SILVER SPRING, Md., Nov. 12 /PRNewswire-USNewswire/ -- 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 approval was based on a study of the company's seasonal flu vaccine in children showing the vaccine's safety and efficacy in inducing antibodies to protect against influenza. These efficacy findings supported approval under FDA's accelerated approval regulation, which helps safe and effective medical products for serious or life-threatening diseases to become available sooner to the public.
As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.
The vaccines will be available in single-dose, preservative-free, pre-filled syringes and in multi-dose vials that contain thimerosal, a mercury derivative, as a preservative.
For more information, see http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm
Photo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO
PRN Photo Desk, photodesk@prnewswire.comU.S. Food and Drug Administration
