National Academies Press: OpenBook

The Anthrax Vaccine: Is It Safe? Does It Work? (2002)

Chapter: Appendix C Information-Gathering Meeting Agendas

« Previous: Appendix B Biographical Sketches
Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×

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

Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×

 

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

Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×

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

Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×

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

Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×

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

Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×

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

Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×

 

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

Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×

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

Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×

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

Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×
Page 218
Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×
Page 219
Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×
Page 220
Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×
Page 221
Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×
Page 222
Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×
Page 223
Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×
Page 224
Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×
Page 225
Suggested Citation:"Appendix C Information-Gathering Meeting Agendas." Institute of Medicine. 2002. The Anthrax Vaccine: Is It Safe? Does It Work?. Washington, DC: The National Academies Press. doi: 10.17226/10310.
×
Page 226
Next: Appendix D Anthrax Vaccine Adsorbed Package Inserts »
The Anthrax Vaccine: Is It Safe? Does It Work? Get This Book
×
Buy Paperback | $50.00 Buy Ebook | $39.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

The vaccine used to protect humans against the anthrax disease, called Anthrax Vaccine Adsorbed (AVA), was licensed in 1970. It was initially used to protect people who might be exposed to anthrax where they worked, such as veterinarians and textile plant workers who process animal hair. When the U. S. military began to administer the vaccine, then extended a plan for the mandatory vaccination of all U. S. service members, some raised concerns about the safety and efficacy of AVA and the manufacture of the vaccine. In response to these and other concerns, Congress directed the Department of Defense to support an independent examination of AVA.

The Anthrax Vaccine: Is It Safe? Does It Work? reports the study’s conclusion that the vaccine is acceptably safe and effective in protecting humans against anthrax. The book also includes a description of advances needed in main areas: improving the way the vaccine is now used, expanding surveillance efforts to detect side effects from its use, and developing a better vaccine.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!