Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum

1. Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum Philadelphia, USA Advisory Committee on Immunization Practices (ACIP) to the Center for Disease Control and Prevention Carol J. Baker, M.D., ACIP Chair Professor Pediatrics, Molecular Virology and Microbiology, Baylor College of Medicine Houston, TX CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

2. Background CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA • Established in 1964 • Role:to provide advice and guidance to the CDC Director and the Office of the Secretary of the Department of Health and Human Services on the most effective means to prevent vaccine-preventable diseases • Vaccines and related agents • (e.g., antisera, immune globulins, antiviral agents) • FDA-licensed vaccines • Federal Advisory Committee Act (FACA)1972 • Mechanism to seek advice and recommendations of U.S. citizens in Federal Government’s decision- making process • Provide relevant and objective advice • Meetings open to the public; all committee documents available for public inspection; public comment each meeting

3. Structure CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA • 15 voting members:(non-government) • 4 year terms • ACIP steering committee nominates, Secretary of DHHS selects • One consumer representative • Members screened for conflicts of interest • 8 ex officio members: representing government agencies involved in immunization (non-voting) • 30 liaison members: representatives of professional societies and organizations responsible for vaccine development & immunization programs (non-voting)

4. Conflicts of Interest • Extensive financial disclosures before appointment as a member of ACIP with annual updating • Before each ACIP meeting, each voting member must disclose COI’s • Those with COI’s may not discuss or vote on vaccines related to manufacturer(s) of the recommendation being voted upon CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

5. Expertise of ACIP Members CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA Infectious diseases Immunology Virology and bacteriology Pediatrics including adolescent medicine Internal and family medicine Nursing Public health, preventive medicine Vaccine research and policy Consumer concerns Health economics, cost-effectiveness

6. ACIP Support from the Centers for Disease Control and Prevention CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA Lead staff for each work group Subject matter experts for each work group Vaccine safety expertise Health Economic analysis expertise Evidence-based medicine expertise Funding

7. ACIP Work Groups (WG) CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA • Gather, analyze and prepare information • Develop draft policies / options for review / vote by full ACIP • Work by teleconference throughout the year • WG is chaired by an ACIP member and must include at least 1 other ACIP member • Other members: lead CDC staff, other CDC staff including Immunization Safety Office, ex officio representatives, liaison members, AIM member and consultants • Task oriented WGs are disbanded when work complete; new WGs formed as required

8. CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

9. What is Considered in Decisions • Disease burden • Surveillance and epidemiology • Vaccine efficacy • Safety • Cost-effectiveness • Program impact CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

10. CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

11. Transparency CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

12. ACIP:Process CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA • 32-daymeetings annually: Feb., June, and Oct. • Agenda items • Topics solicited from ACIP members, liaisons, CDC staff and others using a standard format • Finalized by ACIP Steering Committee • Follow FACA* rules and procedures: open to the public with time for public comment • Meeting slides and minutes: posted on website • Recommendations: final once approved by CDC Director and published in MMWR * Federal Advisory Committee Act

13. Standardization of ACIP Process CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA Guidance for pregnant and breastfeeding women – www.cdc.gov/vaccines/recs/ACIP/rec-vac-preg.htm Economic analysis guidance - www.cdc.gov/vaccines/recs/ACIP/economic-studies.htm Vaccine acronyms and abbreviations – http://www.cdc.gov/vaccines/about/terms/vacc-abbrev.htm Evidence based medicine – (approved in October 2010) Provisional recommendations – www.cdc.gov/vaccines/recs/provisional/default.htm

14. http://www.cdc.gov/vaccines/recs/ACIP/economic-studies.htm CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

15. Evidence-Based Recommendations CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA Modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology approved by ACIP in October 2010 Clear separation between evidence grade and strength of recommendation

16. CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

17. ACIP Web Site www.cdc.gov/vaccines/recs/acip CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

18. Immunization Policy Recommending Bodies CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA ACIP American Academy of Pediatrics Committee on Infectious Diseases American Academy of Family Physicians American College of Physicians American College of Obstetricians and Gynecologists

19. Brief Recommendation An update is published in MMWRWeekly as a Policy Note within 2 months of an ACIP vote CDC Approval Process Following ACIP Vaccine Recommendation Full Recommendation (“ACIP Statement”) Provisional recommendations are posted on ACIP website within 3 weeks of an ACIP vote Final recommendations are published in MMWRRecommendations & Reports within 6-8 months of an ACIP vote *all provisional recommendations, final recommendations, and updates are posted on ACIP website: www.cdc.gov/vaccines/recs/acip CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

20. U.S. Government Role in Purchasing Childhood Vaccines Vaccines for Children program (VFC) Entitlement to certain vulnerable children through 18 years of age 45% of young children eligible for VFC Mandatory funding Inclusion of vaccines in VFC is determinedby the ACIP Section 317 vaccine funding Discretionary No restrictions on vaccine or population CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

21. Pediatric Vaccines Recommended for Children 0 through 6 Years of Age Doses Distributed by Funding Source Calendar Year 2007 Source: Biologics Surveillance Data 2007. Represents a national summary of self-reported distribution data by the vaccine manufacturers. The data are an estimate of the annual national distribution and does not equal administration. Reported data may be incomplete and include possible over-reporting or under-reporting of distribution data and may not reflect all vaccines or manufacturers. “Other” represents all purchases not on CDC contracts, including private, health insurance, and government purchases through other mechanisms. Data do not include influenza vaccine doses. Updated July 17, 2008 CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA

22. Conclusions CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA • Routine immunizations provide a great benefit to infants, children, adolescents, and adults and to society • Immunization is a shared public / private responsibility • The ACIP is a well-functioning, well-respected FACA committee • Many challenges face ACIP and implementation of immunization programs in the U.S. including • financing • supply • acceptance

23. Thank You! CVEP Symposium: Global Vaccines 202X: Access, Equity, Ethics 2-4 May 2011 The Franklin Institute Science Museum. Philadelphia, USA