What information did the FDA use to support the approval of the H1N1 2009 Monovalent flu vaccines?
Vaccines used in the United States must be licensed by FDA. FDA approved these vaccines as a strain change to each manufacturer’s FDA-approved seasonal influenza vaccine. Each of the manufacturers will make the Influenza A (H1N1) 2009 Monovalent vaccines using its well-established, licensed egg-based manufacturing process that is used for 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 safety and effectiveness demonstrated for seasonal influenza vaccine also support the licensure of the Influenza A (H1N1) 2009 Monovalent vaccines produced using the same process as for seasonal vaccine. Clinical studies of the Influenza A (H1N1) 2009 Monovalent vaccines are ongoing. FDA will be assessing information from these studies to determine the optimal dose of the vaccine based on immunogenicity data (the levels of antibodies produced). The Influenza A (H1N1) 2009 Monovalent vaccines will undergo the same rigorous testing and lot release procedures that are in place for seasonal influenza vaccines.
Last Reviewed: 09/17/2009
