FDA H5N1 Update: FDA H5N1 Update: Classification of H5N1 Viruses Classification of H5N1 Viruses and Development of Vaccine and Development of Vaccine Reference Strains Reference Strains Nancy J. Cox, Ph.D. Nancy J. Cox, Ph.D. Director, WHO Collaborating Center for Director, WHO Collaborating Center for Surveillance, Epidemiology and Control Surveillance, Epidemiology and Control of Influenza of Influenza Centers for Disease Control and Centers for Disease Control and Prevention Prevention
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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.
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FDA H5N1 Update:FDA H5N1 Update:Classification of H5N1 Viruses and Classification of H5N1 Viruses and
Development of Vaccine Development of Vaccine Reference StrainsReference Strains
Nancy J. Cox, Ph.D.Nancy J. Cox, Ph.D.
Director, WHO Collaborating Center for Director, WHO Collaborating Center for Surveillance, Epidemiology and Control of Surveillance, Epidemiology and Control of
InfluenzaInfluenza
Centers for Disease Control and PreventionCenters for Disease Control and Prevention
History of H5N1History of H5N1
Currently 2 discrete lineages of H5 HAs descended from Currently 2 discrete lineages of H5 HAs descended from the A/Gs/Guangdong/96 have infected humansthe A/Gs/Guangdong/96 have infected humans
1997 poultry outbreak in Hong Kong1997 poultry outbreak in Hong Kong• 18 human cases, 6 deaths18 human cases, 6 deaths• Direct avian to human transmission: limited H-2-H Direct avian to human transmission: limited H-2-H
transmissiontransmission 2003 ongoing poultry outbreaks and spread2003 ongoing poultry outbreaks and spread
• 2 human cases, 1 death in Hong Kong2 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 2003 - TodayEnd of 2003 - Today• 258 human cases, 154 deaths258 human cases, 154 deaths
Influenza A (H5N1) in Humans, 2003-07Influenza A (H5N1) in Humans, 2003-07**
*December 2003 – February 2007
275 cases and 167 deaths
DjiboutiCases: 1Deaths: 0
WHO H5N1 Vaccine WHO H5N1 Vaccine Development: Principles and Development: Principles and
PracticesPractices Development of H5N1 vaccines is one component of WHO’s overall Development of H5N1 vaccines is one component of WHO’s overall
strategy for pandemic preparednessstrategy for pandemic preparedness
WHO’s 4 Collaborating Centers for Influenza Reference and WHO’s 4 Collaborating Centers for Influenza Reference and Research along with 4 additional H5 Reference Laboratories share Research along with 4 additional H5 Reference Laboratories share H5N1 antigenic and genetic data frequentlyH5N1 antigenic and genetic data frequently
WHO convenes periodic teleconferences of H5 Reference WHO convenes periodic teleconferences of H5 Reference Laboratory representatives to discuss data and apportion tasks Laboratory representatives to discuss data and apportion tasks required for vaccine candidate reference virus productionrequired for vaccine candidate reference virus production
Development of appropriate H5N1 vaccines requires integration of Development of appropriate H5N1 vaccines requires integration of antigenic, genetic and epidemiologic data from human and antigenic, genetic and epidemiologic data from human and veterinary health sectorsveterinary health sectors
H5N1 vaccine candidate reference viruses are chosen on the basis H5N1 vaccine candidate reference viruses are chosen on the basis of antigenic and genetic properties and epidemiologic informationof antigenic and genetic properties and epidemiologic information
Circulation of H5N1 Viruses Circulation of H5N1 Viruses
HA sequences of the majority of H5N1 viruses in avian species HA sequences of the majority of H5N1 viruses in avian species segregate into 2 distinct phylogenetic cladessegregate into 2 distinct phylogenetic clades
Clade 1 viruses circulated in Cambodia, Thailand and Viet Nam Clade 1 viruses circulated in Cambodia, Thailand and Viet Nam and caused human infections during 2004 and 2005 -and in and caused human infections during 2004 and 2005 -and in Thailand in 2006Thailand in 2006
Clade 2 viruses circulated in birds in China and Indonesia Clade 2 viruses circulated in birds in China and Indonesia during 2003–2004 and spread westward during 2005 and 2006 during 2003–2004 and spread westward during 2005 and 2006 to the Middle East, Europe and Africa to the Middle East, Europe and Africa
Clade 2 viruses have caused the majority of human Infections Clade 2 viruses have caused the majority of human Infections since late 2005since late 2005
Multiple sub-clades of clade 2 have been distinguished, three Multiple sub-clades of clade 2 have been distinguished, three
of which (subclades 2.1, 2.2 and 2.3) have been responsible for of which (subclades 2.1, 2.2 and 2.3) have been responsible for human cases and differ in geographical distributionhuman cases and differ in geographical distribution
H5N1 Current Status (Late 2005 H5N1 Current Status (Late 2005 to the Present)to the Present)
The majority of H5N1 viruses detected in avian species in The majority of H5N1 viruses detected in avian species in Africa, Asia and Europe and associated with sporadic Africa, Asia and Europe and associated with sporadic human infections are in Clade 2human infections are in Clade 2
Clade 2.1 viruses circulated in poultry and caused human Clade 2.1 viruses circulated in poultry and caused human infections in Indonesia; clade 2.2 viruses caused outbreaks infections in Indonesia; clade 2.2 viruses caused outbreaks in birds in Africa, Asia and Europe and were most recently in birds in Africa, Asia and Europe and were most recently associated with human infections in Egypt and Nigeria; associated with human infections in Egypt and Nigeria; viruses in clade 2.3 caused poultry outbreaks and human viruses in clade 2.3 caused poultry outbreaks and human cases in China cases in China
Viruses outside this classification nomenclature were Viruses outside this classification nomenclature were isolated from domestic poultry in Asia – two emerging isolated from domestic poultry in Asia – two emerging clades are represented by A/goose/Guiyang/337/06 and clades are represented by A/goose/Guiyang/337/06 and A/chicken/Shanxi/2/2006 virusesA/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 2Subclade 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 *
ConclusionsConclusions H5N1 viruses remain a pandemic threat but have not yet H5N1 viruses remain a pandemic threat but have not yet
developed to the ability to be transmitted efficiently from developed to the ability to be transmitted efficiently from person-to-personperson-to-person
It is not able to predict which if any of the H5N1 It is not able to predict which if any of the H5N1 antigenic/genetic variants might acquire the ability to be antigenic/genetic variants might acquire the ability to be transmitted efficientlytransmitted efficiently
Distinct geographical distribution of H5N1 genetic and Distinct geographical distribution of H5N1 genetic and antigenic variants have been identifiedantigenic variants have been identified
In this instance, specific WHO pre-pandemic vaccine In this instance, specific WHO pre-pandemic vaccine recommendations are not appropriate because it is not recommendations are not appropriate because it is not possible to predict which of the viruses in the distinct possible to predict which of the viruses in the distinct antigenic/genetic groups might acquire the ability to become antigenic/genetic groups might acquire the ability to become efficiently transmissibleefficiently transmissible
Availability of Vaccine Viruses and Availability of Vaccine Viruses and ReagentsReagents
rg A/Viet Nam/1203/2004 (Clade 1) – available from St. Jude CRHrg A/Viet Nam/1203/2004 (Clade 1) – available from St. Jude CRH• Antigen and sheep serum available from CBERAntigen and sheep serum available from CBER
rg A/Viet Nam/1194/2004 (Clade 1) – available from NIBSCrg A/Viet Nam/1194/2004 (Clade 1) – available from NIBSC• Antigen and sheep serum available from NIBSCAntigen and sheep serum available from NIBSC
rg A/Indonesia/05/2005 (Clade 2.1) – available from CDCrg A/Indonesia/05/2005 (Clade 2.1) – available from CDC• Antigen and sheep serum - available soon from CBERAntigen and sheep serum - available soon from CBER
rg A/Turkey/turkey/1/2005 (Clade 2.2) – available from NIBSCrg A/Turkey/turkey/1/2005 (Clade 2.2) – available from NIBSC• Antigen and sheep serum available from NIBSCAntigen and sheep serum available from NIBSC
rg A/BHG/Qinghai Lake/1A/05 (Clade 2.2) – available from St. Juderg A/BHG/Qinghai Lake/1A/05 (Clade 2.2) – available from St. Jude• Reagents not yet in productionReagents not yet in production
rg A/whooper swan/Mongolia/244/2005 (Clade 2.2) – available for rg A/whooper swan/Mongolia/244/2005 (Clade 2.2) – available for researchresearch• Reagents not in productionReagents not in production
rg A/Anhui/1/05 (Clade 2.3) – available from CDCrg A/Anhui/1/05 (Clade 2.3) – available from CDC• Reagents not yet in productionReagents not yet in production
AcknowledgementsAcknowledgements
WHO National Influenza CentersWHO National Influenza Centers WHO Collaborating Centers and Regulatory WHO Collaborating Centers and Regulatory
Authorities in London, Tokyo, Melbourne, Canberra, Authorities in London, Tokyo, Melbourne, Canberra, and Memphisand Memphis
WHO H5 Reference LaboratoriesWHO H5 Reference Laboratories WHO Regional OfficesWHO Regional Offices WHO Headquarters in GenevaWHO Headquarters in Geneva Many colleagues in Azerbaijan, Cambodia, China, Many colleagues in Azerbaijan, Cambodia, China,
Djibouti, Egypt, Indonesia, Iraq, Nigeria, Thailand, Djibouti, Egypt, Indonesia, Iraq, Nigeria, Thailand, Turkey, Vietnam and other affected countriesTurkey, Vietnam and other affected countries
Ministries of Agriculture in affected countries and Ministries of Agriculture in affected countries and FAO and OIE membersFAO and OIE members
Members of the Influenza Division, CDCMembers of the Influenza Division, CDC