FDA Approves Four Vaccines for H1N1 Influenza

Clinical studies have shown robust immune response in adults within 10 days
By Andrea Mongler
HealthDay Reporter

TUESDAY, Sept. 15 (HealthDay News) -- The U.S. Food and Drug Administration has approved four H1N1 influenza vaccines, according to a Sept. 15 news release issued by the agency.

The news release states that the initial lots of the vaccines are expected to be available within the next four weeks, and they will be distributed nationally after that time. Based on preliminary data from clinical studies, the four vaccines induce a robust immune response in healthy adults eight to 10 days after a single dose is given. The optimal dose in children has not yet been determined by clinical studies.

The vaccines are manufactured by CSL Limited, MedImmune L.L.C., Novartis Vaccines and Diagnostics Ltd., and Sanofi Pasteur Inc. Side effects are expected to be similar to those of seasonal flu vaccines. In clinical trials, the H1N1 vaccines have been well-tolerated. People who have severe allergies to chicken eggs -- or to any other substance in the vaccine -- should not be vaccinated, according to the release.

"Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus. This vaccine will help protect individuals from serious illness and death from influenza," FDA's Commissioner of Food and Drugs, Margaret A. Hamburg, M.D., said in a statement.

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