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Sanofi Pasteur Statement

Feb 27, 2007

February 27, 2007 – Today, the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration (FDA) voted to recommend licensure of a 90 mcg H5N1 vaccine. Sanofi pasteur submitted a Biologics Licensing Application to the FDA for this first-generation candidate H5N1 vaccine in collaboration with the U.S. Department of Health and Human Services as a first step toward efforts that will enable the government to stockpile vaccine for use during the early stages of a pandemic.

 

With this vaccine, sanofi pasteur has partnered with the U.S. government to pioneer a path for the development of pandemic vaccines and has successfully achieved scale up of an H5N1 vaccine using existing production technologies.

 

Sanofi pasteur is committed to continuing its robust research and development program for pandemic preparedness. The company is exploring dose sparing strategies; evaluating the use of a new proprietary, non-alum adjuvant; the use of cell culture production processes; and assessing the ability of vaccine formulations to generate immune responses against other strains of the H5N1 virus. Sanofi pasteur is also expanding its manufacturing capacity by building new production facilities in the U.S. and France that will more than double capacity to produce vaccine for both seasonal influenza and in the case of a pandemic.

 

Sanofi pasteur works in partnership with world health bodies, national governments and numerous non-governmental organizations in support of pandemic preparedness.