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 17 February

Vaccine Responses to Recent Influenza isolates Panels of sera obtained from influenza vaccinees were tested for their ability to inhibit heamagglutination of current influenza isolates Post-vaccination antibody titer of current virus isolates compared to vaccine strain of virus (bold) Lower titers (italic) indicate poor antibody inhibition of tested virus isolates 2

1. AUSTRALIA IAN BARR, PH.D. ADULTS A/NEW CALEDONIA/20/99 (H1N1) WHO, AUSTRALIA ELDERLY A/WELLINGTON/01/04 (H3N2) B/JIANSU/10/03 2. EUROPE JOHN WOOD, PH.D. ADULTS A/NEW CALEDONIA/20/99 (H1N1) NIBSC, ENGLAND ELDERLY A/NEW YORK/55/04 (H3N2) B/JIANGSU/10/03 3. JAPAN TAKATO ODIGARI, PH.D. ADULTS A/NEW CALEDONIA/20/99 (H1N1) NIID, JAPAN ELDERLY A/NEW YORK/55/04 (H3N2) B/SHANGHAI/361/02 4. STEFAN GRAVENSTEIN, M.D. ADULTS A/NEW CALEDONIA/20/99 (H1N1) EASTERN VIRGINIA ELDERLY A/NEW YORK/55/04 (H3N2) MEDICAL SCHOOL, PEDIATRIC B/JIANGSU/10/03 USA Serum Panels for Serologies 3

ANTIGENS FOR SEROLOGIES (H3N2) VACCINE STRAIN A/New York/55/04 X-157 REPRESENTATIVE CURRENT STRAINS A/Wisconsin/76/05 A/Hiroshima/52/05 A/Anhui/1239/05 A/Brazil/1742/05 A/North Carolina/13/05 A/Sydney/545/05 A/Lyon/21/06 A/Norway/28/06 A/Gunama/16/05 A/Nagasaki/50/05 4

HI ANTIBODY RESPONSES TO THE H3N2 COMPONENT INFLUENZA VACCINE PEDIATRIC POPULATION 5

HI ANTIBODY RESPONSES TO THE H3N2 COMPONENT INFLUENZA VACCINE ADULT POPULATION ( CBER ) 6

A/NEW YORK/55/2004 VACCINES SUMMARY TABLE (ADULT) VIRUSES WITH > 50% GMT REDUCTION 7

ANTIGENS FOR SEROLOGIES (B) VACCINE STRAIN B/JIANGSU/10/2003* REPRESENTATIVE CURRENT STRAINS B/FLORIDA/7/2004*B/KITAKYUSYU/5/2005* B/GANSU/9/2005*B/PHILIPPINES/1401/2005* B/MADAGASCAR/1509/2005*B/EGYPT/144/2005* B/MALAYSIA/2506/2004+ B/OHIO/1/2005+ B/GUANGONG/321/2005+B/ENGLAND/458/2005+ B/SINGAPORE/21/2005+ * B/YAMAGATA LINEAGE + B/VICTORIA LINEAGE 8

HI ANTIBODY RESPONSES TO THE B COMPONENT INFLUENZA VACCINE PEDIATRIC POPULATION 9

HI ANTIBODY RESPONSES TO THE B COMPONENT INFLUENZA VACCINE ADULT POPULATION (CDC) 10

B/JANGSU/10/2003-LIKE VACCINES SUMMARY TABLE VIRUSES WITH > 50% GMT REDUCTION (ADULT) 11

Influenza Vaccine Responses Summary Studies with sera collected after immunization with current vaccines show that: H1 –Representative recent viruses well inhibited (data not shown) H3 –A/WISCONSIN/67/2005 (H3N2)-like viruses less well inhibited compared to the vaccine strain B –B/YAMAGATA/16/88-lineage Representative recent viruses generally well inhibited compared to the vaccine strain –B/VICTORIA/2/87-lineage Representative B/Malaysia/2506/2004-like viruses poorly inhibited compared to the vaccine strain 12