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INFORMATION FOR THE VACCINE AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE CBER, FDA Information Regarding Seasonal Influenza Viruses FEBRUARY 27, 2013 Nancy J. Cox, Ph. D. Director, Influenza Division Director, WHO COLLABORATING CENTER FOR SURVEILLANCE,

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Information for the vaccine and related biological products advisory committee cber fda

INFORMATION FOR THE VACCINE AND RELATED

BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

CBER, FDA

Information Regarding Seasonal Influenza Viruses

FEBRUARY 27, 2013

Nancy J. Cox, Ph. D.

Director, Influenza Division

Director, WHO COLLABORATING CENTER FOR SURVEILLANCE,

EPIDEMIOLOGY AND CONTROL OF INFLUENZA

Influenza Division

National Center for Immunization and Respiratory Diseases

Coordinating Center for Infectious Diseases

Centers for Disease Control and Prevention

Atlanta, GA 30333


Global influenza surveillance and response network gisrs

Global Influenza Surveillance and Response Network (GISRS)

  • All year around surveillance conducted by GISRS

    • 6 WHOCCs, 140 NICs, 4 ERLs, H5 Reference Laboratories

  • 18-20 Feb 2013 WHO Consultation: Data reviewand analysis; write recommendations

  • Co-Chaired by Dr. Nancy Cox, WHOCC CDC Atlanta and Dr. Masato Tashiro, WHOCC, NIID Tokyo

    • 9 Advisers: Directors of WHOCCs and ERLS

      • Disclosure of potential conflicts of interest

      • 18 observers from NICs, H5 Reference Laboratories, WHOCCs, WHO ERLs, academic partners and the veterinary sector


Information for the vaccine and related biological products advisory committee cber fda

Influenza B – September 2012-January 2013maximum influenza activity


Percentage of influenza viruses by subtypes from 2 september 2012 2 february 2013

Percentage of influenza viruses by subtypes(From 2 September 2012 – 2 February 2013)

A(H5), 6 human viruses

Data source: FluNet, (www.who.int/flunet), Global Influenza Surveillance and Response System (15 February 2013)


Information for the vaccine and related biological products advisory committee cber fda

  • Susceptibility to Neuraminidase Inhibitors: Inhibition of Neuraminidase Activitya

  • Virus collection period: Oct 01, 2012 - Jan 21, 2013

a Viruses were tested in the fluorescent NA inhibition assay. Inhibition is based on fold difference in IC50 of a test virus compared to the median IC50 value for type/subtype. The WHO AVWG criteria: Type A viruses - Normal: <10-fold; Reduced: 10-100-fold; Highly reduced: >100-fold.Type B viruses - Normal: <5-fold; Reduced: 5-50-fold; Highly reduced: >50-fold.

b Influenza B/Maryland/07/2012 virus, GISIAD acc.no for NA: EPI399661.

c H275Y was detected in two A(H1N1)pdm09 viruses.


A h1n1 pdm09 viruses sept 2012 jan 2013

A(H1N1)pdm09 VirusesSept 2012 – Jan 2013


Information for the vaccine and related biological products advisory committee cber fda

Number of A(H1N1)pdm09 Viruses Detected by GISRS

Data source: FluNet, (www.who.int/flunet), Global Influenza Surveillance and Response System (15 February 2013)


Information for the vaccine and related biological products advisory committee cber fda

(H1N1)pdm09 Viruses Characterized During the Past 3Years, September to January


Information for the vaccine and related biological products advisory committee cber fda

(H1N1)pdm09 low reactors in HI assays by WHO CCs


Information for the vaccine and related biological products advisory committee cber fda

HEMAGGLUTINATION INHIBITION REACTIONS OF INFLUENZA A(H1N1)pdm09 VIRUSES (01/23/13)


Information for the vaccine and related biological products advisory committee cber fda

HEMAGGLUTINATION INHIBITION REACTIONS OF INFLUENZA A(H1N1)pdm09 VIRUSES (01/29/13)


Information for the vaccine and related biological products advisory committee cber fda

Antigenic Cartography of A(H1N1)pdm09 Viruses

A/California/07/2009

Sept 2012 to Feb 2013 – Gold, Aug 2011 to Aug 2012 – Blue, Earlier – Grey


Information for the vaccine and related biological products advisory committee cber fda

Evolutionary Relationships Among Influenza A (H1N1)pdm09 Hemagglutinin (HA) Genes, 2012-13

A/Ohio/02/2013 Jan

K163I

V520A

02/22/2013

Current Northern Hemisphere

Vaccine Strain

LR- Low Reactor to A/California/07/2009 Egg

(≥ 8 fold)

F - CDC Reference Antigen

$- CDC Serology Antigen

C$- Common Serology Antigen

@ - Oseltamivir Resistant

# Egg Isolate

* – only HA1 region

October 2012

November 2012

December 2012

January 2013

hk A/Hong Kong/9259/2012 Dec

A/California/09/2013 Jan

usafsam A/SouthDakota/1411/2013 Jan

S84G

A/Massachusetts/02/2013 Jan

niid A/Yokohama/1/2013 Jan *

cnic A/Beijing-Huairou/SWL11348/2012 Dec

nimr A/Ghana/DILI-0902/2012 Oct

A/Tanzania/2085/2012 Dec #

afrims A/Bhutan/BTA-00098/2012

7

afrims A/Nepal/NPBH-00402/2012

A/Wyoming/31/2012 Dec @

S69T

N260D

V520A

usafsam A/SouthCarolina/22/2012 Oct

nhrc A/SouthCarolina/x88/2012

S143G

namru6 A/Peru/FPI03819/2012

A/Washington/24/2012 Jun @ F

A197T

A/Washington/24/2012 Jun @ # F $

A/Japan/1419/2013 Jan

usafsam A/Korea/1419/2013 Jan

cnic A/Beijing/SWLChaoyang-P031/2013 Jan LR

K154K/E

K163Q

A256T

A/Georgia/01/2013 Jan #

usafsam A/NewYork/1428/2013 Jan

K283E

E499K

A/Oman/412/2012 Dec

A/Cote DIvoire/1529/2012 Dec #

S185T

S451N

A/Utah/01/2013 Jan

A/Tanzania/340/2012 Dec #

V234I

hk A/Hong Kong/62/2013 Jan

N125S

A/Gansu-Ganzhou/33/2012 Nov #

A/New York/01/2013 Jan

nimr A/England/658/2012 Dec

nimr A/Norway/35/2013 Jan

A H1pdm09 HA Consensus 2012-13

H51N

I295V

A/India/2150/2012 Dec LR

6

A/India/2192/2012 Dec F $

D97N

A/India/2192/2012 Dec # F

I116M

R205K

A/Wisconsin/02/2013 Jan

A/Florida/02/2013 Jan

nimr A/Ukraine/3/2013 Jan

H138R

V249L

A/Bangladesh/2021/2012 Jul LR F

N156S

A/Bangladesh/2021/2012 Jul LR # F C$

cnic A/Jilin-Chaoyang/SWL1709/2012 Dec

P83S

S203T

I321V

E374K

nimr A/Netherlands/507/2012 Aug @

HA Genetic Groups Since September 2012

A/Chiang Rai/312/2012 Oct $

namru2 A/Cambodia/FSS23932/2012 Dec

niid A/Laos/I650/2012 Aug @ *

afrims A/Thailand/KPPH-00066/2012

A/Minnesota/03/2011 Feb # F

R205K

V249L

I216V

A/Minnesota/03/2011 Feb F

5

A/Minnesota/16/2012 Oct

A/Nigeria/7781/2012 Oct

A/Cote DIvoire/1575/2013 Jan

8

A186T V272A

N473D T474K V520A

nimr A/Dakar/20/2012 Dec

NYMC X181 A/California/07/2009 #

NYMC X179A A/California/07/2009 # F

A/California/07/2009 Apr # F $


Information for the vaccine and related biological products advisory committee cber fda

Evolutionary Relationships Among Influenza A (H1N1)pdm09 Neuraminidase (NA) Genes, 2012-13

02/22/2013

Current Northern Hemisphere

Vaccine Strain

LR- Low Reactor to A/California/07/2009 Egg

(≥ 8 fold)

F - CDC Reference Antigen

$- CDC Serology Antigen

C$- Common Serology Antigen

@ - Oseltamivir Resistant H275Y

# Egg Isolate

HA Genetic Group Shown

October 2012

November 2012

December 2012

January 2013

niid A/Yokohama/1/2013 Jan

N44S

ADD GLY

A/Ohio/02/2013 Jan

N222D

L40V

A/California/09/2013 Jan

7

I106V

N200S

A/Massachusetts/02/2013 Jan

cnic A/Beijing-Huairou/SWL11348/2012 Dec

nimr A/Ghana/DILI-0902/2012 Oct

A/Tanzania/2085/2012 Dec #

A/Georgia/01/2013 Jan #

A/Cote DIvoire/1529/2012 Dec #

nimr A/England/658/2012 Dec

A/New York/01/2013 Jan

nimr A/Norway/35/2013 Jan

A/India/2150/2012 Dec LR

A/Wisconsin/02/2013 Jan

V241I

N369K

6

A/Utah/01/2013 Jan

A/Tanzania/340/2012 Dec #

A N1pdm09 NA Consensus 2012-13

A/Oman/412/2012 Dec

A/India/2192/2012 Dec F $

A/India/2192/2012 Dec # F

A/Florida/02/2013 Jan

A/Gansu-Ganzhou/33/2012 Nov #

A/Washington/24/2012 Jun @ # F $

G41R

N44S ADD GLY

A/Washington/24/2012 Jun @ F

7

A/Wyoming/31/2012 Dec @

V106I

A/Japan/1419/2013 Jan

N248D

cnic A/Beijing/SWLChaoyang-P031/2013 Jan LR

A/Minnesota/03/2011 Feb # F

A/Minnesota/03/2011 Feb F

A/Chiang Rai/312/2012 Oct $

niid A/Laos/I650/2012 Aug @

N386S

LOSS GLY

6

nimr A/Netherlands/507/2012 Aug @

cnic A/Jilin-Chaoyang/SWL1709/2012 Dec

D451G

A/Minnesota/16/2012 Oct

nimr A/Ukraine/3/2013 Jan

A/Bangladesh/2021/2012 Jul LR # F C$

A/Bangladesh/2021/2012 Jul LR F

5

A/Nigeria/7781/2012 Oct

F74V N385T

A/Cote DIvoire/1575/2013 Jan

8

N386K LOSS GLY

nimr A/Dakar/20/2012 Dec

A/California/07/2009 Apr # F $

NYMC X179A A/California/07/2009 # F

NYMC X181 A/California/07/2009 #


Information for the vaccine and related biological products advisory committee cber fda

A(H1N1)pdm09 viruses co-circulated in varying proportions along with A(H3N2) and B viruses.

Regional A(H1N1)pdm09 activity was reported by a few countries in Asia and Central America. An increase in activity was reported, with regional and widespread outbreaks in January in many countries in Europe. Widespread outbreaks were reported in Algeria in January.

Localized and sporadic influenza activity were reported in many other countries in northern Africa, Asia and North America.

Summary - 1


Summary 2

Summary - 2

  • Most A(H1N1)pdm09 viruses were antigenically similar to the recommended vaccine virus A/California/7/2009.

  • Most recent A(H1N1)pdm09 viruses belong to genetic Clades 6 and 7.

  • The majority of A(H1N1)pdm09 viruses were sensitive to oseltamivir. Of the small number of viruses that were resistant to oseltamivir, all had the H275Y mutation.


A h3 n2 v iruses sept 2012 jan 2013

A(H3N2)VirusesSept 2012 – Jan 2013


Information for the vaccine and related biological products advisory committee cber fda

Number of A(H3N2) Viruses Detected by GISRS

Data source: FluNet, (www.who.int/flunet), Global Influenza Surveillance and Response System (15 February 2013)


H3n2 viruses characterized during the past 3 years from september to january

H3N2 Viruses Characterized During the Past 3 Years from September to January

USA

China

Japan

UK

Australia


H3 low reactors in hi assays by who ccs

H3 low reactors in HI assays by WHO CCs


Information for the vaccine and related biological products advisory committee cber fda

HEMAGGLUTINATION INHIBITION REACTIONS OF INFLUENZA H3 VIRUSES (GUINEA PIG RED BLOOD CELLS) (01/24/13)

  • 1. Egg-propagated A/Victoria/361/2011 differs from the cell-propagated A/Victoria/361/2011 at the 3 positions indicated.

  • 2. Substitution in the HAs of the clade 3C viruses compared to cell-propagated A/Victoria/361/2011.

  • 3. Substitution in the HAs of the A/Texas/50/2012 reassortants compared to egg-propagated A/Texas/50/2012.

  • 4. All test viruses were cell-propagated.


Information for the vaccine and related biological products advisory committee cber fda

Antigenic Analysis of Influenza A(H3N2) Viruses - Plaque Reduction Neutralization(MDCK-SIAT)


Information for the vaccine and related biological products advisory committee cber fda

Summary of fold differences between reference viruses and test antigens in HI assays performed by CDC since January 2013


Information for the vaccine and related biological products advisory committee cber fda

Antigenic Cartography of A(H3N2) Viruses

A/Victoria/361/2011-cell

A/Perth/16/2009

A/Victoria/361/2011-egg

Sept 2012 to Feb 2013 – Gold, Aug 2011 to Aug 2012 – Blue, Earlier – Grey


Information for the vaccine and related biological products advisory committee cber fda

H3N2 Hemagglutinin changes compared toA/Victoria/361/2011-cell

Victoria/361/2011

cell grown $

Victoria/361/2011

egg grown $@

Receptor binding site

Antigenic site B

G186V

H156Q

Antigenic site A

S219Y

Antigenic site E

Antigenic site D

Antigenic site C

Glycosylationsite

3C

3C


Information for the vaccine and related biological products advisory committee cber fda

H3N2 Hemagglutinin changes compared to A/Victoria/361/2011-cell

Texas/50/2012 egg

grown $@

Texas/50/2012 cell grown $^

S198P

T128N

G186V

¥ N126

S219F

Q33R

N278K

180° rotation


Information for the vaccine and related biological products advisory committee cber fda

H3N2 Hemagglutinin changes compared toA/Victoria/361/2011- cell

G186V

I226S


Information for the vaccine and related biological products advisory committee cber fda

Evolutionary Relationships Among Influenza A (H3N2) Hemagglutinin (HA) Genes, 2012-13

02/22/2013

Current Northern Hemisphere Vaccine Strain

WHO Recommendation 2013-2014

LR- Low Reactor to A/Victoria/361/2011 cell (≥ 8 fold)

F - CDC Reference Antigen

$- CDC Serology Antigen

C$- Common Serology Antigen

# Egg Isolate

* – only HA1 region

October 2012

November 2012

December 2012

January 2013

A/North Carolina/01/2013 Jan

A/Oklahoma/03/2013 Jan

usafsam A/Georgia/1407/2013 Jan

A/Beijing-Xicheng/12423/2012 Oct $

lrmc A/Qatar/x119/2013 Jan

T128A

LOSS GLY

R142G

A/West Virginia/01/2013 Jan

A/New York/39/2012 Oct #

usafsam A/NewYork/1365/2013 Jan

3C.3

A/Yamaguchi/30/2012 Oct LR

A/Rhode Island/02/2013 Jan

nimr A/Athens GR/14/2013 Jan

A/Virginia/03/2013 Jan

cnic A/Beijing-Huairou/128/2013 Jan *

A/Nebraska/02/2013 Jan

R33Q

A/Oregon/15/2012 Dec

A/Colorado/27/2012 Dec

usafsam A/Alabama/1197/2013 Jan

usafsam A/SouthDakota/1410/2013 Jan

A/Montana/01/2013 Jan

nimr A/England/676/2012 Dec

A/North Dakota/08/2012 Dec

A/New York/03/2013 Jan

usafsam A/Virginia/1373/2013 Jan

A/South Dakota/12/2012 Oct #

A/Ohio/01/2013 Jan

D489N

nhrc A/Illinois/NHRC367623/2012 Dec *

3C

usafsam A/DistrictofColombia/1414/2013 Jan

A/Illinois/01/2013 Jan

lrmc A/Italy/x178/2013 Jan

usafsam A/Guam/1490/2012 Dec

N145S

usafsam A/Florida/1324/2013 Jan

3C.2

nimr A/Sachsen/2/2013 Jan

cnic A/Heilongjiang-Xiangfang/11272/2012 Dec *

A/Ontario/RV2944/2012 Nov

A/North Carolina/02/2013 Jan

namru2 A/Cambodia/FSS22141/2013 Nov

usafsam A/Washington/1531/2013 Jan

A/California/04/2013 Jan

Q33R

N278K

A/Arizona/09/2012 Oct # F

niid A/Yokohama/164/2012 Dec *

A/Delaware/15/2012 Nov F $

A/Delaware/01/2013 Jan LR

S45N

ADD GLY

T48I

A/Seoul/3531/2012 Dec

A H3 HA Consensus 2012-13

A/Texas/50/2012 X-223 # F

I226N

T128N

LOSS GLY

A198P

G186V

S219F

A/Texas/50/2012 X-223A # F

A/Texas/50/2012 Apr # F $

A/Texas/50/2012 Apr F $

H156Q

G186V

S219Y

3C.1

A198S

N312S

A/Hawaii/22/2012 Jul # F

A/Hawaii/22/2012 Jul F $

A/Victoria/361/2011 Oct # F $

N144K

LOSS GLY

A/Victoria/361/2011 IVR-165 # F

A/Victoria/361/2011 Oct F $

nimr A/Cairo/136/2012 Dec

nimr A/Ukraine/551/2012 Dec

V223I

3B

namru2 A/Cambodia/FSS23444/2012 Nov

K62E

K144N

ADD GLY

T212A

N145S

D487N

A/Ohio/02/2012 X-221 # F

A/Ohio/02/2012 Mar # F

N144D

LOSS GLY

N145S D487N

A/Ohio/02/2012 Mar F

L3I D53N

A/Alaska/24/2012 Oct #

3A

HA Genetic Groups Since September 2012

A/Arkansas/05/2012 Dec

A/Tanzania/303/2012 Nov

usafsam A/Texas/1406/2013 Jan

K2E

A/Florida/01/2013 Jan

D53N

Y94H

I230V

E280A

5

N8D LOSS GLY

A/South Carolina/16/2012 Nov $

A/Delaware/23/2012 Dec #

nimr A/Austria/710638/2012 Dec

usafsam A/Florida/1378/2013 Jan

A/Brisbane/299/2011 Aug # F

P162S

I260M

R261Q

6

A/Virginia/16/2012 Dec #

S199A

A/Puerto Rico/36/2012 Jun # F

A/Perth/16/09-like

1

A/Jiangsu-Donghai/57/2012 Sep #

A/Jiangsu-Danyang/1647/2012 Oct #

A/Perth/16/2009 # F


Information for the vaccine and related biological products advisory committee cber fda

Evolutionary Relationships Among Influenza A (H3N2) Neuraminidase (NA) Genes, 2012-13

N43D

02/22/2013

Current Northern Hemisphere Vaccine Strain

WHO Recommendation 2013-2014

LR- Low Reactor to A/Victoria/361/2011 cell (≥ 8 fold)

F - CDC Reference Antigen

$- CDC Serology Antigen

C$- Common Serology Antigen

# Egg Isolate

HA Genetic Group Shown

October 2012

November 2012

December 2012

January 2013

A/New York/39/2012 Oct #

A/West Virginia/01/2013 Jan

A/Rhode Island/02/2013 Jan

A/Virginia/03/2013 Jan

M24T

A/North Carolina/01/2013 Jan

A/Oklahoma/03/2013 Jan

nimr A/England/676/2012 Dec

nimr A/Sachsen/2/2013 Jan

A/Ontario/RV2944/2012 Nov

cnic A/Beijing-Huairou/128/2013 Jan

cnic A/Heilongjiang-Xiangfang/11272/2012 Dec

A/North Dakota/08/2012 Dec

V143M

A/Ohio/01/2013 Jan

A/Illinois/01/2013 Jan

A/Yamaguchi/30/2012 Oct LR

A/Delaware/15/2012 Nov F $

3C

niid A/Yokohama/164/2012 Dec

A N2 Consensus 2012-13

A/Delaware/01/2013 Jan LR

A/Seoul/3531/2012 Dec

cnic A/Beijing-Xicheng/12423/2012 Oct $

A/Oregon/15/2012 Dec

A/Montana/01/2013 Jan

A/Nebraska/02/2013 Jan

A/Hawaii/22/2012 Jul # F

A/Hawaii/22/2012 Jul F $

A/North Carolina/02/2013 Jan

A/Texas/50/2012 Apr # F $

A/Texas/50/2012 Apr F $

D93G

A/Texas/50/2012 X-223A # F

A/Texas/50/2012 X-223 # F

R150H

A/Victoria/361/2011 IVR-165 # F

E258K

N329T LOSS GLY

A/Victoria/361/2011 Oct # F $

A/Victoria/361/2011 Oct F $

L81P

N402D

LOSS GLY

A/Ohio/02/2012 Mar # F

D251V

D304N

3B

A/Ohio/02/2012 Mar F $

nimr A/Cairo/136/2012 Dec

nimr A/Ukraine/551/2012 Dec

S367N

ADD GLY

K369T

I464L

A/South Carolina/22/2012 Nov

A/Virginia/16/2012 Dec #

A/Puerto Rico/36/2012 Jun # F

nimr A/Austria/710638/2012 Dec

5/6

S315R

T148T/I/K

(I/K LOSS GLY)

D151/D/N/V/G/S/A (N ADD GLY)

A/Delaware/23/2012 Dec #

A/Florida/01/2013 Jan

V143M

A/South Carolina/16/2012 Nov $

A/Brisbane/299/2011 Aug # F

A/Tanzania/303/2012 Nov

S416N

E221D

T238A

3A

A/Alaska/24/2012 Oct #

H336N

A/Arkansas/05/2012 Dec

D127N E258K I307M L338F N342D E381G

N402D LOSS GLY R430S

A/Perth/16/09-like

1

A/Jiangsu-Danyang/1647/2012 Oct #

A/Jiangsu-Donghai/57/2012 Sep #

A/Perth/16/2009 # F


Information for the vaccine and related biological products advisory committee cber fda

Summary

  • Influenza A(H3N2) viruses caused widespread outbreaks in North America and were the predominant circulating viruses globally. H3N2 viruses also caused regional or widespread activity in some Asian and European countries.

  • The majority of recent A(H3N2) viruses tested were antigenically similar to the cell-propagated A/Victoria/361/2011 reference virus and egg and cell-propagated A/Texas/50/2012 viruses.

  • Post-infection ferret antisera raised against the egg-propagated A/Victoria/361/2011 virus had HI and neutralization titers that were at least 8-fold lower compared to the homologous titer.

  • The HA genes of most recent A(H3N2) viruses fell into phylogenetic clade 3C while a smaller proportion had HA genes that fell into other phylogenetic clades such as 3A, 3B, 5 and 6. These genetic clades were antigenically indistinguishable.

  • All tested H3N2 viruses remained susceptible to neuraminidase inhibitors.


Information for the vaccine and related biological products advisory committee cber fda

Influenza B Viruses

Sept 2012 – Jan 2013


Introduction

Introduction

  • In recent years both B/Victoria lineage and B/Yamagata lineage viruses have co-circulated.

  • During the 2012/13 Northern Hemisphere season, the proportion of B/Yamagata lineage viruses increased and this lineage predominated in many countries.


Influenza b viruses were 23 of total

Influenza B viruses were 23% of total

Data source: FluNet, (www.who.int/flunet), Global Influenza Surveillance and Response System (15 February 2013)


Information for the vaccine and related biological products advisory committee cber fda

Influenza B viruses analyzed by WHO CCs

September 2012 to January 2013


Influenza b activity

Influenza B activity

Data source: FluNet, (www.who.int/flunet), Global Influenza Surveillance and Response System


Information for the vaccine and related biological products advisory committee cber fda

Number of B Viruses Detected by GISRS

Data source: FluNet, (www.who.int/flunet), Global Influenza Surveillance and Response System (15 February 2013)


B viruses characterized during the past 3 nh seasons sept to jan

B viruses characterized during the past 3 NH seasons (Sept to Jan)


Information for the vaccine and related biological products advisory committee cber fda

B low reactors in HI assays in WHO CCs


Information for the vaccine and related biological products advisory committee cber fda

B/Victoria Lineage Viruses


Information for the vaccine and related biological products advisory committee cber fda

HEMAGGLUTINATION INHIBITION REACTIONS OF INFLUENZA TYPE B VIRUSES (01/25/13)


Information for the vaccine and related biological products advisory committee cber fda

B/Victoria Antigenic Cartography

B/Brisbane/60/2008-cell

Recent B/Victoria lineage viruses are antigenically similar to B/Brisbane/60/2008

Sept 2012 to Feb 2013 – Gold, Aug 2011 to Aug 2012 – Blue, Earlier – Grey


Information for the vaccine and related biological products advisory committee cber fda

Evolutionary Relationships Among Influenza B Victoria Lineage Hemagglutinin (HA) Genes, 2012-13

B/New Jersey/02/2013 Jan LR

B/Virginia/05/2012 Dec LR

N129D

02/22/2013

LR- Low Reactor to B/Brisbane/60/2008 Egg

(≥ 8 fold)

F - CDC Reference Antigen

$ - CDC Serology Antigen

# Egg Isolate

* - HA1 region only

____ 165N

October 2012

November 2012

December 2012

January 2013

B/Texas/02/2013 Jan

B/Wisconsin/16/2012 Dec LR

afrims B/Philippines/AFPA-00149/2012

usamruk B/Kenya/244/2012

aus B/Victoria/824/2012 Oct

B/Bangladesh/3249/2012 Oct

K209N

cnic A/Fujian-Yanping/2322/2012 Dec *

B/India/2024/2012 Nov LR

B/Wyoming/10/2012 Dec

B/Wisconsin/01/2013 Jan LR

B/Bangkok/282/2012 Oct

A154T

afrims B/Thailand/KPPH-00092/2012

nimr B/Jordan/30014/2012 Dec

nimr B/Lyon/2760/2012 Dec

usafsam B/Nevada/847/2012 Dec

G184E

B/Utah/17/2012 Dec

namru6 B/Piura/FPP01690/2012 Dec *

namru6 B/Pampagrande/FPT01070/2012 Dec *

A169E

B/Peru/1634/2012 Oct

usafsam B/Texas/770/2012 Dec

1A

usafsam B/Florida/1189/2012 Dec

nimr B/Bayern/1/2013 Jan

B/Tanzania/335/2012 Dec LR

cnic A/Jiangsu-Tianning/1676/2012 Dec # *

B/Honduras/648/2012 Nov

B/Louisiana/01/2012 Dec

afrims B/Philippines/AFPA-00187/2012

namru6 B/Nicaragua/INI00520/2012 Nov *

cnic A/Jiangsu-Pingjiang/1494/2012 Dec *

B/Nebraska/05/2012 Nov

usafsam B/Nebraska/908/2012 Dec

usafsam B/Nebraska/1075/2012 Dec

B Victoria HA Consensus 2012-13

afrims B/Bhutan/BTF-00088/2012

B/Uganda/2851/2012

B/Nevada/03/2011 Feb F

B/Nevada/03/2011 Feb # F

cnic A/Jiangsu-Qingpu/11269/2012 Oct *

HA Genetic Groups Since September 2012

N218D

B/Jiangsu-Hailing/1740/2012 Sep #

Intra-clade

Reassortants

HA-1A/NA-3

namru6 B/Peru/IRPc00144/2012 *

V15I

nimr B/Denmark/23/2012 Nov

N75K

N165K

S172P

B/Michigan/09/2011 Sep # F

V146I

B/Brisbane/60/2008 Aug # F $

B/Brisbane/60/2008 Aug F

B/Montana/05/2012 Oct # LR F

H122L

V87I

N129S

B/Montana/06/2012 Oct LR

afrims B/Thailand/PMKA1934/2012

N171D

P58S

1B

afrims B/Thailand/KRCH-00010/2012

Intra-clade

Reassortants

HA-1B/NA-4

cnic A/Jiangxi-Xunyang/52/2012 Dec *

L58P

niid B/Laos/I772/2012 Oct *

cnic A/Jiangsu-Runzhou/1697/2012 Nov # *

B/Hiroshima/09/2010 Sep # LR F

B/Ohio/01/2005 Feb # LR F


Information for the vaccine and related biological products advisory committee cber fda

Evolutionary Relationships Among Influenza B Victoria Lineage Neuraminidase (NA) Genes, 2012-13

02/22/2013

LR- Low Reactor to B/Brisbane/60/2008 Egg

(≥ 8 fold)

F - CDC Reference Antigen

$ - CDC Serology Antigen

# Egg Isolate

HA Genetic Group Shown

October 2012

November 2012

December 2012

January 2013

B/Texas/02/2013 Jan

B/Wisconsin/16/2012 Dec LR

B/Virginia/05/2012 Dec LR

B/New Jersey/02/2013 Jan LR

B/Honduras/648/2012 Nov

B/Louisiana/01/2012 Dec insert L76

B/Nebraska/05/2012 Nov

cnic A/Jiangsu-Pingjiang/1494/2012 Dec

cnic A/Jiangsu-Tianning/1676/2012 Dec #

nimr B/Lyon/2760/2012 Dec

1B

B/Montana/05/2012 Oct # LR F

L73F

B/Montana/06/2012 Oct LR

B/Tanzania/335/2012 Dec LR

B/Wisconsin/01/2013 Jan LR

B/Wyoming/10/2012 Dec

1A

B/Peru/1634/2012 Oct

B/Utah/17/2012 Dec

L73F

S295R

nimr B/Bayern/1/2013 Jan

B Victoria NA Consensus 2012-13

nimr B/Jordan/30014/2012 Dec

N198S

S345N

B/Bangkok/282/2012 Oct

aus B/Victoria/824/2012 Oct

N340D

B/India/2024/2012 Nov LR

B/Bangladesh/3249/2012 Oct

K343E

cnic A/Fujian-Yanping/2322/2012 Dec

B/Uganda/2851/2012

B/Nevada/03/2011 Feb # F

V63M

B/Nevada/03/2011 Feb F

D329N

B/Brisbane/60/2008 Aug # F $

I204V

N220K

A358E

B/Brisbane/60/2008 Aug F

B/Jiangsu-Hailing/1740/2012 Sep #

H61Q

K375M

D35G N59D R65S

I348V A395T

cnic A/Jiangsu-Qingpu/11269/2012 Oct

P51S

L73F

N199D

1B

B/Hiroshima/09/2010 Sep # LR F

cnic A/Jiangsu-Runzhou/1697/2012 Nov #

Intra-clade

Reassortants

HA-1A/NA-3

B/Ohio/01/2005 Feb # F

3

B/Michigan/09/2011 Sep # F

T8M L73F A389T S397R

nimr B/Denmark/23/2012 Nov

4

Intra-clade

Reassortants

HA-1B/NA-4

S41P P42S N125K V271I K272Q D320K D329E D340N D342G

cnic A/Jiangxi-Xunyang/52/2012 Dec

D384N A395V K404E D463N A465T ADD GLY


Information for the vaccine and related biological products advisory committee cber fda

B/Yamagata Lineage Viruses

WHO information meeting on influenza vaccine composition for southern hemisphere 2013

20 September 2012 Beijing


Antigenic analysis of b yamagata viruses 1

Antigenic analysis of B/Yamagata viruses (1)


Antigenic analysis of b yamagata viruses 2

Antigenic analysis of B/Yamagata viruses (2)


Information for the vaccine and related biological products advisory committee cber fda

HEMAGGLUTINATION INHIBITION REACTIONS OF INFLUENZA B/YAMAGATA-LINEAGE VIRUSES (01/25/13)


Information for the vaccine and related biological products advisory committee cber fda

B/Yamagata Antigenic Cartography

B/Massachusetts/2/2012-egg

B/Wisconsin/1/2010-egg

Clade 2 and 3 viruses were antigenically distinguishable by many sera

Sept 2012 to Feb 2013 – Gold, Aug 2011 to Aug 2012 – Blue, Earlier – Grey


Information for the vaccine and related biological products advisory committee cber fda

Evolutionary Relationships Among Influenza B Yamagata Lineage Hemagglutinin (HA) Genes, 2012-13

B/Georgia/04/2013 Jan

B/Georgia/02/2013 Jan

usafsam B/Maryland/583/2012 Dec

02/22/2013

Current Northern Hemisphere Vaccine Strain

WHO Recommendation 2013-2014

LR- Low Reactor to B/Wisconsin/01/2010 Egg

(≥ 8 fold)

F - CDC Reference Antigen

$ - CDC Serology Antigen

# Egg Isolate

* - HA1 region only

October 2012

November 2012

December 2012

January 2013

February 2013

B/Ohio/01/2013 Jan

usafsam B/Florida/1376/2013 Jan

B/Texas/01/2013 Jan

lrmc B/Belgium/x54/2012

B/India/2152/2012 Dec

usafsam B/NewYork/1201/2013 Jan

B Yamagata HA Consensus 2012-13

usafsam B/SouthCarolina/1462/2013 Jan

B/Oman/14/2013 Jan

usafsam B/Illinois/704/2012 Dec

T189A

usafsam B/Alaska/1351/2012 Dec

B/Missouri/01/2013 Jan

B/Kansas/02/2012 Dec

B/India/2127/2012 Dec

nimr B/Lyon/2771/2012 Dec

Y2

B/New Mexico/04/2012 Nov $

B/North Carolina/05/2012 Dec

lrmc B/Germany/x170/2013 Jan

usafsam B/Colorado/1468/2013 Jan

usafsam B/Texas/1322/2013 Jan

afrims B/Bhutan/BTG-00006/2012

usafsam A/Oklahoma/1557/2013 Jan

B/Texas/24/2012 Nov #

N197D LOSS GLY

niid B/Yokohama/82/2012 Dec *

B/Chanthaburi/318/2012 Oct

B/Alabama/01/2013 Jan

R48K

P108A

T182A

S230G

B/Massachusetts/02/2012 BX-51B F

B/Massachusetts/02/2012 BX-51C # F

B/Massachusetts/02/2012 Mar # F $

B/Nevada/17/2012 Dec

aus B/Wellington/3/2012 Jul

B/Massachusetts/02/2012 Mar F $

afrims B/Thailand/KPPH-00148/2012

K88R

E479D

B/Estonia/55669/2011 Mar F

aus B/Brisbane/36/2012 Jun

B/Dominican Republic/6986/2012 Dec

V29A L173Q

B/Quebec/RV2958/2012 Nov

M252V

S150I

N166Y

S230D

nimr B/Ghana/DILI-0859/2012 Oct

B/Cote DIvoire/1507/2012 Dec

B/Texas/06/2011 Feb # F

B/Texas/06/2011 Feb F

T182K

T37A

K299E

E313K

usafsam B/Nevada/845/2012 Dec

HA Genetic Groups Since September 2012

nimr B/Rheinland-Pfalz/4/2013 Jan

Y3

B/Vermont/07/2012 Dec

B/Hubei-Wujiagang/158/2009 Mar # F

B/Nong Khai/322/2012 Oct

N116K

cnic B/Heilongjiang-Jiguan/1409/2012 Dec *

K299E

E313K

N203S

B/Hawaii/13/2012 Nov

B/Bangladesh/7005/2012 Oct

B/Wisconsin/01/2010 Feb # F $

B/Wisconsin/01/2010 Feb F $

B/Florida/04/2006 Nov # F


Information for the vaccine and related biological products advisory committee cber fda

Evolutionary Relationships Among Influenza B Yamagata Lineage Neuraminidase (NA) Genes, 2012-13

02/22/2013

Current Northern Hemisphere Vaccine Strain

WHO Recommendation 2013-2014

LR- Low Reactor to B/Wisconsin/01/2010 Egg

(≥ 8 fold)

F - CDC Reference Antigen

$ - CDC Serology Antigen

# Egg Isolate

HA Genetic Group Shown

October 2012

November 2012

December 2012

January 2013

February 2013

B/New Mexico/04/2012 Nov $

B/Ohio/01/2013 Jan

B/Texas/01/2013 Jan

B/Georgia/02/2013 Jan

A55T

B/Georgia/04/2013 Jan

B/Kansas/02/2012 Dec

B Yamagata NA Consensus 2012-13

B/India/2127/2012 Dec

niid B/Yokohama/82/2012 Dec

nimr B/Lyon/2771/2012 Dec

Y2

B/India/2152/2012 Dec

B/Chanthaburi/318/2012 Oct

B/North Carolina/05/2012 Dec

B/Oman/14/2013 Jan

T106I

I248V

S295R

B/Estonia/55669/2011 Mar F

aus B/Wellington/3/2012 Jul

R65H

B/Nevada/17/2012 Dec

B/Massachusetts/02/2012 BX-51B F

B/Massachusetts/02/2012 BX-51C F

B/Massachusetts/02/2012 Mar # F $

B/Massachusetts/02/2012 Mar F $

aus B/Brisbane/36/2012 Jun

B/Cote DIvoire/1507/2012 Dec

L73P

K343E

nimr B/Ghana/DILI-0859/2012 Oct

Q42R

A68T

T125K

K186R

D340N

B/Quebec/RV2958/2012 Nov

D463N

A465T

ADD GLY

B/Dominican Republic/6986/2012 Dec

B/Texas/06/2011 Feb # F

B/Texas/06/2011 Feb F

B/Vermont/07/2012 Dec

Y3

nimr B/Rheinland-Pfalz/4/2013 Jan

B/Hubei-Wujiagang/158/2009 Mar # F

B/Wisconsin/01/2010 Feb # F $

B/Wisconsin/01/2010 Feb F $

B/Hawaii/13/2012 Nov

B/Bangladesh/7005/2012 Oct

B/Nong Khai/322/2012 Oct

cnic B/Heilongjiang-Jiguan/1409/2012 Dec

B/Florida/04/2006 Nov # F


Summary

Summary

  • B/Victoria and B/Yamagata lineage viruses co-circulated.

  • The proportion of B/Yamagata viruses has increased in many countries, while B/Victoria viruses predominated in some countries.

  • B/Victoria lineage viruses

    • Antigenically and genetically remain similar to the previously used vaccine virus, B/Brisbane/60/2008.

  • B/Yamagata lineage viruses

    • HA genes of the viruses were in clade 2 or 3.

    • Clade 3 viruses were antigenically and genetically closely related to the 2012/13 NH vaccine virus, B/Wisconsin/1/2010.

    • Some ferret antisera are able to detect antigenic differences between recent clade 2 and 3 viruses.

    • Clade 2 viruses have circulated widely in recent months.


Summary of a h1n1 pdm09 viruses

Summary of A(H1N1)pdm09 viruses

  • A(H1N1)pdm09 viruses

    • Continued to circulate at relatively low levels

    • Increase observed in some parts of Europe in January

    • Viruses are antigenically similar to A/California/7/2009vaccine virus

    • HA genes are in clades 6 and 7 but these clades are antigentically indistinguishable.


Summary of influenza a h3n2

Summary of influenza A(H3N2)

  • Predominant viruses globally and especially in Canada and the U.S. Some other countries in the Northern Hemisphere reported regional and widespread outbreaks.

  • Most recent viruses have HAs that:

    • Genetically fall into clade 3C; remainder fall into clades 3A, 3B, 5 and 6

    • Antigenically indistinguishable

    • Antigenically similar to cell-propagated A/Victoria/361/2011, egg- and cell- propagated A/Texas/50/2012 viruses

    • Showed at least 8-fold reduction in HI and NT using antisera against egg-propagated A/Victoria/361/2011


Summary of influenza b 1

Summary of influenza B (1)

  • Influenza B viruses circulated and caused outbreaks in many countries.

  • Both B/Victoria/2/87 and B/Yamagata/16/88 lineages co-circulated.

    • B-Vic viruses prevalent in some countries (e.g., China)

    • B-Yam viruses continued to increase in proportion and becoming dominant in many countries

  • The majority of recent B/Victoria/2/87 lineage viruses were antigenically and genetically closely related to B/Brisbane/60/2008.

  • Most recent B/Yamagata/16/88 lineage viruses

    • HA genes fall into clades 2 or 3, with the proportion of clade 2 viruses increasing significantly in Europe and North America

    • Many clade 2 vs. clade 3 viruses are antigenically distinguishable in HI tests especially in laboratories in Melbourne and London


Publications

Publications

  • Vaccine composition recommendation report and summary report on H5/H9 vaccine viruses:

    • WHO GlSRS website:

      • http://www.who.int/influenza/gisrs_laboratory/en/

      • http://www.who.int/influenza/vaccines/virus/en/

    • WHO Weekly Epidemiological Record:

      • http://www.who.int/wer/en/

  • Candidate vaccine viruses and reagents

    • http://www.who.int/influenza/vaccines/virus/en/

  • WHO Global Influenza Surveillance and Response System (GISRS):

    • [email protected]


Acknowledgements

Acknowledgements

  • WHO Collaborating Centers in Beijing, London, Melbourne and Tokyo for seasonal influenza data

  • National Influenza Centers (over 20 submitted written reports in addition to data provided through FluNet)

  • Essential Regulatory Laboratories for human serology data

  • Many staff from CDC’s Influenza Division, including Alexander (Sasha) Klimov, Xiyan Xu, Rebecca Garten, Julie Villanueva, Angie Foust, Wendy Sessions, Elizabeth Blanchard, Thomas Rowe, Jan Mabry, Jackie Katz, Vic Vegilla and many others


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