Influenza Branch VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER, FDA February 16-17, 2005, Bethesda, MD Nancy COX, Ph.D. WHO COLLABORATING.

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Influenza Branch VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER, FDA February 16-17, 2005, Bethesda, MD Nancy COX, Ph.D. WHO COLLABORATING CENTER FOR SURVEILLANCE, EPIDEMIOLOGY AND CONTROL OF INFLUENZA Influenza Branch Division of Viral and Rickettsial Diseases National Center for Infectious Diseases Centers for Disease Control and Prevention Atlanta, GA 30333

Influenza Branch Influenza A(H5N1) December 2003 – February 2005 H5N1 –outbreaks in birds reported H5N1 – outbreaks in birds and humans H5N1 –outbreaks in birds, controlled and final report submitted to OIE

Influenza Branch Human H5N1 Cases, Country H5N1 Cases Deaths Case Fatality Cambodia11100% Thailand171271% Vietnam372978% Total554276%  High case fatality regardless of age  Clinical symptoms similar to earlier cases, including lymphopenia  Diarrhea prominent in some cases  Second wave of infections in Aug 2004-present  Thai family cluster; probable H-to-H transmission

Influenza Branch HK/213/03 CK/KOR/ES/03 HK/97 TH/353/04 VN/1203/04 VN/1194/ ND 20 <10 HK/213/03 CK/KO/ <10 <10 <10 HK/97 VN/1203/03 Antigenic Characterization of H5N1 Influenza Viruses VIRUSES FERRET H5N1 ANTISERA

Influenza Branch  Avian influenza viruses can pose a major risk to global public health (H5N1, H7N7, H9N2, etc.)  Early detection H-2-H transmission of novel influenza viruses is essential  2003/05 Asian viruses are heterogeneous in AV susceptibility and pathogenicity; more lethal in mammals than 1997 strains  Ongoing vaccine development, antiviral stockpiling and pandemic preparedness  Surveillance in animals (birds, swine and other susceptible hosts) is critical  Research agenda needed to enhance our understanding of the genesis of pandemic influenza viruses  Global recognition of need for better communication between human and veterinary health authorities Conclusions

Influenza Branch Influenza: An Emerging Disease that Rolls On

Influenza Branch InfluenzaVirusIsolates Characterized by CDC andOtherWHO Collaborating Centers and Laboratories * (October 2004– February 2005) North America Europe Asia Cent/So America Africa, Oceania Total (%) A(H1N1) (8%) A(H3N2) (75%) B/Yamagata (14%) B/Victoria (3%) Total Preliminary Data 02/14/2005 * Data based on cumulative influenza virus isolates antigenic characterization data provided by WHO Collaborating Centers in Atlanta,London, Melbourne, Tokyo, reports from European Influenza Surveillance Scheme and National Influenza Center, Canada

Influenza Branch Influenza A(H1N1)

Influenza Branch HEMAGGLUTINATION INHIBITION REACTIONS OF INFLUENZA H1 VIRUSES REFERENCE FERRET ANTISERA Date REFERENCE ANTIGENSBJ/262NC/20FUJ/156NEI/52CI/8885PE/3135collectedPassage 1A/BEIJING/262/ /09/95E3/E3 2A/N. CALEDONIA/20/99 * /09/99E4/E2 3A/FUJIAN/156/ /25/00E2/E2 4A/NEIMENGGU/52/ /25/02E2/E4 5A/CHILE/8885/ /03/02E1/E4 6 7 A/PERU/3135/ /09/03X/C3 TEST ANTIGENS 8 A/FLORIDA/04/2004 * /20/04X1/C1 9 A/FLORIDA/03/ /09/04X2/C1 10 A/PRACHINBURI/1749/ /18/04C1/C1 11 A/BANGKOK/1757/ /20/04C1/C1 12 A/PRACHINBURI/1817/ /23/04C1/C1 13 A/BANGKOK/1876/ /27/04C1/C1 14 A/SUPHANBURI/2131/ /04/04C1/C1 15 A/BANGKOK/1752/ /20/04C1/C1 16 A/SUPHANBURI/2130/ /04/04C1/C1 17 A/BANGKOK/1822/ /23/04C1/C1 18 A/RATCHABURI/1847/ /24/04C1/C1 19 A/BANGKOK/1544/2004 * /31/04E3/E1 20 A/SUPHANBURI/2129/ /04/04C1/C1 21 A/SAKAEW/2132/ /04/04C1/C1 22 A/SINGAPORE/14/ /31/04E4/E1 23 A/N. CALEDONIA/9/ /11/04E2/E1 24 A/N. CALEDONIA/3/ /19/04E2/E1 25 A/MALAYSIA/1513/ /10/04E2/E1 26 A/HONG KONG/4555/ /25/04C2/C1 27 A/HONG KONG/4580/ /08/04C2/C1 A/HONG KONG/4596/ /25/04C2/C1 * Serology antigens

Influenza Branch Influenza A(H1) Isolates Characterized by CDC

Influenza Branch Evolutionary Relationships Among Influenza A(H1) HA Genes 0 5 nucleotides (LR) Low reactor in HI # - Egg Isolate * Serology Antigen Jan-Feb-Mar Apr-May-Jun Jul-Aug-Sep Oct-Nov-Dec Date Collected

Influenza Branch Evolutionary Relationships Among Influenza N1 NA Genes Nucleotides *Serology antigen (LR) Low reaction to HI # Egg isolate 0 Scale 3

Influenza Branch HI Antibody Response to Vaccine (adults) % w/HI titer >40 Sera N Antigen % Rise Pre GMT Post GMT Pre Vaccine Post Vaccine 30 A/New Caledonia/20/ A/Bangkok/1544/ A/Florida/04/ Japan 30 A/Netherlands/128/ A/New Caledonia/20/ A/Bangkok/1544/ A/Florida/04/ USA 25 A/Netherlands/128/

Influenza Branch H1 Summary: October 2004 to February 2005  Relatively few H1 viruses have been detected worldwide  The majority of H1N1 viruses were closely related antigenically to the A/New Caledonia/20/99 vaccine strain and no significant variants of H1N1 viruses were detected  No H1N2 viruses were detected  N1 neuraminidase genes of recent H1 viruses were similar to those of viruses isolated prior to October 2004

Influenza Branch Influenza A(H3N2)

Influenza Branch HEMAGGLUTINATION INHIBITION REACTIONS OF INFLUENZA H3 VIRUSES STRAIN DESIGNATIONREFERENCE FERRET ANTISERA Date REFERENCE ANTIGENSWY/3WEL/01ND/01CA/7SN/37collectedPassage 1 A/WYOMING/03/2003 X-147 * /13/03X/E1 2 A/WELLINGTON/01/2004 * /26/04E3/E2 3 A/NORTH DAKOTA/01/ /20/04SpfCK1E4 4 A/CALIFORNIA/07/2004 * /16/04SpfCK1E A/SINGAPORE/37/ /7/2004E4/E1 TEST ANTIGENS 8 A/KENTUCKY/6e/ /27/04SpfC1KE3 9 A/NEW YORK/57/ /28/04X2/C1 10 A/VIRGINIA/02/ /06/05M1/C1 11 A/WISCONSIN/21e/ /29/04SpfCK3E3 12 A/NEW YORK/39e/ /09/04SpfCK2E4 13 A/NEW YORK/02/ /05/05X1/C1 14 A/NEW YORK/03/ /03/05X1/C1 15 A/TEXAS/12/ /29/04M1/C1 16 A/MASSACHUSETTS/01/ /05/05M1/C1 17 A/ALASKA/16/ /12/04X/C1 18 A/NEW YORK/55e/ /18/04SpfCK2E2 19 A/N. HAMPSHIRE/04/ /27/04X/C1 20 A/WISCONSIN/16e/ /22/04SpfCK3E2 21 A/WEST VIRGINIA/01/ /05/05C1/C1 22 A/VIRGINIA/03/ /07/05M1/C1 23 A/ARIZONA/03/ /05/05M2/C1 24 A/GEORGIA/01/ /06/05M1/C1 25 A/CANADA/707/ /16/04X1/C1 26 A/VICTORIA/523/ /03/04E5/E1 27 A/MADRID/RR1734/ /01/04C1/C1 28 A/UNITED KINGDOM/305/ /05/05X/C1 29 A/NORWAY/1103/ /22/04C2/C1 30 A/IRAQ/01/ /29/04X/C1 A/SINGAPORE/68/ nd 11/09/04C1/C2 A/HONG KONG/4465/ /15/04C2/C1 * Serology antigens

Influenza Branch (guinea pig red blood cells) HEMAGGLUTINATION INHIBITION REACTIONS OF INFLUENZA H3 VIRUSES

Influenza Branch Influenza A(H3N2) Isolates Characterized by CDC

Influenza Branch Evolutionary Relationships Among Influenza A(H3) HA Genes

Influenza Branch Evolutionary Relationships Among Influenza N2 NA Genes Ningbo/982/2004 Ningbo/1043/2004 Ningbo/1042/2004 Ningbo/1032/2004(LR)* Ningbo/1114/2004 Ningbo/1018/2004 Hong Kong/2874/2004 HongKong/2976/2004 HongKong/2982/2004 Hong Kong/2874/2004 Ningbo/1119/2004 Hunan/L200-3/2004(LR)* Ningbo/1049/2004 Tennessee/6/2004(LR)* N. Dakota/01/2004# nimr-Lisbon/3/2004 NewYork/55/2004# nimr-Baleares/720/2004 nimr-Ireland/9195/2004 Texas/6/2004 Ningbo/997/2004 Ningbo/1001/2004 NewYork/40/2004# Washington/1/2004 California/7/2004(LR)#* Wellington/1/2004(LR)#* Singapore/15/2004 NewCaledonia/7/2004# Argentina/126/2004 Brazil/1759/2004 nimr-Reunion/581/2004 Hunan/L201-2/2004 Japan/120/2004# Singapore/21/2004 Singapore/36/2004(LR)#* Nepal/1646/2004 Korea/770/2002 Wyoming/3e/2003#* Fujian/411/2002 nihj-Nagasaki/52/2003 Canada/578/2004(LR)* Ningbo/1005/2004 Wuhan/269/2004 FrenchGuyana/12/2004 Uruguay/3173/2004 Peru/1296/2004 Victoria/505/2004# Panama/2007/99 Sydney/5/97 Nucleotides *Serology antigen (LR) Low reactor in HI # egg isolate 0 Scale 7 K221E I392T N92D, EI99K Q432E S18A, F23L, I30V, Y40H, F42C V143G, K172R, V216G, T265I, I307V, N385K, D399E, L437W

Influenza Branch H3 Summary: October 2004 to February 2005  Influenza A (H3N2) viruses circulated in many countries in the Americas, Asia, Europe and Oceania.  In HI tests, A(H3N2) viruses were antigenically heterogeneous. Viruses isolated early in the season were often more closely related to A/Fujian/411/02 and A/Wyoming/3/03.  An increasing proportion of recent isolates were antigenically distinguishable from the A/Wyoming/3/03 and A/Wellington/1/04 vaccine strains and were most closely related to the A/California/7/04 reference virus.  Sequence analysis of N2 neuraminidase genes of recent H3N2 viruses indicates that NAs of recent viruses were genetically distinguishable from that of the Wyoming/3/03 virus (N93D, E199K, Q432E) but were similar to the NAs of A/Wellington/1/04 and A/California/7/04.

Influenza Branch Influenza B

Influenza Branch HEMAGGLUTINATION INHIBITION REACTIONS OF INFLUENZA B VIRUSES

Influenza Branch Influenza B Isolates Characterized by CDC

Influenza Branch Evolutionary Relationships Among Influenza B/Yamagata HA Genes

Influenza Branch Evolutionary Relationships Among Influenza B/Victoria HA Genes 0.01 Hawaii/20/2004 # LR Nevada/1/2005 LR Washington/1/2004 Hawaii/33/2004 # Hawaii/32/2004 # Hawaii/31/2004 # Hawaii/11/2004 # Hawaii/13/2004 # * Aus -Phitsanulok/2053/2004 * Aus -Surin/1597/2004 Aus -Perth/33/2004 Aus -Perth/12/2004 Kyonggi/501/2004 LR Brazil/1921/2004 LR New York/9/2004 Saint Lucia/2185/2004 LR Florida/1/2004 NIID -Sichuan/12/2003 # Taiwan/1558/2004 Talcahuano/6830/2004 # LR Wulumuqi/26/2004 # Hong Kong/318/2004 LR Aus -Malaysia/2276/2004 Hong Kong/312/2004 LR Hong Kong/310/2004 LR Aus -Malaysia/20/2004 NIMR -Israel/12/2004 Paraguay/636/2003 LR Aus -Brisbane/32/2002 # Kazakhstan/222/2004 NIID -Akita/9/2003 # NIMR -Madagascar/72134/2004 Shanghai/47/2003 # Beijing/243/97 # Shandong/7/97 # Fujian/203/2003 # NIID -Longyan/11/2003 # Hong Kong/1434/2002 # Hong Kong/330/2001 # Taiwan/217/97 LR - Low reactor to B/Hong Kong/330/2001 Vaccine Strain # - egg isolate * - Reference antigen K 299 R A 217 S K 80 E K 48 E K 80 R K 129 N I 121 T H 116 R I 121 N D 164 E K 129 E

Influenza Branch Evolutionary Relationships Among Influenza B NA Genes Shd/Sic Reassortants

Influenza Branch B Summary: October 2004 to February 2005   Influenza B viruses continued to circulate in many countries   The majority of analyzed B viruses belonged to the B/Yamagata/16/88 lineage and were closely related antigenically to the B/Shanghai/361/2002 vaccine strain   Most B/Victoria/2/87 lineage viruses analyzed were reassortants, bearing a B/Hong Kong/330/2001-like HA gene and a B/Sichuan/379/99-like NA gene.   B/Victoria/2/87 lineage viruses were antigenically distinguishable from B/Hong Kong/330/2001, the previous vaccine strain from this lineage

Influenza Branch InfluenzaVirusIsolates Characterized by CDC andOtherWHO Collaborating Centers and Laboratories * (October 2004– February 2005) North America Europe Asia Cent/So America Africa, Oceania Total (%) A(H1N1) (8%) A(H3N2) (75%) B/Yamagata (14%) B/Victoria (3%) Total Preliminary Data 02/14/2005 * Data based on cumulative influenza virus isolates antigenic characterization data provided by WHO Collaborating Centers in Atlanta,London, Melbourne, Tokyo, reports from European Influenza Surveillance Scheme and National Influenza Center, Canada