1 H5N1 Influenza Virus Vaccine, A/Vietnam/1203/2004 (Clade 1) VRBPAC Presentation Kenneth P. Guito, MBA Strategic Project Office.

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Presentation transcript:

1 H5N1 Influenza Virus Vaccine, A/Vietnam/1203/2004 (Clade 1) VRBPAC Presentation Kenneth P. Guito, MBA Strategic Project Office

2 H5N1 Influenza Virus Vaccine, A/Vietnam/1203/2004 (Clade 1) VRBPAC Presentation Sanofi pasteur has a long history of manufacturing inactivated influenza vaccine Only Licensed Manufacturing facility in the US World’s largest manufacturer of inactivated influenza vaccine Reliable egg-based manufacturing process Sanofi pasteur has an internal pandemic vaccine development program and has been actively engaged in collaborations as a key partner with government agencies on both continents (MoH, WHO, European Union, HHS)

3 H5N1 Influenza Virus Vaccine, A/Vietnam/1203/2004 (Clade 1) VRBPAC Presentation H5N1 Clinical lot used in DMID Clinical Trial was produced under a Health and Human Services contract manufacturer awarded in 2004 Sanofi pasteur submitted a Biologics License Application (BLA) on 13 October, 2006 Sanofi pasteur manufactured (2004/2005) vaccine stockpiles of the H5N1 Influenza Virus Vaccine, 6 Million 90mcg dose equivalents All H5N1 vaccines were produced utilizing the seasonal Influenza Virus Vaccine manufacturing process which has been licensed since 1980