Immunization Safety Review Committee: or Everything I’ve Learned about Immunization Trustbusters and Strategies to Enha

1. 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

2. 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

3. 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

4. Trustbusters: Incomplete Science • Poorly designed studies • Premature conclusions without timely follow-up by other authoritative researchers • Lack of study and publication • Reasoning by analogy

5. Enhancing Trust • Enlisting respected, neutral agencies

6. 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

7. 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

8. 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

9. Enhancing Trust • Enlisting respected, neutral agencies • More pro-active approach to assessing adverse events

10. Enhancing Trust • Enlisting respected, neutral agencies • More pro-active approach to assessing adverse events • Improving access to correct information

11. 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

12. Enhancing Trust, contin. • Nature of the recommendations made by review panels.

13. 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

14. Implications for Public Health • Case study for other “government mandated” exposures • Natural history • Sources of discontent • Earlier intervention points • Role of communication of risk

15. 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

16. Immunization Safety Review • www.iom.edu/imsafety • Imsafety@nas.edu • 202/334-1342