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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 l.jpg

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


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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


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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


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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


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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


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WHO Recommendations for Influenza Vaccine Composition ProcessNorthern 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.


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Committee Discussion Process

  • 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


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Options for Strain Composition for Process 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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