1. National Immunization Program (NIP)/Advisory Committee on Immunization Practices (ACIP) Report Stephen L. Cochi, MD, MPH Acting Director, National Immunization Program Centers for Disease Control and Prevention National Vaccine Advisory Committee October 6, 2004

2. Upcoming ACIP Meeting October 27-28, 2004 Major Issues:  Influenza vaccine supply/coverage/ effectiveness  Health-care worker influenza vaccination (HICPAC-ACIP document)  Recommendations for use of meningococcal conjugate vaccine

3. Upcoming ACIP Meeting October 27-28, 2004 (Continued)  Review of hepatitis B vaccine use/ recommendations  Varicella epidemiology/program goals/2-dose data  Proposed evidence-based format for ACIP recommendations  Update on cardiac adverse events following smallpox vaccination

4. Pediatric Vaccine Stockpiles  Goal – six month supply for universally recommended vaccines for children  Target quantities currently based on birth cohort  Funding available through VFC Program  To be completed by FY 2007

5. Number of Doses in Millions Note: (1) Status based on recently modified targets by SWAT Team, 9/9/2004 (2) Target adjusted to reflect market demand Source: NIP data 0%0% (2) 33%79%100%7%45%33% (2) 0% % Stockpile Delivered Purchased & Delivered Additional Required For Completion, Not Purchased Current Stockpile Status(1) : Doses Delivered Vs. Target

6. Factors Complicating Stockpiles  Changing market share  Combination vaccines (e.g., DTaP-HepB-IPV)  Overlapping combinations (e.g., DTaP-HepB-IPV and DTaP-Hib-IPV)  Revenue recognition issues currently present a roadblock to progress

7. Vaccine Stockpiles Revenue Recognition “The Committee requests that the Secretary of Health and Human Services, after consultation with the Securities and Exchange Commission and other appropriate agencies, submit a report and recommendations within 90 days to the Committee. The report should include what administrative actions are being taken, solutions proposed, or identify what legislative clarification may be necessary to resolve this problem.” Source: From Senate Labor-HHS Appropriations Subcommittee Report, September 2004

8. Risks of Polio After Eradication' *based on current understanding RiskFrequency to date Annual burden Evolution over time VAPP 2-4/million birth cohort 250-500stable iVDPV 19 identified (since 1963) <1decreases cVDPV1* per year10increases IPV sites 1 accident (1990s) <1 decreases Lab accident 1 investigation NK decreases Deliberate 0 NK unknown After interruption of wild poliovirus, continued use of OPV will compromise the goal of a polio-free world. Expert Consultation on Vaccine-derived Polioviruses (VDPVs), Sept 2003, Geneva

9. Proposed Policy Decision Cessation of OPV for routine immunization Consensus of September 2003 meeting Risks > benefits in absence of wild poliovirus Expectation of countries and stakeholders High opportunity & financial costs of continued OPV. Timing: must occur while population immunity & surveillance sensitivity (for cVPDV emergence) are high. Source: David Heymann’s Polio Eradication Presentation to AACPE, 9/21/04

10. Conditionalities for OPV Cessation  Appropriate containment of all polioviruses.  Global surveillance & notification capacity.  mOPV stockpile & response mechanism.  Coordinated cessation of OPV.  Post OPV vaccination policy in place. Source: David Heymann’s Polio Eradication Presentation to AACPE, 9/21/04