anthracis Strains of Diverse Geographical Origin COL Art Friedlander, U.S. Army Medical Research Institute of Infectious Diseases Discussion 3:00 Group Discussion: What Outstanding Questions Remain About Vaccine Efficacy Against Varying Anthrax Strains? 3:45 Adjourn Open Session Joint Meeting of the Institute of Medicine Committee to Assess the Safety and Efficacy of the Anthrax Vaccine and the Institute of Medicine Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program Wednesday, April 18, 2001 10:30 a.m. Open Session, Oral statements   Master Sergeant (ret) Thomas Starkweather Mr. Sonnie Bates

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The Anthrax Vaccine: Is it Safe? Does it Work?   Col. (ret) Redmond Handy, National Organization of Americans Battling Unnecessary Servicemember Endangerment (NO ABUSE) Ms. Nancy Rugo Capt. John Buck, M.D. MAJ Jon Irelan Capt. Jean Tanner Technical Sergeant Jeffrey Moore Discussion 12:30 p.m. Adjourn Meeting IV July 10-11, 2001 The Foundry Building 1055 Thomas Jefferson Street, NW Washington, DC Meeting Objectives Review studies of the safety of the anthrax vaccine Gather information regarding manufacturing issues surrounding the anthrax vaccine

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The Anthrax Vaccine: Is it Safe? Does it Work? Agenda Tuesday, July 10, 2001 10:15 a.m. Open Session Welcome and introductory remarks Dr. Brian Strom, Chair, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine A review of additional studies of the anthrax vaccine 10:20 Tripler Army Medical Center Survey of AVA Safety COL Glenn Wasserman, Tripler Army Medical Center 10:50 DoD-Wide Medical Surveillance for Potential Long-Term Adverse Events Associated with Anthrax Immunization Dr. Paul Sato, Naval Health Research Center 11:20 Surveillance of Adverse Effects of Anthrax Vaccine Adsorbed Dr. Jeff Lange, U.S. Army Center for Health Promotion and Preventive Medicine 12:30 p.m. Working lunch 1:00 Lack of Effect of Anthrax Vaccination on Pregnancy, Birth, and Adverse Birth Outcome Among Women in Active Service with the U.S. Army MAJ Andrew Wiesen, 3rd Infantry Division Surgeon 1:30 Ambulatory Medical Visits Among Anthrax Vaccinated and Unvaccinated Personnel After Return from Southwest Asia Lt. Col. Paul Rehme, Air National Guard Readiness Center 2:00 Status of the Anthrax Vaccine Research Portfolio LTC John Grabenstein, Anthrax Vaccine Immunization Program Agency 2:30 Adjourn Open Session Closed Session

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The Anthrax Vaccine: Is it Safe? Does it Work? Wednesday, July 11, 2001 Open Session 8:30 a.m. Welcome and introductory remarks Dr. Brian Strom, Chair, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine Dr. Don Metzgar, Member, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine BioPort presentation responding to questions from IOM committee Dr. Larry Winberry, Vice President, Operations Dr. Lallan Giri, Vice President, Quality, Compliance, and Regulatory Affairs Discussion 10:30 Break 10:45 Commentary from FDA Mr. Mark Elengold, Deputy Director, Center for Biologics Evaluation and Research Discussion 12:30 p.m. Adjourn Open Session