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Influenza Virus Vaccine 2007-2008 Strain Selection

Influenza Virus Vaccine 2007-2008 Strain Selection. Rakesh Pandey, Ph.D. Division of Vaccines and Related Products Applications FDA/CBER/OVRR Vaccines and Related Biological Products Advisory Committee, 28 February 2007. VRBPAC Committee Recommendation.

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Influenza Virus Vaccine 2007-2008 Strain Selection

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  1. Influenza Virus Vaccine2007-2008 Strain Selection Rakesh Pandey, Ph.D. Division of Vaccines and Related Products Applications FDA/CBER/OVRR Vaccines and Related Biological Products Advisory Committee, 28 February 2007

  2. VRBPAC Committee Recommendation • Selection of strains for influenza A(H1N1 and H3N2) and B viruses for 2007-2008 influenza vaccines for use in the United States

  3. Why Strains Need to be Changedin Influenza Vaccines? Vaccine efficacy relates to: • Vaccine potency (immunogenicity) • Match of vaccine HA/NA with wild-type viruses • Antigenic drift of HA/NA continuous in influenza A and B viruses • First evidence of reduced vaccine effectiveness because of antigenic drift 2 years after first vaccines licensed for use in United States

  4. Questions to be Answered forStrain Changes Every Year • Are new (drifted or shifted) influenza viruses present? • Are these new viruses spreading in people? • Do current vaccines induce antibodies against the new viruses (HA)? • Are strains suitable for vaccines available?

  5. Strains Selected for 2006-2007 • A/New Caledonia/20/99(H1N1)-like • A/New Caledonia/20/99 –IVR116 • A/Wisconsin/67/2005(H3N2)-like (changed from 2005-2006 season) • A/Wisconsin/67/2005 • A/Hiroshima/52/2005 • B/Malaysia/2506/2004-like (changed from 2005-2006 season, B/Victoria/2/87 lineage) • B/Malaysia/2506/2004 • B/Ohio/1/2005

  6. Current Licensed InfluenzaVaccines (U.S.) • Inactivated influenza vaccines • Fluzone (Sanofi Pasteur) • Fluvirin (Novartis) • Fluarix (GSK) • FluLaval (ID Biomedical) • Live attenuated vaccine • FluMist (MedImmune)

  7. Timelines for Vaccine Production

  8. Time to First Trivalent Vaccine Lot after Strain Change

  9. WHO Consultation on the Composition of Vaccines for the Northern Hemisphere, 2007-2008 • February 11-14, 2007 • Antigenic and genetic characterization of influenza viruses investigated in the WHO Collaborating Centers for Reference and Research on Influenza • Serological studies with inactivated influenza vaccine • Recommendations for vaccine composition for 2007-2008 Northern Hemisphere • www.who.int/csr/disease/influenza/recommendations2007north/en/index.html

  10. WHO Recommendations for Influenza Vaccine CompositionNorthern Hemisphere: 2007-2008 • “ It is recommended that vaccines to be used in the 2007-8 (northern hemisphere winter) contain the following: • an A/Solomon Islands/3/2006(H1N1)-like virus • an A/Wisconsin/67/2005(H3N2)-like virus • a B/Malaysia/2506/2004-like virus ”

  11. Agenda for the Committee • Review surveillance data (epidemiology and antigenic characteristics), serological responses to vaccine, and availability of candidate strains and reagents • Discuss which strains should be recommended for the antigenic composition of the 2007-2008 influenza virus vaccine

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