H1N1 vaccines approved by the FDA

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By Sheilah Downey

Four vaccines to fight the H1N1 virus have been approved and are expected to be distributed nationally "in a few weeks," stated the Food and Drug Administration today.

Preliminary clinical trials on adults indicate the vaccines induce a "robust immune response in most healthy adults eight to 10 days after a single dose," according to the FDA statement.

"The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal vaccines," said Jesse Goodman, FDA chief scientist.

Optimal doses for children are still being studied in clinical trials, said the agency, and recommendations for dosage are expected in the near future.

The H1N1 vaccines are produced in formulations that contain thimerosal, a mercury-containing preservative, and also in formulas that do not contain the mercury.

Side-effects of the vaccine as seen in clinical trials include soreness at the injection site, mild fever, body aches and fatigue for a few days, according to the FDA. For the nasal spray, side effects include runny nose or nasal congestion, sore throats and, in children ages two to six, fever.

The FDA recommended that people with severe or life-threatening allergies to chicken eggs, or any other substance in the vaccine, not be vaccinated.

The vaccines are manufactured by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited and sanofi pasteur Inc.

 

 

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