influenza branch vaccines and related biological products advisory committee cber, fda february...

Influenza BranchInfluenza 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 BranchDivision of Viral and Rickettsial DiseasesNational Center for Infectious Diseases

Centers for Disease Control and PreventionAtlanta, GA 30333


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


Human H5N1 Cases, 2004-Human H5N1 Cases, 2004-20052005

CountryCountry H5N1 CasesH5N1 Cases DeathsDeaths Case Case FatalityFatality

CambodiaCambodia 11 11 100%100%

ThailandThailand 1717 1212 71%71%

VietnamVietnam 3737 2929 78%78%

TotalTotal 5555 4242 76%76%

High case fatality regardless of age Clinical symptoms similar to earlier cases, including lymphopenia Diarrhea prominent in some casesSecond wave of infections in Aug 2004-presentThai family cluster; probable H-to-H transmission


320320160160

80802020

6406408080

808012801280

4040640640

4040640640

HK/213/03HK/213/03

CK/KOR/ES/03CK/KOR/ES/03

HK/97HK/97

TH/353/04TH/353/04

VN/1203/04VN/1203/04

VN/1194/04VN/1194/04

51205120

2020

320320

NDND

2020

<10<10

HK/213/03HK/213/03CK/KO/03CK/KO/03

320320

4040

320320

<10<10

<10<10

<10<10

HK/97HK/97VN/1203/03VN/1203/03

Antigenic Characterization of H5N1 Antigenic Characterization of H5N1 Influenza VirusesInfluenza Viruses

VIRUSES FERRET H5N1 ANTISERA


Avian influenza viruses can pose a major risk to global public Avian influenza viruses can pose a major risk to global public health (H5N1, H7N7, H9N2, etc.)health (H5N1, H7N7, H9N2, etc.)

Early detection H-2-H transmission of novel influenza viruses Early detection H-2-H transmission of novel influenza viruses is essentialis essential

2003/05 Asian viruses are heterogeneous in AV susceptibility 2003/05 Asian viruses are heterogeneous in AV susceptibility and pathogenicity; more lethal in mammals than 1997 strainsand pathogenicity; more lethal in mammals than 1997 strains

Ongoing vaccine development, antiviral stockpiling and Ongoing vaccine development, antiviral stockpiling and pandemic preparednesspandemic preparedness

Surveillance in animals (birds, swine and other susceptible Surveillance in animals (birds, swine and other susceptible hosts) is critical hosts) is critical

Research agenda needed to enhance our understanding of Research agenda needed to enhance our understanding of the genesis of pandemic influenza virusesthe genesis of pandemic influenza viruses

Global recognition of need for better communication Global recognition of need for better communication between human and veterinary health authoritiesbetween human and veterinary health authorities

ConclusionsConclusions


Influenza: An Emerging Disease that Influenza: An Emerging Disease that Rolls OnRolls On


Influenza Virus Isolates Characterized by CDC and Other WHO Collaborating Centers and Laboratories *

(October 2004 – February 2005)

North

America Europe Asia

Cent/So America

Africa, Oceania

Total (%)

A(H1N1) 2 115 74 2 193 (8%)

A(H3N2) 616 402 212 4 458 1692 (75%)

B/Yamagata 98 62 30 1 112 303 (14%)

B/Victoria 18 28 16 3 9 74 (3%)

Total 734 607 332 8 581 2262 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 A(H1N1)


HEMAGGLUTINATION INHIBITION REACTIONS OF INFLUENZA H1 VIRUSESREFERENCE FERRET ANTISERA

DateREFERENCE ANTIGENS BJ/262 NC/20 FUJ/156 NEI/52 CI/8885 PE/3135 collected Passage

1 A/BEIJING/262/95 640 640 160 320 320 40 01/09/95 E3/E32 A/N. CALEDONIA/20/99 * 160 640 320 320 320 160 06/09/99 E4/E23 A/FUJIAN/156/2000 80 640 320 320 160 80 08/25/00 E2/E24 A/NEIMENGGU/52/2002 40 320 160 320 160 40 01/25/02 E2/E45 A/CHILE/8885/2002 40 320 160 160 320 20 07/03/02 E1/E46

7

A/PERU/3135/2003 160 40 80 20 10 640 04/09/03 X/C3

TEST ANTIGENS

8A/FLORIDA/04/2004 * 320 1280 1280 1280 640 320 12/20/04 X1/C1

9A/FLORIDA/03/2004 320 1280 640 640 320 320 12/09/04 X2/C1

10A/PRACHINBURI/1749/2004 320 1280 1280 1280 320 640 09/18/04 C1/C1

11A/BANGKOK/1757/2004 320 1280 1280 1280 640 640 09/20/04 C1/C1

12A/PRACHINBURI/1817/2004 320 1280 1280 1280 640 640 09/23/04 C1/C1

13A/BANGKOK/1876/2004 320 1280 1280 1280 640 320 09/27/04 C1/C1

14A/SUPHANBURI/2131/2004 320 1280 1280 1280 640 320 10/04/04 C1/C1

15A/BANGKOK/1752/2004 320 1280 640 1280 320 320 09/20/04 C1/C1

16A/SUPHANBURI/2130/2004 160 1280 640 1280 320 320 10/04/04 C1/C1

17A/BANGKOK/1822/2004 160 1280 640 1280 320 320 09/23/04 C1/C1

18A/RATCHABURI/1847/2004 320 1280 640 640 320 320 09/24/04 C1/C1

19A/BANGKOK/1544/2004 * 160 640 320 640 320 160 08/31/04 E3/E1

20A/SUPHANBURI/2129/2004 160 640 640 640 320 160 10/04/04 C1/C1

21A/SAKAEW/2132/2004 160 640 320 640 320 320 10/04/04 C1/C1

22A/SINGAPORE/14/2004 160 1280 640 640 320 160 03/31/04 E4/E1

23A/N. CALEDONIA/9/2004 160 1280 640 640 320 320 06/11/04 E2/E1

24A/N. CALEDONIA/3/2004 160 640 640 640 320 160 04/19/04 E2/E1

25A/MALAYSIA/1513/2004 160 640 320 640 160 320 07/10/04 E2/E1

26A/HONG KONG/4555/2004 160 640 640 640 320 160 09/25/04 C2/C1

27A/HONG KONG/4580/2004 160 640 640 640 320 160 10/08/04 C2/C1A/HONG KONG/4596/2004 160 1280 1280 1280 640 320 10/25/04 C2/C1* Serology antigens


Influenza A(H1) Isolates Characterized by CDC

U.S.A. North America

Europe Asia Cent/So America

Africa, Australia,

New Zealand

Total (%)

October 2003 – March 2004

A/N.Caledonia/20/99- like 3 2 1 16 1 2 25 (9%)

A/N.Caledon./20/99 (low) 2 1 3 (11%)

Total 28

April 2004 – September 2004

A/N.Caledonia/20/99- like 1 4 36 2 43 (98%)

A/N.Caledon./20/99 (low) 1 1 (2%)

44

October 2004 – January 2005

A/N.Caledonia/20/99- like 2 12 14(100%)

A/N.Caledon./20/99 (low)

14

Total 5 3 7 65 2 4 86


Evolutionary Relationships Among Influenza A(H1) HA Genes

0 5nucleotides

(LR) Low reactor in HI# - Egg Isolate

* Serology Antigen

Hong Kong/2637/04nimrHong Kong/2637/04

nimrHong Kong/2675/04Taiwan/1559/04niidTaiwan/1559/04

ausChrist Church/106/04ausPhilippines/987/04

Taiwan/1571/04ausPhilippines/936/04

niidOkinawa/42/04ausAyathaya/2111/04

Ayathaya/1720/04Bangkok/1544/04#*ausTaiwan/1559/04

ausBangkok/1940/04Canada/591/04

Singapore/11/2004Massachusetts/1/04

Singapore/5/04ausNew Caledonia/3/04#

ausNew Caledonia/4/04#ausNew Caledonia/9/04#

Indonesia/5840/04Indonesia/5841/04

Singapore/14/04#*ausSingapore/14/04#*

Florida/3/04nimrIreland/15680/04

Florida/4/04*nimrNetherlands/128/04*

twTaiwan/1574/04twTaiwan/1573/04

niidOkayama/53/04niidNagano/1328/03

ausPrachinburi/1686/04Sakaew/2132/04nimrIreland/9728/04Hong Kong/4596/04

Prachinburi/1817/04Nonthaburi/1739/04

ausMalaysia/1513/04#nimrLyon/Chu28824/04

nimrLyon/Gi346/04Saudi Arabia/2526/04

Suphanburi/2129/04Ratchaburi/1847/04New Caledonia/20/99#*V169A, N190D, W255R

V317AY256F

F256YA317V

V317A

R149K

Q285H

T90K, R212KT269N

Y101H

R192K

Jan-Feb-MarApr-May-JunJul-Aug-SepOct-Nov-Dec

Date Collected


Evolutionary Relationships Among Influenza N1 NA Genes

Nucleotides

*Serology antigen(LR) Low reaction to HI

# Egg isolate

0 Scale 3

A/Suphanburi/2129/2004 A/Hong Kong/4555/2004 A/Bangkok/1724/2004 A/Bangkok/1752/2004

A/Bangkok/406/2004# A/Bangkok/1876/2004

A/Bangkok/1507/2004# A/Bangkok/1759/2004

A/Bangkok/1498/2004# A/Bangkok/1757/2004 A/Prachinburi/1817/2004 A/Prachinburi/1749/2004 A/Bangkok/1822/2004

A/Bangkok/1467/2004# A/Nonthaburi/1738/2004

A/Bangkok/1410/2004# A/Nonthaburi/1739/2004 A/Florida/03/2004

A/Florida/04/2004* A/Suphanburi/2130/2004 A/Suphanburi/2131/2004

A/Bangkok/1755/2004 A/Hong Kong/4580/2004

A/Nagano/1328/2003 A/Argentina/678/2003

A/New Mexico/7/2003 aus-A/Malaysia/1003/2003 A/Malaysia/1513/2004# A/Mexico/268/2003

A/Romania/955/2003 nimr-A/Moscow/7/2003 aus-A/Chrischur/1/2003

nimr-A/Israel/2/2003 A/Michigan/5/2003

A/Michigan/4/2003 A/Michigan/6/2003 A/Michigan/1/2003

nimr-A/Barcelona/7891v31/2003 A/Peru/2223/2003 A/Peru/3192/2003

A/Peru/3135/2003 A/Minnesota/18/2003

A/Gansu/185/2003 aus-A/Darwin/1/2003

A/New Caledonia/3/2004# A/Singapore/14/2004

A/Sakaew/2132/2004 A/Singapore/14/2004#*

A/Singapore/23/2004 A/Ayatthaya/2111/2004

A/Bangkok/1544/2004#* A/Bangkok/1699/2004

A/Bangkok/1741/2004 A/Bangkok/1742/2004

A/Hong Kong/2637/2004 A/Ratchaburi/1847/2004

A/Bangkok/1468/2004# A/Ayutthaya/1720/2004

A/Guangzhou/78/2003 A/Sichuan/646/2002

A/Argentina/6/2003 A/New Caledonia/20/99

E332KN450D

V234M

E214G, R222QD382N


HI Antibody Response to 2004-2005 Vaccine(adults)

% w/HI titer >40

Sera N Antigen %

Rise Pre GMT

Post GMT

Pre Vaccine

Post Vaccine

30 A/New Caledonia/20/99 23 21 44 43 67 30 A/Bangkok/1544/2004 17 26 54 53 77

30 A/Florida/04/2004 17 27 54 53 73

Japan

30 A/Netherlands/128/2004 27 27 59 57 77

25 A/New Caledonia/20/99 32 19 54 44 76 25 A/Bangkok/1544/2004 32 23 57 40 76

25 A/Florida/04/2004 24 24 53 48 80

USA

25 A/Netherlands/128/2004 24 26 66 52 80


H1 Summary: October 2004 to February 2005H1 Summary: October 2004 to February 2005

Relatively few H1 viruses have been detected worldwideRelatively few H1 viruses have been detected worldwide

The majority of H1N1 viruses were closely related The majority of H1N1 viruses were closely related antigenically to the A/New Caledonia/20/99 vaccine strain and antigenically to the A/New Caledonia/20/99 vaccine strain and no significant variants of H1N1 viruses were detectedno significant variants of H1N1 viruses were detected

No H1N2 viruses were detectedNo H1N2 viruses were detected

N1 neuraminidase genes of recent H1 viruses were similar to N1 neuraminidase genes of recent H1 viruses were similar to those of viruses isolated prior to October 2004those of viruses isolated prior to October 2004


Influenza A(H3N2)


HEMAGGLUTINATION INHIBITION REACTIONS OF INFLUENZA H3 VIRUSESSTRAIN DESIGNATION REFERENCE FERRET ANTISERA

DateREFERENCE ANTIGENS WY/3 WEL/01 ND/01 CA/7 SN/37 collected Passage

1 A/WYOMING/03/2003 X-147 * 640 80 160 160 40 02/13/03 X/E12 A/WELLINGTON/01/2004 * 160 320 320 320 320 01/26/04 E3/E23 A/NORTH DAKOTA/01/2004 80 160 640 320 160 10/20/04 SpfCK1E44 A/CALIFORNIA/07/2004 * 160 80 320 320 160 09/16/04 SpfCK1E3

6

7

5 A/SINGAPORE/37/2004 160 160 640 640 640 6/7/2004 E4/E1

TEST ANTIGENS

8

A/KENTUCKY/6e/2004 320 320 640 1280 1280 11/27/04 SpfC1KE3

9

A/NEW YORK/57/2004 320 160 640 640 160 12/28/04 X2/C1

10

A/VIRGINIA/02/2005 320 320 1280 640 640 01/06/05 M1/C1

11

A/WISCONSIN/21e/2004 160 160 320 320 160 11/29/04 SpfCK3E3

12

A/NEW YORK/39e/2004 160 160 640 640 320 11/09/04 SpfCK2E4

13

A/NEW YORK/02/2005 160 80 320 320 160 01/05/05 X1/C1

14

A/NEW YORK/03/2005 160 40 320 320 80 01/03/05 X1/C1

15

A/TEXAS/12/2004 160 80 320 320 160 12/29/04 M1/C1

16

A/MASSACHUSETTS/01/2005 160 80 320 640 160 01/05/05 M1/C1

17

A/ALASKA/16/2004 160 80 320 160 80 12/12/04 X/C1

18

A/NEW YORK/55e/2004 80 80 320 320 160 11/18/04 SpfCK2E2

19

A/N. HAMPSHIRE/04/2004 80 40 160 160 160 12/27/04 X/C1

20

A/WISCONSIN/16e/2004 40 80 320 160 80 11/22/04 SpfCK3E2

21

A/WEST VIRGINIA/01/2005 80 40 160 160 40 01/05/05 C1/C1

22

A/VIRGINIA/03/2005 80 80 320 160 80 01/07/05 M1/C1

23

A/ARIZONA/03/2005 80 40 160 160 80 01/05/05 M2/C1

24

A/GEORGIA/01/2005 80 40 160 160 80 01/06/05 M1/C1

25

A/CANADA/707/2004 160 80 320 320 80 11/16/04 X1/C1

26

A/VICTORIA/523/2004 80 160 320 320 640 11/03/04 E5/E1

27

A/MADRID/RR1734/2004 320 160 640 640 320 12/01/04 C1/C1

28

A/UNITED KINGDOM/305/2005 160 80 320 320 80 01/05/05 X/C1

29

A/NORWAY/1103/2004 80 20 80 160 40 11/22/04 C2/C1

30

A/IRAQ/01/2004 80 40 160 160 80 12/29/04 X/C1A/SINGAPORE/68/2004 160 160 160 320 nd 11/09/04 C1/C2A/HONG KONG/4465/2004 80 20 160 160 40 09/15/04 C2/C1

* Serology antigens


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

STRAIN DESIGNATION REFERENCE FERRET ANTISERADate

REFERENCE ANTIGENS WY/3 WEL/01 VIC/500 CA/07 collected Passage

1 A/WYOMING/03/2003 X-147 * 640 40 160 80 02/13/03 X/E12 A/WELLINGTON/01/2004 * 320 640 1280 640 01/26/04 E3/E23 A/VICTORIA/500/2004 40 40 160 160 08/13/04 E6/E24 A/CALIFORNIA/07/2004 * 80 80 160 320 09/16/04 SPpfCK3E3

TEST ANTIGENS

5 A/VERMONT/10/2004 320 160 640 640 12/13/04 X/C26 A/NEW YORK/63/2004 320 80 640 640 12/06/04 X1/C27 A/NEW HAMPSHIRE/09/2004 320 160 640 640 12/13/04 MX/C28 A/NEW HAMPSHIRE/10/2004 320 80 320 160 12/13/04 MX/C29 A/NEW HAMPSHIRE/11/2004 160 160 320 640 12/26/04 MX/C2

10 A/NEW HAMPSHIRE/07/2004 320 80 640 320 12/12/04 MX/C211 A/NEW YORK/62/2004 160 40 320 320 12/06/04 X2/C212 A/VERMONT/11/2004 160 80 320 320 12/08/04 X/C213 A/NEW HAMPSHIRE/05/2004 160 40 320 320 12/09/04 MX/C214 A/NEW HAMPSHIRE/08/2004 160 40 320 320 12/10/04 MX/C215 A/CALIFORNIA/08/2004 80 40 160 160 10/12/04 M2/C216 A/LOUISIANA/02/2004 80 40 160 160 12/15/04 X/C217 A/COLORADO/08/2004 160 80 320 320 12/20/04 MX/C218 A/LOUISIANA/03/2004 160 80 320 320 12/21/04 X/C219 A/WASHINGTON/13/2004 160 80 320 320 12/14/04 X/C220 A/NEW JERSEY/09/2004 160 80 320 640 12/03/04 X/C221 A/PERU/218/2004 80 20 160 160 12/20/04 X/C222 A/PERU/225/2004 80 40 160 160 12/28/04 X/C223 A/IRAQ/29/2004 160 40 160 320 12/21/04 X/C224 A/KOREA/298/2004 160 20 160 320 12/29/04 X/C225 A/HUNAN/L198-5/2004 160 40 320 320 09/06/04 C3/C2

* Serology antigens


Influenza A(H3N2) Isolates Characterized by CDC



Africa, Australia,

New Zealand

Total (%)

April 2004 – September 2004

A/Fujian/411/2002-like 29 17 4 143 151 4 348 (82.3%)

A/Fujian/411/2002 (low) 7 45 8 1 61 (14.4%)

A/California/7/2004-like * 11 2 13* (3.1%)

A/Wellington/1/2004-like 1 1 (0.2%)

Total 423

October 2004 – January 2005

A/Fujian/411/2002-like 119 12 2 14 1 1 149 (57%)

A/Fujian/411/2002 (low) 27 4 1 1 33 (12.5%)

A/California/7/2004-like * 59 3 3 9 2 2 78* (30%)

A/Wellington/1/2004-like 1 1 (0.5%)

Total 261

Total 241 36 9 224 162 12 684 * A/California/7/2004 ferret antiserum was used starting from January 5, 2005 Preliminary data 02/09/2005


Evolutionary Relationships Among Influenza A(H3) HA Genes

0.01

NIID-Kobe/189/2004 Aus-Malaysia/25/2004 LR

Wisconsin/16/2004 # Wisconsin/19/2004 # North Dakota/1/2004 # LR

Georgia/1/2004 LR Texas/6/2004 LR

New York/39/2004 # New York/55/2004

New York/40/2004 # Nepal/1646/2004 LR

NIMR-Latvia/15743/2004

Singapore/36/2004 # LR * Singapore/37/2004 # LR

Aus-Victoria/512/2004 # Maryland/2/2004 LR

Washington/1/2004 # LR NIMR-Lisbon/4/2004

California/7/2004 # LR * Alaska/3/2004 # LR

Aus-Wellington/1/2004 # * El Salvador/43/2004 LR

Japan/120/2004 # Wisconsin/21/2004 #

Guangdong/596/2004 LR Canada/578/2004 LR *

Hong Kong/2874/2004 LR Hunan/L200-3/2004 *

Tennessee/6/2004 LR * NIID-Mie/1/2005

Ningbo/1032/2004 * Aus-Victoria/500/2004 #

NIID-Sendai/67/2004 Hong Kong/1186/2003 # LR

Fujian/411/2002 Korea/770/2002

Texas/40/2003 # Wyoming/3/2003 (X-147) # *

Peru/1296/2004 LR Panama/2007/99 #

LR - Low reactor to A/Wyoming/3/2003

Vaccine Strain# - egg isolate

* - Reference antigen

K 145 N

D 188 N

N 278 K

K 145 NK 326 T

S 227 P

22


Evolutionary Relationships Among Influenza N2 NA GenesNingbo/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

K221EI392T

N92D, EI99KQ432E

S18A, F23L, I30V, Y40H, F42CV143G, K172R, V216G, T265I, I307V, N385K, D399E, L437W


H3 Summary: October 2004 to February 2005 Influenza A (H3N2) viruses circulated in many countries in the Influenza A (H3N2) viruses circulated in many countries in the

Americas, Asia, Europe and Oceania.Americas, Asia, Europe and Oceania.

In HI tests, A(H3N2) viruses were antigenically heterogeneous. In HI tests, A(H3N2) viruses were antigenically heterogeneous. Viruses isolated early in the season were often more closely related Viruses isolated early in the season were often more closely related to A/Fujian/411/02 and A/Wyoming/3/03.to A/Fujian/411/02 and A/Wyoming/3/03.

An increasing proportion of recent isolates were antigenically An increasing proportion of recent isolates were antigenically

distinguishable from the A/Wyoming/3/03 and A/Wellington/1/04 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 vaccine strains and were most closely related to the A/California/7/04 reference virus.reference virus.

Sequence analysis of N2 neuraminidase genes of recent H3N2 Sequence analysis of N2 neuraminidase genes of recent H3N2 viruses indicates that NAs of recent viruses were genetically viruses indicates that NAs of recent viruses were genetically distinguishable from that of the Wyoming/3/03 virus (N93D, E199K, distinguishable from that of the Wyoming/3/03 virus (N93D, E199K, Q432E) but were similar to the NAs of A/Wellington/1/04 and Q432E) but were similar to the NAs of A/Wellington/1/04 and A/California/7/04. A/California/7/04.


Influenza B


STRAIN DESIGNATION REFERENCE FERRET ANTISERADate

REFERENCE ANTIGENS SIC/379 SHA/361 JIL/20 JIA/10 FL/7 HK/1434 BRIS/32 HI/13 collected Passage

1 B/SICHUAN/379/99 640 320 80 160 640 20 10 5 12/02/99 E2/E12 B/SHANGHAI/361/2002 640 320 160 160 640 40 5 5 06/12/02 E2/E23 B/JILIN/20/2003 * 320 160 160 160 640 20 5 5 02/21/03 E2/E44 B/JIANGSU/10/2003 80 80 80 1280 320 5 5 5 09/11/03 E3/E25 B/EGYPT/2040/2004 640 320 160 320 1280 20 5 5 04/27/04 C2/C26 B/FLORIDA/07e/2004 * 320 160 80 160 640 20 10 5 10/01/04 E37 B/SHANDONG/07/1997 10 5 5 5 5 640 320 640 11/03/97 E4/E38 B/HONG KONG/1434/2002 10 5 5 5 5 1280 640 640 01/15/02 E59 B/BRISBANE/32/2002 10 5 5 5 10 640 640 640 07/02/02 E2/E4

10 B/HAWAII/13/2004 * 5 5 5 5 5 320 160 320 06/21/04 E2

TEST ANTIGENS

11 B/COLORADO/04e/2004 * 320 320 80 160 640 20 5 5 11/09/04 E212 B/OREGON/01/2005 160 160 80 320 640 20 5 5 01/03/05 R1/C113 B/WEST VIRGINIA/01/2004 160 160 80 320 640 10 5 5 12/28/04 C1/C114 B/WASHINGTON/03/2004 320 320 160 640 640 10 5 5 12/30/04 M1/C115 B/VIRGINIA/01/2005 160 160 80 320 640 20 5 5 01/03/05 M1/C116 B/ARIZONA/01/2005 80 160 80 320 640 10 5 5 01/05/05 M1/C117 B/NEW YORK/27/2004 160 160 80 320 640 20 5 5 12/29/04 M1/C118 B/MISSISSIPPI/02/2005 80 160 80 320 640 10 5 5 01/10/05 X/C119 B/NEVADA/02/2005 160 160 80 640 640 10 5 5 01/16/05 M1/C120 B/TEXAS/06/2004 160 160 80 320 320 20 5 5 12/30/04 M1/C121 B/NORTH DAKOTA/02/2004 160 160 80 640 640 20 5 5 12/29/04 M2/C122 B/NORWAY/1102/204 80 160 80 320 640 10 5 5 11/22/04 C2/C123 B/TURKEY/187/2004 320 160 40 40 320 20 10 5 12/27/04 X/C124 B/FUJIAN/430/2004 * 160 160 80 80 320 10 5 5 09/04/04 E1C2/C1E225 B/NEVADA/01/2005 5 5 5 5 5 160 80 40 01/04/05 X/C126 B/TEXAS/01/2005 5 5 5 5 5 80 40 20 01/10/05 M1/C127 B/HONG KONG/310e/2004 20 20 5 5 20 640 320 640 11/24/04 E228 B/HONG KONG/312/2004 5 5 5 5 5 80 40 40 11/29/04 C2/C129 B/HONG KONG/318/2004 5 5 5 5 5 160 80 40 12/15/04 C2/C130 B/SINGAPORE/15/2004 5 5 5 5 5 320 640 640 11/08/04 C2/C131 B/SINGAPORE/14/2004 5 5 5 5 5 320 320 320 11/02/04 C2/C132 B/SINGAPORE/18/2004 5 5 5 5 5 160 80 40 11/22/04 C2/C133 B/SINGAPORE/08/2004 5 5 5 5 5 80 40 40 08/16/04 C2/C134 B/SINGAPORE/11/2004 5 5 5 5 5 160 40 40 10/08/04 C2/C135 B/SINGAPORE/16/2004 5 5 5 5 5 80 40 40 11/10/04 C2/C136 B/SINGAPORE/17/2004 5 5 5 5 5 80 40 40 11/19/04 C2/C1

HEMAGGLUTINATION INHIBITION REACTIONS OF INFLUENZA B VIRUSES


Influenza B Isolates Characterized by CDC



Africa, Australia,

New Zealand

Total (%)

April 2004 – September 2004 B/Hong Kong/330/2001-like 4 1 2 7 (5%)

%% B/HK/330/2001 (low) 10 1 8 19 (13%) B/Shanghai/361/2002-like 36 6 1 30 24 12 109 (74%) B/Shanghai/361/2002 (low) 4 2 3 3 12 (8%) Total 147 October 2004 – February 2005 B/Hong Kong/330/2001-like 2 2 4 (3%) B/HK/330/2001 (low) 16 9 4 29 (25%) B/Shanghai/361/2002-like 61 3 11 1 76 (64%) B/Shanghai/361/2002 (low) 7 1 1 9 (8%) Total 118

Total 140 6 5 57 40 17 265 Preliminary Data 02/14/2005


Evolutionary Relationships Among Influenza B/Yamagata HA Genes

0.01

North Carolina/5/2004 LR New Jersey/1/2005 LR

NIMR-Madrid/g1695/2004 Hawaii/18/2004 # LR

Hawaii/19/2004 # LR Egypt/2040/2004

NIMR-Norway/1102/2004 NIID-Yokohama/5/2004

Aus-Victoria/501/2004 # Aus-Brisbane/5/2004 #

California/3/2004 LR Colorado/4/2004 # LR *

Massachusetts/3/2004 Saint Lucia/1689/2004 LR

Washington/2/2004 Peru/1322/2004 LR

Pennsylvania/4/2004 LR Florida/7/2004 # LR * Canada/580/2004

NIID-Hyogo/6/2004 Argentina/584/2004

Concepcion/8881/2004 # Montana/1/2004 # LR

Aus-Christchurch/27/2004 # Aus-Christchurch/33/2004 #

Ulan-Ude/6/2003 # Fujian/437/2004 # LR

Wuhan/281/2004 LR Aus-Victoria/508/2004 #

Jilin/20/2003 # Jiangsu/10/2003 # *

Shandong/22/2003 # Hong Kong/307/2004

Chanthaburi/218/2003 Aus-Brisbane/4/2004 #

NIID-Shizuoka/144/2004 # Shanghai/361/2002 #

Harbin/7/94 # Sichuan/379/99 #

LR - Low reactor to B/Shanghai/361/2002



V 252 M

N 123 SM 252 I

H 40 YL 131 P

K 129 ND 233 AG 256 R

I 180 V


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



K 299 R

A 217 S

K 80 E

K 48 EK 80 RK 129 N

I 121 T

H 116 RI 121 ND 164 E

K 129 E


Evolutionary Relationships Among Influenza B NA Genes

Sh

d/S

ic Re

asso

rtan

ts

Taiwan/1547/2004 Jiangsu/10/2003#*

Jilin/20/2003 nihj-Shizuoka/2/2004 Shandong/22/2003# Fujian/437/2004# Fujian/393/04#

HongKong/64/2004 Fujian/430/2004(LR)*

Shanghai/361/2002 Shizuoka/58/2004# nihj-shizuoka/58/2004

Sichuan/379/99 aus-Brisbane/32/2002

Madagascar/72134/2004 Paraguyy/6362003 Wulumuqi/26/2004

Talcahuano/6830/2004# Peru/658/2004

Phitsanulok/2053/2004(LR)* Okinawa/1/2004

Hawaii/10/2004 Hawaii/09/2004# Hawaii/20/2004# Hawai/13/2004(LR)#*

UlanUde/6/2003 Brazil/658/2004 Florida/7/2004(LR)#*

Concepcion/8881/2004# Canada/508/2004 Victoria/509/2004#

Christchurch/33/2004# Victoria/50/2004

Oslo/586/2004 Brisbane/05/2004# nimr-Norway/110-2/2004

Massachusetts/3/2004 NewYork/17/2004 Colorado/03/2004# Colorado/05/2004# Colorado/4/2004#*

Harbin/7/94 Yamagata/16/88

Victoria/2/87 Shandong/7/97 HongKong/330/2001

Singapore/222/79

nucleotides

*Serology antigen(LR) Low reaction in HI# egg isolate vaccine

0 Scale 7

K125N, S397ID463N

T42P, E148G,S198NI248V, N342D, K373ET389A

T42Q, T49I, K186RN219K, N235D, S244PD329N, N324D, D392E E436T


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 Virus Isolates Characterized by CDC and Other WHO Collaborating Centers and Laboratories *

(October 2004 – February 2005)

North

America Europe Asia

Cent/So America

Africa, Oceania

Total (%)

A(H1N1) 2 115 74 2 193 (8%)

A(H3N2) 616 402 212 4 458 1692 (75%)

B/Yamagata 98 62 30 1 112 303 (14%)

B/Victoria 18 28 16 3 9 74 (3%)

Total 734 607 332 8 581 2262 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 vaccines and related biological products advisory committee cber, fda february...

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