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FDA approves H1N1 vaccines from four companies


ROCKVILLE, Md. The Food and Drug Administration has approved four vaccines for influenza A(H1N1).

The agency announced Tuesday the approval of vaccines by Novartis, Sanofi-Aventis, CSL and MedImmune, all of which manufacture the vaccines using the same processes. The vaccines, which are produced in chicken eggs, are available in versions with and without the mercury-containing preservative thimerosal.

“Today’s approval is good news for our nation’s response to the 2009 H1N1 influenza virus,” FDA commissioner Margaret Hamburg said in a statement. “This vaccine will help protect individuals from serious illness and death from influenza.”

The agency said that based on preliminary data from adults participating in clinical studies, the vaccines induce “robust” immune responses in most health adults eight to 10 days after a single dose. Clinical studies are underway to determine the optimal dose in children.

The vaccines will be distributed nationally when the first lots become available, which is expected within the next four weeks.

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