Appendix E

Agendas of Public Meetings Held by the Committee

February 9, 2012
The Pew Charitable Trusts
901 E Street, NW
Washington, DC 20004

Welcome and Overview

Ada Sue Hinshaw, Ph.D., R.N.

Committee Chair

Presentation of the Charge from the National Vaccine Program Office

Bruce Gellin, M.D., M.P.H.

Deputy Assistant Secretary for Health

Director, National Vaccine Program Office, U.S. Department of Health and Human Services

Review of the IOM Committee to Review Adverse Effects of Vaccines

Ellen Wright Clayton, J.D., M.D.

Chair of the IOM Committee to Review Adverse Effects of Vaccines

Craig-Weaver Professor of Pediatrics, Vanderbilt University

National Vaccine Information Center Perspectives

Barbara Loe Fisher

Co-Founder and President, National Vaccine Information Center

Provider Perspectives

Gary Freed, M.D., M.P.H.

Professor, Department of Health Management and Policy, University of Michigan School of Public Health

Director, Division of General Pediatrics

The Percy and Mary Murphy Professor of Pediatrics and Child Health Delivery



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Appendix E Agendas of Public Meetings Held by the Committee February 9, 2012 The Pew Charitable Trusts 901 E Street, NW Washington, DC 20004 Welcome and Overview Ada Sue Hinshaw, Ph.D., R.N. Committee Chair Presentation of the Charge from the National Vaccine Program Office Bruce Gellin, M.D., M.P.H. Deputy Assistant Secretary for Health Director, National Vaccine Program Office, U.S. Department of Health and Human Services Review of the IOM Committee to Review Adverse Effects of Vaccines Ellen Wright Clayton, J.D., M.D. Chair of the IOM Committee to Review Adverse Effects of Vaccines Craig-Weaver Professor of Pediatrics, Vanderbilt University National Vaccine Information Center Perspectives Barbara Loe Fisher Co-Founder and President, National Vaccine Information Center Provider Perspectives Gary Freed, M.D., M.P.H. Professor, Department of Health Management and Policy, University of Michigan School of Public Health Director, Division of General Pediatrics The Percy and Mary Murphy Professor of Pediatrics and Child Health Delivery 201

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202 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY The Use of Clinical Trials for Childhood Vaccines Susan Ellenberg, Ph.D. Professor of Biostatistics and Associate Dean for Clinical Research Perelman School of Medicine at the University of Pennsylvania Ethical Issues in Clinical Trials Robert (Skip) Nelson, M.D., Ph.D. Senior Pediatric Ethicist/Lead Medical Officer, Food and Drug Administration National Center for Immunization and Respiratory Diseases (NCIRD), Centers for Disease Control and Prevention (CDC) Melinda Wharton, M.D., M.P.H. Deputy Director, NCIRD, CDC Captain, U.S. Public Health Service Immunization Safety Office (ISO), CDC Frank DeStefano, M.D., M.P.H. Director, ISO, CDC Data and Approaches in National and International Immunization Studies Saad Omer, Ph.D., M.P.H., M.B.B.S. Assistant Professor, Hubert Department of Global Health Epidemiology, Emory University Rollins School of Public Health Assistant Professor, Emory Vaccine Center Immune Profiling Research Chuck Hackett, Ph.D. Deputy Director, Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases OPEN SESSION—Opportunity for Attendee Comments Adjourn

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APPENDIX E 203 March 8, 2012 Talaris Conference Center 4000 NE 41st Street Seattle, WA 98105 Welcome and Overview Ada Sue Hinshaw, Ph.D., R.N. Committee Chair Welcome from Washington State Department of Health Mary Selecky Secretary of Health, Washington State Department of Health Maxine Hayes, M.D., M.P.H. State Health Officer, Washington State Department of Health Washington State’s Immunization Programs Janna Bardi, M.P.H. Office Director, Immunization and Child Profile Office Washington State Department of Health Findings on Alternative Immunization Schedule Practices Douglas Opel, M.D., M.P.H. Assistant Professor of Pediatrics, Adjunct Assistant Professor of Bioethics and Humanities University of Washington Treuman Katz Center for Pediatric Bioethics Seattle Children’s Research Institute Assessing the Safety of Vaccines at the FDA: Pre- and Postlicensure Evaluations Marion F. Gruber, Ph.D. (by phone) Acting Director, Office of Vaccines Research and Review Center for Biologics Evaluation and Research Office of Medical Products and Tobacco Food and Drug Administration Karen Farizo, M.D. (by phone) Acting Associate Director for Medical Policy and Safety Office of Vaccines Research and Review Center for Biologics Evaluation and Research Office of Medical Products and Tobacco Food and Drug Administration

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204 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY Issues Leading to Vaccine Hesitancy Douglas Opel, M.D., M.P.H. Assistant Professor of Pediatrics, Adjunct Assistant Professor of Bioethics and Humanities University of Washington Treuman Katz Center for Pediatric Bioethics Seattle Children’s Research Institute Process for Immunization Schedule Recommendations Edgar Marcuse, M.D., M.P.H. Professor of Pediatrics, Adjunct Professor of Epidemiology, University of Washington Associate Medical Director, Quality Improvement, Seattle Children’s Hospital Decision Making at Advisory Committee on Immunization Practices in Response to Unanticipated Adverse Event Detection Jeffrey Duchin, M.D. Chief, Communicable Disease Epidemiology and Immunization Section Public Health Seattle and King County, Washington Provider Self-Efficacy and Tools to Improve Immunization Rates David Grossman, M.D., M.P.H. Medical Director, Preventive Care Group Health Cooperative Group Health Research Institute and the Vaccine Safety Datalink Michael L. Jackson, Ph.D., M.P.H. Assistant Scientific Investigator Group Health Research Institute OPEN SESSION—Opportunity for Attendee Comments Adjourn

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APPENDIX E 205 May 29, 2012 The Pew Charitable Trusts 901 E Street, NW Washington, DC 20004 Welcome and Overview Ada Sue Hinshaw, Ph.D., R.N. Committee Chair U.S. Childhood Immunization Schedule Decisions Margaret B. Rennels, M.D. Professor of Pediatrics, University of Maryland School of Medicine (retired) Independent Consultant Question and Answer Vaccine Policy and Safety Surveillance in the United Kingdom Elizabeth Miller (by phone) Head, Immunization Division Communicable Disease Surveillance Centre Health Protection Agency, Colindale, United Kingdom Question and Answer Vaccine Decisions: Policy Making and Priority Setting in Canada Charlotte Moore Hepburn, M.D., F.R.C.P.C., F.A.A.P. Lead, Child Health Policy Initiative Assistant Professor, University of Toronto School of Medicine S  taff Paediatrician, Division of Paediatric Medicine, The Hospital for Sick Children Question and Answer Advisory Committee on Immunization Practices Decision Making Melinda Wharton, M.D., M.P.H. Deputy Director, National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention Captain, U.S. Public Health Service Question and Answer

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206 THE CHILDHOOD IMMUNIZATION SCHEDULE AND SAFETY Alternative Immunization Schedules: A Feasibility Study for Evaluating Vaccine Safety and the Risk of Pertussis Jason Glanz, Ph.D. Epidemiologist, Institute for Health Research Kaiser Permanente Colorado Question and Answer Study Designs for the Safety Evaluation of Different Childhood Immuniza- tion Schedules Martin Kulldorff, Ph.D. Professor, Biostatistician, Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Question and Answer Commentary on Commissioned Paper and Other Committee Considerations Michael A. Stoto, Ph.D. Professor of Health Systems Administration and Population Health Georgetown University School of Nursing and Health Studies Question and Answer OPEN SESSION—Opportunity for Attendee Comments Adjourn