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

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: 2/2/2010.

abrir aquí:
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm181956.htm