1 / 6

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.

ull
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related