Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory.

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Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products OVRR/CBER/FDA Prepared for Vaccines and Related Biological Products Advisory Committee 18 February 2009

Serum Panels Used for Serology AUSTRALIA, IAN BARR, PH.D. ADULTS A/Solomon Islands IVR-145 (H1N1) WHO, AUSTRALIA ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2) B/Florida/4/2006 EUROPE, JOHN WOOD, PH.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1) NIBSC, ENGLAND ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2) B/Florida/4/2006 JAPAN, TAKATO ODIGARI, PH.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1) ) NIID, JAPAN ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2) B/Florida/4/2006 USA, STEFAN GRAVENSTEIN, M.D. ADULTS A/Brisbane/59/2007 IVR-148 (H1N1) EASTERN VIRGINIA ELDERLY A/Uruguay/716/2007 NYMC X175C(H3N2) MEDICAL SCHOOLPEDIATRIC B/Florida/4/2006

Antigens for Serology (H1N1) 8 VACCINE STRAIN A/BRISBANE/59/2007 2B REPRESENTATIVE CURRENT STRAINS A/Brazil/5943/2008 2B A/England/412/2008 2B A/Hiroshima/48/2008-E 2B A/Hiroshima/48/2008-C 2B A/Pennsylvania/8/2008 2B A/Victoria/501/2008 2B A/Hong Kong/1870/2008-E 2C A/Hong Kong/1870/2008-C 2C A/Guam/1/2007 2C A/Shiga/8/2008 2C A/Perth/200/2008 2C

HI ANTIBODY RESPONSES TO THE H1N1 ADULT POPULATION (NIBSC) 3 NAntigen% Rise Pre- vacc GMT Post- vacc GMT Pre- vacc % HI>40 Post- vacc % HI>40 EU24A/Brisbane/59/ A/Brazil/5943/2008 2B A/England/412/2008 2B A/Hiroshima/48/2008-C 2B A/Hiroshima/48/2008-E 2B A/Hong Kong/1870/2008 2C A/Pennsylvania/8/2008 2B USA24A/Brisbane/59/ A/Brazil/5943/2008 2B A/England/412/2008 2B A/Hiroshima/48/2008-C 2B A/Hiroshima/48/2008-E 2B A/Hong Kong/1870/2008 2C A/Pennsylvania/8/2008 2B JP24A/Brisbane/59/ A/Brazil/5943/2008 2B A/England/412/2008 2B A/Hiroshima/48/2008-C 2B A/Hiroshima/48/2008-E 2B A/Hong Kong/1870/2008 2C A/Pennsylvania/8/2008 2B

HI ANTIBODY RESPONSES TO THE H1N1 Elderly POPULATION (NIBSC) 3 NAntigen% Rise Pre- vacc GMT Post- vacc GMT Pre- vacc % HI>40 Post- vacc % HI>40 EU24A/Brisbane/59/ A/Brazil/5943/2008 2B A/England/412/2008 2B A/Hiroshima/48/2008-C 2B A/Hiroshima/48/2008-E 2B A/Hong Kong/1870/2008 2C A/Pennsylvania/8/2008 2B USA24A/Brisbane/59/ A/Brazil/5943/2008 2B A/England/412/2008 2B A/Hiroshima/48/2008-C 2B A/Hiroshima/48/2008-E 2B A/Hong Kong/1870/2008 2C A/Pennsylvania/8/2008 2B JP24A/Brisbane/59/ A/Brazil/5943/2008 2B A/England/412/2008 2B A/Hiroshima/48/2008-C 2B A/Hiroshima/48/2008-E 2B A/Hong Kong/1870/2008 2C A/Pennsylvania/8/2008 2B

A/Brisbane/59/2007 Vaccine SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (Adults) 7

A/Brisbane/59/2007 Vaccine SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (Elderly) 6

A/Brisbane/59/2007 Vaccine SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (Pediatric) 7

Antigens for Serology (H3N2) 2 VACCINE STRAIN A/Brisbane/10/2007 A/Uruguay/716/2007 REPRESENTATIVE CURRENT STRAINS A/BRISBANE/24/2008 A/Missouri/5/2008 A/Norway/2118/2008 A/Taiwan/471/2008 A/New York/09/2008 A/Tennessee/04/2008 A/Kanagawa/65/2008

HI ANTIBODY RESPONSES TO THE H3N2 ADULT POPULATION (CBER) PopulationNAntigen % Rise Pre- vacc GMT Post- vacc GMT Pre- vacc % HI>40 Post- vacc % HI>40 EU24A/Brisbane/10/ A/Uruguay/716/ A/Brisbane/24/ A/Missouri/5/ A/Taiwan/471/ JP24A/Brisbane/10/ A/Uruguay/716/ A/Brisbane/24/ A/Missouri/5/ A/Taiwan/471/ USA24A/Brisbane/10/ A/Uruguay/716/ A/Brisbane/24/ A/Missouri/5/ A/Taiwan/471/

HI ANTIBODY RESPONSES TO THE H3N2 Elderly POPULATION (CBER) PopulationNAntigen % Rise Pre- vacc GMT Post- vacc GMT Pre- vacc % HI>40 Post- vacc % HI>40 EU24A/Brisbane/10/ A/Uruguay/716/ A/Brisbane/24/ A/Missouri/5/ A/Taiwan/471/ JP24A/Brisbane/10/ A/Uruguay/716/ A/Brisbane/24/ A/Missouri/5/ A/Taiwan/471/ USA24A/Brisbane/10/ A/Uruguay/716/ A/Brisbane/24/ A/Missouri/5/ A/Taiwan/471/

A/Brisbane/10/2007-like VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (ADULT) 12

A/Brisbane/10/2007-like VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (ELDERLY) 13

A/Brisbane/10/2007-like VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (Pediatric) 13

Antigens for Serology (B) VACCINE STRAIN-Yam B/Florida/4/2006 B/Brisbane/3/2008 REPRESENTATIVE CURRENT STRAINS B/Indiana/01/2008 B/England/145/2008 B/Bangladesh/3333/2007 B/Cape Town/337/2008 B/Fujian Gulou/1272/2008 B/Brisbane/33/2008 B/England/393/208 B/Tochigi/15/2008 B/Brisbane/60/2008 B/Perth/210/

HI ANTIBODY RESPONSES TO B ADULT POPULATION (Australia) 15 NAntigen % Rise Pre- GMT Post- GMT Pre % > 40 Post % > 40 AUS24B/Brisbane/3/2008-Yam B/Cape Town/337/2008-Yam B/Indiana/1/2008-Yam B/Brisbane/60/2008-Vic B/Perth/210/2008-Vic B/Fujian/Gulou/1272/2008-Vic EU24B/Brisbane/3/2008-Yam B/Cape Town/337/2008-Yam B/Indiana/1/2008-Yam B/Brisbane/60/2008-Vic B/Perth/210/2008-Vic B/Fujian/Gulou/1272/2008-Vic

HI ANTIBODY RESPONSES TO THE B COMPONENT ADULT POPULATION (Australia) NAntigen % Rise Pre- GMT Post- GMT Pre % > 40 Post % > 40 US24B/Brisbane/3/2008-Yam B/Cape Town/337/2008-Yam B/Indiana/1/2008-Yam B/Brisbane/60/2008-Vic B/Perth/210/2008-Vic B/Fujian/Gulou/1272/2008-Vic JP24B/Brisbane/3/2008-Yam B/Cape Town/337/2008-Yam B/Indiana/1/2008-Yam B/Brisbane/60/2008-Vic B/Perth/210/2008-Vic B/Fujian/Gulou/1272/2008-Vic

HI ANTIBODY RESPONSES TO B Elderly POPULATION (Australia) 15 NAntigen % Ri se Pre- GMT Post- GMT Pre % > 40 Post % > 40 AUS24B/Brisbane/3/2008-Yam B/Cape Town/337/2008-Yam B/Indiana/1/2008-Yam B/Brisbane/60/2008-Vic B/Perth/210/2008-Vic B/Fujian/Gulou/1272/2008-Vic EU24B/Brisbane/3/2008-Yam B/Cape Town/337/2008-Yam B/Indiana/1/2008-Yam B/Brisbane/60/2008-Vic B/Perth/210/2008-Vic B/Fujian/Gulou/1272/2008-Vic

HI ANTIBODY RESPONSES TO THE B COMPONENT Elderly POPULATION (Australia) NAntigen % Rise Pre- GMT Post- GMT Pre % > 40 Post % > 40 US24B/Brisbane/3/2008-Yam B/Cape Town/337/2008-Yam B/Indiana/1/2008-Yam B/Brisbane/60/2008-Vic B/Perth/210/2008-Vic B/Fujian/Gulou/1272/2008-Vic JP24B/Brisbane/3/2008-Yam B/Cape Town/337/2008-Yam B/Indiana/1/2008-Yam B/Brisbane/60/2008-Vic B/Perth/210/2008-Vic B/Fujian/Gulou/1272/2008-Vic

B/Florida/4/2006 VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (ADULT) 18

B/Florida/4/2006 VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (ELDERLY) 19

B/Florida/4/2006 VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (Paediatric) 19

Serologic Conclusions Studies with human sera collected after immunization with current vaccines show that: H1N1 –Representative recent viruses were modestly inhibited by HA antibodies to current vaccine strains (A/Brisbane/59/2007-like virus). H3N2 –Representative recent viruses were well inhibited by HA antibodies to current vaccine strain (A/Brisbane/10/2007-like virus). B –B/VICTORIA/2/87-lineage Representative recent viruses were not well inhibited by HA antibodies to current vaccine strain (B/Florida/4/2006-like virus). –B/YAMAGATA/16/88-lineage Representative recent viruses were well inhibited by HA antibodies to the current vaccine strain. 20