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Vaccines for the 21st Century: A Tool for Decisionmaking (2000)

Chapter: Appendix 29: Questions Posed to Outside Experts and List of Responders

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Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
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APPENDIX 29
Questions Posed to Outside Experts and List of Responders

If possible, please list references for specific estimates.

1. What is your estimate of overall and age-specific incidence (rate or cases per year)?

OR

What is your estimated incidence of clinical disease, subclinical infection, latent infection, and chronic infection?

2. Is the incidence of the disease changing? In what manner and why?

3. What groups are at greatest risk of illness (e.g., by age, sex, ethnicity, socioeconomic status, immunologic competence, geographic area)?

4. What are specific risk factors for this illness?

5. Please describe typical patterns for the clinical course of this illness, inclu-ding variations in presentation, variations of patterns and severity, complications, case fatality, relapses and sequelae, duration of stages of illness and sequelae, and proportion of cases following each course.

6. Please describe typical forms of care and estimate their effectiveness and cost.

7. What strategies are currently available to prevent this condition (e.g., vector control, treatment of water supply, reduction of behavioral risks [IV drug use, unprotected sexual contact], etc.)?

Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

8. How would you compare these strategies in terms of effectiveness, cost, and practicality to a likely vaccine?

9. What are the known components of immunity for this organism (antibody to what antigens, T-cells, B-cells, etc.)?

10. What are the critical determinants of an immune response associated with protection against infection?

11. What are the correlates of immunity (e.g., surrogates for protection) that may be useful or necessary for vaccine development?

12. To your knowledge, is vaccine development for this disease occurring now? If so, describe the type of vaccine (what antigen, live or killed, subunit, naked DNA, etc.).

13. Who (individual, group, company) is working on this vaccine?

14. How far has vaccine development progressed (preclinical, clinical trials: Phase I, II, or III)?

15. When could Phase III trials be expected to start for such a vaccine?

16. When could such a vaccine be expected to be licensed for use?

17. If a vaccine is not in development, what new knowledge is necessary to undertake vaccine development?

18. Who should develop it (e.g., industry, government, military)?

19. What are the barriers to success in developing a vaccine (money for research, scientific knowledge, correlates of immunity, lack of animal model, public perceptions, etc.)?

20. Please estimate future R&D funding (public and private) needed to achieve licensure of a vaccine and postmarketing costs.

21. Is this vaccine likely to be part of a combination vaccine (with other antigens)?

22. For an anticipated vaccine, please estimate its likely efficacy, likely cost per dose, and number of doses needed for complete immunization (initial series, frequency of boosters).

Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

23. What would be the appropriate target population for a vaccine (e.g., all infants, adolescents, pregnant women, older adults [age 65+], residents of an endemic area)?

24. What would be the anticipated time interval between vaccination of an individual in the target population and the realization by that individual of the health benefits?

25. What would be the anticipated time interval between vaccination in a target population and realizing health benefits to unvaccinated individuals from “herd immunity”?

26. Would delivery of this vaccine incur special costs (e.g., form of administra-tion, education for providers or the public, etc.)? If so, please identify and esti-mate those costs.

27. What factors could be expected to influence acceptance of the vaccine?

28. If possible, please identify recent key articles on this condition/ organism or on development of a vaccine against it that you think represent the best current thinking.

29. If there is a recently published article with which you particularly disagree, please identify and explain.

30. Please identify any other experts who should be consulted.

LIST OF RESPONDERS

Ann M.Arvin, M.D.

Department of Pediatric Infectious Diseases

School of Medicine

Stanford University

Palo Alto, CA

Robert Baughn, Ph.D.

VA Medical Center

Houston, TX

Robert B.Belshe, M.D.

Department of Infectious Diseases

St. Louis University School of Medicine

St. Louis, MO

Robert Betts, M.D.

University of Rochester

Rochester, NY

Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Dr. Martin J.Blaser

Division of Infectious Diseases

Vanderbilt University, School of Medicine

Nashville, TN

Dr. Thomas Broker

Biochemistry Department

University of Alabama at Birmingham

Dr. Robert Brunham

Medicine—Microbiology

University of Manitoba

Winnipeg, Manitoba, CANADA

Dr. Francis V.Chisari

The Scripps Research Institute

Molecular and Experimental Medicine

La Jolla, CA

H.Fred Clark, D.V.M., Ph.D.

The Children’s Hospital of Philadelphia

Frank M.Collins, M.D.

Mycobacteriology Laboratory

Division of Bacterial Products

Food and Drug Administration

Bethesda, MD

Robert Couch

Microbiology and Immunology

Baylor College of Medicine

Houston, TX

Christopher P.Crum, M.D.

Brigham & Women’s Hospital

Boston, MA

Dr. Stephen J.Czinn

Department of Pediatrics

Case Western University

Rainbow Babies and Children’s Hospital

Cleveland, OH

James B.Dale, M.D.

Veterans Administration Medical Center

Memphis, TN

George S.Deepe, Jr., M.D.

Division of Infectious Diseases

University of Cincinnati

Dr. Gail Demmler

Pediatrics

Baylor College of Medicine

Houston, TX

Floyd W.Denny, M.D.

Chapel Hill, NC

Peter Densen, M.D.

Department of Internal Medicine

University of Iowa

Iowa City, IA

Michele Estabrook, M.D.

Division of Pediatric Infectious Diseases

Rainbow Babies and Childrens Hospital

Cleveland, OH

Monica M.Farley, M.D.

Departments of Medicine and Infectious Diseases

Emory University School of Medicine and the VA Medical Center

Atlanta, GA

Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Mark Fendrick, M.D.

Department of Internal Medicine

University of Michigan Hospital

Ann Arbor, MI

Vincent A.Fischetti, Ph.D.

Rockefeller University

New York, NY

Stacey C.FitzSimmons, Ph.D.

Cystic Fibrosis Foundation

Bethesda, MD

Dr. Ian H.Frazer

Papillomavirus Research Unit

Lions Human Immunology Laboratory

University of Queensland

Princess Alexandra Hospital

Woolloongabba, AUSTRALIA

John N.Galgiani, M.D.

VA Medical Center

Tucson, AZ

Denise A.Galloway, Ph.D.

Departments of Microbiology and Pathology

University of Washington

Seattle, WA

Dr. Donald Ganem

Microbiology and Immunology

University of California

School of Medicine

San Francisco, CA

Lutz Gissmann, Ph.D.

Department of Obstetrics and Gynecology

Stritch School of Medicine

Loyola University Medical Center

Maywood, IL

Paul Glezen

Microbiology and Immunology

Baylor College of Medicine

Houston, TX

Emil Gotschlich, M.D.

Laboratory for Bacterial Pathogenesis/Immunology

The Rockefeller University

New York, NY

Dan M.Granoff, M.D.

Chiron Biocine

Emeryville, CA

John R.Graybill, M.D.

Audie L.Murphy VA Hospital

Division of Infectious Diseases

San Antonio, TX

Harry B.Greenberg, M.D.

Department of Medicine

Stanford University

Palo Alto, CA

Thomas L.Hale, Ph.D.

Department of Enteric Infections

Walter Reed Army Institute of Research

Washington, D.C.

Dr. Scott B.Halstead

Department of the Navy

Naval Medical Research and Development Command

National Naval Medical Center

Bethesda, MD

Sharon L.Hillier, Ph.D.

Magee-Women’s Hospital

Pittsburgh, PA

Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Harold J.Jennings, Ph.D.

National Research Council of Canada

Division of Biological Sciences

Ottawa, Ontario CANADA

Dennis L.Kasper, M.D.

Channing Laboratory

Harvard Medical School

Boston, MA

Ben Z.Katz, M.D.

Northwestern University Medical School

Division of Infectious Diseases

The Children’s Memorial Hospital

Chicago, IL

Theo Kirkland, M.D.

Veterans Medical Center

San Diego, CA

Dr. Robert Kurman

Johns Hopkins Hospital

Baltimore, MD

Dr. Myron M.Levine

University of Maryland School of Medicine

Baltimore, MD

Sheila A.Lukehart, Ph.D.

Department of Medicine

Division of Infectious Diseases

Harborview Medical Center

Seattle, WA

Kenneth McIntosh, M.D.

Division of Infectious Diseases

Children’s Hospital

Boston, MA

Dr. Suzanne M.Michalek

University of Alabama

Birmingham, AL

Dr. Andrew J.Morgan

Department of Pathology and Microbiology

School of Medical Sciences

University of Bristol

Bristo, UNITED KINGDOM

Dr. Richard Moss

School of Medicine

Stanford University

Stanford, CA

Brian Murphy, M.D.

Division of RVS, NIAID

National Institutes of Health

Bethesda, MD

Dr. James Nataro

Center for Vaccine Development

The University of Maryland

Baltimore, MD

Kristin Nichol, M.D.

Veterans Medical Center

Minneapolis, MN

Demosthenes Pappagianis, M.D.

University of California School of Medicine

Microbiology and Immunology

Davis, CA

Peter R.Paradiso, Ph.D.

Lederle-Praxis Biologicals

West Henrietta, NY

Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Robert F.Pass, M.D.

Professor, Director, Pediatric Infectious Disease

University of Alabama at Birmingham

Gerald B.Pier, Ph.D.

Harvard Medical School

Boston, MA

Dr. Stanley Plotkin

Pasteur Merieux Connaught Co.

Marnes-la-Coquette, FRANCE

Alice Prince

Department of Pediatrics

Columbia-Presbyterian Medical Center

New York, NY

Justin D.Radolf, M.D.

University of Southwestern Texas

Department of Medicine

Division of Infectious Diseases

Dallas, TX

Dr. Rino Rappuoli

Head, Research and Development

Vaccine Sclavo SA

Sienna, ITALY

Dr. Cliona Rooney

Department of Virology

St. Jude Children’s Research Hospital

Memphis, TN

Craig E.Rubens, M.D., Ph.D.

Division of Infectious Diseases

Children’s Hospital and Medical Center

Seattle, WA

Julius Schachter, Ph.D.

Professor of Epidemiology

University of California, San Francisco

Chlamydia Research Laboratory

San Francisco General Hospital

Dr. Mark Schiffman

NIH-National Cancer Institute

Bethesda, MD

Dr. Richard C.Schlegel

Department of Pathology

Georgetown University School of Medicine

Washington, DC

John Schrieber, M.D.

Pediatric Infectious Diseases

Rainbow Babies and Children’s Hospital

Cleveland, OH

Anne Schuchat, M.D.

Meningitis and Special Pathogens

Centers for Disease Control and Prevention

Atlanta, GA

Keerti V.Shah, Ph.D.

Johns Hopkins School of Hygiene, Immunology and Infectious Disease

Baltimore, MD

Arnold L.Smith, M.D.

University of Missouri Medical School

Columbia, MO

Fred Sparling, M.D.

Chair, Department of Medicine

University of North Carolina

Chapel Hill, NC

Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×

Walter E.Stamm, M.D.

Division of Allergy and Infectious Diseases

University of Washington Medical Center

Seattle, WA

Stuart Starr, M.D.

Allergy, Immunology, and Infectious Diseases

Children’s Hospital

Philadelphia, PA

Dr. Allen Steere

Tufts University

Boston, MA

David A.Stevens, M.D.

Santa Clara Valley Medical Center

Division of Infectious Diseases

San Jose, CA

Dennis Stevens, M.D., Ph.D.

Veterans Affairs Medical Center

Boise, ID

Dr. Lode J.Swinnen

Section of Hematology/Oncology

Loyola University Medical Center

Maywood, IL

Martin A.Taubman, D.D.S., Ph.D.

Department of Immunology

Forsyth Dental Center

Boston, MA

Dr. Ram P.Tewari

Department of Microbiology and Immunology

Southern Illinois University

Springfield, IL

L.Joseph Wheat, M.D.

Wishard Memorial Hospital

Department of Medicine

Indianapolis, IN

Richard Whitley, M.D.

Pediatrics, Microbiology and Medicine

University of Alabama at Birmingham

Dr. Gary Wormser

Infectious Diseases

New York Medical College

Valhalla, NY

Peter F.Wright, M.D.

Pediatric Infectious Diseases

Vanderbilt University Medical Center

Nashville, TN

Dr. T.C.Wu

Johns Hopkins Hospital

Baltimore, MD

Michael Yancey, M.D.

Maternal-Fetal Medicine

Department of the Army

Headquarters, Tripler Army Medical Center

Tripler AMC, HI

Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 435
Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 436
Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 437
Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 438
Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 439
Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 440
Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 441
Suggested Citation:"Appendix 29: Questions Posed to Outside Experts and List of Responders." Institute of Medicine. 2000. Vaccines for the 21st Century: A Tool for Decisionmaking. Washington, DC: The National Academies Press. doi: 10.17226/5501.
×
Page 442
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Vaccines for the 21st Century: A Tool for Decisionmaking Get This Book
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Vaccines have made it possible to eradicate the scourge of smallpox, promise the same for polio, and have profoundly reduced the threat posed by other diseases such as whooping cough, measles, and meningitis.

What is next? There are many pathogens, autoimmune diseases, and cancers that may be promising targets for vaccine research and development.

This volume provides an analytic framework and quantitative model for evaluating disease conditions that can be applied by those setting priorities for vaccine development over the coming decades. The committee describes an approach for comparing potential new vaccines based on their impact on morbidity and mortality and on the costs of both health care and vaccine development. The book examines:

  • Lessons to be learned from the polio experience.
  • Scientific advances that set the stage for new vaccines.
  • Factors that affect how vaccines are used in the population.
  • Value judgments and ethical questions raised by comparison of health needs and benefits.

The committee provides a way to compare different forms of illness and set vaccine priorities without assigning a monetary value to lives. Their recommendations will be important to anyone involved in science policy and public health planning: policymakers, regulators, health care providers, vaccine manufacturers, and researchers.

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