The U.S. Food and Drug Administration has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available sometime within the next four weeks.
"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, MD. "This vaccine will help protect individuals from serious illness and death from influenza."
The vaccines are made by CSL Limited, MedImmune, Novartis Vaccines and Diagnostics Limited and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.
"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, MD, the FDA's acting chief scientist.
The FDA reported that, based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.
The FDA is working with governmental and non-governmental organizations to enhance the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program.
Vaccines against three seasonal virus strains are already available, but they do not protect against the 2009 H1N1 virus.