Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

The four manufacturers will make the Influenza A (H1N1) 2009 Monovalent vaccines using the established manufacturing processes for their seasonal influenza vaccines.  FDA approved these vaccines as a strain change to each manufacturer’s seasonal influenza vaccine.  There is considerable experience with seasonal influenza vaccine development and production and influenza vaccines produced by this technology have a long and successful track record of safety and effectiveness in the United States.  The Influenza A (H1N1) 2009 Monovalent vaccines will undergo the usual testing and lot release procedures that are in place for seasonal influenza vaccines.

Lot release information will be updated weekly.  Last update: 11/18/2009.

Manufacturer	Total Number of Lots Released by FDA
CSL Limited	11
MedImmune LLC	41
Novartis Vaccines and Diagnostics Limited	37
Sanofi Pasteur, Inc.	51