1. Influenza Vaccine Responses Zhiping Ye, M.D., Ph.D. Division of Viral Products Prepared for Vaccines and Related Biological Products Advisory Committee 17 February 2006 1

2. 2005-2006 Vaccine Responses to Recent Influenza isolates Panels of sera obtained from 2005-2006 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

3. 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

4. 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

5. HI ANTIBODY RESPONSES TO THE H3N2 COMPONENT 2005-2006 INFLUENZA VACCINE PEDIATRIC POPULATION 5

6. HI ANTIBODY RESPONSES TO THE H3N2 COMPONENT 2005-2006 INFLUENZA VACCINE ADULT POPULATION ( CBER ) 6

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

8. 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

9. HI ANTIBODY RESPONSES TO THE B COMPONENT 2005-2006 INFLUENZA VACCINE PEDIATRIC POPULATION 9

10. HI ANTIBODY RESPONSES TO THE B COMPONENT 2005-2006 INFLUENZA VACCINE ADULT POPULATION (CDC) 10

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

12. 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