1. Update of The National Vaccine Plan Bruce G. Gellin, M.D., M.P.H., and Raymond A. Strikas, MD National Vaccine Program Office Department of Health and Human Services

2. Presentation Outline Statutory basis for the National Vaccine Program Office and National Vaccine Plan Review of the National Vaccine Plan and areas for revision –Goals and objectives –Priorities Vision for a revised National Vaccine Plan Evolution of Immunization Issues since 1994 Scope of the revision Process for revision

3. Statutory Basis for the National Vaccine Program* Title XXI Public Health Service Act (P.L. 99-660, Section 2102): National Vaccine Program Director [the Assistant Secretary of Health] shall coordinate and provide direction for –Vaccine research –Vaccine development –Safety and efficacy testing of vaccines –Licensing of vaccine manufacturers and vaccines –Production and procurement of vaccines –Distribution and use of vaccines –Evaluating the need for and the effectiveness and adverse effects of vaccines –Governmental and non-governmental activities –Funding of federal activities *The National Vaccine Program Office monitors, coordinates, and provides leadership for the overall collaborative effort that is the Program.

4. Statutory Basis for the National Vaccine Program Office - 2 Title XXI Public Health Service Act (P.L. 99-660, Section 2103): –NVP Director shall prepare and issue a plan for the implementation of the responsibilities of the Director under section 2102. –The plan shall establish priorities in [list in sec. 2102] and describe an optimal use of resources to carry out such priorities, and describe how each of the various departments and agencies will carry out their functions in consultation and coordination with the Program and in conformity with such priorities.

5. 1994 National Vaccine Plan Goals* 1.Develop new and improved vaccines 2.Ensure the optimal safety and effectiveness of vaccines and immunization 3.Better educate the public and members of the health professions on the benefits and risks of immunization 4.Achieve better use of existing vaccines to prevent disease, disability, and death *Tab 7 in meeting notebook: Goals and Objectives

6. 1994 National Vaccine Plan Priorities Childhood Immunization Initiative: –Improving quality, quantity of vaccination delivery services –Increasing community participation, education, partnerships –Reducing vaccine cost –Improving monitoring of disease and vaccination coverage –Improving vaccines and vaccine use

7. 1994 National Vaccine Plan Priorities - 2 Vaccine Development –HIV vaccines –CDC Emerging Infections Plan –NIAID Blue Ribbon Panel Improve pertussis, measles vaccines Combined vaccines STD vaccines Respiratory, enteric vaccines New approaches for vaccine delivery Vaccine safety Policy and Program Development –Pandemic Plan update –Address unmet needs

8. National Vaccine Plan Status Completed in 1994 Reviewed at NVPO retreat – 1997 –NVPO, agencies’ activities related to each Goal, Objective and Strategy catalogued, reviewed No other formal evaluation performed –Evaluation may be difficult, given broad sweep of the Plan’s Goals and Objectives. –Virtually all vaccine-related activities fit in it No revisions since publication

9. Vision for National Vaccine Plan Update 1/19/07: Charge from the Assistant Secretary for Health that the plan be updated “to reflect current priorities and potential future directions … will provide valuable input to me and to HHS in our consideration of forthcoming budget initiatives.” “The updated Plan should summarize current priorities for vaccine- and immunization-related research, development and use; contribute to efforts to prioritize the use of existing resources; and identify needs for new resources.” Complete the new Plan in early 2008 “so it can be used during deliberations of FY 2009 budget initiatives.”

10. Evolution of Immunization Issues since 1994 Disease incidence changes New vaccines New schedules for children and adults Changes in vaccine coverage Implementation of immunization information systems (registries) Adolescent immunization focus Impact of bio-defense and pandemic preparedness activities

11. Comparison of 20 th Century Annual Morbidity and Current Morbidity: Vaccine-Preventable Diseases Disease 20th Century Annual Morbidity † (1994) 2005 †† Percent Decrease to 2005 Smallpox48,164(0) 0100% Diphtheria175,885(2) 0100% Measles503,282(895) 66> 99% Mumps152,209(1322) 314> 99% Pertussis147,271(3290) 25,61683% Polio (paralytic)16,316(9*) 1*> 99% Rubella47,745(209) 11> 99% Congenital Rubella Syndrome823(7) 1> 99% Tetanus1,314 (29) 2798% Haemophilus influenzae 20,000(329) 226**99% † Source: CDC. MMWR April 2, 1999. 48: 242-264 † † Source: CDC. MMWR. August 18, 2006 / 55(32);880-893 *Vaccine-associated paralytic polio (VAPP) ** Type b and unknown (< 5 years of age) Numbers in yellow indicate at or near record lows in 2005

12. Disease Pre-Vaccine Era Estimated Annual Morbidity † (1994) 2005 Estimated Morbidity † Percent Decrease Hepatitis A117,333 (115,000) 19,183 84% Hepatitis B (acute)66,232 (35,000) 15,352 77% Pneumococcus (invasive) all ages63,067( 2 ) 40,32536% < 5 years of age16,069( 2 ) 4,40073% Varicella4,085,120( 2 ) 817,02480% Comparison of Pre-Vaccine Era Estimated Annual Morbidity and Current Estimated Morbidity: Vaccine- Preventable Diseases † Unpublished CDC data, reported November 2006 2 as fpr pre-vaccine era

13. New Vaccine Indications since 1994* 1994 –typhoid Vi polysaccharide –Hib/CRM 197 conjugate –plague 1995 – varicella 1996 - hepatitis A 1998 –rhesus rotavirus –lyme disease 2000 – pneumococcal conjugate 2003 – live attenuated influenza 2005 –meningococcal conjugate –TdaP for adolescents and adults 2006 –bovine rotavirus –zoster –human papillomavirus *not all new vaccines licensed are represented

14. General Recommendations on Immunization, 1994

17. Recommended Adult Immunization Schedule, 2007, by Medical or Occupational Indication

18. Vaccine-Specific Coverage Rates Among Pre-school Aged Children 1967 to 2005 DTP(3+) † MMR(1+) Hib (3+)Varicella (1+) † DTP(3+) is not a Healthy People 2010 objective. DTP(4) is used to assess Healthy People 2010 objectives. Note: Children in the USIS and NHIS were 24-35 months of age. Children in the NIS were 19-35 months of age. Source: USIS (1967-1985), NHIS (1991-1993) CDC, NCHS, and NIS (1994-December 2003), CDC, NIP and NCHS; No data from 1986-1990 due to cancellation of USIS because of budget reductions 2010 Target Percent Hep B (3+) Polio (3+) PCV7 (3)+

19. Receipt of influenza vaccination during the previous 12 months by race/ethnicity among persons >65, 1989-2005, National Health Interview Survey Healthy People 2010 Goal Survey Year

20. Healthy People 2010 Percentage of persons aged 18 – 64 years who reported receiving influenza vaccination during the preceding 12 months, by race/ethnicity and survey year – National Health Interview Survey, United States, 1989 – 2005

21. Immunization Information Systems (Registries) Outgrowth of 1993 Childhood Immunization Initiative NVAC initiative 1997 and reports in 1999, 2001, and 2007 As of 12/31/05 –56% of children <6 yrs are participating in an IIS –75% of public providers participating –44% of private providers participating –Only one state had not worked to develop an IIS

22. Adolescent Immunization “Hot button” issues*: –School and non-traditional venue vaccination –School mandates/laws –Informed consent *G. Freed, NVAC, 6/6/06

23. Biodefense and Pandemic Preparedness Project BioShield: –a secure funding source for the purchase of critical medical countermeasures, such as vaccines, therapeutics, and diagnostics; –authorizes $5.6 billion over 10 years (not all for infectious disease threats, but includes anthrax, botulism, smallpox) Pandemic Preparedness: –2004: $43 M to assure egg supply –2004-05: $264 M for clade 1 influenza A/H5N1 vaccine –2006: $1.2 B for cell-based vaccines, antigen-sparing approaches –2007 on:$ TBD for next generation vaccines, new cell-based facilities, and retrofitting facilities

24. Other Continuing Challenges Vaccine safety Vaccine financing International vaccine issues Vaccine Supply Achieving Adult Immunization Goals Influenza

25. Scope of National Vaccine Plan Revision Federal plan (comprehensive within the federal government) Address priorities for 2008-2010 Include timelines and metrics, where feasible Begin with current priorities to develop goals and objectives Link to Healthy People 2010

26. Purposes of a Plan to Consider Define our path, or a roadmap Identify needs for resources Demonstrate that we have an important job, foster teambuilding Communicate to others what we do

27. Revision Process HHS interagency task force (at some point include non-HHS agencies: e.g., DoD, VA, USAID) Get agencies’ priorities for 2007-2010 Assess whether to evaluate impact of 1994 plan, and how NVAC to review, comment Other stakeholders (how to engage?) Public engagement?