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Vaccines and Related Biological Products Avisory Committee
Sanofi Pasteur, Inc.
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.
Sanofi Pasteur Briefing Document (pdf)
Portions of this document have been determined to be exempt
from disclosure under the Freedom of Information Act (the
FOIA) (5 U.S.C. §552). These redacted portions will appear
as white space on the screen or on the printed page.
Topic 1: Safety and Immunogenicity of H5N1 Influenza Virus Vaccine, A/Vietnam/1203/2004 (clade 1), 90µg/mL, Manufactured by Sanofi Pasteur (htm)
Errata: Topic 1: Safety & Immunogenicity of H5N1 Influenza Virus Vaccine, A/Vietnam/1203/2004 (clade 1), 90µg/mL, Manufactured by Sanofi Pasteur – Page 16 (htm)
Topic 1: Pharmacovigilance plan for an H5N1 Inactivated Influenza Vaccine Manufactured by Sanofi Pasteur (htm)
Topic 2: Clinical Development of Influenza Vaccines for Pre-pandemic Uses (htm)
Bibliography 1 (htm)
Bibliography 2 (htm)