Food and Drug Administration

Vaccines and Related Biological Products Advisory Committee

February 20-21, 2008

FDA

Topic I: FDA Brief Introduction/FDA Presentation/Questions, Steven Rosenthal, M.D., FDA (ppt) (html)

Topic II:  FDA Introduction, Jerry Weir, Ph.D., FDA (.ppt) (html)

Vaccine Responses, Zhiping Ye, M.D., Ph.D., FDA (ppt) (html)

Availability of Strains and Reagents, Rajesh Gupta, Ph.D., FDA (2008-4348S2-6.ppt) (2008-4348S2-6.html)

Topic III: Summary of FDA/NIH/WHO December 2007 Workshop: Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development, Hana Golding, Ph.D., FDA (ppt) (html)

Pandemic and Pre-pandemic Influenza Vaccine Development Issues, Joseph Toerner, M.D., M.P.H., FDA (ppt) (html)

Sponsor

Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Topic I:  Sponsor Presentation, Clare Kahn, Ph.D., Leonard Friedland, M.D., Thomas Verstraeten, M.D., GlaxoSmithKline Biologicals (.ppt) (html)

Topic II: U.S. Surveillance, Joseph Bresee, M.D., CDC (ppt) (html)

World Surveillance/Strain Characterization, Nancy Cox, Ph.D., CDC (pdf)

Vaccine Effectiveness Report, Major Thomas Gibbons, Ph.D., Chris Myers, Ph.D., Angela Owens, M.P.H., DOD (ppt) (html)

Comments from Manufacturers, Tony Colegate, Novartis Vaccines and Diagnostics (ppt) (html)

Topic III: Update on H5N1 Surveillance, Nancy Cox, Ph.D., CDC (pdf)

Open Public Hearing

1.  Open Public Hearing Comment, Manon Cox, Protein Sciences Corporation (ppt) (html)

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