National Vaccine Advisory Committee Report from the Chair Gus Birkhead, MD, MPH NVAC Chair February 3, 2010

Report from the Chair - Overview Approval of meeting minutes Approval of meeting minutes NVAC membership status report NVAC membership status report Review of current meeting agenda Review of current meeting agenda 2009 State of the National Vaccine Program Report 2009 State of the National Vaccine Program Report

Prior NVAC Meeting Minutes August 2009 tele-conference meeting August 2009 tele-conference meeting –Minutes reviewed and certified by chair and posted to NVAC website –Approval vote by full committee September 2009 September 2009 –Under review November 2009 November 2009 –Under review December 2009 December 2009 –Under review January 2009 January 2009 –Under review

NVAC Membership

RAND Evaluation of NVAC Recommendations to NVAC Recommendations to NVAC –Proactively seek input regarding priority vaccine and immunization issues for HHS through regular meetings with the ASH –Craft recommendations that are more specific in terms of what actions are needed, who should take them, and over what time period –Think strategically about how to reach intended audiences –Monitor the status of recommendations on a regular basis

NVAC Meeting Follow-up Matrix of identified action items from meetings back to September 2008 Matrix of identified action items from meetings back to September 2008 –56 action items tracked 35 closed/fully completed 35 closed/fully completed 17 open/in progress 17 open/in progress –4 will be addressed this meeting 4 need clarification 4 need clarification

Recent Accomplishments H1N1 influenza response H1N1 influenza response –Reports and recommendations from H1N1 Vaccine Safety Risk Assessment Working Group National Vaccine Plan review National Vaccine Plan review –Defining criteria for review and prioritization –NVAC input into review of priorities Publication of Pediatrics supplement on vaccine finance Publication of Pediatrics supplement on vaccine finance

Current Agenda (1) National Vaccine Plan National Vaccine Plan Vaccine Safety Vaccine Safety –Vaccine Safety Working Group –H1N1 Vaccine Safety Risk Assessment Working Group –Update on recommendations to CDC ISO

Current Agenda (2) Vaccine Finance Vaccine Finance –Update on implementation of 2008 NVAC recommendations –Briefing on examination of first dollar coverage for vaccinations Health care reform and vaccination Health care reform and vaccination

Current Agenda (3) Adult Immunization update Adult Immunization update 2010 NVPO Communications Plan 2010 NVPO Communications Plan Vaccine Stockpile Vaccine Stockpile Influenza Influenza –Seasonal and H1N1 pandemic

State of the National Vaccine Program Report Follow-up to State of the National Vaccine Program Report, February 2009 Follow-up to State of the National Vaccine Program Report, February 2009 –Update on activities throughout the Program – NVPO and NVAC –Addressing recommendations made in February 2009 State of the Program Report –Identification of priority areas for the coming year

State of the National Vaccine Program Report 2009 has seen many brought many changes in the National Vaccine Program 2009 has seen many brought many changes in the National Vaccine Program –New Federal administration and new ASH New opportunities for coordination New opportunities for coordination –H1N1 influenza pandemic Activities can be seen as a microcosm of the larger vaccination system Activities can be seen as a microcosm of the larger vaccination system Lessons learned can be applied broadly across the system Lessons learned can be applied broadly across the system –First revision of National Vaccine Plan since its creation in 1994

State of the National Vaccine Program Report Update on 2009 State of the Program Report recommendations Update on 2009 State of the Program Report recommendations –NVP should be given the resources and effective organizational authority within HHS to carry out its mission. A new ASH appointed as part of the new Federal administration. A new ASH appointed as part of the new Federal administration. New NVPO staff New NVPO staff –Deputy Director –Communications Director –Finance Director –Additional staff for safety and administration

State of the National Vaccine Program Report Update on 2009 State of the Program Report recommendations Update on 2009 State of the Program Report recommendations –The National Vaccine Plan should specifically address how the NVPO will improve its effectiveness Awaiting the final version of the National Vaccine Plan Awaiting the final version of the National Vaccine Plan –The NVP should be evaluated regularly and its effectiveness reviewed as part of each revision of the National Vaccine Plan Reviewing National Vaccine Plan to see if such mechanisms are in place Reviewing National Vaccine Plan to see if such mechanisms are in place –The NVPO should improve the effectiveness of NVAC based on recommendations from the NVAC evaluation report. This is an ongoing process This is an ongoing process

State of the National Vaccine Program Report Priorities for the NVP in 2010 Priorities for the NVP in 2010 –In addition to regular NVAC and NVPO business and ongoing NVAC working groups, three areas have been identified as priorities for the Program Complete work on the National Vaccine Plan Complete work on the National Vaccine Plan Conduct/participate in a review of the 2009 H1N1 response Conduct/participate in a review of the 2009 H1N1 response Review the RAND report on the effectiveness of NVAC and revise NVAC procedures accordingly Review the RAND report on the effectiveness of NVAC and revise NVAC procedures accordingly

Title XXI Public Health Service Act Sec. 2102: National Vaccine Program Responsibilities: 1)Vaccine Research 2)Vaccine Development 3)Safety and efficacy testing of vaccines 4)Licensing of vaccine manufacturers and vaccines 5)Production and procurement of vaccines 6)Distribution and use of vaccines 7)Evaluating the need for, the effectiveness, and adverse effects of vaccines and immunization activities 8)Coordinating governmental and non- governmental activities 9)Funding of federal agencies

NVAC: Future meeting dates In-person In-person –June 2-3 –September Tele-conference Tele-conference –As needed for H1N1 response, National Vaccine Plan or other issues