INFORMATION FOR THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER, FDA (Swine and Avian Influenza) FEBRUARY 25, 2011 Nancy J. Cox, Ph.D.

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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

Swine-Origin Influenza A Viruses, 2009 –2011

Zoonotic infections with swine influenza viruses in subtypelineagelocationnumber of cases H3N2Triple reassortantUSA7 H1N1Eurasian avian-likeSwitzerland2 H1N1Eurasian avian-likeChina1

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

Hemagglutination Inhibition Reactions of Influenza A(H3N2) Viruses

02/23/ SOIV H3N2 SOIV H3N2 Seasonal H3N2 Evolutionary Relationships Among Swine-origin Influenza A(H3N2) HA Genes, A/Minnesota/11/2010 H3N2 A/Wisconsin/12/2010 H3N2 A/Pennsylvania/40/2010 H3N2 A/Minnesota/09/2010 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 A/swine/Missouri/02980/2010 H3N2 A/swine/Kansas/02/2009 H3N2 A/swine/Minnesota/02981/2010 H3N2 A/swine/Pennsylvania/ /2010 H3N2 A/Pennsylvania/14/2010 H3N2 A/swine/Pennsylvania/ /2010 H3N2 A/swine/Pennsylvania/ /2010 H3N2 A/swine/Manitoba/12707/2005 H3N2 A/Iowa/16/2009 H3N2 A/Ontario/1252/2007 H3N2 A/Ontario/RV1273/2005 H3N2 A/swine/Ontario/33853/2005 H3N2 A/swine/Iowa/A /2010 H3N2 A/swine/Illinois/03041/2010 H3N2 A/swine/North Carolina/R08/2008 H3N2 A/swine/Illinois/ /2010 H3N2 A/swine/Illinois/A /2010 H3N2 A/swine/Illinois/03040/2010 H3N2 A/Kansas/13/2009 H3N2 A/swine/Illinois/ /2009 H3N2 A/swine/Illinois/02945/2010 H3N2 A/swine/Iowa/03017/2010 H3N2 A/turkey/Ohio/313053/2004 H3N2 A/swine/Oklahoma/001142/2009 H3N2 A/swine/Pennsylvania/ /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 A/Amsterdam/4112/1992 H3N2 A/Victoria/7/1987 H3N N6S T10M N53D G78D K122Q G124S G142G/E/K K145N S189R/K N31D R229I D101Y K140R K156N E158D/N S186G S193N R261Q M10T A106V S124N H155Y K173N V196I N278K A304V S107T H155Y A163E T203I T117N L164Q N276E R299K P273H

02/23/ SOIV H3N2 SOIV H3N2 SOIV H1N2 Seasonal H3N2 Evolutionary Relationships Among Swine-origin Influenza A (H3N2) NA Genes, A/Pennsylvania/40/2010 H3N2 A/Wisconsin/12/2010 H3N2 A/Minnesota/09/2010 H3N2 A/swine/Iowa/A /2010 H3N2 A/swine/North Carolina/R08/2008 H3N2 A/Michigan/09/2007 H1N2 A/Kansas/13/2009 H3N2 A/swine/Illinois/ /2009 H3N2 A/swine/Illinois/ /2010 H3N2 A/swine/Illinois/A /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 A/swine/North Carolina/2003 H3N2 A/turkey/OH/313053/2004 H3N2 A/Minnesota/11/2010 H3N2 A/swine/Oklahoma/001142/2009 H3N2 A/Pennsylvania/14/2010 H3N2 A/swine/Pennsylvania/ /2010 H3N2 A/swine/Pennsylvania/ /2010 H3N2 A/swine/Pennsylvania/ /2010 H3N2 A/swine/Pennsylvania/ /2010 H3N2 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 A/Beijing/32/92 H3N2 A/Beijing/353/1989 H3N T16I Y40H E41D I62T V50A D197N Y284F N329S H336Y S367N K369T P386A N402D C42Y D147N K199N S372L R400K T71I G143R T153S V307M V313A E344K K369E L370F E381K K385N I409V V412I G414D N402K I20T G143R I176M K199R N358D E381Q

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

A(H5N1) Viruses September 2010– February 2011

Country, area or territoryHostGenetic clade BangladeshPoultryunknown CambodiaPoultry Human 1111 China, Hong Kong SARWild birds Human Poultry (chicken carcass) Egypt Poultry Humans2.2.1 IndonesiaPoultry2.1.3 Human2.1.2 JapanWild birds Poultry Republic of KoreaWild birds Poultry MyanmarPoultry2.3.4 NepalPoultry2.3.2 Viet NamPoultry2.3.2, Reported A(H5N1) Activity

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

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

H5N1 – clade 1 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 (←) 1

H5N1 – clade 1

H5N1 – clade D A F B E FC 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 (←) F C E

H5N1 – clade 2.2.1

H5N1 – clade 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

H5N1 – clade 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 (←) 2.3.2

H5N1 – clade 2.3.2

H5N1 – 7 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 (←) 7

A(H5N1) candidate vaccine viruses Candidate vaccine virusesCladeInstitution*Availability A/Cambodia/R / NIBSCYes A/Viet Nam/1203/20041CDC and SJ/HKUYes A/Viet Nam/1194/20041NIBSCYes A/duck/Hunan/795/ SJ/HKUYes A/Indonesia/5/ CDCRequires Indonesian permission A/bar-headed goose/Qinghai/1A/ SJ/HKU Yes A/chicken/India/NIV33487/ CDC/NIVYes A/whooper swan/Mongolia/244/ SJ Yes A/Egypt/3300-NAMRU3/ CDC Yes A/Egypt/2321-NAMRU3/ CDC Yes A/turkey/Turkey/1/ NIBSCYes A/common magpie/Hong Kong/5052/ SJ/HKUYes A/Anhui/1/ CDCYes A/duck/Laos/3295/ FDAYes A/japanese white eye/Hong Kong/1038/ SJ/HKUYes A/goose/Guiyang/337/20064SJ/HKUYes A/chicken/Viet Nam/NCVD-016/20087CDC Yes Reassortants prepared and awaiting regulatory approvalCladeInstitution*Availability A/chicken/Hong Kong/AP156/ SJ/HKUMarch 2011 A/chicken/Viet Nam/NCDV-03/20087CDCPending Viruses proposed by WHO for candidate vaccine preparation CladeInstitution* A/Egypt/N03072/2010 # A/Hubei/1/2010-like A/barn swallow/Hong Kong/D /2010-like CDC SJ/HKU

A(H9) Viruses September 2010– February 2011

Viruses tested by HI since September 2010 highlighted in yellow Pre-pandemic vaccine viruses CDC HI reference viruses Human infections indicated with a red arrow (←) A (H9) Hemagglutinin February 2011 B Y280-like ck/Bei ← ← ← ← ← A Y280-like (G9) Ck/Bei-like B Y280-like Ck/Bei

← ← ← ← A (H9) Hemagglutinin February 2011 G1 Early North American Early Eurasian Korean Vietnamese Eurasian North American

HI assay of H9 influenza viruses

Vaccine candidate A(H9N2) viruses Available Vaccine Viruses VirusTypeCladeInstitution*Availability A/Hong Kong/1073/99Wild typeG1NIBSCYes A/chicken/Hong Kong/G9/97 (NIBRG-91) Reverse geneticsY280/G9NIBSCYes A/chicken/Hong Kong/G9/97 (IBCDC-2)ConventionalY280/G9CDCYes Reassortant prepared and awaiting regulatory approval VirusTypeCladeInstitution*Availability A/Hong Kong/33982/2009 (IBCDC-RG26) Reverse genetics G1CDCMay 2011

InstitutionVaccine strainStrainSubtype NIBSC CDC St Jude CDC St Jude NIBSC wt NIBRG-60 NIBRG-63 IBCDC-1 rg IBCDC-5 rg NIBRG-109 A/turkey/Italy/3889/99 (H7N1) (low path) A/mallard/Netherlands/12/2000 (H7N3) A/mallard/Netherlands/12/2000 (H7N1) A/mallard/Netherlands/12/2000 (H7N3)* A/Netherlands/219/2003 (H7N7) A/Turkey/Virginia/2002 (H7N2)* A/Canada/rv444/2004 (H7N3) A/New York/107/2003 (H7N2) H7 NIBSC NIBRG-107 NIBRG-147 A/mallard/England/727/2006 (H2N3) A/Singapore/1/57 (H2N2) H2 CDC NIBSC IBCDC-4 ARIV-1 A/pheasant/NJ/135/98 (H5N2) A/duck/Singapore-Q/F119-3/17 (H5N3)* H5 NIBSCNIBRG-196A/swine/Iowa/15/30H1 Non-H5N1 and non-H9N2 candidate vaccine viruses

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