1. Pandemic Influenza: Planning and Preparedness Ben Schwartz, M.D. National Vaccine Program Office, U.S. Department of Health and Human Services NVAC Meeting, October 5, 2004 “The pandemic clock is ticking; we just don’t know what time it is.”

2. Presentation Objectives Comment on the H5N1 threat in Asia Summarize recent and ongoing pandemic preparedness activities Public release of the HHS Pandemic Influenza Preparedness and Response Plan Other activities

3. The H5N1 Influenza Pandemic Threat Avian infection in 9 countries 34 human cases and 23 deaths (68%) Culled >100 m chickens Avian infection in 4 countries 7 human cases and 6 deaths (86%) Person-to-person? 200320041997199819992000 2001 2002 Avian infection in Hong Kong 18 human cases and 6 deaths (33%) Culled poultry Ongoing avian H5N1 infections

4. Deaths from 20 th Century Pandemics & Extrapolations to Current Populations 19181957/68 Case fatality rate3%<1% Actual Deaths U.S.675,00052,000 Global20-30 million 1-4 million Projected deaths* U.S..95 – 2.2 million 104,000 – 243,000 * Projections based on estimates by Meltzer

5. The HHS Pandemic Influenza Preparedness and Response Plan Released for 60-day public comment period on August 26, 2004 Public comments submitted on paper & electronically NVAC, ACIP, ASTHO, IDSA are developing organizational responses Plan is to be a “living document” with periodic revisions as needed Thus, comments always are welcomed

6. Pandemic Plan Components Core plan with preparedness and response sections DHHS Conops plan for public health and medical emergencies Annexes (12) providing... Guidance to health departments and other health care organizations Detailed information on critical issues Comparative and historical perspectives

7. Outstanding Issues Purchase and distribution of pandemic vaccine Priority groups for vaccination Priority groups and strategies for antiviral drugs Approaches to indemnification and liability protection

8. Need for Additional Specificity & Development of Supportive Materials Needed specifics Strategies to decrease international and community transmission Definition of frontline health care workers or essential community service providers Needed materials Software for monitoring vaccination coverage and recall for second dose, if needed Communications messages and materials

9. Ongoing Pandemic Preparedness Activities, 1 Vaccine Clinical testing of H5N1 investigational lot 2 million dose H5N1 stockpile RFP to assure security of egg supply for vaccine, and production of annual investigational lots RFP to diversify U.S. influenza vaccine production and increase surge capacity through cell-culture based vaccine Research on improved development of reference strains, new vaccine production technologies, approaches to increase immunogenicity, etc.

10. Ongoing Pandemic Preparedness Activities, 2 Antiviral drugs Addition of oseltamivir to the Strategic National Stockpile Inter-agency meeting of HHS/DoD/VA on antiviral strategies and stockpiling State & health care system preparedness Addition of pandemic planning as BT cooperative agreement critical benchmark Regional planning meetings for health departments Development of tabletop exercises HRSA BT hospital preparedness program

11. Ongoing Pandemic Preparedness Activities, 3 International activities Cooperative agreement enhancing surveillance in 10 Asian countries Support for WHO regarding coordination of human and animal surveillance Support to WPRO for pandemic planning in Asia APEC projects to assess pandemic planning, promote inter-sectoral involvement, and enhance preparedness Modeling focus on pandemic outbreak containment using public health measures and antiviral drugs

12. Conclusions During the past couple years, there has been substantial progress in preparedness Many challenges remain Key decisions Further planning & gap filling Vaccine & antiviral preparedness International surveillance & cooperation Release of the pandemic plan allows broader engagement & facilitates stakeholder involvement