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

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Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products Prepared for Vaccines and Related Biological Products Advisory Committee 28 February 2007

Serum panels used for serology AUSTRALIA IAN BARR, PH.D. ADULTS A/NEW CALEDONIA/20/99 (H1N1) WHO, AUSTRALIA ELDERLY A/NEW YORK/55/04 (H3N2) B/MALAYSIA/2506/05 EUROPE JOHN WOOD, PH.D. ADULTS A/NEW CALEDONIA/20/99 (H1N1) NIBSC, ENGLAND ELDERLY A/WISCONSIN/67/05 (H3N2) or A/HIROSHIMA/52/2006 (H3N2) B/MALAYSIA/2506/05 JAPAN TAKATO ODIGARI, PH.D. ADULTS A/NEW CALEDONIA/20/99 (H1N1) NIID, JAPAN ELDERLY A/HIROSHIMA/52/2006 (H3N2) B/MALAYSIA/2506/05 USA STEFAN GRAVENSTEIN, M.D. ADULTS A/NEW CALEDONIA/20/99 (H1N1) EASTERN VIRGINIA ELDERLY A/WISCONSIN/67/05 (H3N2) MEDICAL SCHOOL, PEDIATRIC B/MALAYSIA/2506/05 1

Antigens for serology (H1N1) VACCINE STRAIN A/New Caledonia/20/99 IVR116 REPRESENTATIVE CURRENT STRAINS l A/England/555/2006 l A/Fukushima/141/2006 l A/Guangxigangbei/322/2006 l A/St. Petersburg/8/2006 l A/Hong Kong/2652/2006* l A/Norway/2289/2006* l A/Solomon Islands/3/2006* * K144E Change Present 2

HI ANTIBODY RESPONSES TO THE H1N1 ADULT POPULATION (UK) TrialVirus strainPre- vacc % HI>40 Post- vacc % HI>40 % rise pre- vacc GMT Post- vacc GMT Adult EU –W 24A/New Caledonia/20/ A/England/555/ A/Fukushima/141/ A/Norway/2289/2006 *(K114E) A/Solomon Islands/3/06 *(K114E) A/St. Petersburg/8/ A/Virginia/1/ Adult Australi a 24A/New Caledonia/20/ A/England/555/ A/Fukushima/141/ A/Norway/2289/2006 *(K114E) A/Solomon Islands/3/06 *(K114E) A/St. Petersburg/8/ A/Virginia/1/

HI ANTIBODY RESPONSES TO THE H1N1 ADULT POPULATION (UK) TrialNo. of Sera Virus strainPre- vacc % HI>40 Post- vacc % HI>40 % rise pre- vacc GMT Post- vacc GMT Adult USA 24A/New Caledonia/20/ A/England/555/ A/Fukushima/141/ A/Norway/2289/2006 *(K114E) A/Solomon Islands/3/06 *(K114E) A/St. Petersburg/8/ A/Virginia/1/ Adult Japan 30A/New Caledonia/20/ A/England/555/ A/Fukushima/141/ A/Norway/2289/2006 *(K114E) A/Solomon Islands/3/06 *(K114E) A/St. Petersburg/8/ A/Virginia/1/

A/New Caledonia/20/99 VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION ( ADULT) 5

Antigens for serology (H3N2) VACCINE STRAIN A/Wisconsin/67/2005 X161B A/Hiroshima/52/2006 IVR-142 REPRESENTATIVE CURRENT STRAINS l A/Brisbane/9/2006 l A/Hiroshima/33/2005 l A/Norway/2250/2006 l A/Sendai-H/F131/2006 l A/Santiago/7981/2006 l A/Canada/1212/2006* l A/Lyon/1292/2006* *Canada/Nepal Genetic Group 6

HI ANTIBODY RESPONSES TO THE H3N2 ADULT POPULATION (CDC) TrialNAntigen % Rise Pre- vacc GMT Post- vacc GMT Pre- vacc % HI>40 Post- vacc % HI>40 Australia24A/Wisconsin/67/ A/Brisbane/9/ A/Santiago/7981/ A/Canada/1212/2006* A/Hiroshima/33/ UK24A/Wisconsin/67/ A/Brisbane/9/ A/Santiago/7981/ A/Canada/1212/2006 * A/Hiroshima/33/

HI ANTIBODY RESPONSES TO THE H3N2 ADULT POPULATION (CDC) PopulationNAntigen % Rise Pre- vacc GMT Post- vacc GMT Pre- vacc % HI>40 Post- vacc % HI>40 Japan30A/Wisconsin/67/ A/Brisbane/9/ A/Santiago/7981/ A/Canada/1212/2006 * A/Hiroshima/33/ USA24A/Wisconsin/67/ A/Brisbane/9/ A/Santiago/7981/ A/Canada/1212/2006 * A/Hiroshima/33/

A/Wisconsin/67/2005-like VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION ( ADULT) 9

Antigens for serology (B) VACCINE STRAIN B/Malaysia/2506/2004 ( B/Victora/2/87-HA lineage) REPRESENTATIVE CURRENT STRAINS l B/Bangladesh/5278/2006 l B/Texas/39/2006 l B/Chongqing-Y/131/2006 l B/Madagascar/2866/2006 l B/Michigan/2/2006* l B/Taiwan/79/2006* l B/Florida/4/2006* l B/Egypt/144/2005* * B/Yamagata/16/88-HA lineage 10

HI ANTIBODY RESPONSES TO B ADULT POPULATION (CDC) NAntigen % Rise Pre- vacc GMT Post- vacc GMT Pre- vacc % HI>40 Post- vacc % HI>40 UK24B/Malaysia/2506/ B/Ohio/1/ B/Chongqing/Yz131/ B/Texas/39/ B/Florida/4/2006* B/Michigan/2/2006* Japan30B/Malaysia/2506/ B/Ohio/1/ B/Chongqing/Yz131/ B/Texas/39/ B/Florida/4/2006* B/Michigan/2/2006* USA24B/Malaysia/2506/ B/Ohio/1/ B/Chongqing/Yz131/ B/Texas/39/ B/Florida/4/2006* B/Michigan/2/2006*

B/Malaysia/2560/2004 VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION ( ADULT) 12

Serologic conclusions Studies with sera collected after immunization with current vaccines show that: l H1 – Recent viruses not well inhibited compared to the current vaccine strain l H3 – Recent viruses not well inhibited compared to the current vaccine strain l B – Recent B/Vic lineage viruses generally well inhibited compared to the current vaccine strain 13