America Responds: An HHS 2009-H1N1 Retrospective to Advance All Hazards Preparedness Discussion with the National Vac

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

2. RAND Team: Melinda Moore Lori Uscher-Pines Emily Gillen

3. H1N1 Retrospective • Conducting a comprehensive evaluation of HHS’s 2009-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

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

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?

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

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Areas for improvement • Uncertainty in vaccine production not clearly conveyed within the government or to the public • Outdated production technology limits how quickly vaccine can be produced Key successes and challenges from your perspective?

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?

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 federalvaccination 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?

10. Vaccine Safety • Key successes • Rapid expansion of the system to monitor adverse events • Collaborative and supportive safety system with NVPO andindependentVaccine 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?

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?

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?

13. Lessons Learned and Implications • Implications for the next influenza pandemic? • Implications for seasonal epidemics? • Implications for all-hazards preparedness?

14. Thank you so much for your time and input today. If you have any further comments and suggestions, please send them to:H1N1_Retrospective@rand.org