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FDA Approves Vaccines for 2009 H1N1 Influenza Virus (Oct. 9, 2009)

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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, which is expected within the next four weeks. The bulk of vaccines will arrive after Oct. 15.

The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes. The 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative that some people believe is linked to autistism in children, and in formulations that do not contain thimerosal.   

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. People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and, in children 2 to 6 years old, fever.

 




     

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