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1 Investments in Innovation: Seasonal Influenza Preparedness Pandemic Influenza Preparedness Bruce Gellin, MD, MPH Director National Vaccine Program Office Department of Health and Human Services
2 Influenza Means War The appalling pandemic of 1918 in the last months of the exhausting conflict of World War I, with massive mobilization of armies and upheaval of civilian populations, has irrevocably linked those two catastrophes. It demonstrated that virulent influenza may be more devastating to human life than war itself... the onset of another war inevitably recalled the specter of 1918 and the possibility that... [it] would again result in the epidemiologic conditions which would heighten the severity of influenza to a catastrophic level Dr. Thomas Francis Jr, Chairman, US Influenza Commission (1941)
3 Influenza Vaccine s WWII Origins Improving virus yields from embryonated eggs Improving titration accuracy Ultracentrifuge and electrophoresis purification Concentrating and purifying the virus on a large scale Develop uniform standards for potency and purity Field studies to provide the first reliable proof of safety and efficacy. Standardized record systems, observation procedures, and viral and serological tests It was possible to obtain participation of entire units so that vaccinated persons and controls could be properly designated rather than depending upon the less desirable and unpredictable use of volunteers" K. Hoyt: Vaccine Innovation: Lessons from World War II (2006)
4 Vaccine Supply and Innovation Institute of Medicine 1985 Recent advances in all aspects of biotechnology and particularly gene manipulation offer powerful new approaches to many previously intractable problems. These technologies, combined with a better understanding of the immune process, have opened a new era in vaccine development.
5 HHS Pandemic Influenza Plan: Vaccine Goal #1: Vaccine Goals To establish and maintain a dynamic pre-pandemic influenza vaccine stockpile sufficient for 20 million persons (at 2 doses/person) Vaccine Goal #2: To provide pandemic vaccine to all U.S. citizens within 6 months of a pandemic declaration: 600 million doses pandemic vaccine
6 HISTORICAL PERSPECTIVE Estimated Annual Domestic Production of Pandemic Influenza Vaccine: Capacity, and Need 300 People vaccinated* (Millions) A B C A: Annual domestic capacity B: National need *Assumes 2 doses/person, 90 ug/dose
7 Influenza Vaccine: Surge Capacity Vaccine Production After Pandemic Virus Emerges x 0 Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Months After Pandemic Begins
8 Transforming Technology Egg-based production Cell-based production
9 U.S. Pandemic Influenza Vaccine Capacity Forecast: Antigen Production 400 U.S. Pandemic Influenza Vaccine Capacity (Antigen Alone 90 ug/dose) Current and Projected US Pandemic Influenza Vaccine Capacity V a c c i n e C o u r s e s ( M ) Vaccine Courses H06 2H06 1H07 2H07 1H08 2H08 1H09 2H09 1H10 2H10 1H11 2H11 x Egg Cell
10 Transforming Technology: Reverse Genetics
11 Timing of Pandemic Vaccine Availability PREPARE SEED MONOVALENT PRODUCTION PANDEMIC IDENTIFIED FILL/TEST VACCINATION (Licensed vs. EUA) MONTHS
12 Transforming Technology: Recombinant Influenza Vaccine GOAL: Decrease the timeline of vaccine production in response to a newly emerged pandemic influenza strain. The timeline for the availability of egg- and cell-based inactivated pandemic influenza vaccines in the U.S. is estimated at weeks post-pandemic onset, which may be towards the end of a first pandemic wave. Recombinant-based influenza vaccines, which may not be dependent on pandemic influenza virus reference strain availability and the production and calibration of potency assay reagents needed for inactivated influenza vaccines, may be available 8 to 12 weeks post-pandemic onset. HHS Request for Proposal: August 2007
13 Transforming Technology: Adjuvants U.S. Pandemic Influenza Vaccine Capacity Forecast U.S. PANDEMIC VACCINE GOAL TIMELINES (300 M Vaccine Courses) Months Ag Alone (90 ug) Adjuvants
14 Evolution of the H5N1 Hemagglutinin Gene Candidate Vaccine Reference Viruses ck/shannxi/62/04 dk/guangxi/13/04 ck/yunnan/30/04 ck/yunnan/115/04 ck/yunnan/374/04 Indonesia/7/05 Indonesia/5/05 Indonesia/CDC742/06 Indonesia/CDC940/06 Indonesia/CDC1031/07 Indonesia/CDC1047/07 Indonesia/CDC887/06 Indonesia/CDC938/06 Indonesia/CDC1032/07 Indonesia/CDC1046/07 Barhdgs/Qinghai/1A/05 ck/liaoning/23/05 Barhdgs/Qinghai/12/05 ck/krasnodar/01/06 Azerbaijan/001161/06 swan/iran/754/06 Turkey/15/06 Iraq/207NAMRU-3/06 ck/nigeria/641/06 whswan/mongolia/244/05 tky/turkey/1/05 Egypt/14724NAMRU-3/06 Djibouti/5691NAMRU-3/06 dk/egypt/22533/06 Egypt/0636NAMRU-3/07 egret/egypt/1162namru-3/06 dk/hunan/15/04 scalybreastedmunia/hongkong/45/07 JapaneseWhiteEye/HongKong/1038/06 Anhui/1/05 dk/laos/3295/06 ck/malaysia/935/06 common magpie/hong Kong/645/06 Guangxi/1/05 House Crow/Hong Kong/719/07 JapaneseWhiteEye/Hong Kong/737/07 WhiteBackedMunia/HongKong/828/07 Thailand/676/05 Vietnam/JP14/05 ck/cambodia/013lc1b/05 Vietnam/JPHN30321/05 Vietnam/1203/04 Vietnam/1194/04 Clade 1 Vietnam/HN30408/05 Thailand/16/04 Hong Kong/213/03 migdk/jiangxi/1653/05 ck/hunan/41/04 ck/hunan/2292/06 ck/shanxi/2/06 New subgroup ck/myanmar/ b/06 ck/yunnan/71/05 ck/guiyang/237/06 gs/guiyang/1325/06 dk/guiyang/50406 gs/fujian/bb/03 New subgroup gs/vietnam/gz-3/05 Hong Kong/156/97 gs/guangdong/1/96 Clade 2.1 Clade 2.2 Clade 2.3
15 HHS Prepandemic Vaccine Stockpile
16 HHS Pandemic Vaccine Mix and Match Study Strategic Goal: Expand the supply of influenza vaccines available during a pandemic by optimization of antigen content using adjuvants Specific Aim: Determine whether stockpiled H5N1 antigens manufactured by one company can be used safety and effectively with adjuvants from other manufacturers during an influenza pandemic under Emergency Use Authorization.
17 Seasonal Influenza Preparedness Pandemic Influenza Preparedness Enhanced immunogenicity Broader Protection New delivery platforms Different vaccines for different populations Shortening vaccine production times Improving distribution and vaccine tracking Decreasing impact of seasonal and pandemic influenza
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