Appendix B
Information-Gathering Meeting Agendas

Meeting I October 31, 2000

The Foundry Building 1055 Thomas Jefferson Street, NW Washington, DC

Agenda

Open Session

8:00 a.m.

Welcome, introductory remarks, and introductions by committee members and meeting attendees

Philip Brachman, M.D., Chairman, Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program

8:15

Review of charge

Philip Brachman, M.D.

8:30

Congressional staff presentation of history/motivation of appropriation

Mr. Brent Jaquet, Appropriations Fellow, Office of Congressman C.W. Bill Young

8:45

Sponsor presentation on the study charge

Jose F. Cordero, M.D., M.P.H., Assistant Surgeon General, Deputy Director, National Immunization Program, CDC

9:00

Background on anthrax

Col. Arthur M. Friedlander, M.D., U.S. Army Medical Research Institute of Infectious Diseases, DOD

LTC John D. Grabenstein, R.Ph., Ph.D., Clinical Operations, Anthrax Vaccine Immunization Program Agency



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Appendix B Information-Gathering Meeting Agendas Meeting I October 31, 2000 The Foundry Building 1055 Thomas Jefferson Street, NW Washington, DC Agenda Open Session 8:00 a.m. Welcome, introductory remarks, and introductions by committee members and meeting attendees Philip Brachman, M.D., Chairman, Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program 8:15 Review of charge Philip Brachman, M.D. 8:30 Congressional staff presentation of history/motivation of appropriation Mr. Brent Jaquet, Appropriations Fellow, Office of Congressman C.W. Bill Young 8:45 Sponsor presentation on the study charge Jose F. Cordero, M.D., M.P.H., Assistant Surgeon General, Deputy Director, National Immunization Program, CDC 9:00 Background on anthrax Col. Arthur M. Friedlander, M.D., U.S. Army Medical Research Institute of Infectious Diseases, DOD LTC John D. Grabenstein, R.Ph., Ph.D., Clinical Operations, Anthrax Vaccine Immunization Program Agency

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10:00 Vaccine Adverse Events Reporting System (VAERS) background Gina Mootrey, D.O., M.P.H., Senior Research Officer, Vaccine Safety Development Activity, Epidemiology and Surveillance Division, National Immunization Program, CDC M. Miles Braun, M.D., M.P.H., Division of Epidemiology, Office of Biostatistics & Epidemiology, Center for Biologics Evaluation and Research, FDA 10:30 Break 10:45 Background on Anthrax Vaccine Expert Committee (AVEC) Vito Caserta, M.D., M.P.H., National Vaccine Injury Compensation Program, Health Resources and Services Administration, DHHS 11:00 Sponsor overview of CDC research program Benjamin Schwartz, M.D., Acting Director, Epidemiology & Surveillance Division, National Immunization Program, CDC Michael M. McNeil, M.D., M.P.H., Chief, Anthrax Vaccine Safety Activity, Epidemiology & Surveillance Division, National Immunization Program Kristine Sheedy, Ph.D., Health Communication Specialist, Vaccine Safety Development Activity, Epidemiology & Surveillance Division, National Immunization Program Gina Mootrey, D.O., M.P.H., Senior Research Officer, Vaccine Safety Development Activity, Epidemiology & Surveillance Division, National Immunization Program 12:15 p.m. Lunch 1:15 Sponsor overview of CDC research program, continued Bradley A. Perkins, M.D., National Center for Infectious Diseases, CDC 2:00 Adjourn Meeting II February 8, 2001 The Foundry Building 1055 Thomas Jefferson Street, NW Washington, DC Agenda Open Session 9:00 a.m. Welcome, introductory remarks, and introductions by committee members and meeting attendees Philip Brachman, M.D., Chairman, Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program 9:15 Review of charge Philip Brachman, M.D.

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9:25 The National Center for Infectious Diseases Anthrax Vaccine Research Program: anthrax vaccine clinical trials Bradley Perkins, M.D., Chief, Meningitis & Special Pathogens Branch, Division of Bacterial Mycotic Diseases, National Center for Infectious Diseases, CDC 10:10 National Immunization Program opening remarks Benjamin Schwartz, M.D., Associate Director for Science, Epidemiology & Surveillance Division, National Immunization Program, CDC 10:20 Introduction to National Immunization Program Anthrax Vaccine Safety & Efficacy Research Program Michael M. McNeil, M.D., M.P.H., Chief, Anthrax Vaccine Safety Activity, Epidemiology & Surveillance Division, National Immunization Program, CDC 10:30 Break 10:45 Survey of knowledge, attitudes, and beliefs regarding the anthrax vaccine among military personnel Deborah Gust, Ph.D., Behavioral Scientist, Vaccine Safety & Development Activity, Epidemiology & Surveillance Division, National Immunization Program, CDC 11:15 Enhancing the reporting of vaccine adverse events: a survey of military vaccine providers Robert Pless, M.D., Medical Epidemiologist, Vaccine Safety & Development Activity, Epidemiology & Surveillance Division, National Immunization Program, CDC 11:45 Working lunch 12:45 p.m. Data mining in Vaccine Adverse Event Report System Betsy Cadwell, M.S.P.H., Mathematical Statistician, Data Management Division, National Immunization Program, CDC 1:15 Assessing the safety of anthrax vaccine: a meta-analysis Betsy Cadwell, M.S.P.H. 2:00 Adjourn

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Meeting III April 18–19, 2001 The Cecil and Ida Green Building 2001 Wisconsin Avenue, NW Washington, DC Agenda Wednesday, April 18 Open Session 10:30 a.m. Oral statements MS (ret) Thomas Starkweather Mr. Sonnie Bates Col. (ret) Redmond Handy, National Organization of Americans Battling Unnecessary Servicemember Endangerment (NO ABUSE) Ms. Nancy Rugo Capt. John Buck, M.D. Major Jon Irelan Capt. Jean Tanner Technical Sergeant Jeffrey Moore   Discussion 12:30 p.m. Adjourn Thursday, April 19 Open Session 8:00 a.m. Welcome, introductory remarks, review of charge, and call to order Philip Brachman, M.D., Chairman 8:10 National Center for Infectious Diseases anthrax vaccine research program Bradley Perkins, M.D., Chief, Meningitis & Special Pathogens Branch, Division of Bacterial Mycotic Diseases, National Center for Infectious Diseases, CDC 8:15 Update on human clinical trial Nina Marano, D.V.M., M.P.H., Medical Epidemiologist, Meningitis & Special Pathogens Branch, Division of Bacterial Mycotic Diseases, National Center for Infectious Diseases, CDC 8:40 Nonhuman primate studies David Ashford, D.V.M., M.P.H., D.Sc., Medical Epidemiologist, Meningitis & Special Pathogens Branch, Division of Bacterial Mycotic Diseases, National Center for Infectious Diseases, CDC

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9:05 Primary study points—measurement of anti-PA antibody Conrad Quinn, Ph.D., Chief, Microbial Pathogenesis and Immune Response Laboratory, Meningitis & Special Pathogens Branch, Division of Bacterial Mycotic Diseases, National Center for Infectious Diseases, CDC 10:25 Break 10:40 Sub-study: human leukocyte antigen (HLA) Robert Jacobson 11:05 Progesterone Laurie Kamimoto, M.D., National Immunization Program, CDC 11:25 SF-36 health survey Stacey Martin, M.S., National Immunization Program, CDC 11:45 Lunch 12:30 p.m. Adjourn Meeting IV July 2, 2001 The Foundry Building 1055 Thomas Jefferson St., NW Washington, DC Agenda Open Session 10:00 a.m. Call to order, introductions 10:15 Introduction and overview of CDC anthrax vaccine program Dixie Snider, M.D., M.P.H., Associate Director for Science, CDC 10:30 Definition of safety and acceptability goals/components of CDC anthrax vaccine program and relevance of activities associated with these goals/components Ben Schwartz, M.D., Associate Director for Science, Epidemiology and Surveillance Division, National Immunization Program, CDC Ramses Sadek, Ph.D., Statistician, Data Management Division, National Immunization Program, CDC Michael McNeil, M.D., M.P.H., Chief, Anthrax Vaccine Safety Activity, Epidemiology and Surveillance Division, National Immunization Program, CDC Randy Louchart, R.N., M.P.H., Deputy Chief, Anthrax Vaccine Safety Activity, Epidemiology and Surveillance Division, National Immunization Program, CDC 12:00 p.m. Lunch Break

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1:00 Definition of efficacy goal/component of CDC anthrax vaccine program, relevance of activities associated with this goal/component Bradley Perkins, M.D., Chief, Meningitis & Special Pathogens Branch, Division of Bacterial Mycotic Diseases, National Center for Infectious Diseases, CDC 2:15 Comments, questions, and answers Discussion with the committee members 3:00 Adjourn Meeting V January 7, 2002 The Foundry Building 1055 Thomas Jefferson St., NW Washington, DC Agenda Open Session 9:00 a.m. Call to order, introductions Philip Brachman, M.D., Chairman, Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program 9:15 Introductory presentation—National Immunization Program anthrax vaccine safety activities above & beyond research • Pre- and post-exposure investigational new drug (IND) use of AVA • The Vaccine Healthcare Center (VHC) Network partnership with DoD Randy Louchart, R.N., M.P.H., Deputy Chief, Anthrax Vaccine Safety Activity, Epidemiology and Surveillance Division, National Immunization Program, CDC Addressing IOM Concerns and Input from External Expert Panels 9:45 Research priorities and the study of long-term health effects of AVA Michael McNeil, M.D., M.P.H., Chief, Anthrax Vaccine Safety Activity, Epidemiology and Surveillance Division, National Immunization Program, CDC 10:45 Survey of military personnel about their knowledge, attitudes, and beliefs concerning AVA Deborah Gust, Ph.D., Behavioral Scientist, Vaccine Safety & Development Activity, Epidemiology & Surveillance Division, National Immunization Program, CDC 11:15 Use of DMSS to test AVA adverse events hypotheses Ben Schwartz, M.D., Associate Director for Science, Epidemiology and Surveillance Division, National Immunization Program, CDC 11:45 Other AVA safety research activities and collaborations—questions and comments National Immunization Program staff

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12:00 p.m. Lunch break 1:00 Overview of efficacy component of CDC anthrax vaccine program Bradley Perkins, M.D., Chief, Meningitis & Special Pathogens Branch, Division of Bacterial Mycotic Diseases, National Center for Infectious Diseases, CDC 1:30 Update on human study Nina Marano, D.V.M., M.P.H., Medical Epidemiologist, Meningitis & Special Pathogens Branch, Division of Bacterial Mycotic Diseases, National Center for Infectious Diseases, CDC 2:15 Update on nonhuman primate study Jairam Lingappa, M.D., Ph.D., Medical Epidemiologist, Meningitis & Special Pathogens Branch, Division of Bacterial Mycotic Diseases, National Center for Infectious Diseases, CDC Dave Ashford, D.V.M., M.P.H., D.Sc., Medical Epidemiologist, Meningitis & Special Pathogens Branch, Division of Bacterial Mycotic Diseases, National Center for Infectious Diseases, CDC 3:00 Break 3:15 Update on correlates of protection study Conrad Quinn, Ph.D., Medical Epidemiologist, Meningitis & Special Pathogens Branch, Division of Bacterial Mycotic Diseases, National Center for Infectious Diseases, CDC 4:00 Committee members’ discussion: comments, questions, and answers 5:00 Adjourn

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