FDA approves swine flu vaccines

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WALLA WALLA -The U.S. Food and Drug Administration announced Tuesday it has approved four vaccines against the 2009 H1N1 -- swine flu -- influenza virus.


The vaccines will be distributed nationally after the initial lots become available, expected to be within the next four weeks, official said,

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

The vaccines are made by CSL Limited; MedImmune, LLC; Novartis Vaccines and Diagnostics Limited; 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 Dr. Jesse Goodman, FDA's acting chief scientist.

Based on preliminary information from adults participating in multiple clinical studies, the new 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.

Clinical studies under way will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if necessary and the findings are expected in the near future.

People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated. However, in the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.

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.


Sheila Hagar can be reached at sheilahagar@wwub.com or 526-8322. Check out her blog at blogs.ublabs.org/fromthestorageroom.

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