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INFORMATION FOR THE VRBPAC, CEBR, FDA May 16, 2007

INFORMATION FOR THE VRBPAC, CEBR, FDA May 16, 2007. Alexander Klimov, PhD., ScD Deputy Director. WHO Collaborating Center for Surveillance, Epidemiology and Control of Influenza. Influenza Division National Center for Immunization and Respiratory Diseases

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INFORMATION FOR THE VRBPAC, CEBR, FDA May 16, 2007

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  1. INFORMATION FOR THE VRBPAC, CEBR, FDAMay 16, 2007 Alexander Klimov, PhD., ScD Deputy 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

  2. Evolutionary Relationships Among Influenza H3N2 HA (HA1), 2007 A/Memphis/07/2007 ◄ Feb LR LR- low reactor to A/Wisconsin/67/2005* * Some viruses may be low avid Vaccine Strain # Egg isolate Reference Antigens in Boldface ◄ Adamantane Resistant A/Texas/04/2007 ◄ Jan A/Georgia/02/2007 ◄ Jan LR A/Texas/03/2007 Jan LR nor A/Norway/365/2007 Feb A/Missouri/01/2007 ◄ Jan LR nor A/Norway/136/2007 Jan A/Canada/366/2007 ◄ Jan LR A/Colorado/03/2007 ◄ Jan A/Lyon/1331/2006 ◄ Dec LR REFAG A/Lyon Chu/01 412/2007 ◄ Jan LR A/North Carolina/01/2007 ◄ Jan LR A/New Mexico/03/2007 Jan nor A/Norway/415/2007 Feb A/Missouri/02/2007 ◄ Feb LR A/Missouri/03/2007 ◄ Feb LR A/Canada/111/2007 ◄ Jan LR Brisbane-like A/North Carolina/02/2007 ◄ Jan LR A/Colorado/04/2007 ◄ Jan LR A/Korea/7236/2007 ◄ Jan LR A/Indiana/01/2007 ◄ Jan I192V A/Indiana/02/2007 ◄ Feb A/New Jersey/03/2007 ◄ LR A/Hawaii/08/2006 ◄ Dec LR REFAG A/Idaho/01/2007 ◄ Jan LR A/Idaho/02/2007 ◄ Jan LR A/Idaho/03/2007 ◄ LR K140I A/New York/02/2007 ◄ Jan LR A/Washington/01/2007 ◄ Jan LR A/New Mexico/01/2007 Jan LR nor A/Norway/405/2007 Feb K173E A/New Mexico/02/2007 Jan A/Wisconsin/03/2007 A/Wisconsin/03/2007 # A/Brazil/1898/2006 ◄ Jun # G50E A/Santiago/7981/2006 ◄ Jun # nimr A/Brisbane9/2006 Jun A/Wyoming/02/2006 ◄ Feb # A/Honduras/93/2005 ◄ REFAG LR 122D, 138S, 156Q, 186V, 223I nimr A/Belgium/G0080/2007 Jan A/Kentucky/03/2006 ◄ # REFAG LR A/Florida/02/2007 ◄ Jan LR A/Florida/2e/2006 ◄ Jan # A/Wisconsin/67/2005 X161B ◄ A/Peru/5102/2006 ◄ Jul # A/Peru/5107/2006 ◄ Jul # aus A/Thailand/29/2007 A/Korea/122/2007 Jan LR A/Korea/7123/2007 Jan LR niid A/Shizuoka/18/2007 aus A/Victoria/500/2007 A/Texas/01/2007 Jan A/New Jersey/02/2007 Jan LR A/Lyon/27/2007 sen Jan LR N6I R142G L157S K173E A/Canada/267/2007 Jan LR A/Indiana/03/2007 Jan LR A/Nepal/1445/2006 Jul LR A/Nepal/921/2006 Jul # A/Lyon/22/2007 sen Jan A/Canada/125/2007 Jan A/Canada/315/2007 Jan A/Canada/85/2007 Jan LR Nepal-like T128A Loss of Gly motif at 126 A/Canada/264/2007 Jan A/New Jersey/05/2007 Feb LR A/New York/03/2007 Feb LR A/Canada/1212/2006 Dec LR A/Wisconsin/02/2007 Jan LR R142G N144D Loss of Gly motif at 144 A/Korea/7210/2007 ◄ Jan bafb A/Korea/210/2007 niid A/Osaka/1/2007 niid A/Kochi/1/2007 niid A/Yamaguchi/1/2007 bafb A/Washington/7361/2007 niid A/Ishikawa/1/2007 S124R Loss of Gly motif at 124 A/Japan/7288/2007 ◄ Jan LR A/Japan/7217/2007 ◄ Jan niid A/Sendai/12/2007 A/Florida/01/2007 ◄ Jan LR niid A/Mie/1/2007 A/Canada/305/2007 ◄ Jan LR bafb A/California/7383/2007 A/Hong Kong/2831/2005 ◄ REFAG niid A/Hiroshima/33/2006 Jan # A/Ukraine/13/2006 REFAG LR A/California/07/2004 A/Bangladesh/1817/2005 May # A/New York/55e/2004 A/Fujian/411/2002 0.002

  3. Genetic Analysis of 2006-07 H3N2 Influenza Viruses • Two major genetic groups in the HA • A/Brisbane/9/2006: • ~52% of the recent isolates • 67% - reduced titers against ferret antiserum* raised to A/Wisconsin/67/2005 in HI test • * Some may be low avid viruses • Egg isolate A/Wisconsin/03/2007 – reassortant in progress • A/Nepal/921/2006: • ~46% of recent isolates. • 66% - reduced titers against ferret antiserum* raised to A/Wisconsin/67/2005 in HI • * Some may be low avid viruses • The only egg isolate – A/Nepal/921/2006 • X165 reassortant from this virus has been created

  4. Influenza A(H3N2) Isolates Characterized by CDC Preliminary data 05/16/2007 * Some may be low-avid viruses.

  5. HI REACTIONS OF INFLUENZA H3 VIRUSES

  6. HI REACTIONS OF INFLUENZA H3 VIRUSES

  7. HI and MN Antibody Response of 2006-07 Vaccine Recipients to H3N2 viruses

  8. MN Antibody Response of 2006-07 Vaccine Recipients to H3N2 viruses

  9. Conclusions • Two major genetic groups in the H3 HA: A/Nepal/921/2006 and A/Brisbane/9/2006 • HI tests using ferret antisera to the A/Nepal/921/06 reassortant virus indicates that this virus is not a superior vaccine candidate when compared with the A/Wisconsin vaccine strain • Although post infection ferret antisera to Nepal/921 and Canada/1212 cover recent H3N2 viruses somewhat better than antiserum to A/Wisconsin/67/2005-wt virus, there is not a reciprocal two way difference in antibody titers when these three viruses are compared • Microneutralization tests conducted with postinfection ferret serum (data not shown) also indicated that only a one way difference and not a two way reciprocal difference could be detected between Wisconsin-like and Nepal-like viruses.

  10. Conclusions (cont.) • A microneutralization (MN) titers with human post • vaccination sera are higher than HI titers (as expected) • 6. There is not consistent reductions in • the serum antibodies from US adults when comparing the • homologous titer using the Wisconsin strain with that • obtained with Nepal-like viruses tested • We do see reductions, however, in the serum antibody titers • in elderly and children when comparing the Nepal-like viruses • with the homologous Wisconsin vaccine strain • Over all conclusion: we cannot detect a reciprocal two way • difference in HAI or microneutralization titers for the Nepal- • like viruses and the ferret antiserum to the reassortant made • using the Nepal/921 virus is not superior in covering recent • strains. Therefore, these results are consistent with the • February decisions to recommend the A/Wisconsin/67/2005 • viruses be in the influenza vaccine for 2007-08 influenza • season

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