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Rakesh Pandey, Ph.D. Division of Vaccines and Related Products Applications/OVRR/CBER/FDA

Vaccines and Related Biological Products Advisory Committee 18 February 2009 Topic 2: Considerations and Implications for adding two B Strains to the Seasonal Influenza Vaccine. Rakesh Pandey, Ph.D. Division of Vaccines and Related Products Applications/OVRR/CBER/FDA. INTRODUCTION.

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Rakesh Pandey, Ph.D. Division of Vaccines and Related Products Applications/OVRR/CBER/FDA

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  1. Vaccines and Related Biological Products Advisory Committee 18 February 2009 Topic 2: Considerations and Implications for adding two B Strains to the Seasonal Influenza Vaccine Rakesh Pandey, Ph.D. Division of Vaccines and Related Products Applications/OVRR/CBER/FDA

  2. INTRODUCTION • 2007 VRBPAC discussed the challenges with regard to thetwo co-circulating antigenically distinct lineages of influenza B viruses, B/Yamagata and B/Victoria • Is there a public health need for inclusion of a second influenza B strain in the seasonal vaccine ? • What is the public health impact of mismatches of the B strain in the vaccine ? • What is the regulatory pathway for developing and licensing a quadrivalent influenza vaccine ? • Manufacturing capacity • Clinical requirements for safety and efficacy

  3. Background • Influenza B viruses do not have subtypes • Current trivalent seasonal influenza vaccines contain a single B component • There is limited information on the effectiveness of the B component in the vaccine • Relatively small number of studies have evaluated efficacy in general • In these studies, the limited B circulation did not allow a reliable calculation of effectiveness specific for the circulating strains

  4. Background (cont’d) • Antigenic composition of influenza vaccines may change yearly • Influenza vaccine is the only vaccine for which annual recommendations are made for composition of the vaccine • All manufacturers generate vaccine with the same influenza strain composition • It is the only vaccine for which reagents for standardization are prepared and distributed yearly to manufacturers

  5. Influenza B Strains Recommended for Inclusion in Recent Year’s Vaccines • 2000-2001 B/Beijing/184/93-like virus (Yamagata) • 2001-2002 B/Sichuan/379/99-like virus (Yamagata) • 2002-2003 B/Hong Kong/330/01-like virus (Victoria) • 2003-2004 B/Hong Kong/330/01-like virus (Victoria) • 2004-2005 B/Shanghai/361/2002-like virus (Yamagata) • 2005-2006 B/Shanghai/361/2002-like virus (Yamagata) • 2006-2007 B/Malaysia/2506/2004-like virus (Victoria) • 2007-2008 B/Malaysia/2506/2004-like virus (Victoria) • 2008-2009 B/Florida/4/2006-like virus (Yamagata) • 2009-2010 ?????

  6. Currently Licensed Influenza Vaccines • Fluzone (Sanofi Pasteur) • Fluvirin (Novartis) • Fluarix (GSK) • FluLaval (ID Biomedical) • Afluria (CSL) • FluMist (MedImmune)

  7. Manufacturing Capacity of Licensed Influenza Vaccines • Has substantially increased over the last 4-5 years • More than 130 million doses of vaccine produced this season (2008/2009) • May increase further with use of novel influenza vaccine platforms such as non-egg based manufacturing processes • May enable manufacturers to more easily adjust to manufacturing issues (e.g., poor growth of one strain) related to formulating with additional strains

  8. Issues to Consider • What clinical data are needed to establish safety and immunogenicity of vaccines with an additional B strain? • What is the global impact of the U.S. recommending a quadrivalent influenza vaccine containing two B strains? • Are there subpopulations, e.g., pediatric and elderly, that would benefit from an influenza vaccine containing two B strains?

  9. Issues to Consider (cont’d) • What would be the mechanism for recommending a second B strain? • What would be the basis of such recommendation? • What are the implications for vaccine manufacturers and for VRBPAC if WHO does not recommend a second B strain? • What are the implications if the data does not suggest a second B strain in any particular year? • Would better coverage of influenza B strains compensate for potential loss or delay in vaccine availability due to adding a second B strain • What are the implications of influenza B growth rates and lack of hgr, production constraints of 4 monovalents, reagent availability, etc.?

  10. Focus of Discussionfor the Committee • Based on the data presented by the CDC in their model please discuss whether two type B strains should be recommended for the antigenic composition of the seasonal influenza vaccines • Please discuss the public health 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

  11. BACK-UP SLIDE

  12. Alternative Vaccine Formulations for Influenza B Viruses • Quadrivalent vaccine: 2 B strains + 2 A strains (4 x 15 mcg/HA = 60 mcg HA/dose) • Quadrivalent vaccine: 2 B strains (2 x 7.5 mcg/HA) + 2 A strains (2 x 15 mcg/HA) = 45 mcg HA/dose • Monovalent influenza B vaccine (15 mcg HA/dose) administered with seasonal trivalent vaccine

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