FDA H5N1 Update: Classification of H5N1 Viruses and Development of Vaccine Reference Strains FDA H5N1 Update: Classification of H5N1 Viruses and Development.

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FDA H5N1 Update: Classification of H5N1 Viruses and Development of Vaccine Reference Strains FDA H5N1 Update: Classification of H5N1 Viruses and Development of Vaccine Reference Strains Nancy J. Cox, Ph.D. Director, WHO Collaborating Center for Surveillance, Epidemiology and Control of Influenza Centers for Disease Control and Prevention

History of H5N1  Currently 2 discrete lineages of H5 HAs descended from the A/Gs/Guangdong/96 have infected humans  1997 poultry outbreak in Hong Kong 18 human cases, 6 deaths 18 human cases, 6 deaths Direct avian to human transmission: limited H-2-H transmission Direct avian to human transmission: limited H-2-H transmission  2003 ongoing poultry outbreaks and spread 2 human cases, 1 death in Hong Kong 2 human cases, 1 death in Hong Kong 1 death in Beijing (from time of SARS) 1 death in Beijing (from time of SARS)  End of Today 258 human cases, 154 deaths 258 human cases, 154 deaths Azerbaijan, Cambodia, China, Djbouti, Egypt, Indonesia, Iraq, Laos, Nigeria, Thailand, Turkey, Vietnam Azerbaijan, Cambodia, China, Djbouti, Egypt, Indonesia, Iraq, Laos, Nigeria, Thailand, Turkey, Vietnam

Vietnam Cases: 93 Deaths: 42 Thailand Cases: 25 Deaths: 17 Cambodia Cases: 6 Deaths: 6 Indonesia Cases: 81 Deaths: 63 China Cases: 22 Deaths: 14 Turkey Cases: 12 Deaths: 4 Iraq Cases: 3 Deaths: 2 Azerbaijan Cases: 8 Deaths: 5 Egypt Cases: 22 Deaths: 13 Influenza A (H5N1) in Humans, * * December 2003 – February cases and 167 deaths Djibouti Cases: 1 Deaths: 0

WHO H5N1 Vaccine Development: Principles and Practices  Development of H5N1 vaccines is one component of WHO’s overall strategy for pandemic preparedness  WHO’s 4 Collaborating Centers for Influenza Reference and Research along with 4 additional H5 Reference Laboratories share H5N1 antigenic and genetic data frequently  WHO convenes periodic teleconferences of H5 Reference Laboratory representatives to discuss data and apportion tasks required for vaccine candidate reference virus production  Development of appropriate H5N1 vaccines requires integration of antigenic, genetic and epidemiologic data from human and veterinary health sectors  H5N1 vaccine candidate reference viruses are chosen on the basis of antigenic and genetic properties and epidemiologic information

Circulation of H5N1 Viruses  HA sequences of the majority of H5N1 viruses in avian species segregate into 2 distinct phylogenetic clades  Clade 1 viruses circulated in Cambodia, Thailand and Viet Nam and caused human infections during 2004 and and in Thailand in 2006  Clade 2 viruses circulated in birds in China and Indonesia during 2003–2004 and spread westward during 2005 and 2006 to the Middle East, Europe and Africa  Clade 2 viruses have caused the majority of human Infections since late 2005  Multiple sub-clades of clade 2 have been distinguished, three of which (subclades 2.1, 2.2 and 2.3) have been responsible for human cases and differ in geographical distribution

H5N1 Current Status (Late 2005 to the Present)  The majority of H5N1 viruses detected in avian species in Africa, Asia and Europe and associated with sporadic human infections are in Clade 2  Clade 2.1 viruses circulated in poultry and caused human infections in Indonesia; clade 2.2 viruses caused outbreaks in birds in Africa, Asia and Europe and were most recently associated with human infections in Egypt and Nigeria; viruses in clade 2.3 caused poultry outbreaks and human cases in China  Viruses outside this classification nomenclature were isolated from domestic poultry in Asia – two emerging clades are represented by A/goose/Guiyang/337/06 and A/chicken/Shanxi/2/2006 viruses

Hong Kong/156/97 Vietnam/JP14/05 ck/Cambodia/013LC1b/05 Vietnam/1194/04 Vietnam/1203/04 Vietnam/HN30408/05 Thailand/16/04 Vietnam/JPHN30321/05 Clade 1 Hong Kong/213/03 Indonesia/CDC523/06 Indonesia/CDC699/06 Indonesia/CDC326/06 Indonesia/5/05 Indonesia/CDC184/05 Indonesia/7/05 dk/KulonProgoBBVET9/04 ck/Indonesia/CDC25/05 Indonesia/6/05 ck/Brebes/BBVET2/05 Indonesia/CDC594/06* ck/Dairi/BPPVI/05 Clade 2 Subclade 1 ck/Yunnan/374/04 ck/Yunnan/115/04 ck/Yunnan/493/05 ck/Yunnan/447/05 dk/Guangxi/13/04 ck/Guangxi/12/04 whooping swan/Mongolia/244/05 bar headed gs/Qinghai/1A/05 * Turkey/65596/06 Turkey/15/06 Iraq/207NAMRU3/06 ck/Nigeria/641/06 mld/Italy/332/06 turkey/Turkey/1/05 Egypt/2782NAMRU3/06 Djibouti/5691NAMRU3/06 ck/Nigeria42/06 migratory dk/Jiangxi/2136/05 gs/Kazakhstan/464/05 ck/Krasnodar/01/06 Azerbaijan/011162/06 swan/Iran/754/06 Clade 2 Subclade 2 dk/Laos3295/06 Anhui/1/05 Anhui/2/05 Japanese white-eye/Hong Kong/1038/06 ck/Malaysia935/06 Vietnam/30850/05 Guangxi/1/05 dk/Hunan/15/04 qa/Guangxi/575/05 dk/Vietnam/Ncvdcdc95/05 Clade 2 Subclade 3 migratory dk/Jiangxi/1653/05 gs/Guangdong/1/96 * Karo cluster Indonesia/CDC625/06* H5 HA

HI Reactions of Influenza H5 Viruses 1 A/VIETNAM/1194/04 2 A/VIETNAM/1203/04 3 A/THAILAND/16/04 4 A/INDONESIA/5/05 RG 5 A/INDONESIA/CDC357/06 6 A/INDONESIA/CDC625/06* 7 A/TURKEY/15/05 8 A/w.swan/MG/244/05 RG 9 A/b-h gs/QINGHAI/1/05 RG 10 A/turkey/TURKEY/1/05 11 A/duck/HUNAN/15/04 12 A/ANHUI/1/05 13 A/GUANGXI/1/ nd 80 nd 80 nd 160 < nd nd 160 < <10 10 <10 nd <10 20 nd < nd 20 <10 10 nd nd nd < nd <10 10 <10 20 < <10 10 < <20 nd 40 nd nd nd 160 nd 10 < nd nd nd 160 A/VN/1194/04A/VN/1203/04 A/TH/16/04 A/INDO/5/05A/INDO/357/06A/INDO/625/06 A/TURKEY/15/05A/ws/MG/244/05A/bhg/QINGHAI/1/05 A/ty/TURKEY/1/05A/dk/HUNAN/15/04 A/ANHUI/1/05 A/GUANGXI/1/05 Reference Ferret Antisera Clade 2-1 Clade 2-2 Clade 2-3 Clade 1

HI Reactions of Influenza H5 Viruses Reference Ferret Antisera 1 A/VIETNAM/1203/04 * 2 A/THAILAND/16/04 3A/INDONESIA/5/05 * 4A/INDONESIA/357/06 5A/w.swan/MG/244/05 6 A/b-h gs/QINGHAI/1/05 7A/ANHUI/1/05 * 8A/GUANGXI/1/ < VN < <10 20 TH1604 < INDO505 < INDO35706 < <10 wsMG QINGHAI05 10 < ANHUI GUANGXI05 HK/156/97 Vietnam/1194/04 Vietnam/1203/04 1 HK/213/03 Indonesia/5/ w. swan/Mongolia/244/05 b.h.gs/Qinghai/1A/05 ty/Turkey/1/ Anhui/1/ gs/Guangdong/1/96

Hong Kong/156/97 Vietnam/1194/04 Vietnam/1203/04 Clade 1 Hong Kong/213/03 Indonesia/5/05 Clade 2-3 whooping swan/Mongolia/244/05 bar headed gs/Qinghai/1A/05 * turkey/Turkey/1/05 Anhui/1/05 gs/Guangdong/1/96 Resistant Asn-31 Sensitive Ser-31 Clade 2-1 ~80% resistant Asn-31 or Ala-27 Clade 2-2 Sensitive Ser-31 H5N1 Virus Resistance to M2 Channel Blockers

Hong Kong/156/97 Vietnam/1194/04 Vietnam/1203/04 Clade 1 Hong Kong/213/03 Indonesia/5/05 Clade 2-3 whooping swan/Mongolia/244/05 bar headed gs/Qinghai/1A/05 * turkey/Turkey/1/05 Anhui/1/05 gs/Guangdong/1/96 Sensitive Several resistant mutants isolated from treated patients Sensitive Clade 2-1 Sensitive Clade 2-2 Generally Sensitive - but moderately resistant viruses detected H5N1 Resistance to Neuraminidase Inhibitors

HI REACTIONS OF INFLUENZA H5 VIRUSES

? ck/Shannxi/62/04 ck/Yunnan/447/05|ck/Yunnan/493/05 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 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 ck/Myanmar/ B/06 ck/Yunnan/71/05 ck/Guiyang/237/06 gs/Guiyang/1325/06 dk/Guiyang/50406 gs/Fujian/bb/03 gs/Vietnam/GZ-3/05 Hong Kong/156/97 gs/Guangdong/1/96 Candidate Vaccine Reference Viruses Clade 2.1 Clade 2.2 Clade 2.3 Clade 1 Evolution of the H5N1 Hemagglutinin Gene New subgroup

Conclusions  H5N1 viruses remain a pandemic threat but have not yet developed to the ability to be transmitted efficiently from person-to-person  It is not able to predict which if any of the H5N1 antigenic/genetic variants might acquire the ability to be transmitted efficiently  Distinct geographical distribution of H5N1 genetic and antigenic variants have been identified  In this instance, specific WHO pre-pandemic vaccine recommendations are not appropriate because it is not possible to predict which of the viruses in the distinct antigenic/genetic groups might acquire the ability to become efficiently transmissible

Availability of Vaccine Viruses and Reagents  rg A/Viet Nam/1203/2004 (Clade 1) – available from St. Jude CRH Antigen and sheep serum available from CBER Antigen and sheep serum available from CBER  rg A/Viet Nam/1194/2004 (Clade 1) – available from NIBSC Antigen and sheep serum available from NIBSC Antigen and sheep serum available from NIBSC  rg A/Indonesia/05/2005 (Clade 2.1) – available from CDC Antigen and sheep serum - available soon from CBER Antigen and sheep serum - available soon from CBER  rg A/Turkey/turkey/1/2005 (Clade 2.2) – available from NIBSC Antigen and sheep serum available from NIBSC Antigen and sheep serum available from NIBSC  rg A/BHG/Qinghai Lake/1A/05 (Clade 2.2) – available from St. Jude Reagents not yet in production Reagents not yet in production  rg A/whooper swan/Mongolia/244/2005 (Clade 2.2) – available for research Reagents not in production Reagents not in production  rg A/Anhui/1/05 (Clade 2.3) – available from CDC Reagents not yet in production Reagents not yet in production

Acknowledgements  WHO National Influenza Centers  WHO Collaborating Centers and Regulatory Authorities in London, Tokyo, Melbourne, Canberra, and Memphis  WHO H5 Reference Laboratories  WHO Regional Offices  WHO Headquarters in Geneva  Many colleagues in Azerbaijan, Cambodia, China, Djibouti, Egypt, Indonesia, Iraq, Nigeria, Thailand, Turkey, Vietnam and other affected countries  Ministries of Agriculture in affected countries and FAO and OIE members  Members of the Influenza Division, CDC

Thank You