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.
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Questions and Answers[ARCHIVED] Influenza A (H1N1) 2009 Monovalent Vaccines Questions and Answers[ARCHIVED] Use of Influenza A (H1N1) 2009 Monovalent Influenza Vaccine in Pregnant Women[ARCHIVED] Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release H1N1 Flu vaccine availability and formulation. Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients[ARCHIVED] Influenza A (H1N1) 2009 Monovalent Vaccine Safety Monitoring[ARCHIVED] Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application(PDF - 49KB) This guidance finalizes that draft guidance.Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus,” dated November 2009. Vaccines Approved for H1N1 Influenza Virus[ARCHIVED]
FDA Consumer Update
FDA Expands Use of CSL Limited’s Seasonal and H1N1 Vaccines to Infants and Children[ARCHIVED] Fraudulent H1N1 Products Widget Influenza Virus Vaccine Actions 2009 H1N1 (Swine) Flu Virus (Biologics) H1N1 specific information for vaccines, blood and other areas of concern FDA 2009 H1N1 (Swine) Flu Page FDA is working to address human infection with the 2009 H1N1 flu virus as part of a team led by the Department of Health and Human Services. Commissioners Letter to Health Care Professionals