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Influenza Virus Vaccine 2011-2012 Strain Selection

Influenza Virus Vaccine 2011-2012 Strain Selection. Vaccines and Related Biological Products Advisory Committee (2/25/2011) Jerry P. Weir, Ph.D., Director Division of Viral Products/OVRR/CBER/FDA. Purpose of Today’s VRBPAC Committee Discussion.

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Influenza Virus Vaccine 2011-2012 Strain Selection

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  1. Influenza Virus Vaccine2011-2012 Strain Selection Vaccines and Related Biological Products Advisory Committee (2/25/2011) Jerry P. Weir, Ph.D., Director Division of Viral Products/OVRR/CBER/FDA

  2. Purpose of Today’s VRBPAC Committee Discussion • Review influenza surveillance and epidemiology data, antigenic characteristics of recent virus isolates, serological responses to current vaccines, and the availability of candidate vaccine strains and reagents • Make recommendations for the strains of influenza A (H1N1 and H3N2) and B viruses to be included in 2011-2012 influenza vaccines for use in the United States

  3. Considerations for Vaccine Strain Selection • Vaccine effectiveness depends on match between the hemagglutinin (HA) and neuraminidase (NA) of the vaccine and the HA/NA of circulating strains of virus • Antigenic drift of HA & NA continuous for influenza A and B • Antigenic shift to a new HA subtype much less frequent • Antibody to HA correlated with vaccine efficacy • Timelines for influenza vaccine production are relatively fixed • Strain selection in February necessary for availability of vaccine for subsequent northern hemisphere winter (influenza season) • Ample vaccine supplies and timely availability depends on several factors that are influenced by strain selection • Growth properties of strains (and available reassortants) used for vaccine production • Availability of strain specific reagents (inactivated vaccines) to ensure potency of new vaccine

  4. Types of Analyses Used forVaccine Strain Selection • Epidemiology of circulating strains (CDC) • Surveillance data from U.S. and around the world • Antigenic relationships among contemporary viruses and candidate vaccine strains (CDC/DOD/CBER) • Hemagglutination inhibition (HI) tests using post-infection ferret sera • HI tests using panels of sera from humans receiving TIV • Virus neutralization tests • Antigenic cartography • Phylogenetic analyses of HA and NA genes • Vaccine effectiveness • Manufacturing considerations (CBER/vaccine manufacturers) • Availability and characteristics of vaccine strains and high-growth reassortants • Availability of potency reagents for inactivated vaccines

  5. Review of the 2010-2011 Influenza Vaccine Strain Selection Process • VRBPAC strain selection – 2/22/2010 • Committee recommended the following strains for inclusion in U.S. 2010-2011 trivalent influenza vaccines • A/California/7/2009 (H1N1)-like virus • change from the 2009-2010 vaccine recommended A/Brisbane/59/2007 (H1N1)-like virus following emergence of novel H1N1 during 2009 • A/Perth/16/2009 (H3N2)-like virus • change from the 2009-2010 vaccine recommended A/Brisbane/10/2007 (H3N2)-like virus • B/Brisbane/60/2008-like virus (B/Victoria lineage) • no change from 2009-2010 vaccine recommendation

  6. WHO Recommendations for Influenza Vaccine CompositionNorthern Hemisphere: 2011-2012 • “It is recommended that the following viruses be used for influenza vaccines in the 2010-2011 influenza season (northern hemisphere winter): • an A/California/7/2009 (H1N1)-like virus • an A/Perth/16/2009 (H3N2)-like virus • a B/Brisbane/60/2008-like virus” • “As in previous years, national or regional control authorities approve the composition and formulation of vaccines used in each country” • VRBPAC and CBER for the U.S.

  7. Committee Discussion • Which influenza strains should be recommended for the antigenic composition of the 2011-2012 influenza virus vaccine in the U.S.? • Data to be considered includes: • the epidemiology of circulating influenza viruses • the antigenic characteristics of influenza virus strains currently circulating in human populations • the serologic responses to circulating influenza viruses of persons immunized with current influenza virus vaccines • manufacturing considerations including the availability of suitable vaccine candidate strains

  8. Options for Strain Composition for 2010-2011 Influenza Vaccines • Influenza A (H1N1) • Retain current vaccine strain A/California/7/2009 (H1N1)-like virus • Replace current vaccine strain with an alternative vaccine virus • Candidates? • Influenza A (H3N2) • Retain current vaccine strain A/Perth/16/2009 (H3N2)-like virus • Replace current vaccine strain with an alternative vaccine virus • Candidates? • Influenza B • Retain current B/Brisbane/60/2008-like virus (B/Victoria lineage) • Replace current vaccine strain with alternative vaccine strain (e.g., B/Yamagata lineage) • Candidates?

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