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INFORMATION FOR THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE, CBER, FDA February 20, INFORMATION FOR THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE, CBER, FDA February 20, 2003 Bethesda, MD 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

U. S. SURVEILLANCE U. S. SURVEILLANCE

WHO/NREVSS Collaborating Laboratories National Summary, 2002 -03 WHO/NREVSS Collaborating Laboratories National Summary, 2002 -03

Percentage of Visits for ILI Reported by Sentinel Providers National Summary, 2002 -03 Percentage of Visits for ILI Reported by Sentinel Providers National Summary, 2002 -03

Weekly Influenza Activity Estimates Reported by State & Territorial Epidemiologists Week ending February 8, Weekly Influenza Activity Estimates Reported by State & Territorial Epidemiologists Week ending February 8, 2003 - Week 6 No Report No Activity Sporadic Regional Widespread

Pneumonia and Influenza Mortality for 122 U. S. Cities Week Ending 02/08/03 “Epidemic” Threshold Pneumonia and Influenza Mortality for 122 U. S. Cities Week Ending 02/08/03 “Epidemic” Threshold Seasonal Baseline 1999 10 2000 20 30 40 50 10 2001 20 30 40 50 10 2002 20 30 40 50 10 2003 20 30 40 50 10

INFLUENZA A(H 1) VIRUSES INFLUENZA A(H 1) VIRUSES

EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA A(H 1) HA 1 GENES H 1 N 2 Canada/649/2002* EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA A(H 1) HA 1 GENES H 1 N 2 Canada/649/2002* Michigan/2/2003 T 96 A New York/3/2003 Washington/8/2002 Canada/642/2002(LR) A 193 T, A 218 T, V 178 I North Carolina/7/2002 Peru/3084/2002 New York/2/2003 Pennsylvania/1/2003 New York/26/2002 Hawaii/10/2002# South Dakota/2/2002 Jilin/5/2002# Florida/7/2002 Peru/3090/2002(LR)* Colombia/3575/2002 Wuhan/6/2002 W 255 R Neimongol/31/2002# Neimongol/43/2002# Hong Kong/841/2002 Alaska/1/2002 Texas/49/2002 Hubei/18/2002(LR)# * serology antigen Sichuan/656/2002 Mexico/935/2002 # egg isolate Wisconsin/12/2002 (LR) low reactor to A/New Caledonia/20/99 Guatemala/48/2002 vaccine strain Texas/52/2002 Guizhou/198/2002 Massachussetts/5/2002* Oklahoma/3/2002 Texas/1/2003 bafb. Korea/1136/2002 New Jersey/5/2002 Michigan/1/2003 New York/1/2003 Chile/10751/2002# Chile/8196/2002# E 82 G Chile/13309/2002# Chile/8829/2002(LR)# nihj. Akita/25/2002# D 275 G Chile/8885/2002(LR)# Alaska/3/2002 Arizona/13/2002 Yamaguchi/12/2002 E 125 b. G, K 166 M Georgia/8/2002 Hawaii/15/2001(LR) Russia/2187/2002(LR)# New Caledonia/20/99#* V 169 A

EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA A(N 1) NA GENES Hong Kong/1252/2000 Wuhan/251/2000# Hong Kong/241/2000 Wuhan/292/2000# EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA A(N 1) NA GENES Hong Kong/1252/2000 Wuhan/251/2000# Hong Kong/241/2000 Wuhan/292/2000# Russia/11/2001 Shenzhen/201/2000# Hawaii/18/99 Fujian/156/2000# Hawaii/1/2000 Nanchang/8/2000# nimr-Hong Kong/1799/2000 Taiwan/1486/2001 Hubei/288/2001*# Hong Kong/747/2001* Brazil/821/2001* Pusan/124/99 D 386 N New Caledonia/20/99*# Vaccine strain aus-New Caledonia/11/2000 nimr-Ishikawa/42/98 Colorado/2/2001 Hawaii/15/2001* Bangkok/255/2001*# Washington/6/2001 nimr-Asuncion/1041/2000 nimr-Brazil/202/2000 Bangkok/163/2000 California/26/99 Peru/1261/99 Peru/1798/99 nimr-Moscow/17/98 nimr-Hong Kong/4859/98 Beijing/262/95 New York/14/2000 Colorado/1/2001 Chile/5255/2000 *Serology Antigen Chile/5724/2000 # Egg isolate nimr-Oslo/1734/98 Bayern/7/95 10 nucleotides Taiwan/1/86 R 222 Q D 344 N V 75 I

Summary: Influenza A(H 1 N 1 and H 1 N 2) Viruses • Since Summary: Influenza A(H 1 N 1 and H 1 N 2) Viruses • Since last winter, H 1 N 1 and H 1 N 2 viruses have been reported primarily from the Americas (Canada, Chile and the U. S. ). • Most (>95%) of recent H 1 viruses have HAs that are antigenically and genetically similar to that of the current vaccine strain, A/New Caledonia/20/99 • The NAs of current H 1 N 1 viruses are similar antigenically and genetically to the N 1 of A/New Caledonia/20/99 • The NAs of current H 1 N 2 viruses are similar to to those of currently circulating H 3 N 2 viruses

INFLUENZA A(H 3 N 2) VIRUSES INFLUENZA A(H 3 N 2) VIRUSES

EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA A(H 3) HA 1 GENES Sydney/5/97 # Moscow/10/99 # A EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA A(H 3) HA 1 GENES Sydney/5/97 # Moscow/10/99 # A 106 N 144 Beijing/301/2002 (LR) Anhui/550/2002 (LR) Fujian/411/2002 ** Beijing/178/2002 (LR) BAFB-Korea/172/2003 Georgia/1/2003 (LR) NIID-Ishikawa/102/2002 ** NIID-Osaka-c/70/2002 Washington/3/2003 Memphis/4/2003 (LR) Memphis/1/2003 (LR) PHLS-England/448/2002 (LR) NIID-Toyama/29/2002 Massachusetts/1/2003 (LR) Hawaii/19/2002 (LR) Hunan/407/2002 Korea/770/2002 (LR) California/9/2002 Alaska/4/2002 Japan/910/2002 (LR) L 25 I NIMR-Egypt/151/2002 New Jersey/4/2002 (LR) ** H 75 Q NIMR-Switzerland/7494/2002 Guam/228/2002 (LR) H 155 T Taiwan/1521/2002 (LR) Philippines/160283/2002 (LR) A 131 T Hong Kong/1143/2002 (LR) Hong Kong/1554/2002 Aus-Singapore/44/2002 (LR) Can-Canada/rv 6222/2002 NIID-Shiga/41/2002 R 50 G Hawaii/13/2002 Aus-Taiwan/8/2002 E 83 K Guangzhou/405/2002 Hubei/61/2002 (LR) V 202 I Zhejiang/8/2002 (LR) India/25502/2002 W 222 R Aus-Perth/2002 (LR) # NIID-Hyogo/3/2002 G 225 D Aus-Brisbane/5/2002 (LR) # Hong Kong/1550/2002 # Beijing/144/2001 NIID-Akita/69/2002 # England/1/2003 Arizona/1/2002 Oklahoma/2/2002 A 304 P Wisconsin/17/2001 Washington/3/2002 Aus-Bangkok/109/2002 (LR) # Texas/4/2002 Illinois/1/2002 Connecticut/1/2002 Brazil/2458/2002 Brazil/1727/2002 (LR) # NIMR-Dakar/50/2002 ** Turkey/1035/2002 Chile/6416/2001 # North Carolina/8/2002 V England/449/2002 New York/21/2002 D Louisiana/2/2002 Hawaii/11/2002 Aus-Sydney/23/2002 NIID-Fukuoka/15/2002 Utah/6/2002 New York/55/2001 (LR) Hawaii/4/2002 Aus-Victoria/241/2002 New York/28/2002 NIMR-Madagascar/66213/2002 Fujian/140/2000 # Panama/2007/99 # ** Moscow/5/2000 # Q 156 H Vaccine Strain Egg-Grown Isolate # Serology Antigen ** Low Reactor (LR) 10 nucleotides

EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA A(N 2) NA GENES Vaccine Strain Wuhan/396/2001 Wuhan/388/2001 V 30 EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA A(N 2) NA GENES Vaccine Strain Wuhan/396/2001 Wuhan/388/2001 V 30 T, C 42 F CNIC/114/2001 Hong Kong/1307/2001 Guangzhou/1191/2001 Singapore/54/2001 A 18 S, L 23 F, V 307 I Shenzhen/499/2000# Hong Kong/1269/2001 Singapore/41/2001 Nepal/1610/2001 Singapore/15/2001* Thailand/80891/2001 Hawaii/23/2001 Wisconsin/12/2001 nimr-Moscow/10/2001# G 414 S Hong Kong/762/2001* Hong Kong/648/2001*# Hawaii/21/2001* Philippine/78890/2001* Hawaii/29/2001 K 172 R Alaska/14/2001* Alaska/8/2001 Chile/6416/2001*# Argentina/302/2001 Argentina/10/2001 Argentina/3758/2001# Argentina/3759/2001*# S 332 F, Q 432 E Massachusetts/2/2001 North Carolina/1/2001 South Australia/102/2001* Florida/6/2001 Panama/2007/99*# Sydney/5/97 10 nucleotides *Serology antigen # Egg isolate

Summary: Influenza A(H 3 N 2) Viruses • H 3 N 2 viruses have Summary: Influenza A(H 3 N 2) Viruses • H 3 N 2 viruses have caused recent outbreaks in Japan, Korea and China • An increasing proportion of recent H 3 N 2 isolates are not well inhibited by post-infecton and postimmunization antiserum • H 3 N 2 viruses with aa changes at 155 and 156 (Site B) tend to be poorly inhibited by antibodies to the vaccine virus • Low reacting viruses with aa changes at 155 and 156 have been detected in Asia, Europe and the Americas

INFLUENZA B VIRUSES INFLUENZA B VIRUSES

Currently Circulating Type B HA Lineages Yamagata Lineage 25 nucleotides Victoria Lineage Hong Kong/330/2001 Currently Circulating Type B HA Lineages Yamagata Lineage 25 nucleotides Victoria Lineage Hong Kong/330/2001

EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA B HA 1 GENES (YAMAGATA LINEAGE) Harbin/7/94 # K 48 EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA B HA 1 GENES (YAMAGATA LINEAGE) Harbin/7/94 # K 48 R T 168 N N 126 D H 40 Y R 69 G T 121 A R 136 K N 165 D T 182 A K 183 N L 58 F N 126 D Beijing/184/93 # NIID-Fukushima/24/2002 Shanghai/361/2002 # Taiwan/143999/2002 (LR) NIMR-Madagascar/65186/2002 Moscow/16/2002 # NIID-Astrakhan/10/2002 # Egg-Grown Isolate # California/2/2002 Serology Antigen ** NIID-Ulan Ude/4/2002 # Low Reactor (LR) Russia/4/2002 (LR) # NIID-Yunnan/406/2001 # Colorado/3/2002 (LR) Fujian/407/2001 # NIMR-St. Petersburg/1/2002 NIMR-Finland/141/2002 Nevada/1/2002 NIMR-Hong Kong/293/2002 NIID-Yunnan/8/2002 # Yunnan/9/2002 (LR) # Yunnan/163/2002 # Aus-Bangkok/60/2002 Ohio/2/2002 Brazil/2459/2002 (LR) Gaughwa/19/2002 (LR) Aus-Sydney/2002 Aus-Sydney/3/2002 NIID-Sendai/h 1754/2001 (LR) #** NIPH-Oslo/668/2002 NIID-Akita/2/2002 # NIID-Sapporo/7/2002 (LR) Hong Kong/1470/2002 (LR) # NIPH-Oslo/1870/2002 Tennessee/4/2002 (LR) Arizona/4/2002 (LR) Chile/3162/2002 (LR) # New York/44/2002 NIID-Shizuoka/15/2001 #** NIMR-Lazio/1/2002 NIMR-Lyon/125/2002 Peru/3132/2002 (LR) NIMR-Barcelona/460/2002 Colombia/3438/2002 Mexico/418/2001 (LR) Fujian/141/2001 # Aus-Victoria/504/2000 # 10 nucleotides NIID-Shizuoka/480/2000 # NIMR-Perm/3/2002 Sichuan/379/99 #** Yamanashi/166/98 #

EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA B HA 1 GENES (VICTORIA LINEAGE) I 121 T H EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA B HA 1 GENES (VICTORIA LINEAGE) I 121 T H 116 R E 121 N D 164 E Thailand/163343/2002 (LR) South Carolina/8/2002 (LR) Aus-Brisbane/17/2002 # Iowa/3/2002 (LR) # Idaho/4/2002 (LR) Aus-Auckland/14/2002 Aus-Brisbane/32/2002 (LR) #** Aus-Brisbane/28/2002 # Aus-Perth/82/2002 NIMR-Lisbon/190/2002 Louisiana/1/2002 (LR) NIMR-Madagascar/67860/2002 #** Tianjin/130/2002 Oman/16291/2001 (LR) California/5/2002 Taiwan/1519/2002 (LR) Brazil/1730/2002 # Nevada/5/2002 New York/43/2002 Texas/57/2002 (LR) ** Wisconsin/1/2003 Missouri/12/2002 NIMR-Hong Kong/302/2002 Hawaii/5/2002 (LR) Hong Kong/1351/2002 # Panama/486105/2002 Chile/13677/2002 # Mexico/963/2002 (LR) Argentina/mc 16/2002 (LR) Brazil/1733/2002 (LR) # Guatemala/20/2002 (LR) New Hampshire/1/2002 Beijing/243/97 # Shandong/7/97 #** Guam/345/2002 NIID-Saitama/22/2002 # NIID-Sendai/h 1023/2002 # NIID-Tokyo/127/2002 # NIID-Shiga/20/2002 # Hong Kong/1115/2002 (LR) # Hong Kong/167/2002 # Hong Kong/1345/2002 # Hong Kong/1434/2002 #** Wisconsin/7/2002 Guangzhou/332/2002 (LR) # Taiwan/1507/2002 (LR) Hong Kong/330/2001 #** Hong Kong/335/2001 # NIID-Akita/27/2001 # Taiwan/217/97 Vaccine Strain Egg-Grown Isolate # Serology Antigen ** Low Reactor (LR) 5 nucleotides

EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA B NA GENES Sichuan/379/99*# Johannesburg/5/99 Alaska/16/2000 Shenzhen/804/2001# P 42 S, EVOLUTIONARY RELATIONSHIPS AMONG INFLUENZA B NA GENES Sichuan/379/99*# Johannesburg/5/99 Alaska/16/2000 Shenzhen/804/2001# P 42 S, R 69 E Victoria/504/2000* Shizuoka/480/2000 Brazil/956/2001*# Hong Kong/692/2001* Texas/22/20001* Niid-Shizuoka/15/2001*# E 148 G nimr-Yamanashi/166/98 Brazil/952/2001# Argentina/132/2001 D 329 N Argentina/69/2001 Wuhan/2/2001# Johannesburg/69/2001*# Fujian/407/2001 Vaccine Strain P 42 Q, N 219 K, Wuhan/356/2001# D 392 E *Serology Antigen Osaka/18/2001 # Egg isolate Shenzhen/306/2001# Sichuan/317/2001*# Sichuan/776/2001# Harbin/7/94 Hawaii/36/2001 Hawaii/10/2001# M 50 T, C 54 S, Hong Kong/28/2001 V 60 F, R 436 K Hong Kong/6/2001 Hong Kong/330/2001* Canada/464/2001 Hong Kong/22/2001 Bangkok/34/99 Bangkok/54/99 Shandong/7/97 10 nucleotides Yamagata/16/88

Summary: Influenza B Viruses • Influenza B viruses are predominating in the U. S. Summary: Influenza B Viruses • Influenza B viruses are predominating in the U. S. and much of Europe during the current season • Influenza B viruses on the “Victoria lineage have predominated worldwide; B viruses on the Sichuan lineage were isolated infrequently • Most recent influenza B viruses have NAs most closely related antigenically and genetically to that of the B/Sichuan ref. Virus • The influenza B viruses have remained stable genetically and antigenically since last September