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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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: 4/1/2010.

Manufacturer Total Number of Lots Released by FDA
CSL Limited 47
ID Biomedical 11
MedImmune LLC 96
Novartis Vaccines and Diagnostics Limited 88
Sanofi Pasteur, Inc. 227
 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002