US Pharm. 2009;34(12):10.
Silver Spring, MD — The FDA approved the use of the CSL Limited’s 2009 H1N1 influenza vaccine to include children ages 6 months and older. Previously, this vaccine was 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, MD, FDA commissioner. The expanded approval also covers the company’s seasonal flu vaccine. Because CSL’s seasonal and H1N1 monovalent vaccines contain a small amount of egg protein, they should not be administered to anyone allergic to eggs or egg products. The vaccines will be available in single-dose, preservative-free, prefilled syringes and in multidose vials that contain thimerosal, a mercury derivative, as a preservative.