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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

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

purpose of today s vrbpac committee discussion
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
considerations for vaccine strain selection
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
types of analyses used for vaccine strain selection
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
review of the 2010 2011 influenza vaccine strain selection process
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
who recommendations for influenza vaccine composition northern hemisphere 2011 2012
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.
committee discussion
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
options for strain composition for 2010 2011 influenza vaccines
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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