1. Public Health Options for Implementing Vaccine Recommendations: A Framework for State Decision Making Donald Williamson, M.D. National Vaccine Advisory Working Group on Public Health Options for Implementing Vaccine Recommendations

2. Factors Increase in scope and complexity of schedule Increase in cost of new/comb vaccines Increase in public questioning about immunization/immunization requirements Increase in expectations about disease elimination Increased international commitments to interrupt transmission and achieve eradication Use of school immunization requirements as a strategy to control transmission of disease Use of school immunization requirements as a strategy to increase immunization coverage

3. Problem In light of these factors, state officials are faced with increased challenges as they implement vaccines newly recommended for universal use. ASTHO approached NVAC for assistance.

4. Strategy NVAC convened a Working Group to help state policy makers develop guidance around this issue.

5. Process Literature review –ASTHO Survey Regional Stakeholder Meetings –Nashville, Boston, DC Working group deliberations

6. Conclusions from Stakeholder Meetings 2001-2002 Immunizations are a benefit not only to the individual but also to society as a whole and thus immunization requirements for entry into daycare/school/colleges have been repeatedly affirmed by society in general. The process for state decision making regarding implementation of vaccine recommendations has been effective. (“system is not broken”) Immunization requirements that do not consider financial constraints will not be optimally effective. –Need to prioritize –Economic barriers include more than payment of vaccine

7. Recommendations State guidelines for addressing national immunization recommendations Effective implementation of state immunization recommendations and requirements Monitoring implementation of state immunization requirements Development of new knowledge

8. Recommendations The following recommendations are intended to be broad in application, but the specific language uses school systems as an example.

9. Guidelines Recommendation (1) States should consider a variety of factors: –Nature of disease for individual and community –Vaccine related issues for the individual and community –Personal choice issues

10. Guidelines Recommendation (2) States should consider underlying principles: –A variety of strategies are useful in implementing vaccine recommendations –Optimal approaches balance population protection and adverse events, while respecting personal choice –Requirements may be most appropriate for disease with highest morbidity, transmissibility, and other costs

11. Guidelines Recommendation (3) Development of state policies and programs is a public process and should incorporate appropriate participation from Stakeholders and be consistent with the State’s regulatory and legislative environment.

12. Implementation Recommendation (4) State/local public health officials should develop an implementation plan for state immunization recommendations and requirements. –Implementers should participate –Plan should address procedure for Implementation, enforcement, exemptions, and monitoring of disease, exemptions and coverage

13. Implementation Recommendation (5) All stakeholders should be educated about benefits and risks. –Consumers –Providers –School officials

14. Implementation Recommendation (6) Exemption provisions should respect parental choice while maintaining high coverage. –Develop and implement procedures to ensure that compliance with requirements through receiving vaccinations is at least as easy as obtaining exemptions –Minimize economic and access barriers –Develop exemption procedures that facilitate informed decision making

15. Implementation Recommendation (7) All parents considering non-medical exemptions have information on: –Risk/benefit of vaccination and consequence of non-compliance –Consequences for unvaccinated children with medical exemptions

16. Implementation Recommendation (8) State health departments should work with school officials to remove financial disincentives for enforcement of school entry requirements.

17. Monitoring Recommendation (9) States should monitor and evaluate their implementation of requirements and revise them accordingly. –Compile exemptions data at state and local level –Work with CDC to improve reporting exemption rates by exemption category

18. Monitoring Recommendation (10) CDC should summarize and report exemption data submitted by the states and provide technical assistance.

19. New Knowledge Recommendation (11) Research should be conducted to develop new knowledge on: –Effective strategies other than requirements –Aspects of requirements, including: Effective implementation Effective enforcement Representative participation Impact on public and professional attitudes

20. Unresolved Issues Should the existence and stringency of immunization requirements and exemptions reflect the public health importance of a disease? Should there be exemptions other than medical? –Should religious/ philosophical/ personal exemptions be re-categorized as ‘non-medical’? Do states have an obligation to fund required vaccines?