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INFORMATION FOR THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER, FDA (Swine and Avian Influenza

INFORMATION FOR THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER, FDA (Swine and Avian Influenza) FEBRUARY 25, 2011 Nancy J. Cox, Ph.D. Director WHO COLLABORATING CENTER FOR SURVEILLANCE, EPIDEMIOLOGY AND CONTROL OF INFLUENZA Influenza Division

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INFORMATION FOR THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER, FDA (Swine and Avian Influenza

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  1. INFORMATION FOR THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER, FDA (Swine and Avian Influenza) FEBRUARY 25, 2011 Nancy J. Cox, Ph.D. Director WHO COLLABORATING CENTER FOR SURVEILLANCE, EPIDEMIOLOGY AND CONTROL OF INFLUENZA Influenza Division National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention Atlanta, GA 30333

  2. Swine-Origin Influenza A Viruses, 2009–2011

  3. Zoonotic infections with swine influenza viruses in 2009-2010

  4. Triple Reassortant Swine Origin Influenza A(H3N2) Viruses PB2 PB1 PA HA NP NA MP NS Classical Swine – North American Lineage Avian – North American Lineage Seasonal H3N2

  5. Hemagglutination Inhibition Reactions of Influenza A(H3N2) Viruses

  6. Evolutionary Relationships Among Swine-origin Influenza A(H3N2) HA Genes, 2010-2011 T117N L164Q N276E R299K A/Minnesota/11/2010 H3N2 S107T H155Y A163E T203I A/Wisconsin/12/2010 H3N2 A/Pennsylvania/40/2010 H3N2 A/Minnesota/09/2010 H3N2 P273H 02/23/11 2010 SOIV H3N2 SOIV H3N2 Seasonal H3N2 A/swine/Minnesota/02948/2009 H3N2 A/swine/Kansas/03/2009 H3N2 A/swine/Illinois/02940/2010 H3N2 A/swine/Minnesota/03008/2010 H3N2 M10T A106V S124N H155Y K173N V196I N278K A304V A/swine/Missouri/02980/2010 H3N2 A/swine/Kansas/02/2009 H3N2 A/swine/Minnesota/02981/2010 H3N2 A/swine/Pennsylvania/62170-3/2010 H3N2 A/Pennsylvania/14/2010 H3N2 A/swine/Pennsylvania/62170-2/2010 H3N2 A/swine/Pennsylvania/62170-4/2010 H3N2 A/swine/Manitoba/12707/2005 H3N2 A/Iowa/16/2009 H3N2 A/Ontario/1252/2007 H3N2 D101Y K140R K156N E158D/N S186G S193N R261Q A/Ontario/RV1273/2005 H3N2 A/swine/Ontario/33853/2005 H3N2 N6S T10M N53D G78D K122Q G124S G142G/E/K K145N S189R/K A/swine/Iowa/A01057188/2010 H3N2 A/swine/Illinois/03041/2010 H3N2 A/swine/North Carolina/R08/2008 H3N2 A/swine/Illinois/53612-7/2010 H3N2 A/swine/Illinois/A01057087/2010 H3N2 A/swine/Illinois/03040/2010 H3N2 A/Kansas/13/2009 H3N2 A/swine/Illinois/53612-1/2009 H3N2 A/swine/Illinois/02945/2010 H3N2 A/swine/Iowa/03017/2010 H3N2 N31D R229I A/turkey/Ohio/313053/2004 H3N2 A/swine/Oklahoma/001142/2009 H3N2 A/swine/Pennsylvania/057108-1/2010 H3N2 A/swine/IN/PU542/2004 H3N1 A/swine/North Carolina/2003 H3N2 A/New York/55/1996 H3N2 A/Sydney/5/1997 H3N2 A/New York/224/1998 H3N2 A/Wyoming/3e5/2003 H3N2 A/California/7/2004 H3N2 A/Wisconsin/67/2005 H3N2 A/Brisbane/10/2007 H3N2 A/Perth/16/2009 H3N2 A/Victoria/208/2009 H3N2 A/California/10/1997 H3N2 A/Wuhan/359/1995 H3N2 A/AnnArbor/3/1993 H3N2 A/Johannesburg/33/94 H3N2 A/Beijing/32/92 H3N2 A/Hong Kong/34/1990 H3N2 A/Beijing/353/1989 H3N2 0.01 A/Amsterdam/4112/1992 H3N2 A/Victoria/7/1987 H3N2

  7. Evolutionary Relationships Among Swine-origin Influenza A (H3N2) NA Genes, 2010-2011 I20T G143R I176M K199R N358D E381Q 02/23/11 2010 SOIV H3N2 SOIV H3N2 SOIV H1N2 Seasonal H3N2 A/Pennsylvania/40/2010 H3N2 A/Wisconsin/12/2010 H3N2 A/Minnesota/09/2010 H3N2 A/swine/Iowa/A01057188/2010 H3N2 A/swine/North Carolina/R08/2008 H3N2 A/Michigan/09/2007 H1N2 N402K A/Kansas/13/2009 H3N2 T71I G143R T153S V307M V313A E344K K369E L370F E381K K385N I409V V412I G414D A/swine/Illinois/53612-1/2009 H3N2 A/swine/Illinois/53612-7/2010 H3N2 A/swine/Illinois/A01057087/2010 H3N2 A/swine/Kansas/03/2009 H3N2 A/swine/Kansas/02/2009 H3N2 A/Iowa/16/2009 H3N2 A/Ontario/1252/2007 H3N2 A/Ontario/RV1273/2005 H3N2 A/swine/Ontario/33853/2005 H3N2 C42Y D147N K199N S372L R400K A/swine/North Carolina/2003 H3N2 A/turkey/OH/313053/2004 H3N2 A/Minnesota/11/2010 H3N2 A/swine/Oklahoma/001142/2009 H3N2 T16I Y40H E41D I62T A/Pennsylvania/14/2010 H3N2 A/swine/Pennsylvania/62170-3/2010 H3N2 A/swine/Pennsylvania/62170-2/2010 H3N2 A/swine/Pennsylvania/62170-4/2010 H3N2 V50A D197N Y284F N329S H336Y A/swine/Pennsylvania/057108-1/2010 H3N2 S367N K369T P386A N402D A/swine/Manitoba/12707/2005 H3N2 A/Wyoming/03/2003 H3N2 A/California/7/2004 H3N2 A/Wisconsin/67/2005 H3N2 A/Brisbane/10/2007 H3N2 A/Victoria/208/2009 H3N2 A/Hawaii/07/2009 H3N2 A/Perth/16/2009 H3N2 A/New York/224/1998 H3N2 A/Sydney/5/1997 H3N2 A/Wuhan/359/1995 H3N2 A/Johannesburg/33/1994 H3N2 0.005 A/Beijing/32/92 H3N2 A/Beijing/353/1989 H3N2

  8. Risk Assessment for S-O A(H3N2) Viruses Is Ongoing • Epi assessment for illness in family members • Serology for family members with ILI at the same time as the index case • Transmissibility in the ferret model • Seroprevalence in different age groups • Development of high growth reassortments • NYMC has developed one vaccine candidate and is working on others

  9. A(H5N1)VirusesSeptember 2010– February 2011

  10. Reported A(H5N1) Activity

  11. A(H5N1) infection in humans Total cases 521 (15) Deaths 307 (7)

  12. 2.3.4 2.3.3 (2005) 2.3.2 2.3.1 (2005) 2.2.1 2.2 2.5 (2004) 2.4 (2005) 2.1 1 9 (2005) 8 6 (2004) 5 (2004) 7 4 (2006) 3 (2001) 0 (2000) A/goose/Guangdong/1/96 0.005 Evolution of Influenza A (H5) Hemagglutinin February 2011 Clades in red represent groups with viruses detected in humans or birds during 2009 and/or 2010 Numbers in parentheses indicate last year of known circulation

  13. PR8 reassortant vaccine viruses CDC HI reference viruses Viruses analyzed at CDC since September 2010 WHO VC meeting *Indicates most recent viruses tested (Oct / Nov 2010 collection dates) Human infections indicated with a red arrow (←) H5N1 – clade 1 1

  14. H5N1 – clade 1

  15. PR8 reassortant vaccine viruses CDC HI reference viruses Viruses analyzed at CDC since September 2010 WHO VC meeting *Indicates most recent viruses tested (Oct / Nov 2010 collection dates) Human infections indicated with a red arrow (←) H5N1 – clade 2.2.1 F E F FC E B A 2.2.1 C D

  16. H5N1 – clade 2.2.1

  17. PR8 reassortant vaccine viruses CDC HI reference viruses Viruses analyzed at CDC since September 2010 WHO VC meeting *Indicates most recent viruses tested (Oct / Nov 2010 collection dates) Human infections indicated with a red arrow (←) H5N1 – clade 2.3.4 2.3.4

  18. H5N1 – clade 2.3.4

  19. PR8 reassortant vaccine viruses CDC HI reference viruses Viruses analyzed at CDC since September 2010 WHO VC meeting *Indicates most recent viruses tested (Oct / Nov 2010 collection dates) Human infections indicated with a red arrow (←) H5N1 – clade 2.3.2 2.3.2

  20. H5N1 – clade 2.3.2

  21. PR8 reassortant vaccine viruses CDC HI reference viruses Viruses analyzed at CDC since September 2010 WHO VC meeting *Indicates most recent viruses tested (Oct / Nov 2010 collection dates) Human infections indicated with a red arrow (←) H5N1 – 7 7

  22. A(H5N1) candidate vaccine viruses

  23. A(H9)Viruses September 2010– February 2011

  24. A/chicken/Ningxia/R13/2009 A/chicken/Shandong/1231/2008 A/swine/Taizhou/5/2008 A/chicken/Shandong/12/2008 A/chicken/Jilin/G12/2009 A/chicken/Yunnandh/101/2008 A/duck/Honghe/111/2009 A/chicken/Guangdong/Y1/2009 A/chicken/Guangdong/G9/2009 A/Hong Kong/3239/2008 A/chicken/Wenshan/412/2009 A/chicken/Shandong/22/2008 A/chicken/Henan/622/2006 A/chicken/Baoshan/111/2009 A/chicken/Baoshan/711/2008 A/chicken/Guangdong/02/2007 A/chicken/Yunnan/qujing09/07 A/chicken/HongKong/TP38/03 A/chicken/Guangdong/1/2002 A/silky chicken/Shantou/4600/2003 A/chicken/Hong Kong/1162-6/2000 A/swine/Guangxi/7/2007 A/chicken/Hong Kong/1453-5/2000 A/swine/Henan/2/2004 A/chicken/Osaka/aq58/2001 A/chicken/Shandong/ZB/2007 A/Shaoguan/408/98 A/Shaoguan/447/98 A/Chicken/Shandong/1/98 A/chicken/Shantou/2098/2000 A/duck/Guangdong/GZ01/2001 A/Quail/Shanghai/8/96 A/chicken/HongKong/NT142/03 A/chicken/Osaka/aq19/2001 A/chicken/HongKong/CSW291/03 A/duck/Fujian/FQ107/2007 A/Duck/Hong Kong/Y280/97 A/chicken/Shandong/2h/2001 A/chicken/Yokohama/aq134/2002 A/Chicken/Jiangsu/2/98 A/chicken/Guangxi/2389/2005 A/LBM/HongKong/1226/99 A/chicken/Osaka/aq69/2001 A/chicken/Shandong/1/2008 A/chicken/Guangxi/521/2005 A/swine/Shandong/fJN/2003 A/chicken/Guangxi/KMIII/1999 A/chicken/Yunnan/522/2002 A/chicken/Guangdong/6/97 A Y280-like (G9) A/Chicken/Hong Kong/G9/97 A/Swine/Hong Kong/10/98 A/Swine/Hong Kong/9/98 A/Chicken/Guangdong/11/97 A/chicken/Hebei/sjz2/2001 A/Chicken/Gansu/1/99 A/chicken/Beijing/ne/1999 A/chicken/Yunnan/nh/2001 A/chicken/Osaka/aq48/97 A/Chicken/Jiangsu/1/99 A/Chicken/Ningxia/5/99 A/chicken/Shijiazhuang/2/98 A/Chicken/Beijing/1/94 A/quail/Shantou/365/2002 A/Guangzhou/333/1999 A/partridge/Shantou/24/2000 ck/Bei-like A/chukkar/Shantou/338/2002 A/quail/Shantou/1780/2003 A/chicken/Hunan/4246/2005 A/Hong Kong/2108/2003 A/chukkar/Shantou/22116/2005 A/Hong Kong/33982/2009 A/Hong Kong/35820/2009 A/chicken/Dubai/339/2001 A/Chicken/Iran/TH77/1998 A/Chicken/Pakistan/4/99 A/ck/Saudi Arabia/EPD-22-01/2002 A/turkey/Israel/89/2005 A/quail/Saudi Arabia/10137-N3/06 A/turkey/Israel/619/2002 A/turkey/NeveIlan/90710/00 A/turkey/Germany/R90/95 A/turkey/Germany/R33/96 A/duck/Hong Kong/Y439/97 A/mallard/Ireland/PV46B/1993 A/pink-footed goose/Netherlands/1/2006 A/Eurasian wigeon/Netherlands/3/2005 A/Eurasian wigeon/Netherlands/4/05 A/Bewicks swan/Netherlands/5/2007 Eurasian A/duck/Viet Nam/68/2001 H9N3 A/duck/VietNam/340/2001 H9N3 A/gadwall/Netherlands/1/2006 A/mallard/Austria/WV1090234/2007 A/teal/Switzerland/WV1070694/2007 A/mallard/Switzerland/WV1080879/2008 A/guinea fowl/Italy/2361/05 A/laughing gull/Delaware/12/2006 A/sanderling/Delaware/449/2006 A/shorebird/Delaware/554/2007 H9N1 A/shorebird/DE/261/2003 H9N5 A/common murre/Oregon/19497-004/05 H9N5 A/chicken/Korea/HC0410/2009 A/duck/Korea/SH0909/2009 A/chicken/Korea/HC09/2009 A/chicken/Korea/SH0802/2008 Korean A/pheasant/Korea/LBM190/2008 A/pheasant/Korea/LBM180/2008 A/chicken/Cheongju/ADL0401/2004 A/swine/Korea/S452/2004 A/Chicken/Korea/38349-p96323/96 A/chicken/Korea/01310/2001 A/duck/Vietnam/NCVD-222/2009 H9N1 A/duck/Vietnam/NCVD-225/2009 A/duck/Vietnam/OIE-2327/2009 Vietnamese A/duck/Vietnam/OIE-2313/2009 A/duck/Vietnam/NCVD-227/2009 A/duck/Vietnam/NCVD-226/2009 A/knot/DE/2552/1987 H9N5 A/laughing gull/Delaware/2718/1987 H9N5 A/ruddy turnstone/DE/2731/1987 H9N1 A/ruddy turnstone/DE/510/1988 H9N6 A/mallard/Alberta/11/1991 A/mallard/Alberta/17/1991 North American A/mallard/Alberta/321/1988 A/turkey/TX/10-49-89/1989 A/mallard/Alberta/743/1983 H9N1 A/goose/MN/5733-1/1980 A/turkey/TX/4-1-81/1981 A/ns/Alaska/8BM3470/2008 A/duck/Hong Kong/168/77 A/duck/Hong Kong/610/79 A/turkey/Hungary/1061/80 Early Eurasian A/Turkey/Pavia/40/83 A/Duck/Hong Kong/784/79 A/duck/Hong Kong/644/79 A/duck/Hong Kong/448/78 A/Shorebird/Delaware/9/96 A/Quail/Arkansas/29209-1/93 Early North American A/Turkey/Minnesota/38391-6/95 A/Turkey/Wisconsin/1/66 0.02 A (H9) Hemagglutinin February 2011 Pre-pandemic vaccine viruses CDC HI reference viruses Human infections indicated with a red arrow (←) ← Viruses tested by HI since September 2010 highlighted in yellow B Y280-like B Y280-like ← ← Ck/Bei ck/Bei A Y280-like (G9) ← Ck/Bei-like ←

  25. A/chicken/Ningxia/R13/2009 A/chicken/Shandong/1231/2008 A/swine/Taizhou/5/2008 A/chicken/Shandong/12/2008 A/chicken/Jilin/G12/2009 A/chicken/Yunnandh/101/2008 A/duck/Honghe/111/2009 A/chicken/Guangdong/Y1/2009 A/chicken/Guangdong/G9/2009 A/Hong Kong/3239/2008 A/chicken/Wenshan/412/2009 A/chicken/Shandong/22/2008 A/chicken/Henan/622/2006 A/chicken/Baoshan/111/2009 A/chicken/Baoshan/711/2008 A/chicken/Guangdong/02/2007 A/chicken/Yunnan/qujing09/07 A/chicken/HongKong/TP38/03 A/chicken/Guangdong/1/2002 A/silky chicken/Shantou/4600/2003 A/chicken/Hong Kong/1162-6/2000 A/swine/Guangxi/7/2007 A/chicken/Hong Kong/1453-5/2000 A/swine/Henan/2/2004 A/chicken/Osaka/aq58/2001 A/chicken/Shandong/ZB/2007 A/Shaoguan/408/98 A/Shaoguan/447/98 A/Chicken/Shandong/1/98 A/chicken/Shantou/2098/2000 A/duck/Guangdong/GZ01/2001 A/Quail/Shanghai/8/96 A/chicken/HongKong/NT142/03 A/chicken/Osaka/aq19/2001 A/chicken/HongKong/CSW291/03 A/duck/Fujian/FQ107/2007 A/Duck/Hong Kong/Y280/97 A/chicken/Shandong/2h/2001 A/chicken/Yokohama/aq134/2002 A/Chicken/Jiangsu/2/98 A (H9) Hemagglutinin February 2011 A/chicken/Guangxi/2389/2005 A/LBM/HongKong/1226/99 A/chicken/Osaka/aq69/2001 A/chicken/Shandong/1/2008 A/chicken/Guangxi/521/2005 A/swine/Shandong/fJN/2003 A/chicken/Guangxi/KMIII/1999 A/chicken/Yunnan/522/2002 A/chicken/Guangdong/6/97 A Y280-like (G9) A/Chicken/Hong Kong/G9/97 A/Swine/Hong Kong/10/98 A/Swine/Hong Kong/9/98 A/Chicken/Guangdong/11/97 A/chicken/Hebei/sjz2/2001 A/Chicken/Gansu/1/99 A/chicken/Beijing/ne/1999 A/chicken/Yunnan/nh/2001 A/chicken/Osaka/aq48/97 A/Chicken/Jiangsu/1/99 A/Chicken/Ningxia/5/99 A/chicken/Shijiazhuang/2/98 A/Chicken/Beijing/1/94 A/quail/Shantou/365/2002 A/avian/Saudi Arabia/910134/2006 A/ck/Saudi Arabia/10136-N3/2006 A/Chicken/Iran/TH186/2007 A/chicken/Tripura/105131/2008 A/Hong Kong/1074/99 A/Quail/Hong Kong/A17/99 A/Hong Kong/1073/99 A/Quail/Hong Kong/G1/97 A/chukkar/Shantou/22116/2005 G1 A/Hong Kong/33982/2009 A/Hong Kong/35820/2009 A/chicken/Dubai/339/2001 A/Chicken/Iran/TH77/1998 A/Chicken/Pakistan/4/99 A/ck/Saudi Arabia/EPD-22-01/2002 A/turkey/Israel/89/2005 A/quail/Saudi Arabia/10137-N3/06 A/turkey/Israel/619/2002 A/turkey/NeveIlan/90710/00 A/turkey/Germany/R90/95 A/turkey/Germany/R33/96 A/duck/Hong Kong/Y439/97 A/mallard/Ireland/PV46B/1993 A/pink-footed goose/Netherlands/1/2006 A/Eurasian wigeon/Netherlands/3/2005 A/Eurasian wigeon/Netherlands/4/05 A/Bewicks swan/Netherlands/5/2007 Eurasian A/duck/Viet Nam/68/2001 H9N3 A/duck/VietNam/340/2001 H9N3 A/gadwall/Netherlands/1/2006 A/mallard/Austria/WV1090234/2007 A/teal/Switzerland/WV1070694/2007 A/mallard/Switzerland/WV1080879/2008 A/guinea fowl/Italy/2361/05 A/laughing gull/Delaware/12/2006 A/sanderling/Delaware/449/2006 A/shorebird/Delaware/554/2007 H9N1 A/shorebird/DE/261/2003 H9N5 A/common murre/Oregon/19497-004/05 H9N5 A/chicken/Korea/HC0410/2009 A/duck/Korea/SH0909/2009 A/chicken/Korea/HC09/2009 A/chicken/Korea/SH0802/2008 Korean A/pheasant/Korea/LBM190/2008 A/pheasant/Korea/LBM180/2008 A/chicken/Cheongju/ADL0401/2004 A/swine/Korea/S452/2004 A/Chicken/Korea/38349-p96323/96 A/chicken/Korea/01310/2001 A/duck/Vietnam/NCVD-222/2009 H9N1 A/duck/Vietnam/NCVD-225/2009 A/duck/Vietnam/OIE-2327/2009 Vietnamese A/duck/Vietnam/OIE-2313/2009 A/duck/Vietnam/NCVD-227/2009 A/duck/Vietnam/NCVD-226/2009 A/knot/DE/2552/1987 H9N5 A/laughing gull/Delaware/2718/1987 H9N5 A/ruddy turnstone/DE/2731/1987 H9N1 A/ruddy turnstone/DE/510/1988 H9N6 A/mallard/Alberta/11/1991 A/mallard/Alberta/17/1991 North American A/mallard/Alberta/321/1988 A/turkey/TX/10-49-89/1989 A/mallard/Alberta/743/1983 H9N1 A/goose/MN/5733-1/1980 A/turkey/TX/4-1-81/1981 A/ns/Alaska/8BM3470/2008 A/duck/Hong Kong/168/77 A/duck/Hong Kong/610/79 A/turkey/Hungary/1061/80 Early Eurasian A/Turkey/Pavia/40/83 A/Duck/Hong Kong/784/79 A/duck/Hong Kong/644/79 A/duck/Hong Kong/448/78 A/Shorebird/Delaware/9/96 A/Quail/Arkansas/29209-1/93 Early North American A/Turkey/Minnesota/38391-6/95 A/Turkey/Wisconsin/1/66 0.02 ← ← G1 ← ← Eurasian Korean Vietnamese North American Early Eurasian Early North American

  26. HI assay of H9 influenza viruses

  27. Vaccine candidate A(H9N2) viruses

  28. Non-H5N1 and non-H9N2 candidate vaccine viruses

  29. Acknowledgements • Influenza Division CDC • Virus Surveillance and Diagnosis Branch • Rebecca Garten • Henrietta Hall • Theresa Wallis • Larisa Gubareva • Xiyan Xu • Alexander Klimov • Immunology and Pathogenesis Branch • Vic Veguilla • Kathy Hancock • Jackie Katz • Molecular Virology and Vaccines Branch • Todd Davis • James Stevens • Ruben Donis • Influenza Sequencing Activity • Catherine Smith • John Barnes • Michael Shaw • State Public Health Laboratories • National Influenza Centers • WHO Collaborating Centers on Influenza • The OFFLU Network, USDA and Many Others

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