FDA approves vaccines for 2009 H1N1 influenza virus

The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus.

The FDA press release says the vaccines will be distributed nationally after the initial lots become available. “Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This vaccine will help protect individuals from serious illness and death from influenza.” CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. amde the vaccines and all manufacture the H1N1 vaccines using the same processes. ”The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,” said Jesse Goodman, M.D., FDA acting chief scientist. The 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal just as the seasonal influenza vaccinesare. Anyone who has either severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.