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

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.

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"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 seasonal flu vaccine. The expanded approval also covers the
company's seasonal flu vaccine.

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.

Common adverse events experienced by children after administration of seasonal
and H1N1 vaccines typically include pain, redness and swelling at the
injection site as well as, in some cases, irritability, loss of appetite and
drowsiness.

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.

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, pre-filled
syringes and in multi-dose vials that contain thimerosal, a mercury
derivative, as a preservative.

Both vaccines are manufactured by CSL Ltd. of Australia.

For more information, see
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm

Media Inquiries: Pat El-Hinnawy, (301) 796-4763,
patricia.el-hinnawy@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Pat El-Hinnawy of the U.S. Food and Drug Administration, +1-301-796-4763,
patricia.el-hinnawy@fda.hhs.gov