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are covered by the National Vaccine Injury Compensation Program. Also in 1995, the National Vaccine Advisory Committee (NVAC) of the National Vaccine Program Office of DHHS added a Vaccine Safety Subcommittee to its efforts. In 1999, this subcommittee expanded its scope and was renamed the Vaccine Safety and Communication Subcommittee. Concern over cases of vaccine-associated paralytic poliomyelitis prompted another CDC committee—the Advisory Committee on Immunization Practices—to recommend in 1997 that the immunization schedule be changed to replace oral poliovirus vaccine with inactivated poliovirus vaccine (CDC, 2000e).

But since the mid-1990s, a number of additional challenges to the safety of vaccinations have gained attention in various settings. During 1999–2000, the Committee on Government Reform of the U.S. House of Representatives held seven hearings on vaccine-safety issues. The media have covered these issues on news programs such as 60 Minutes, 20/20, and Nightline, and the Internet is playing an increasingly important communications role. Also, many consumer and professional organizations have sponsored conferences and scientific symposia to address vaccine safety.

Given these growing concerns, CDC and the National Institutes of Health (NIH) recognized the need for an independent, expert group to address vaccine safety in a timely and objective manner. 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 vaccine-safety concerns. Committee members have expertise in pediatrics, neurology, immunology, internal medicine, infectious diseases, genetics, epidemiology, biostatistics, risk perception and communication, decision analysis, public health, nursing, and ethics. To preclude any real or perceived conflicts of interest, candidate members were subject to strict selection criteria that excluded anyone who had financial ties to vaccine manufacturers or their parent companies, previous service on major vaccine advisory committees, and prior expert testimony or publications on issues of vaccine safety. While all committee members share a belief in the benefits of vaccines, none of them has a vested interest in the vaccine-safety issues that will 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 vaccine-safety hypotheses each year during the 3-year study period (2001–2003). The Interagency Vaccine Group, comprising officials from the National Vaccine Program Office at DHHS, the National Immunization Program and the National Center for Infectious Diseases at the CDC, the National Institute for Allergy and Infectious Dis-

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