THE CHARGE TO THE COMMITTEE

Since the mid-1990s, challenges to the safety of immunizations seem to have gained prominence in public and scientific debate. Given these persistent and growing concerns about immunization safety, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) recognized the need for an independent, expert group to address immunization safety in a timely and objective manner. The IOM has been involved in such issues since the 1970s. (A brief chronology can be found in Appendix A.) In 1999, as a result of IOM’s previous work and its access to independent scientific experts, CDC and NIH began a year of discussions with IOM to develop the Immunization Safety Review project to address vaccine safety issues both existing and emerging.

The Immunization Safety Review Committee is responsible for examining a broad variety of immunization safety concerns. Committee members have expertise in pediatrics, neurology, immunology, internal medicine, infectious diseases, genetics, epidemiology, bio statistics, risk perception and communication, decision analysis, public health, nursing, and ethics. While all the committee members share the view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group. Additional discussion of the committee composition can be found in the Foreword written by Dr. Kenneth Shine, President of the IOM.

The committee is charged with examining three immunization safety hypotheses each year during the three-year study period (2001–2003). These hypotheses are selected by the Interagency Vaccine Group (IAG)—made up of officials from the National Vaccine Program Office at the Department of Health and Human Services (DHHS), the National Immunization Program and the National Center for Infectious Diseases at the CDC, the National Institute for Allergy and Infectious Diseases at the NIH, the Department of Defense, the Food and Drug Administration (FDA), the National Vaccine Injury Compensation Program at the Health Resources and Services Administration (HRSA), the Centers for Medicare and Medicaid Services (CMS, formerly the Health Care Financing Administration), and the Agency for International Development. For each topic, the committee reviews relevant literature and submissions by interested parties, and holds an open scientific meeting, followed directly by a one-to two-day closed meeting, to formulate its conclusions and recommendations. The committee’s findings are released to the public in a brief consensus report 60–90 days after its meeting.

For each hypothesis to be examined, the committee assesses both the scientific evidence and the significance of the issue for society.

  • The scientific assessment has two components: an examination of the epidemiological and clinical evidence regarding a possible causal relationship



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Immunization Safety Review: Multiple Immunizations and Immune Dysfunction THE CHARGE TO THE COMMITTEE Since the mid-1990s, challenges to the safety of immunizations seem to have gained prominence in public and scientific debate. Given these persistent and growing concerns about immunization safety, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) recognized the need for an independent, expert group to address immunization safety in a timely and objective manner. The IOM has been involved in such issues since the 1970s. (A brief chronology can be found in Appendix A.) In 1999, as a result of IOM’s previous work and its access to independent scientific experts, CDC and NIH began a year of discussions with IOM to develop the Immunization Safety Review project to address vaccine safety issues both existing and emerging. The Immunization Safety Review Committee is responsible for examining a broad variety of immunization safety concerns. Committee members have expertise in pediatrics, neurology, immunology, internal medicine, infectious diseases, genetics, epidemiology, bio statistics, risk perception and communication, decision analysis, public health, nursing, and ethics. While all the committee members share the view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group. Additional discussion of the committee composition can be found in the Foreword written by Dr. Kenneth Shine, President of the IOM. The committee is charged with examining three immunization safety hypotheses each year during the three-year study period (2001–2003). These hypotheses are selected by the Interagency Vaccine Group (IAG)—made up of officials from the National Vaccine Program Office at the Department of Health and Human Services (DHHS), the National Immunization Program and the National Center for Infectious Diseases at the CDC, the National Institute for Allergy and Infectious Diseases at the NIH, the Department of Defense, the Food and Drug Administration (FDA), the National Vaccine Injury Compensation Program at the Health Resources and Services Administration (HRSA), the Centers for Medicare and Medicaid Services (CMS, formerly the Health Care Financing Administration), and the Agency for International Development. For each topic, the committee reviews relevant literature and submissions by interested parties, and holds an open scientific meeting, followed directly by a one-to two-day closed meeting, to formulate its conclusions and recommendations. The committee’s findings are released to the public in a brief consensus report 60–90 days after its meeting. For each hypothesis to be examined, the committee assesses both the scientific evidence and the significance of the issue for society. The scientific assessment has two components: an examination of the epidemiological and clinical evidence regarding a possible causal relationship