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Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule

Posted Jan 31 2012 4:57pm

The U.S. Institutes of Medicine (IOM) will hold a meeting to discuss the feasibility of studying health outcomes in vaccinated and unvaccinated children. Health Outcomes Related to the Recommended Childhood Immunization Schedule will be held on February 9.

Activity Description

The IOM will conduct an independent assessment surrounding the feasibility of studying health outcomes in children who were vaccinated according to the CDC recommended schedule and those who were not (e.g. children who were unvaccinated or vaccinated with an alternate schedule). The IOM will review scientific findings and stakeholder concerns related to the safety of the recommended childhood immunization schedule. Further, the IOM will identify potential research approaches, methodologies, and study designs that could inform this question, including an assessment of the potential strengths and limitations of each approach, methodology and design, as well as the financial and ethical feasibility of doing them. A report will be issued in mid-2012 summarizing the IOM’s findings and conclusions.

Draft Agenda
11:00-12:00 OPEN SESSION

11:00-11:15 Welcome and Overview
Ada Sue Hinshaw, Ph.D., R.N.
Committee Chair

11:15-11:35 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, US Department of
Health and Human Services

11:35-12:00 Review of IOM’s Committee to Review Adverse Effects of Vaccines
Ellen Wright Clayton, J.D., M.D.
Chair of the IOM Committee to Review Adverse Effects of
Craig-Weaver Professor of Pediatrics, Vanderbilt University


1:00-5:00 OPEN SESSION

1:00-1:20 National Vaccine Information Center Perspectives
Barbara Loe Fisher
Co-Founder & President, National Vaccine Information Center

1:20-1:40 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

1:40-2:00 The Use of Clinical Trials for Childhood Vaccines
Susan Ellenberg, Ph.D.
Professor of Biostatistics and Associate Dean for Clinical
Perelman School of Medicine at the University of Pennsylvania

2:00-2:20 Ethical Issues in Clinical Trials
Robert (Skip) Nelson, M.D., Ph.D.
Senior Pediatric Ethicist/Lead Medical Officer, Food and Drug

2:20-2:40 BREAK

2:40-3:05 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, US Public Health Services

3:05-3:25 Immunization Safety Office (ISO) CDC
Frank DeStefano, M.D., M.P.H.
Director, ISO, CDC

3:25-3:45 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

3:45-4:05 Immune Profiling Research
Chuck Hackett, Ph.D.
Deputy Director, Division of Allergy, Immunology, and
National Institute of Allergy and Infectious Disease

4:05-5:00 OPEN SESSION*—Opportunity for Attendee Comments


  1. Catherina:
    will this be available online (preferably recorded and as transcript)?
  2. Science Mom:
    Why on Earth would they give BLF a platform for her nonsense? I too would love to see the transcripts from the draft meeting as well as subsequent meetings. In any event, I hope this goes forward although negative (if reported), i.e. vaccines are not correlated with autism, allergies, diabetes and nose hair overgrowth, results will be met with the usual denial and charge of cover-up.
  3. Catherina:
    vaccines definitely stop nose hair overgrowth - my grandpa just had the smallpox vaccine and had massive nose hair, my son has had DTaP/IPV/hib/hepB/menC/flu every year/MMR and not a single hair exits his little nostrils
  4. Sullivan:
    "...results will be met with the usual denial and charge of cover-up." In the mean time, this will be used to say: "see, the government knows there is something wrong. Why else would they do this study?" My guess is that they are going to do this study eventually. If they wait, it will be in reaction mode, after some group like GR puts out their own study.

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