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Vaccines and Related Biological Products Advisory committee – February 28, 2007

Topic 4: Influenza B Strain – Discussion of Circulating Lineages Introduction. Vaccines and Related Biological Products Advisory committee – February 28, 2007. Jerry P. Weir, Ph.D. Director Division of Viral Products/OVRR/CBER/FDA.

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Vaccines and Related Biological Products Advisory committee – February 28, 2007

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  1. Topic 4: Influenza B Strain – Discussion of Circulating Lineages Introduction Vaccines and Related Biological Products Advisory committee –February 28, 2007 Jerry P. Weir, Ph.D.Director Division of Viral Products/OVRR/CBER/FDA

  2. Influenza B Strain – Discussion of Circulating LineagesIntroduction • Influenza B viruses are not divided into subtypes and current vaccines contain a single B component • Two distinct antigenic and genetic lineages of influenza B co-circulate • B/Yamagata lineage - B/Yamagata/16/88 reference strain • B/Victoria lineage - B/Victoria/2/87 reference strain • Influenza viruses from each lineage periodically become dominant • Previous VRBPAC discussions have asked whether consideration should be given to alternative vaccination strategies in order to address this issue

  3. Influenza B Strains Recommended for Inclusion in Recent Year’s Vaccines • 2006-2007 B/Malaysia/2506/2004-like virus (B/Victoria lineage) • 2005-2006 B/Shanghai/361/2002-like (B/Yamagata lineage) • 2004-2005 B/Shanghai/361/2002-like (B/Yamagata lineage) • 2003-2004 B/Hong Kong/330/01-like (B/Victoria lineage) • 2002-2003 B/Hong Kong/330/01-like (B/Victoria lineage) • 2001-2002 B/Sichuan/379/99-like virus (B/Yamagata lineage) • 2000-2001 B/Beijing/184/93-like virus (B/Yamagata lineage)

  4. Influenza B Strain Discussion -VRBPAC Agenda • Introduction – Jerry Weir, CBER • Background – Robert Couch, Baylor College of Medicine • Regulatory Implications for Alternative Vaccination Strategies – Sara Gagneten, CBER • Manufacturers Comments – Tony Colegate, Novartis • Discussion and Comments from the Committee and Other Interested Stakeholders

  5. Influenza B Strain Discussion -Goals • Review the available data regarding the Yamagata and Victoria lineages of influenza B • Genetic and antigenic relatedness • Epidemiology • Cross-protective responses to vaccines derived from each strain • Morbidity and mortality associated with influenza B • Assess various options to provide vaccine coverage for strains of both lineages • Examine regulatory and manufacturing considerations for such options

  6. Influenza B Strains -Focus of Discussion • Please discuss the medical significance and concerns presented by the 2 circulating lineages of influenza B and whether such concerns can be addressed by means of an alternative vaccination strategy • Please discuss the feasibility of the various options for expanded vaccine coverage of the 2 lineages of influenza B • Quadrivalent vaccines • Supplemental vaccines • Other options • Please discuss possible future steps for manufacturers and public health agencies • In the context of the global nature of influenza vaccine recommendations and production

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