On Sept. 15, 2009, the U.S. Food and Drug Administration (FDA) approved four Influenza A (H1N1) 2009 Monovalent Vaccines for the active immunization of individuals against influenza disease caused by pandemic (H1N1) 2009 virus.

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.

The four vaccines were made by CSL Limited, MedImmune, Novartis Vaccines, and Sanofi Pasteur. The FDA approval was based on data from multiple clinical trials examining the vaccines’ protective effects against influenza A (H1N1) in adults.