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Immunization Safety Review Committee: or Everything I’ve Learned about Immunization Trustbusters and Strategies to Enhance that Trust. Marie C. McCormick, Committee Chair Harvard School of Public Health National Vaccine Advisory Committee June 3, 2003.
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Immunization Safety Review Committee: or Everything I’ve Learned about Immunization Trustbusters and Strategies to Enhance that Trust Marie C. McCormick, Committee Chair Harvard School of Public Health National Vaccine Advisory Committee June 3, 2003
Trustbusters: Formulation of Vaccine Policy • Recent rapid expansion of the childhood vaccine schedule not well explained to the public • Apparent abrupt changes in vaccine policies for “safety” reasons: thimerosal and rotavirus • Perceived conflict of interest on official panels making recommendations for the vaccine schedule
Trustbusters: Adverse Events • Exposing one’s child to a governmentally “mandated” risk • Perceived exemption from legal recourse, i.e. suits • Adverse event reporting system seems unresponsive • The same agency sets the policy and examines the adverse event • Context of lack of experience with the wild type disease
Trustbusters: Incomplete Science • Poorly designed studies • Premature conclusions without timely follow-up by other authoritative researchers • Lack of study and publication • Reasoning by analogy
Enhancing Trust • Enlisting respected, neutral agencies
Getting Outside Assistance • Institute of Medicine • Medical Academy of the National Academy of Sciences (1863) • Founded in 1970 • (At least) five prior vaccine safety reports
Criteria for Committee Selection • No financial ties with vaccine manufacturers or their parent companies • No past or present service on vaccine advisory committees • No expert testimony, publications on issues of vaccine safety • No current or recent funding from CDC on vaccine issues
Rationale for These Criteria • An objective and independent committee that would not be subject to criticisms of conflict of interest • Given the uncertainty surrounding the hypotheses that would come before the committee in the future, the IOM wanted to ensure consistency in the committee membership
Enhancing Trust • Enlisting respected, neutral agencies • More pro-active approach to assessing adverse events
Enhancing Trust • Enlisting respected, neutral agencies • More pro-active approach to assessing adverse events • Improving access to correct information
Enhancing Trust • Enlisting respected, neutral agencies • More pro-active approach to assessing adverse events • Improving access to correct information • Early identification of emerging concerns, of the dimensions of the concern, and of strategies to allay concerns
Enhancing Trust, contin. • Nature of the recommendations made by review panels.
Issues Needing Further Attention • Communication about the introduction of or changes in vaccines to the childhood schedule to professionals and the public • Composition and rationale of federal policy-making committees • Broaden the policy framework to include ethical and economic issues
Implications for Public Health • Case study for other “government mandated” exposures • Natural history • Sources of discontent • Earlier intervention points • Role of communication of risk
Next Steps • Report on influenza vaccine under preparation • One additional meeting to be held in fall, 2003 • Preparation of manuscripts for publication in professional journals • Preparation of an all-encompassing summary written for the lay public
Immunization Safety Review • www.iom.edu/imsafety • Imsafety@nas.edu • 202/334-1342