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FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children

Published in Drug Week, November 27th, 2009

The U.S. Food and Drug Administration has approved the use of CSL Limited's 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older.

"Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of children's vaccines available is an important step in responding to the H1N1 outbreak," said Margaret A. Hamburg, M.D., commissioner of food and drugs.

The company's 2009 H1N1 vaccine is manufactured and tested using the same well-established licensing processes that have been in place for many years for the company's...

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