America Responds: An HHS 2009-H1N1 Retrospective to Advance All Hazards Preparedness Discussion with the National Vaccine Advisory Committee June 3, 2010

Center for Domestic and International Health Security 2 RAND Team: Melinda Moore Lori Uscher-Pines Emily Gillen

Center for Domestic and International Health Security 3 H1N1 Retrospective Conducting a comprehensive evaluation of HHS’s H1N1 preparedness and response activities Offers the opportunity to capture lessons learned, make changes, and further improve response capabilities –Key successes –Areas for improvement –Recommended changes

Center for Domestic and International Health Security 4 Multiple Methods Being Used to Identify Key Successes and Areas for Improvement Document review –E.g., after action reviews, reports, media Electronic survey of federal employees In depth interviews with key decision makers Stakeholder dialogue sessions

Center for Domestic and International Health Security 5 Our Discussion Today Will Inform the Evaluation of HHS’s Response to H1N1 We seek your input on: Key successes –What went well? –What factors made the success possible? –What can be done to build upon this success and further improve response capabilities? Areas for improvement –What didn’t work well? –What were the barriers to success? –Do you have any specific recommendations on how to address the problem/improve future performance?

Center for Domestic and International Health Security 6 Organization for Today’s Discussion We will present illustrative examples of successes and areas for improvement identified by federal stakeholders Vaccine Pillar –Vaccine development and production –Vaccine distribution and administration –Vaccine financing –Vaccine safety –Vaccine related communication and education Coordination of governmental and non-governmental agencies Lessons learned and implications going forward

Center for Domestic and International Health Security 7 Vaccine Development and Production Key successes –Rapid development and clinical evaluation of an H1N1 vaccine –FDA's clear guidance that the vaccine would be licensed as a strain change Areas for improvement –Uncertainty in vaccine production not clearly conveyed within the government or to the public –Outdated production technology limits how quickly vaccine can be produced Key successes and challenges from your perspective?

Center for Domestic and International Health Security 8 Vaccine Distribution and Administration Key successes –Use of the VFC program as template for vaccine distribution –Use of new, innovative approaches to vaccine delivery (e.g., drive- through clinics, school-located clinics) Areas for improvement –Distribution was chaotic and appeared haphazard to those on the receiving end –Inadequate systems to determine how many and who had been vaccinated –Distribution system did not make best use of big box retailers, particularly early on Key successes and challenges from your perspective?

Center for Domestic and International Health Security 9 Vaccine Financing Key successes –Existing contracts with vaccine manufacturers allowed HHS to quickly assess manufacturing capacity –Medicare, Medicaid and SCHIP provided timely reimbursement on claims for vaccine administration –Emergency supplemental funds to send federal vaccination teams to states (e.g., Delaware) Areas for improvement –Decision to purchase adjuvant did not adequately account for storage costs –State share of Medicaid and SCHIP reimbursement for administration fees created a financial burden for states Key successes and challenges from your perspective?

Center for Domestic and International Health Security 10 Vaccine Safety Key successes –Rapid expansion of the system to monitor adverse events –Collaborative and supportive safety system with NVPO and independent Vaccine Safety Risk Assessment Working Group (reporting to NVAC) Areas for improvement –Confusion within DOJ regarding who would handle counterfeit vaccine Key successes and challenges from your perspective?

Center for Domestic and International Health Security 11 Communication and Education on Vaccines Key successes –Strong communication prior to release of vaccine (e.g., community mitigation strategies, cough into your sleeve, etc.) Areas for improvement –Need for additional outreach to minority populations –Issue of over-promising and under-delivering –Educating the media on limitations of passive adverse events surveillance system –Need better communication and education about the value of vaccines for pandemic H1N1, seasonal influenza, and more generally Key successes and challenges from your perspective?

Center for Domestic and International Health Security 12 Coordination Key successes –Having vaccine leads/liaisons located at both CDC and ASPR Areas for improvement –Confusion on role of vaccine pillar lead in ASPR How was coordination across HHS agencies with regard to vaccine/vaccination pillar (e.g., NIH, FDA, CDC, OS – ASPR, NVPO, etc.)? Other coordination issues specific to vaccine? Key successes and challenges from your perspective?

Center for Domestic and International Health Security 13 Lessons Learned and Implications Implications for the next influenza pandemic? Implications for seasonal epidemics? Implications for all-hazards preparedness?

Center for Domestic and International Health Security 14 Thank you so much for your time and input today. If you have any further comments and suggestions, please send them to: